European Union Aviation Safety Agency

Notice of Proposed Amendment 2019-05 (B)

Embodiment of safety management system (SMS) requirements into
Part-145 and Part 21
RMT.0251 PHASE II
EXECUTIVE SUMMARY
With reference to Rulemaking Task (RMT).0251 Phase II in EPAS 2019-2023, this Notice of Proposed
Amendment (NPA) proposes amendments to Annex I (Part 21) to Regulation (EU) No 748/2012 and Annex II
(Part-145) to Regulation (EU) No 1321/2014, in order to:
— introduce safety management principles that implement ICAO Annex 19; and
— foster an organisational culture for effective safety management and effective occurrence reporting in
accordance with Commission Regulation (EU) No 376/2014.
Note 1: Phase I of RMT.0251 was limited to the introduction of safety management requirements into Part-
CAMO (see Opinion No 06/2016).
Note 2: The review of the occurrence reporting system was governed by RMT.0681, but certain additional
changes are proposed through this RMT, in light of the principles of ICAO Annex 19, Chapter 5.
This NPA proposes to consider the applicability of safety management systems (SMSs) to Part-145 approved
maintenance organisations, as well as to production and design organisations that are approved in accordance
with Subparts G and J of Part 21.
By doing so, safety will be enhanced through:
— the establishment of safety policies and objectives that are associated with sufficient resources;
— the systematic identification of hazards, and a risk management system;
— the safety assurance system, including giving consideration to safety performance; and
— safety promotion.
This RMT also aims to streamline the procedures for oversight, and introduce a set of new, common
management system requirements for competent authorities to increase their efficiency.
NPA 2019-05 is divided into three parts. The present NPA 2019-05 (B) includes the draft implementing rules
(IRs) as well the draft Acceptable Means of Compliance (AMC) and Guidance Material (GM) for Part 21.
NPA 2019-05 (A) includes:
— the procedural information pertaining to the regulatory proposal;
— the explanatory note to the proposed amendments;
— the regulatory impact assessment; and
— a detailed summary of the proposed amendments (see Chapter 7 ‘Appendices’).
The draft IRs as well as the draft AMC and GM for Part-145 are proposed in NPA 2019-05 (C).
Action area: Systemic enablers to safety — safety management
Affected rules: Part-145 and Part 21
Affected stakeholders: AMOs (Part-145); POA holders; DOA holders; ETSOA holders; competent authorities
Driver: Safety Rulemaking group: No (but Focused Consultation Group)
Impact assessment: Full Rulemaking Procedure: Standard

12.7.2017 17.4.2019 2020/Q1 2020/Q3 2020/Q3

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Table of contents

Draft cover regulation (EU) xxx/xxx amending Regulation (EU)

No 748/2012 (Draft EASA opinion) ................................ 11
Article 1 ........................................................................................................................... 12
Article 2 ........................................................................................................................... 12

Draft Annex (Draft EASA opinion) ................................................. 13

21.1 General Competent authority ........................................................................ 13
SECTION A TECHNICAL REQUIREMENTS ............................................................................. 14
SUBPART A — GENERAL PROVISIONS ............................................................................. 14
21.A.1 Scope........................................................................................................... 14
21.A.3A Failures, malfunctions and defects Occurrence reporting ....................... 14
21.A.5 Record-keeping ........................................................................................... 16
21.A.9 Investigations .............................................................................................. 17
SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES ...................... 18
21.A.44 Obligations of the holder .......................................................................... 18
21.A.55 Record-keeping ......................................................................................... 18
SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES 19
21.A.105 Record-keeping ....................................................................................... 19
21.A.109 Obligations and EPA marking.................................................................. 19
SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES ........................................................ 20
21.A.118A Obligations and EPA marking ............................................................... 20
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 21
21.A.124A Alternative means of compliance ......................................................... 21
21.A.125B Findings ................................................................................................. 21
21.A.125C Duration and continued validity ........................................................... 22
21.A.126 Production inspection system ................................................................ 22
21.A.129 Obligations of the manufacturer ............................................................ 24
SUBPART G — PRODUCTION ORGANISATION APPROVAL.............................................. 25
21.A.134A Alternative means of compliance ......................................................... 25
21.A.139 Quality Production management Ssystem ............................................. 25
21.A.143 Exposition................................................................................................ 28
21.A.145 Approval requirements Resources ......................................................... 29
21.A.147 Changes to the approved production management system organisation
................................................................................................................................ 31
21.A.157 Investigations .......................................................................................... 31
21.A.158 Findings ................................................................................................... 31
21.A.159 Duration and continued validity ............................................................. 32
21.A.165 Obligations of the holder ........................................................................ 32
SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF
AIRWORTHINESS .............................................................................................................. 35
21.A.180 Inspections .............................................................................................. 35

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21.A.181 Duration and continued validity ............................................................. 35

SUBPART I — NOISE CERTIFICATES .................................................................................. 36
21.A.210 Inspections .............................................................................................. 36
21.A.211 Duration and continued validity ............................................................. 36
SUBPART J — DESIGN ORGANISATION APPROVAL ......................................................... 37
21.A.239 Design assurance management system.................................................. 37
21.A.243 Data Handbook ....................................................................................... 39
21.A.245 Resources Approval requirements ......................................................... 40
21.A.247 Changes in to the design management assurance system ..................... 41
21.A.257 Investigations .......................................................................................... 41
21.A.258 Findings ................................................................................................... 41
21.A.259 Duration and continued validity ............................................................. 42
21.A.263 Privileges ................................................................................................. 43
21.A.265 Obligations of the holder ........................................................................ 44
SUBPART M — REPAIRS .................................................................................................... 46
21.A.447 Record-keeping ....................................................................................... 46
21.A.451 Obligations and EPA marking.................................................................. 46
SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS .............. 47
21.A.604 ETSO Aauthorisation for an Aauxiliary Ppower Uunit (APU) .................. 47
21.A.609 Obligations of holders of ETSO authorisations ....................................... 47
21.A.613 Record-keeping ....................................................................................... 47
21.A.615 Inspection by the Agency ........................................................................ 48
21.A.619 Duration and continued validity ............................................................. 48
SUBPART P — PERMIT TO FLY .......................................................................................... 49
21.A.705 Competent authority .............................................................................. 49
21.A.721 Inspections .............................................................................................. 49
21.A.723 Duration and continued validity ............................................................. 49
21.A.729 Record-keeping ....................................................................................... 49
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES .................................................. 51
SUBPART A — GENERAL PROVISIONS .............................................................................. 51
21.B.5 Scope ........................................................................................................... 51
21.B.10 Oversight documentation ......................................................................... 51
21.B.15 Information to EASA ................................................................................. 51
21.B.20 Obligations of the competent authority ................................................... 51
21.B.20 Immediate reaction to a safety problem .................................................. 51
21.B.25 Requirements for the organisation of the competent authority.............. 52
21.B.25 Management system ................................................................................ 52
21.B.30 Documented procedures .......................................................................... 54
21.B.30 Allocation of tasks to qualified entities .................................................... 54
21.B.35 Changes in the management system organisation and procedures ........ 54
21.B.40 Resolution of disputes .............................................................................. 55
21.B.45 Reporting/coordination ............................................................................ 55
21.B.55 Record-keeping ......................................................................................... 55
21.B.65 Suspension, limitation and revocation ..................................................... 57
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ........ 58
21.B.115 Alternative means of compliance ........................................................... 58
21.B.120 Investigation............................................................................................ 58
21.B.120 Initial certification procedure ................................................................. 59

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21.B.125 Findings and corrective actions .............................................................. 60

21.B.130 Issue of letter of agreement ................................................................... 61
21.B.145 Limitation, suspension and revocation of a letter of agreement ........... 62
21.B.150 Record-keeping ....................................................................................... 62
SUBPART G — PRODUCTION ORGANISATION APPROVAL ............................................... 63
21.B.215 Alternative means of compliance ........................................................... 63
21.B.220 Investigation............................................................................................ 63
21.B.220 Initial certification procedure ................................................................. 64
21.B.221 Oversight principles ................................................................................ 65
21.B.222 Oversight programme ............................................................................. 66
21.B.225 Findings and corrective actions .............................................................. 67
21.B.230 Issue of certificate ................................................................................... 69
21.B.235 Continued surveillance ........................................................................... 69
21.B.240 Amendment of a production organisation approval .............................. 69
21.B.240 Changes to a production organisation approval..................................... 70
21.B.245 Suspension and revocation of a production organisation approval ....... 70
21.B.260 Record-keeping ....................................................................................... 71
SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED CERTIFICATES OF
AIRWORTHINESS .............................................................................................................. 72
21.B.330 Suspension and revocation of certificates of airworthiness and restricted
certificates of airworthiness .................................................................................. 72
21.B.345 Record-keeping ....................................................................................... 72
SUBPART I — NOISE CERTIFICATES .................................................................................. 73
21.B.430 Suspension and revocation of a noise certificate ................................... 73
21.B.445 Record-keeping ....................................................................................... 73
SUBPART J — DESIGN ORGANISATION APPROVAL .......................................................... 74
21.B.430 Initial certification procedure ................................................................. 74
21.B.431 Oversight principles ................................................................................ 74
21.B.432 Oversight programme ............................................................................. 75
21.B.433 Findings and corrective actions .............................................................. 76
21.B.435 Changes to a design organisation approval ............................................ 78
SUBPART P — PERMIT TO FLY .......................................................................................... 79
21.B.530 Revocation of permits to fly.................................................................... 79
21.B.545 Record-keeping ....................................................................................... 79
APPENDICES TO ANNEX I .................................................................................................. 80
EASA FORMS ..................................................................................................................... 80
Appendix VIII — Aircraft statement of conformity — EASA Form 52 .................... 81
Appendix X — Production organisation approval certificate — EASA Form 55 .... 85
Appendix XI — Letter of agreement for production without production
organisation approval — EASA Form 65 ................................................................ 87

Draft AMC & GM to Annex I (Part 21) to Regulation (EU)

No 748/2012 (Draft EASA Decision) ............................... 88
GM1 Annex I Definitions ........................................................................................ 88
GM2 Annex I Acronyms.......................................................................................... 90
GM1 21.1 Competent authority ............................................................................. 91
GM1 21.1(c) Competent authority......................................................................... 92

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SECTION A TECHNICAL REQUIREMENTS ............................................................................. 93

SUBPART A — GENERAL PROVISIONS .............................................................................. 93
AMC1 No 1 to 21.A.3A(a)(1) Occurrence reporting Collection, investigation and
analysis of data related to Flammability Reduction Means (FRM) Reliability ....... 93
AMC2 No 2 to 21.A.3A(a)(1) Occurrence reporting Collection, investigation and
analysis of data related to ETOPS significant occurrences .................................... 93
GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting The system for collection,
investigation and analysis of data .......................................................................... 94
GM2 21.A.3A(b)(a) and (b) Occurrence reporting ................................................. 94
GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting ............................................. 94
GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting ..................................... 98
AMC1 21.A.3A(b)(2)(d) Occurrence reporting Reporting to the Agency ............... 98
AMC1 21.A.5 Record-keeping ................................................................................ 99
GM1 21.A.5 Record-keeping .................................................................................. 99
AMC1 21.A.5(a) and 21.A.433(a) Record-keeping ............................................... 100
GM1 21.A.5(a) and (b) Record-keeping ............................................................... 101
AMC1 21.A.5(e) Record-keeping .......................................................................... 102
GM1 21.A.9 Investigations ................................................................................... 103
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 105
AMC1 No1 to 21.A.122 Eligibility — Link between design and production ......... 105
AMC1 21.A.124 Application ................................................................................. 106
GM 21.A.124(a) Application – Application form .................................................. 107
AMC1 21.A.124A Alternative means of compliance ............................................ 108
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data
.............................................................................................................................. 108
GM No 2 to 21.A.158(a) Examples of level one findings...................................... 108
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 108
GM 21.A.126(b)(6) Production inspection system – Recording and record keeping
.............................................................................................................................. 109
SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR PRODUCTS, PARTS AND
APPLIANCES .................................................................................................................... 110
GM 21.A.134 Application – Application form and manner.................................. 110
AMC1 21.A.134 Application ................................................................................. 110
AMC1 21.A.134A Alternative means of compliance ............................................ 111
GM1 21.A.139(c) Production management system ............................................. 112
AMC1 21.A.139(c) Production management system ........................................... 113
AMC1 21.A.139(c)(1) Production management system ...................................... 115
GM1 21.A.139(c)(1) Production management system ........................................ 116
AMC1 21.A.139(c)(2) Production management system ...................................... 116
GM1 21.A.139(c)(2) Production management system ........................................ 116
AMC1 21.A.139(c)(3) Production management system ...................................... 117
AMC1 21.A.139(c)(3) and (4) Production management system .......................... 117
GM1 21.A.139(c)(4)(ii) Production management system .................................... 120
AMC1 21.A.139(c)(4)(ii) Production management system .................................. 121
AMC1 21.A.139(c)(5) Production management system ..................................... 121
GM1 21.A.139(c)(5) Production management system ........................................ 121
AMC1 21.A.139(c)(5)(i) Production management system ................................... 122
GM1 21.A.139(c)(5)(i) Production management system ..................................... 122
AMC1GM No1 to 21.A.139(d)(a) Production management system Quality system
.............................................................................................................................. 123

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AMC1 GM 21.A.139(d)(2)(b)(1) Production management system Quality System –

Elements of the quality system ............................................................................ 124
GM1 No 2 to 21.A.139(d)(1)(a) Production management system Quality System –
Conformity of supplied parts or appliances ......................................................... 124
AMC No 1 to 21.A.139(d)(2)(ii)(b)(1)(ii) Production management system Vendor
and sub-contractor assessment, audit and control – Production Organisation
Approval (POA) holder using documented arrangements with other parties for
assessment and surveillance of a supplier. .......................................................... 126
AMC No 2 to 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system Vendor
and sub-contractor assessment, audit and control - Production Organisation
Approval (POA) holder using other party supplier certification .......................... 128
GM1 21.A.139(d)(2)(ii) Production management system.................................... 130
AMC1 21.A.139(e) Production management system .......................................... 130
AMC1 21.A.139(f) Production management system ........................................... 131
GM No 1 to 21.A.139(b)(2) Quality System – Independent quality assurance
function ................................................................................................................ 132
GM1 No 2 to 21.A.139(f)(b)(2) Production management system Quality System –
Adequacy of procedures and monitoring function .............................................. 132
GM1 21.A.143 Exposition – Production Organisation Exposition (POE) .............. 132
AMC1 21.A.143(a)(1) Exposition .......................................................................... 133
AMC1 21.A.145(a) Resources ............................................................................... 134
GM1 21.A.145(a) Resources Approval Requirements ......................................... 134
GM1 21.A.145(b)(2) Resources Approval Requirements – Airworthiness, noise,
fuel venting and exhaust emissions /production data procedures ..................... 134
AMC1 21.A.145(c)(1) Resources .......................................................................... 135
GM1 21.A.145(c)(1) Resources Approval Requirements – Accountable manager
.............................................................................................................................. 135
AMC1 GM 21.A.145(c)(2) Resources Approval Requirements – Responsible
managers .............................................................................................................. 136
AMC2 21.A.145(c)(2) Resources .......................................................................... 138
AMC1 21.A.145(d)(1) Resources Approval Requirements – Certifying staff ....... 139
AMC 21.A.145(d)(2) Approval requirements – Record of certifying staff ........... 140
AMC1 21.A.145(d)(2)(3) Resources Approval requirements – Evidence of
authorisation ........................................................................................................ 141
AMC1 21.A.147 Changes to the production management system ...................... 141
GM1 21.A.147(a) Changes to the approved production management system
organisation — Significant changes ..................................................................... 143
GM1 21.A.149 Transferability .............................................................................. 144
AMC1 21.A.153 Changes to the terms of approval — Application for a change to
the terms of approval........................................................................................... 144
GM 21.A.157 Investigations – Arrangements ...................................................... 144
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data
.............................................................................................................................. 145
GM No 2 to 21.A.158(a) Examples of level one findings...................................... 145
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 146
GM 21.A.165(d) and (h) Obligations of the holder – Recording and archiving
system .................................................................................................................. 146
SUBPART J — DESIGN ORGANISATION APPROVAL ........................................................ 148
GM1 21.A.239(c) Design management system .................................................... 148
AMC1 21.A.239(c) Design management system .................................................. 149
AMC1 21.A.239(c)(1) Design management system ............................................. 151

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GM1 21.A.239(c)(1) Design management system ............................................... 152

AMC1 21.A.239(c)(2) Design management system ............................................. 152
GM1 21.A.239(c)(2) Design management system ............................................... 153
AMC1 21.A.239(c)(3) and (4) Design management system ................................. 154
AMC1 21.A.239(c)(3) Design management system - ........................................... 155
AMC1 21.A.239(c)(4)(ii) Design management system ......................................... 156
GM1 21.A.239(c)(4)(ii) Design management system ........................................... 157
AMC1 21.A.239(c)(5) Design management system ............................................. 157
GM1 21.A.239(c)(5) Design management system ............................................... 158
AMC1 21.A.239(c)(5)(i) Design management system .......................................... 158
GM1 21.A.239(c)(5)(i) Design management system ............................................ 159
GM No 1 to 21.A.239(d)(a) Design assurance management system ................... 159
AMC1 21.A.239(d) Design management system ................................................. 165
AMC2 GM No 2 to 21.A.239(d)(a) Design management system Design assurance
system for minor changes to type design or minor repairs to products ............. 171
AMC 21.A.239(a)(3) Design assurance system – Independent system monitoring
.............................................................................................................................. 171
AMC1 21.A.239(d)(2)(b) Design management assurance system - Independent
checking function of the demonstration of compliance ...................................... 171
GM1 21.A.239(d)(3)(c) Design management system Design assurance system.. 172
AMC1 21.A.239(e) Design management system ................................................. 172
AMC1 21.A.239(f) Design management system .................................................. 173
AMC1 No 1 to 21.A.243(a) Data requirements Handbook .................................. 173
AMC2 No 2 to 21.A.243(a) Data requirements – Model content of handbook for
organisations designing minor changes to type design or minor repairs to
products Handbook.............................................................................................. 176
AMC1 21.A.243(d) Handbook .............................................................................. 177
GM1 No 1 to 21.A.243(d) Handbook Statement of qualifications and experience
.............................................................................................................................. 178
GM No AMC2 to 21.A.243(d) Handbook Data requirements – – Statement of the
qualification and experience – Organisations designing minor changes to type
design or minor repairs to products .................................................................... 181
AMC GM No 1 to 21.A.245 Requirements for approval Resources ..................... 182
AMC GM No 2 to 21.A.245 Resources Requirements for approval – Organisations
designing minor changes to type design or minor repairs to products ............... 183
AMC1 21.A.245(a) Resources ............................................................................... 184
AMC1 21.A.245(b) Resources............................................................................... 185
AMC2 21.A.245(b) Resources............................................................................... 186
AMC1 21.A.247 Changes to the design management system ............................. 187
GM1 21.A.247 Changes to in the design management assurance system .......... 187
GM 21.A.257(a) Investigations ............................................................................. 189
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 189
SUBPART M — REPAIRS .................................................................................................. 190
AMC 21.A.433(a) and 21.A.447 Repair design and record keeping ..................... 190
SUBPART P — PERMIT TO FLY ........................................................................................ 191
GM 21.A.705 Competent authority ..................................................................... 191
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES ................................................ 192
SUBPART A — GENERAL PROVISIONS ............................................................................ 192
GM 21.B.20 Responsibility for implementation................................................... 192
AMC1 21.B.25 Management system.................................................................... 192

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AMC2GM 21.B.25(a) Organisation Management system .................................... 193

GM 21.B.25(b) Resources..................................................................................... 194
GM 21.B.25(c) Qualification and training ............................................................ 195
AMC1 21.B.25(a)(1) Management system ........................................................... 195
GM1 21.B.25(a)(2) Management system ............................................................. 196
AMC1 21.B.25(a)(3) Management system ........................................................... 198
AMC2 21.B.25(a)(3) Management system ........................................................... 198
AMC3 21.B.25(a)(3) Management system ........................................................... 199
AMC1 21.B.25(a)(5) Management system ........................................................... 200
GM1 21.B.25(a)(5) Management system ............................................................. 201
AMC1 21.B.25(d) Management system ............................................................... 202
AMC 21.B.30(a) Documented procedures ........................................................... 203
GM1 21.B.30 Allocation of tasks to qualified entities .......................................... 203
AMC 21.B.35(a) Changes ...................................................................................... 204
GM No 1 to 21.B.45 Co-ordination with other related activities ......................... 204
GM No 2 to 21.B.45 Co-ordination ...................................................................... 204
GM No 3 to 21.B.45 Reporting – Information relevant to registers established by
the Agency............................................................................................................ 205
AMC1 21.B.55(a) Record-keeping ........................................................................ 205
AMC1 21.B.55(a)(1) Record-keeping.................................................................... 205
GM1 21.B.55 Record-keeping .............................................................................. 206
GM1 21.B.55(e) Record-keeping .......................................................................... 207
AMC1 21.B.65 Suspension, limitation and revocation......................................... 207
AMC1 21.B.65(c) Suspension, limitation and revocation..................................... 208
GM1 21.B.65 Suspension, limitation and revocation........................................... 208
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 209
GM1 21.B.115 and 21.B.215 Alternative means of compliance .......................... 210
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance ............... 210
AMC1 21.B.120(a) Initial certification procedure ................................................ 210
AMC2 21.B.120(a) Initial certification procedure Investigation team –
Qualification criteria for the investigation team members ................................. 211
AMC3 21.B.120(a)(c)(1) Initial certification procedure........................................ 211
AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure Investigation
preparation and planning..................................................................................... 214
GM1 21.B.120(c)(5) and (6) Initial certification procedure Auditing and
investigation findings ........................................................................................... 215
AMC1 21.B.120(d) Initial certification procedure ................................................ 215
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective
actions Objective evidence .................................................................................. 215
GM1 21.B.125(b) Findings and corrective actions ............................................... 216
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions ........... 216
AMC1 21.B.125(d) Findings and corrective actions ..................................... 216
AMC 21.B.130 Issue of the letter of agreement .................................................. 216
GM 21.B.130(b) Issue of the letter of agreement ................................................ 217
AMC1 21.B.140 Amendment of a letter of agreement ........................................ 217
GM 21.B.150(d) Record keeping – Traceability of release certificates ................ 217
SUBPART G — PRODUCTION ORGANISATION APPROVAL ............................................. 218
GM1 21.B.115 and 21.B.215 Alternative means of compliance .......................... 218
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance ............... 218
AMC1 21.B.220 and 21.B.221 Initial certification procedure .............................. 218
AMC1 21.B.220 and 21.B.430 Initial certification procedure ............................. 219

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AMC1 GM No 1 to 21.B.220(c) Procedures for investigation– Investigation

preparation and planning Initial certification procedure ................................... 219
AMC2GM 21.B.220(a) Initial certification procedure Investigation team ........... 220
AMC 21.B.220(c) Procedures for investigation – Evaluation of applications ...... 221
GM1 No 2 to 21.B.220(c) Initial certification procedure Procedures for
investigation — GeneralROCEDURES FOR INVESTIGATION ................................. 222
GM2 No 3 to 21.B.220(c) Initial certification procedure - Procedures for
investigation – POA applications received from organisations with
facilities/partners/ suppliers/sub-contractors located in a third country ........... 244
GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures for
investigation — Competent authority surveillance of suppliers of a POA holder
located in other Member States .......................................................................... 246
AMC1 21.B.220(d)(1) Initial certification procedure............................................ 252
AMC1 21.B.221(a), (b) and (c) Oversight principles ............................................. 253
AMC1 21.B.222 and 21.B.432 Oversight programme .......................................... 253
GM1 21.B.222(a) Oversight programme.............................................................. 254
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 254
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 254
GM1 21.B.222(b) Oversight programme ............................................................. 255
AMC1 21.B.222(b)(1) Oversight programme ....................................................... 255
GM1 21.B.222(b)(1)(ii) Oversight programme ..................................................... 255
AMC1 21.B.222(c) Oversight programme ............................................................ 256
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme .................................. 257
AMC1 21.B.222(d) Oversight programme............................................................ 258
GM1 21.B.225(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective
actions Objective evidence .................................................................................. 258
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions ........... 258
AMC1 21.B.225(d)(a) Findings and corrective actions Notification of findings ... 258
AMC No 1 to 21.B.230 Issue of the certificate ..................................................... 259
GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. . 259
GM 21.B.235(b) Maintenance of the POA - Work allocation within the competent
authority............................................................................................................... 260
GM 21.B.235(b) and (c) Continued surveillance .................................................. 261
AMC 21.B.235(c) Continuation of POA ................................................................ 261
AMC1 No 1 to 21.B.240 Changes to a production organisation approval
Application for significant changes or variation of scope and terms of the POA 261
GM 21.B.245 Continued validity .......................................................................... 264
AMC 21.B.245 Corrective action plan .................................................................. 265
SUBPART J — DESIGN ORGANISATION APPROVAL ........................................................ 266
AMC1 21.B.220 and 21.B.430 Initial certification procedure ............................. 266
AMC1 21.B.430 and 21.B.431 Initial certification procedure .............................. 266
AMC1 21.B.430(a) Initial certification procedure ................................................ 267
AMC1 21.B.430(d)(1) Initial certification procedure............................................ 267
AMC1 21.B.431(a), (b) and (c) Oversight principles ............................................. 268
AMC1 21.B.222 and 21.B.432 Oversight programme .......................................... 268
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 268
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 269
AMC1 21.B.432(b)(1) Oversight programme ....................................................... 269
AMC1 21.B.432(c) Oversight programme ............................................................ 269
AMC2 21.B.222(c) and 21.B.432(c) Oversight programme.................................. 270
AMC1 21.B.432(d) Oversight programme ........................................................... 270

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GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and corrective actions 271
AMC1 21.B.433(d) Findings and corrective actions ............................................. 271
AMC1 21.B.435 Changes to a design organisation approval ............................... 271

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Proposed amendments to Part 21

The text of the amendment is arranged to show deleted text, new or amended text as shown below:
— deleted text is struck through;
— new or amended text is highlighted in grey;
— text proposed to be added or amended by Opinion No 07/2016, whose adoption by the
European Commission is pending, is highlighted in blue;
— an ellipsis ‘[…]’ indicates that the rest of the text is unchanged.

Important note: ‘easy-to-read document’

Under each modified requirement (i.e. implementing rules), the blue underlined AMC or GM, when
also modified, can be accessed through the associated hyperlinks [press Ctrl and click]. In order to
return to the previous view (i.e. initial text), please use [press Alt + left arrow].

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Proposed amendments to Part 21

Draft cover regulation (EU) xxx/xxx amending Regulation (EU) No 748/2012

(Draft EASA opinion)

Article 1
Annex I (Part 21) to Commission Regulation (EU) No 748/2012 is amended in accordance with the
Annex to this Regulation.

Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from [2 years after the entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,

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Draft Annex (Draft EASA opinion)

[Note: related AMC/GM:
— GM1 Annex I Definitions
— GM2 Annex I Acronyms]

21.1 General Competent authority

For the purpose of this Annex I (Part 21), the ‘competent authority’ shall be:
(a) for Section A, Subparts B, D, E, J, K, M, O, and Q, EASA;
(b) for Section A, Subparts F, G, H, and I:
(a1) for organisations having that have their principal place of business in a Member State,
the authority designated by that Member State; or the Agency EASA if so requested by
that Member State; or
(b2) for organisations having that have their principal place of business in a non-member
State third country, the Agency EASA.
(c) for Section A, Subpart P:
(1) for registered aircraft, the authority designated by the Member State of registry;
(2) for unregistered aircraft, the authority designated by the Member State which
prescribed the identification marks.

[Note: related AMC/GM:

— GM1 21.1 Competent authority
— GM1 21.1(c) Competent authority]

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SECTION A TECHNICAL REQUIREMENTS

SUBPART A — GENERAL PROVISIONS

21.A.1 Scope
This Section Subpart establishes general provisions governing the rights and obligations of the
applicant for, and holder of, any certificate issued or to be issued in accordance with this Section
Annex.

21.A.3A Failures, malfunctions and defects Occurrence reporting

(a) System for Collection, Investigation and Analysis of Data
The holder of Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons
who hold or who have applied for a type-certificate type certificate, restricted type certificate
type-certificate, supplemental type certificate type-certificate, European Technical Standard
Order (ETSO) authorisation, major repair design approval or any other relevant approval
deemed to have been issued under this Regulation Annex shall:
(1) have establish and maintain a system for collecting, investigating and analysing
mandatory and voluntary occurrence reports in order to identify any adverse trends or
to address any deficiencies, and to extract reportable occurrences. The system shall
include:
(i) reports of and information related to failures, malfunctions, defects or other
occurrences which cause or might cause adverse effects on the continuing
airworthiness of the product, part or appliance covered by the type certificate
type-certificate, restricted type certificate type-certificate, supplemental type
certificate type-certificate, ETSO authorisation, major repair design approval or
any other relevant approval deemed to have been issued under this Annex
Regulation.; and
(ii) internal errors, near misses, and hazards that do not fall under point (i).
(2) Information about this system shall be made available to all make available to known
operators of the product, part or appliance and, on request, to any person authorised
under other associated implementing Regulations, the information about the system
established in accordance with point (a)(1), and on how to provide such reports of and
information related to failures, malfunctions, defects or other occurrences.
(b3) Reporting to the Agency
The holder of a type-certificate, restricted type-certificate, supplemental
type-certificate, ETSO authorisation, major repair design approval or any other relevant
approval deemed to have been issued under this Regulation shall report to the Agency
EASA any failure, malfunction, defect or other occurrence of which it is aware related to
a product, part, or appliance covered by the type certificate type-certificate, restricted
type certificate type-certificate, supplemental type certificate type-certificate, ETSO

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authorisation, major repair design approval or any other relevant approval deemed to
have been issued under this Annex Regulation, and which has resulted in or may result
in an unsafe condition, in accordance with Commission Implementing Regulation (EU)
2015/1018.
(b) Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons who hold or
have applied for a production approval under Subpart G, or who produce a product, part or
appliance under Subpart F, shall:
(1) establish and maintain a system for collecting and assessing internal mandatory and
voluntary occurrence reports, including reports on internal errors, near misses, and
hazards, in order to identify any adverse trends or to address any deficiencies, and
extract reportable occurrences. This system shall include the evaluation of relevant
information related to occurrences, and the promulgation of the related information;
(2) report to the holder of the type certificate, restricted type certificate or design
approval, all cases in which products, parts or appliances have been released by the
production organisation and subsequently identified to have deviations from the
applicable design data, and investigate with the holder of the type certificate, restricted
type certificate or design approval to identify those deviations which could lead to an
unsafe condition, in accordance with Commission Implementing Regulation (EU)
2015/1018;
(3) report to EASA and the competent authority of the Member State the deviations which
could lead to an unsafe condition that were identified according to point (2);
(4) if the production organisation acts as a supplier to another production organisation,
also report to that other organisation all cases in which it has released products, parts
or appliances to that organisation and subsequently identified them to have possible
deviations from the applicable design data.
(2c) The These reports defined in points (a) and (b) shall appropriately safeguard the
confidentiality of the reporter and of the persons mentioned in the report and be made in a
form and manner established by the competent authority Agency, as soon as practicable and
in any case dispatched not later than 72 hours after the identification of the possible unsafe
condition, unless exceptional circumstances prevent this.
(c) Investigation of Reported Occurrences
(d1.) Without prejudice to Regulation (EU) No 376/2014, if When an occurrence reported under
point (b) point (a)(3), or under point (b)(3) points 21.A.129(f)(2) or 21.A.165(f)(2) results from
a deficiency in the design, or a manufacturing production deficiency, the holder of the type
certificate type-certificate, restricted type certificate type-certificate, supplemental type
certificate type-certificate, major repair design approval, ETSO authorisation, or any other
relevant approval deemed to have been issued under this Annex Regulation, or the production
organisation manufacturer as appropriate, shall investigate the reason for the deficiency and
report to the Agency EASA and to the competent authority of the Member State the results of
its investigation and any action it is taking or proposes to take to correct that deficiency.

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(2.e) If the Agency competent authority finds that an action is required to correct the deficiency,
the holder of the type certificate type-certificate, restricted type certificate type-certificate,
supplemental type certificate type-certificate, major repair design approval, ETSO
authorisation, or any other relevant approval deemed to have been issued under this Annex
Regulation, or the production organisation manufacturer as appropriate, shall submit the
relevant data to the Agency competent authority.

[Note: related AMC/GM:

— AMC1 21.A.3A(a)(1) Occurrence reporting
— AMC2 21.A.3A(a)(1) Occurrence reporting
— GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting
— GM2 21.A.3A(b)(a) and (b) Occurrence reporting
— GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting
— GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting
— AMC1 21.A.3A(b)(2)(d) Occurrence reporting]

21.A.5 Record-keeping
All natural or legal persons who hold or who have applied for a type certificate, restricted type
certificate, supplemental type certificate, ETSO authorisation, major repair design approval, permit
to fly, production organisation approval or letter of agreement under this Annex shall:
(a) when designing a product, part or appliance or changes or repairs to them, maintain
relevant design information/data, and retain them at the disposal of EASA in order to provide
the information necessary to ensure their continued airworthiness, the continued validity of
the operational suitability data, and continued compliance with the applicable environmental
protection requirements;
(b) when producing a product, part or appliance:
(1) maintain the relevant records produced under the production system that was used to
justify the conformity of the products, parts or appliances, and retain them in order to
provide the information necessary to ensure the continued airworthiness of the
product, part or appliance;
(2) for production organisations approved in accordance with Subpart G, record all details
of the work carried out and establish a record-keeping system that incorporates the
requirements imposed on its partners, suppliers and subcontractors, and ensures the
conservation of the data used to justify the conformity of the products, parts or
appliances. This data shall be held at the disposal of the competent authority and be
retained in order to provide the information necessary to ensure the continuing
airworthiness of the products, parts or appliances; and
(c) with regard to permits to fly:
(1) maintain documents produced to establish and justify the flight conditions, and retain
them at the disposal of EASA and the competent authority in order to provide the
information necessary to ensure the continued airworthiness of the aircraft;

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(2) when issuing a permit to fly under the privilege of approved organisations, maintain the
documents associated with it, including inspection records, documents that support the
approval of flight conditions and the permit to fly itself, retain them at the disposal of
EASA or the competent authority, and in order to provide the information necessary to
ensure the continued airworthiness of the aircraft;
(d) retain records of competence and the qualifications of personnel who are involved in design
or production, in independent monitoring of compliance and adequacy, and in safety
management if required by points 21.A.139, 21.A.145, 21.A.239 or 21.A.245; and
(e) when employing personnel who exercise the privileges of the approved organisation
according to points 21.A.163 or 21.A.263, or who carry out the independent monitoring of
compliance and adequacy according to points 21.A.139(f) and 21.A.239(f), retain the records
of their authorisation.

[Note: related AMC/GM:

— AMC1 21.A.5 Record-keeping
— GM1 21.A.5 Record-keeping
— AMC1 21.A.5(a) and 21.A.433(a) Record-keeping
— GM1 21.A.5(a) and (b) Record-keeping
— AMC1 21.A.5(e) Record-keeping]

21.A.9 Investigations
(a) All organisations who hold or who have applied for a type certificate, restricted type
certificate, supplemental type certificate, ETSO authorisation, major repair design approval,
permit to fly, design organisation approval, production organisation approval or letter of
agreement under this Annex, shall make arrangements that allow the competent authority to
make any investigations, including investigations of partners, supplier and subcontractors,
that are necessary to determine the compliance and the continued compliance of the
organisation with the applicable requirements of this Annex.
(b) Design and production organisations and applicants for, or holders of, permits to fly or ETSO
authorisations shall allow the competent authority to review any report and make any
inspection and perform or witness any test that is necessary to check the compliance of the
organisation with this Annex, and to inspect the technical data files.

[Note: related AMC/GM:

— GM1 21.A.9 Investigations]

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SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE

CERTIFICATES

21.A.44 Obligations of the holder

Each holder of a type-certificate type certificate or restricted type certificate type-certificate shall:
(a) undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.55, 21.A.5,
21.A.9, 21.A.57, 21.A.61 and 21.A.62; and, for this purpose, shall continue to meet the
qualification requirements for eligibility under point 21.A.14; and
(b) specify the marking in accordance with Subpart Q.

21.A.55 Record-keeping
All relevant design information, drawings and test reports, including inspection records for the
product tested, shall be held by the type-certificate or restricted type-certificate holder at the
disposal of the Agency and shall be retained in order to provide the information necessary to ensure
the continued airworthiness, continued validity of the operational suitability data and compliance
with applicable environmental protection requirements of the product.

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SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED

TYPE CERTIFICATES

21.A.105 Record-keeping
For each change, all relevant design information, drawings and test reports, including inspection
records for the changed product tested, shall be held by the applicant at the disposal of the Agency
and shall be retained in order to provide the information necessary to ensure the continued
airworthiness, continued validity of the operational suitability data and compliance with applicable
environmental protection requirements of the changed product.

21.A.109 Obligations and EPA marking

The holder of a minor change approval to a type certificate type-certificate shall:
(a) undertake the obligations laid down in points 21.A.4, 21.A.105, 21.A.5, 21.A.9, 21.A.107 and
21.A.108; and
(b) specify the marking, including EPA (European Part Approval) letters, in accordance with point
21.A.804(a).

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SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES

21.A.118A Obligations and EPA marking

Each holder of a supplemental type certificate type-certificate shall:
(a) undertake the obligations:
(1). laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.105, 21.A.5, 21.A.9, 21.A.119,
21.A.120A and 21.A.120B;
(2). implicit in the collaboration with the type certificate type-certificate holder under
point 21.A.115(d)(2);
and for this purpose continue to meet the criteria of point 21.A.112B;
(b) specify the marking, including EPA letters, in accordance with point 21.A.804(a).

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SUBPART F — PRODUCTION WITHOUT PRODUCTION

ORGANISATION APPROVAL

21.A.124A Alternative means of compliance

(a) Alternative means of compliance to the AMC adopted by EASA may be used by an
organisation to establish compliance with Regulation (EU) 2018/11391 and the delegated and
implementing acts adopted on the basis thereof.
(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to
implementing it, provide the competent authority with a full description of the alternative
means of compliance. The description shall include any revisions to manuals or procedures
that may be relevant, as well as an assessment that demonstrates compliance with Regulation
(EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
The organisation may implement these alternative means of compliance subject to prior
approval by the competent authority, and upon receipt of the notification.

[Note: related AMC/GM:

 AMC1 21.A.124A Alternative means of compliance]

21.A.125B Findings
(a) When objective evidence is found showing non-compliance of the holder of a letter of
agreement with the applicable requirements of this Annex I (Part 21), the finding shall be
classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable design data and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).
(ca) After receipt of notification of findings issued by the competent authority according to point
21.B.125:
(1). in case of a level 1 one or level 2 finding, the holder of the letter of agreement shall
demonstrate corrective action to the satisfaction of the competent authority that it has
taken adequate corrective action within the time period set by the competent authority
in accordance with point 21.B.125 within a period of no more than 21 working days
after written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the competent
authority shall be appropriate to the nature of the finding but in any case initially shall

1
Or EASA if EASA is the competent authority.

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not be more than three months. In certain circumstances and subject to the nature of
the finding, the competent authority may extend the three months period subject to
the provision of a satisfactory corrective action plan agreed by the competent authority;
(2). a level 3 three finding shall not require immediate action by the holder of the letter of
agreement.
(db) In case of level 1 one or level 2 two findings, the letter of agreement may be subject to a
partial or full limitation, suspension and revocation under point 21.B.65 21.B.145. The In that
case, the holder of the letter of agreement shall provide confirmation of the receipt of the
notice of limitation, suspension or revocation of the letter of agreement in a timely manner.

[Note: related AMC/GM:

 GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]

21.A.125C Duration and continued validity

(a) The letter of agreement shall be issued for a limited duration not exceeding one year. It shall
remain valid unless:
(1.) the holder of the letter of agreement fails to demonstrate compliance with the
applicable requirements of this Annex Subpart; or
(2) the competent authority is prevented by the holder or any of its partners or
subcontractors from performing the investigations in accordance with point 21.A.9;
(32.) there is evidence that the production organisation manufacturer cannot maintain
satisfactory control of the manufacture of products, parts, or appliances under the
agreement; or
(43.) the production organisation manufacturer no longer meets the requirements of point
21.A.122; or
(54.) the letter of agreement has been surrendered, revoked under point 21.B.145, 21.B.65,
surrendered or has expired.
(b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the
competent authority.

21.A.126 Production inspection system

(a) The production inspection system required under point 21.A.125A(a) shall provide a means for
determining whether:
(1). incoming materials, and bought or subcontracted parts, used in the finished product are
as specified in the applicable design data;
(2). incoming materials, and bought or subcontracted parts, are properly identified;
(3). processes, manufacturing techniques and methods of assembly affecting the quality
and safety of the finished product are accomplished in accordance with specifications
accepted by the competent authority; and

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(4). design changes, including material substitutions, have been approved under Subpart D
or E and controlled before being incorporated in the finished product.
(b) The production inspection system required by point 21.A.125A(a), shall also be such as to
ensure that:
(1). parts in process are inspected for conformity with the applicable design data at points
in production where accurate determinations can be made;
(2). materials subject to damage and deterioration are suitably stored and adequately
protected;
(3). current design drawings are readily available to manufacturing and inspection
personnel, and used when necessary;
(4). rejected materials and parts are segregated and identified in a manner that precludes
installation in the finished product; and
(5). materials and parts that are withheld because of departures from design data or
specifications, and that are to be considered for installation in the finished product, are
subjected to an approved engineering and manufacturing review procedure. Those
materials and parts determined by this procedure to be serviceable shall be properly
identified and reinspected if rework or repair is necessary. Materials and parts rejected
by this procedure shall be marked and disposed of to ensure that they are not
incorporated in the final product.;
6. records produced under the production inspection system are maintained, identified
with the completed product or part where practicable, and retained by the
manufacturer in order to provide the information necessary to ensure the continued
airworthiness of the product.

[Note: related AMC/GM:

 GM 21.A.126 Production inspection system (unchanged)

 GM 21.A.126(a)(1) Production inspection system —Conformity of supplied parts, appliances

and material (unchanged)
 GM 21.A.126(a)(2) Production inspection system — Identification of incoming materials and
parts (unchanged)
 GM No 1 to 21.A.126(a)(3) Production inspection system — List of specifications
(unchanged)

 GM No 2 to 21.A.126(a)(3) Production inspection system — Means of checking of the

production processes (unchanged)

 GM 21.A.126(a)(4) Production inspection system — Applicable design/production data

procedures (unchanged)
 GM 21.A.126(b)(1) Production inspection system — Inspection of parts in process
(unchanged)

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 GM 21.A.126(b)(2) Production inspection system — Suitable storage and protection

(unchanged)
 GM 21.A.126(b)(3) Production inspection system — Use of derived data instead of original
design data (unchanged)
 GM 21.A.126(b)(4) Production inspection system — Segregation of rejected material
(unchanged)

 GM 21.A.126(b)(5) Production inspection system — Engineering and manufacturing review

procedure (unchanged)
 GM 21.A.126(b)(6) Production inspection system — Recording and record keeping (moved to
GM1 21.A.5(a) and (b))]

21.A.129 Obligations of the manufacturer

Each organisation producing manufacturer of a product, part or appliance being manufactured
under this Subpart shall:
(a) make each product, part or appliance available for inspection by the competent authority;
(b) maintain at the place of manufacture the technical data and drawings necessary to determine
whether the product conforms to the applicable design data;
(c) maintain the production inspection system that ensures that each product conforms to the
applicable design data and is in condition for safe operation;
(d) provide assistance to the holder of the type certificate type-certificate, restricted type
certificate type-certificate or design approval in dealing with any continuing airworthiness
actions that are related to the products, parts or appliances that have been produced; and
(e) comply with Subpart A of this Annex. establish and maintain an internal occurrence reporting
system in the interest of safety, to enable the collection and assessment of occurrence reports
in order to identify adverse trends or to address deficiencies, and to extract reportable
occurrences. This system shall include evaluation of relevant information relating to
occurrences and the promulgation of related information;
(f) 1. report to the holder of the type-certificate, restricted type-certificate or design
approval, all cases where products, parts or appliances have been released by the
manufacturer and subsequently identified to have deviations from the applicable design
data, and investigate with the holder of the type-certificate, restricted type-certificate
or design approval to identify those deviations which could lead to an unsafe condition;
2. report to the Agency and the competent authority of the Member State the deviations
which could lead to an unsafe condition identified according to point (1). Such reports
shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;
3. where the manufacturer acts as supplier to another production organisation, report
also to that other organisation all cases where it has released products, parts or

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appliances to that organisation and subsequently identified them to have possible

deviations from the applicable design data.

[Note: related AMC/GM:

 GM 21.A.129(a) Availability for inspection by the competent authority (unchanged)

 AMC No 1 to 21.A.129(c) Obligations of the manufacturer — Conformity of prototype

models and test specimens (unchanged)

 AMC No 2 to 21.A.129(c) Obligations of the manufacturer —Conformity with Applicable

Design Data (unchanged)
 AMC No 3 to 21.A.129(c) Obligations of the manufacturer condition for safe operation
(unchanged)]

SUBPART G — PRODUCTION ORGANISATION APPROVAL

21.A.134A Alternative means of compliance

(a) Alternative means of compliance to the AMC adopted by EASA may be used by an
organisation to establish compliance with Regulation (EU) 2018/11391 and the delegated and
implementing acts adopted on the basis thereof.
(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to
implementing it, provide the competent authority with a full description of the alternative
means of compliance. The description shall include any revisions to manuals or procedures
that may be relevant, as well as an assessment that demonstrates compliance with Regulation
(EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
The organisation may implement these alternative means of compliance subject to prior
approval by the competent authority, and upon receipt of the notification.

[Note: related AMC/GM:

 AMC1 21.A.134A Alternative means of compliance]

21.A.139 Quality Production management Ssystem

(a) The production organisation shall establish, implement, and maintain a production
management system that includes a safety management system and a quality system with
clear lines of responsibility and accountability throughout the organisation demonstrate that it
has established and is able to maintain a quality system.
(b) The production management system shall:
(1) correspond to the size of the organisation, and to the nature and complexity of its
activities, taking into account the hazards and associated risks inherent in these
activities; and

1
Or EASA if EASA is the competent authority.

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(2) be established under the direct accountability of a single accountable manager

according to point 21.A.145(c)(1).
(c) As part of the safety management element of the production management system, the
production organisation shall:
(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;
(2) appoint key safety personnel to execute the safety policy in accordance with
point 21.A.145(c)(2);
(3) establish, implement and maintain a safety risk management process that includes:
(i) hazard identification in all domains of the organisation and its production
activities, resulting from analysis of the occurrences collected according to point
21.A.3A; and
(ii) safety risk assessment and mitigation;
(4) establish, implement and maintain a safety assurance process that includes:
(i) the measurement and monitoring of safety performance;
(ii) the management of changes in accordance with points 21.A.143(b) and 21.A.147;
and
(iii) principles for continuous improvement of the safety management system;
(5) promote safety in the organisation through:
(i) training and education; and
(ii) communication.
(d) As part of the quality management element of the production management system, the
production organisation shall:
(1) The quality system shall be documented. This quality system shall be such as to enable
the organisation to ensure that each product, part or appliance produced by the
organisation or by its partners, or supplied from or subcontracted to outside parties,
conforms to the applicable design data and is in condition for safe operation, and thus
exercise the privileges set forth as defined in point 21.A.163.
(2b) The quality system shall contain establish, implement, and maintain, as applicable,
within the scope of approval, control procedures for:
(i) document issue, approval, or change;
(ii) vendor and subcontractor assessment audit and control;
(iii) verification that incoming products, parts, materials, and equipment, including
items supplied new or used by buyers of products, are as specified in the
applicable design data;
(iv) identification and traceability;
(v) manufacturing processes;

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(vi) inspection and testing, including production flight tests;

(vii) calibration of tools, jigs, and test equipment;
(viii) non-conforming item control;
(ix) airworthiness coordination with the applicant for, or holder of, the design
approval;
(x) records the completion and retention of records;
(xi) personnel the competence and qualification qualifications of personnel;
(xii) the issue of airworthiness release documents;
(xiii) handling, storage and packing;
(xiv) internal quality audits and the resulting corrective actions;
(xv) work within the terms of approval performed at any location other than the
approved facilities;
(xvi) work carried out after the completion of production but prior to delivery, to
maintain the aircraft in a condition for safe operation;
(xvii) issue issuance of permit to fly and approval of associated flight conditions.
(3) The control procedures need to include specific provisions for any critical parts in the
control procedures for any critical parts.
(e) The production organisation shall document, in accordance with point 21.A.143, all the key
processes of the production management system, and maintain a process for:
(1) amending that documentation; and
(2) making personnel aware of their responsibilities under the production management
system.
(f) The production organisation shall include in the production management system An
independent quality assurance function to monitor monitoring of compliance with, and the
adequacy of, the production management system and its documented procedures of the
quality system. This monitoring shall include a feedback system to the person or group of
persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point
21.A.145(c)(1) to ensure, as necessary, corrective action.
(g) If the organisation holds other organisation certificates issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, the
production organisation may integrate the production management system with the
management system that is required for the issuance of the other certificate(s).

[Note: related AMC/GM:

— GM1 21.A.139(c) Production management system
— AMC1 21.A.139(c) Production management system
— AMC1 21.A.139(c)(1) Production management system
— GM1 21.A.139(c)(1) Production management system
— AMC1 21.A.139(c)(2) Production management system

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— GM1 21.A.139(c)(2) Production management system

— AMC1 21.A.139(c)(3) and (4) Production management system
— AMC1 21.A.139(c)(3) Production management system
— GM1 21.A.139(c)(4)(ii) Production management system
— AMC1 21.A.139(c)(4)(ii) Production management system
— AMC1 21.A.139(c)(5) Production management system
— GM1 21.A.139(c)(5) Production management system
— AMC1 21.A.139(c)(5)(i) Production management system
— GM1 21.A.139(c)(5)(i) Production management system
— AMC1 21.A.139(d) Production management system
— AMC1 21.A.139(d)(2) Production management system
— GM1 21.A.139(d)(1) Production management system
— AMC1 21.A.139(d)(2)(ii) Production management system
— AMC2 21.A.139(d)(2)(ii) Production management system
— GM1 21.A.139(d)(2)(ii) Production management system
— AMC1 21.A.139(e) Production management system
— AMC1 21.A.139(f) Production management system]

21.A.143 Exposition
(a) As part of the production management system, the The organisation shall establish submit to
the competent authority a production organisation exposition that provides providing directly
or by cross reference the following information:
(1). a statement signed by the accountable manager confirming that the production
organisation exposition and any associated manuals which define the approved
organisation's compliance with this Annex Subpart will be complied with at all times;
(2). the title(s) and names of managers accepted by the competent authority in accordance
with point 21.A.145(c)(2);
(3). the duties accountabilities and responsibilities of the manager(s) as required by
point 21.A.145(c)(2) including matters on which they may deal directly with the
competent authority on behalf of the organisation;
(4). an organisational chart showing the associated chains of accountability and
responsibility of the managers as required by point 21.A.145(c)(1) and (2);
(5). a list of the certifying staff as referred to in point 21.A.145(d);
(6). a general description of the man-power resources;
(7). a general description of the facilities located at each address specified in the production
organisation's certificate of approval;
(8). a general description of the production organisation's scope of work relevant to the
terms of approval;
(9). the procedure for the notification of organisational changes to the competent
authority;
(10). the amendment procedure for the production organisation exposition;
(11). a description of the quality production management system, the policy, processes and
the procedures as required by point 21.A.139(b)(1);

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(12). a list of those outside parties referred to in point 21.A.139(a). 21.A.139(d)(1); and
(13). if flight tests are to be conducted, a flight test operations manual defining the
organisation’s policies and procedures in relation to flight test. The flight test operations
manual shall include:
(i) a description of the organisation’s processes for flight test, including the flight
test organisation involvement into the permit to fly issuance process;
(ii) crewing policy, including composition, competency, currency and flight time
limitations, in accordance with Appendix XII to this Annex I (Part 21), where
applicable;
(iii) procedures for the carriage of persons other than crew members and for flight
test training, when applicable;
(iv) a policy for risk and safety management and associated methodologies;
(v) procedures to identify the instruments and equipment to be carried; and
(vi) a list of documents that need to be produced for flight test.
(b) The production organisation exposition shall be amended as necessary to remain an up-to-
date description of the organisation, and copies of any amendments shall be supplied to the
competent authority.

[Note: related AMC/GM:

— AMC to 21.A.143, 21.A.243, 21.A.14(b), 21.A.112B(b) and 21.A.432B(b) Flight Test
Operations Manual (FTOM) (unchanged);
— GM1 21.A.143 Exposition
— AMC1 21.A.143(a)(1) Exposition]

21.A.145 Approval requirements Resources

The production organisation shall demonstrate, on the basis of the information submitted in
accordance with point 21.A.143 that:
(a) with regard to general approval requirements, facilities, working conditions, equipment and
tools, processes and associated materials, number and competence of staff, and general
organisation are adequate to discharge the obligations under point 21.A.165;
(b) with regard to all necessary airworthiness and environmental, noise, fuel venting and exhaust
emissions data:
(1). the production organisation is in receipt of such data from the Agency EASA, and from
the holder of, or applicant for, the type certificate type-certificate, restricted type
certificate type-certificate or design approval, including any exemption granted against
the CO2 production cut-off requirements, to determine conformity with the applicable
design data;

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(2). the production organisation has established a procedure to ensure that airworthiness
and environmental noise, fuel venting and exhaust emissions data are correctly
incorporated in its production data;
(3). such data are kept up to date and made available to all personnel who need access to
such data to perform their duties;
(c) with regard to management and staff:
(1). a an accountable manager has been nominated by the production organisation, and is
accountable to the competent with authority to ensure that, His or her responsibility
within the organiszation, shall consist of ensuring that all production is performed to
the required standards and that the production organisation is continuously in
compliance with the requirements of the management system referred to in point
21.A.139, and the data and the procedures identified in the exposition referred to in
point 21.A.143;
(2). the accountable manager shall nominate a person or group of persons have been
nominated by the production organisation to ensure that the organisation is in
compliance with the requirements of this Annex I (Part 21), and are identified, together
with the extent of their authority. Such person(s) shall act under the direct authority of
the accountable manager referred to in point (1). The persons nominated shall be able
to show the appropriate knowledge, background and experience to discharge their
responsibilities;
(3). staff at all levels have been given appropriate authority to be able to discharge their
allocated responsibilities and that there is full and effective coordination within the
production organisation in respect of airworthiness, noise, fuel venting and exhaust
emission data matters;
(d) with regard to certifying staff, authorised by the production organisation to sign the
documents issued under point 21.A.163 under the scope or terms of approval:
(1). the knowledge, background (including other functions in the organisation), and
experience of the certifying staff are appropriate to discharge their allocated
responsibilities;
2. the production organisation maintains a record of all certifying staff which shall include
details of the scope of their authorisation;
(2). certifying staff are provided with evidence of the scope of their authorisation.

[Note: related AMC/GM:

— AMC1 21.A.145(a) Resources
— GM1 21.A.145(a) Resources
— GM1 21.A.145(b)(2) Resources
— AMC1 21.A.145(c)(1) Resources
— GM1 21.A.145(c)(1) Resources
— AMC1 21.A.145(c)(2) Resources
— AMC2 21.A.145(c)(2) Resources
— AMC1 21.A.145(d)(1) Resources
— AMC1 21.A.145(d)(2)Resources]

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21.A.147 Changes to the approved production management system

organisation
(a) After the issue of a production organisation approval, each change to the approved
production management system organisation that is significant to the showing demonstration
of conformity or to the airworthiness and environmental characteristics of noise, fuel venting
and exhaust emissions of the product, part or appliance, particularly changes to the quality
system, shall be approved by the competent authority before being implemented. Before the
implementation of the change, an An application for approval shall be submitted in writing to
the competent authority, and the organisation shall demonstrate, to the competent authority
before implementation of the change, that it will continue to comply with this Subpart Annex
after the implementation.
(b) The competent authority shall establish the conditions under which a production organisation
approved under this Subpart may operate during such changes unless the competent
authority determines that the approval should be suspended.

[Note: related AMC/GM:

— AMC1 21.A.147 Changes to the production management system
— GM1 21.A.147 Changes to the production management system]

21.A.157 Investigations
A production organisation shall make arrangements that allow the competent authority to make any
investigations, including investigations of partners and subcontractors, necessary to determine
compliance and continued compliance with the applicable requirements of this Subpart.

21.A.158 Findings
(a) When objective evidence is found showing non-compliance of the holder of a production
organisation approval with the applicable requirements of this Annex I (Part 21), the finding
shall be classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable design data and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).
(ca) After receipt of notification of findings issued by the competent authority according to point
21.B.225,
(1). in case of a level 1 or level 2 one findings, the holder of the production organisation
approval shall demonstrate corrective action to the satisfaction of the competent
authority that it has taken adequate corrective action within a the time period set by

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the competent authority in accordance with point 21.B.225 of no more than 21 working
days after written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the competent
authority shall be appropriate to the nature of the finding but in any case initially shall
not be more than three months. In certain circumstances and subject to the nature of
the finding the competent authority may extend the three months period subject to the
provision of a satisfactory corrective action plan agreed by the competent authority;
(2)3. a level 3 three finding shall not require immediate action by the holder of the
production organisation approval.
(db) In case of level 1 one or level 2 two findings, the production organisation approval may be
subject to a partial or full limitation, suspension or revocation under point 21.B.245 21.B.65. In
that case, the The holder of the production organisation approval shall provide confirmation
of receipt of the notice of limitation, suspension or revocation of the production organisation
approval in a timely manner.

[Note: related AMC/GM:

— GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]

21.A.159 Duration and continued validity

(a) A production organisation approval shall be issued for an unlimited duration. It shall remain
valid unless:
(1). the production organisation fails to demonstrate compliance with the applicable
requirements of this Subpart Annex; or
(2). the competent authority is prevented by the holder or any of its partners or
subcontractors to perform the investigations in accordance with point 21.A.9 21.A.157;
or
(3). there is evidence that the production organisation cannot maintain satisfactory control
of the manufacture of products, parts or appliances under the approval; or
(4). the production organisation no longer meets the eligibility requirements of
point 21.A.133; or
(5). the certificate has been surrendered or revoked under point 21.B.65 21.B.245 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority.

[Note: related AMC/GM:

— GM 21.A.159(a)(3) Evidence of a lack of satisfactory control (unchanged)]

21.A.165 Obligations of the holder

The holder of a production organisation approval shall:

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(a) ensure that the production organisation exposition furnished in accordance with point
21.A.143 and the documents to which it refers, are used as basic working documents within
the organisation;
(b) maintain the production organisation in conformity with the data and procedures approved
for the production organisation approval;
(c) (1). determine that each completed aircraft conforms to the type design and is in condition
for safe operation prior to submitting statements of conformity to the competent
authority; or
(2). determine that other products, parts or appliances are complete and conform to the
approved design data and are in a condition for safe operation before issuing an
EASA Form 1 to certify conformity to approved design data and condition for safe
operation;
(3). additionally, in the case of engines, determine that the completed engine is in
compliance with the applicable emissions requirements on the date of manufacture of
the engine;
(4). determine that other products, parts or appliances conform to the applicable data
before issuing an EASA Form 1 as a conformity certificate.
(d) record all details of work carried out;
(e) establish and maintain an internal occurrence reporting system in the interest of safety, to
enable the collection and assessment of occurrence reports in order to identify adverse trends
or to address deficiencies, and to extract reportable occurrences. This system shall include
evaluation of relevant information relating to occurrences and the promulgation of related
information;
(f) 1. report to the holder of the type-certificate or design approval, all cases where products,
parts or appliances have been released by the production organisation and
subsequently identified to have possible deviations from the applicable design data, and
investigate with the holder of the type-certificate or design approval in order to identify
those deviations which could lead to an unsafe condition;
2. report to the Agency and the competent authority of the Member State the deviations
which could lead to an unsafe condition identified according to point (1). Such reports
shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;
3. where the holder of the production organisation approval is acting as a supplier to
another production organisation, report also to that other organisation all cases where
it has released products, parts or appliances to that organisation and subsequently
identified them to have possible deviations from the applicable design data;
(dg) provide assistance to the holder of the type certificate type-certificate or design approval in
dealing with any continuing airworthiness actions that are related to the products parts or
appliances that have been produced;

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(h) establish an archiving system incorporating requirements imposed on its partners, suppliers
and subcontractors, ensuring conservation of the data used to justify conformity of the
products, parts or appliances. Such data shall be held at the disposal of the competent
authority and be retained in order to provide the information necessary to ensure the
continuing airworthiness of the products, parts or appliances;
(ei) where, under its terms of approval, the holder issues a certificate of release to service,
determine that each completed aircraft has been subjected to necessary maintenance and is
in condition for safe operation, prior to issuing the certificate;
(fj) where applicable, under the privilege of point 21.A.163(e), determine the conditions under
which a permit to fly can be issued;
(gk) where applicable, under the privilege of point 21.A.163(e), establish compliance with points
21.A.711(c) and (e) before issuing a permit to fly to an aircraft.;
(h) comply with Subpart A of this Annex.

[Note: related AMC/GM:

— GM 21.A.165(a) Obligations of the holder — Basic working document (unchanged);
— GM No 1 to 21.A.165(c) Obligations of the holder — Conformity of prototype models and
test specimens (unchanged);
— GM No 2 to 21.A.165(c) Obligations of holder — Conformity with type design (unchanged);
— GM No 3 to 21.A.165(c) Obligations of the holder — Condition for safe operation
(unchanged);
— GM No 4 to 21.A.165(c) Airworthiness Release or Conformity Certificate (unchanged);
— AMC 21.A.165(c)(3) Applicable emissions requirements (unchanged);
— GM 21.A.165(c)(3) Definitions of engine type certification date and production date
(unchanged);
— GM 21.A.165(d) and (h) Obligations of the holder — Recording and archiving system (moved
to — GM1 21.A.5(a) and (b))]

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SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED

CERTIFICATES OF AIRWORTHINESS

21.A.180 Inspections
The holder of the airworthiness certificate shall provide access to the aircraft for which that
airworthiness certificate has been issued upon request by the competent authority of the Member
State of registry.

21.A.181 Duration and continued validity

(a) An airworthiness certificate shall be issued for an unlimited duration. It shall remain valid
subject to:
(1). compliance with the applicable type-design and continuing airworthiness requirements;
and
(2). the aircraft remaining on the same register; and
(3). the type certificate type-certificate or restricted type certificate type-certificate under
which it is issued not being previously invalidated under point 21.A.51;
(4). the certificate not being surrendered or revoked under point 21.B.65 21.B.330 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of
the Member State of registry.

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SUBPART I — NOISE CERTIFICATES

21.A.210 Inspections
The holder of the noise certificate shall provide access to the aircraft for which that noise certificate
has been issued upon request by the competent authority of the Member State of registry or by the
Agency for inspection.

21.A.211 Duration and continued validity

(a) A noise certificate shall be issued for an unlimited duration. It shall remain valid subject to:
(1). compliance with the applicable type-design, environmental protection and continuing
airworthiness requirements; and
(2). the aircraft remaining on the same register; and
(3). the type certificate type-certificate or restricted type certificate type-certificate under
which it is issued not being previously invalidated under point 21.A.51;
(4). the certificate not being surrendered or revoked under point 21.B.430 21.B.65 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of
the Member State of registry.

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SUBPART J — DESIGN ORGANISATION APPROVAL

21.A.239 Design assurance management system

(a) The design organisation shall establish, implement, and maintain a design management
system that includes a safety management system and a design assurance system with clear
lines of responsibility and accountability throughout the organisation.
(b) The design management system shall:
(1) correspond to the size of the organisation and the nature and complexity of its
activities, taking into account the hazards and the associated risks that are inherent in
these activities; and
(2) be established under the direct accountability of a single manager according to point
21.A.245(a).
(c) As part of the safety management element of the design management system, the design
organisation shall:
(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;
(2) appoint key safety personnel to execute the safety policy in accordance with
point 21.A.245(b);
(3) establish, implement and maintain a safety risk management process that includes:
(i) hazard identification in all domains of the organisation and its design activities,
resulting from analysis of the occurrences collected according to point 21.A.3A;
and
(ii) safety risk assessment and mitigation;
(4) establish, implement and maintain a safety assurance process that includes:
(i) measurement and monitoring of safety performance;
(ii) management of changes in accordance with points 21.A.243(c) and 21.A.247; and
(iii) principles for continuous improvement of the safety management system; and
(5) promote safety in the organisation through:
(i) training and education; and
(ii) communication.
(d) As part of the design assurance element of the design management system, the design
organisation shall:
(a1) The design organisation shall demonstrate that it has established and is able to
maintain a design assurance system for establish, implement and maintain a system for
the control and supervision of the design, and of design changes, of products, parts and
appliances covered by the application. This design assurance system shall be such as to
enable the organisation to ensure that:

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(i)1. to ensure that the design of the products, parts and appliances or the design
change thereof, comply with the applicable type-certification basis, the applicable
operational suitability data certification basis and the environmental protection
requirements; and
(ii)2. to ensure that its responsibilities are properly discharge its responsibilities
discharged in accordance with the appropriate provisions of this Annex I (Part
21); and the terms of approval issued under point 21.A.251;
(2) establish, implement and maintain an independent verification function of the
demonstration of compliance on the basis of which the organisation declares
compliance with the applicable airworthiness, operational suitability and environmental
protection requirements; and
(3) specify the manner in which the design assurance system accounts for the acceptability
of the parts or appliances that are designed or the tasks that are performed by partners
or subcontractors according to methods which are the subjects of written procedures.
(e) The design organisation shall document, in accordance with point 21.A.243, all the key
processes of the design management system, and maintain a process for:
(1) amending that documentation;
(2) making personnel aware of their responsibilities under the design management system;
(f) Include in the design management system independent monitoring of to independently
monitor the compliance with, and the adequacy of, the design management system and its
documented procedures of the system. This monitoring shall include a feed-back system to
the a person or a group of persons referred to in point 21.A.245(b), and ultimately to the
manager referred to in point 21.A.245(a) to ensure, as necessary, that corrective action takes
place. having the responsibility to ensure corrective actions.
(g) If the organisation holds other organisation certificates that were issued on the basis of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof, the design organisation may integrate the design management system with the
management system that is required for the issuance of the other certificate(s).
(b) The design assurance system shall include an independent checking function of the showings
of compliance on the basis of which the organisation submits compliance statements and
associated documentation to the Agency.
(c) The design organisation shall specify the manner in which the design assurance system
accounts for the acceptability of the parts or appliances designed or the tasks performed by
partners or subcontractors according to methods which are the subject of written procedures.

[Note: related AMC/GM:

— GM1 21.A.239(c) Design management system
— AMC1 21.A.239(c) Design management system
— AMC1 21.A.239(c)(1) Design management system
— GM1 21.A.239(c)(1) Design management system
— AMC1 21.A.239(c)(2) Design management system
— GM1 21.A.239(c)(2) Design management system

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— AMC1 21.A.239(c)(3) and (4) Design management system

— AMC1 21.A.239(c)(3) Design management system
— AMC1 21.A.239(c)(4)(ii) Design management system
— GM1 21.A.239(c)(4)(ii) Design management system
— AMC1 21.A.239(c)(5) Design management system
— GM1 21.A.239(c)(5) Design management system
— AMC1 21.A.239(c)(5)(i) Design management system
— GM1 21.A.239(c)(5)(i) Design management system
— GM1 21.A.239(d) Design management system
— AMC1 21.A.239(d) Design management system
— AMC2 21.A.239(d) Design management system
— AMC1 21.A.239(d)(2) Design management system
— GM1 21.A.239(d)(3) Design management system
— AMC1 21.A.239(e) Design management system
— AMC1 21.A.239(f) Design management system]

21.A.243 Data Handbook

(a) The As part of the design management system, the design organisation shall furnish establish
a handbook to the Agency describing, directly or by cross-reference, the organisation, the
relevant procedures and the products or changes to products to be designed and, where
relevant, the interfaces with and the control of partners or subcontractors. If flight tests are to
be conducted, a flight test operations manual defining the organisation’s policies and
procedures in relation to flight test shall be furnished established. The flight test operations
manual shall include:
(1i) a description of the organisation’s processes for flight test, including the flight test
organisation involvement into the permit to fly issuance process;
(2ii) crewing policy, including composition, competency, currency and flight time limitations,
in accordance with Appendix XII to this Annex I (Part 21), where applicable;
(3iii) procedures for the carriage of persons other than crew members and for flight test
training, when applicable;
(4iv) a policy for risk and safety management and associated methodologies;
(5v) procedures to identify the instruments and equipment to be carried;
(6vi) a list of documents that need to be produced for flight test.
(b) Where any parts or appliances or any changes to the products are designed by partner
organisations or subcontractors, the handbook shall include a statement of how the design
organisation is able to give, for all parts and appliances, the assurance of compliance required
by point 21.A.239(b), and shall contain, directly or by cross-reference, descriptions and
information on the design activities and organisation of those partners or subcontractors, as
necessary to establish this statement.
(c) The handbook shall be amended as necessary to remain an up-to-date description of the
organisation, and copies of amendments shall be supplied to the Agency EASA.
(d) The design organisation shall furnish establish and maintain a statement of the qualifications
and experience of the management staff and other persons in the organisation responsible for

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making decisions affecting airworthiness, operational suitability data and environmental

protection in the organisation.

[Note: related AMC/GM:

— AMC to 21.A.143, 21.A.243, 21.A.14(b), 21.A.112B(b) and 21.A.432B(b) Flight Test
Operations Manual (FTOM) (unchanged);
— AMC1 21.A.243(a) Handbook
— AMC2 21.A.243(a) Handbook
— AMC1 21.A.243(d) Handbook
— GM1 21.A.243(d) Handbook
— AMC2 21.A.243(d) Handbook]

21.A.245 Resources Approval requirements

The design organisation shall demonstrate, on the basis of the information submitted in accordance
with point 21.A.243 that, in addition to complying with point 21.A.239:
(a) The organisation shall nominate a head of the design organisation with authority for ensuring
that within the organisation, all design activities are performed to the required standards and
that the design organisation is continuously in compliance with the requirements of the
management system referred to in point 21.A.239 and the procedures identified in the
handbook referred to in point 21.A.243.
(b) Depending on the size of the organisation and on the nature and complexity of its activities,
the head of the design organisation shall nominate and identify, together with the extent of
their authority:
(1) a chief of the office of airworthiness;
(2) a chief of the independent monitoring of compliance and adequacy function; and
(3) any other person or group of persons who are needed to ensure that the organisation is
in compliance with the requirements of this Annex.
(c) The person or group of persons identified in point (b) shall:
(1) act under the direct authority of the head of the design organisation; and
(2) be able to show the appropriate knowledge, background and experience to discharge
their responsibilities.
(d) The design organisation shall ensure that:
(a1) the staff in all technical departments are of sufficient numbers and experience and have
been given appropriate authority to be able to discharge their allocated responsibilities
and these, together with the accommodation, facilities and equipment, are adequate to
enable the staff to achieve the airworthiness, operational suitability and environmental
protection objectives for the product;
(b2) there is full and efficient coordination between departments and within departments in
respect of airworthiness, operational suitability and environmental protection matters.

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[Note: related AMC/GM:

— AMC1 21.A.245 Resources
— AMC2 21.A.245 Resources
— AMC1 21.A.245(a) Resources
— AMC1 21.A.245(b) Resources
— AMC2 21.A.245(b) Resources]

21.A.247 Changes in to the design management assurance system

After the issue of a design organisation approval, each change to the design management assurance
system that is significant to the showing demonstration of compliance or to the airworthiness,
operational suitability and environmental protection of the product, part or appliance shall be
approved by the Agency EASA. Before the implementation of the change, an An application for
approval shall be submitted in writing to the Agency EASA, and the design organisation shall
demonstrate to the Agency, on the basis of the submission of the proposed changes to the
handbook, and before implementation of the change, that it will continue to comply with this
Subpart Annex after the implementation.

[Note: related AMC/GM:

 AMC1 21.A.247 Changes to the design management system
 GM1 21.A.247 Changes to in the design management assurance system]

21.A.257 Investigations
(a) The design organisation shall make arrangements that allow the Agency to make any
investigations, including investigations of partners and subcontractors, necessary to
determine compliance and continued compliance with the applicable requirements of this
Subpart.
(b) The design organisation shall allow the Agency to review any report and make any inspection
and perform or witness any flight and ground test necessary to check the validity of the
compliance statements submitted by the applicant under point 21.A.239(b).

21.A.258 Findings
(a) When objective evidence is found showing non-compliance of the holder of a design
organisation approval with the applicable requirements of this Annex I (Part 21), the finding
shall be classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable requirements and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).

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(ac) After receipt of notification of findings issued by EASA according to point 21.B.433 under the
applicable administrative procedures established by the Agency,
(1)1. in case of a level 1 or level 2 one findings, the holder of the design organisation
approval shall demonstrate to the satisfaction of EASA that it has taken adequate
corrective action within the time period set by EASA in accordance with 21.B.433 to the
satisfaction of the Agency within a period of no more than 21 working days after
written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the Agency shall be
appropriate to the nature of the finding but in any case initially shall not be more than
three months. In certain circumstances and subject to the nature of the finding the
Agency may extend the three months period subject to the provision of a satisfactory
corrective action plan agreed by the Agency;
(2)3. a level 3 three finding shall not require immediate action by the holder of the design
organisation approval.
(bd) In case of level 1 one or level 2 two findings, the design organisation approval may be subject
to a partial or full limitation, suspension or revocation under the applicable administrative
procedures established by the Agency point 21.B.65. In that case, the The holder of the design
organisation approval shall provide confirmation of the receipt of the notice of limitation,
suspension or revocation of the design organisation approval in a timely manner.

[Note: related AMC/GM:

 GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]

21.A.259 Duration and continued validity

(a) A design organisation approval shall be issued for an unlimited duration. It shall remain valid
unless:
(1)1. the design organisation fails to demonstrate compliance with the applicable
requirements of this Subpart Annex; or
(2)2. the Agency EASA is prevented by the holder or any of its partners or subcontractors to
from performing perform the investigations in accordance with point 21.A.9 21.A.257;
or
(3)3. there is evidence that the design management assurance system cannot maintain
satisfactory control and supervision of the design of products or changes thereof under
the approval; or
(4) the design organisation no longer meets the eligibility requirements of point 21.A.233;
or
(5)4. the certificate has been surrendered or revoked under point 21.B.65 or surrendered the
applicable administrative procedures established by the Agency.
(b) Upon surrender or revocation, the certificate shall be returned to the Agency EASA.

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21.A.263 Privileges
(a) (Reserved) The holder of a design organisation approval shall be entitled to perform design
activities under this Annex I (Part 21) and within its scope of approval.
(b) (Reserved) Subject to point 21.A.257(b), the Agency shall accept without further verification
the following compliance documents submitted by the applicant for the purpose of obtaining:
1. the approval of flight conditions required for a permit to fly; or
2. a type-certificate or approval of a major change to a type-certificate; or
3. a supplemental type-certificate; or
4. an ETSO authorisation under point 21.A.602B(b)(1); or
5. a major repair design approval.
(c) The A holder of a design organisation approval shall be entitled, within the scope of its terms
of approval as established by EASA and under the relevant procedures of the design
management assurance system:
(1)1. to classify changes to the type certificate type-certificate or to a supplemental type
certificate type-certificate and repair designs as ‘major’ or ‘minor’;
(2)2. to approve minor changes to type certificate type-certificate or to a type certificate
supplemental type-certificate and minor repair designs;
(3)3. (Reserved) to issue information or instructions containing the following statement: ‘The
technical content of this document is approved under the authority of DOA ref. EASA.
21J. [XXXX].’;
(4)4. (Reserved) to approve minor revisions to the aircraft flight manual and supplements,
and issue such revisions containing the following statement: ‘Revision No [YY] to AFM
(or supplement) ref. [ZZ] is approved under the authority of DOA ref. EASA. 21J.
[XXXX].’;
(5)5. to approve the design of certain major repair designs under Subpart M to products or
Auxiliary Power Units (APUs)for which it holds the type-certificate or the supplemental
type-certificate or ETSO authorisation;
(6)6. to approve for certain aircraft, the flight conditions under which a permit to fly can be
issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for
the purpose of point 21.A.701(a)(15);
(7)7. to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has
designed or modified, or for which it has approved in accordance with under
point 21.A.263(c)(6) the flight conditions under which the permit to fly can be issued,
and when where the design organisation itself:
(i) is controlling controls under its Design Organisation Approval the configuration of
the aircraft and
(ii) is attesting attests conformity with the design conditions approved for the flight.

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(7)7. to approve certain major changes to a type certificate type-certificate under Subpart D;
and
(8)8. to issue certain supplemental type certificate type-certificates under Subpart E and
approve certain major changes to those certificates.

[Note: related AMC/GM:

— GM 21.A.263(b) DOA privilege related to compliance documents (unchanged)
— AMC 21.A.263(b)(1) Compliance documents with conditions related to engine or propeller
without a type-certificate or with unapproved changes and fitted on aircraft for which a
permit to fly is requested (unchanged)
— AMC No 1 to 21.A.263(c)(1) Procedure for the classification of changes to type certificate
(TC) and repairs as minor or major (unchanged)
— AMC No 2 to 21.A.263(c)(1) Privileges —Organisations designing minor changes to a type
certificate (TC) or minor repairs to products: classification procedure (unchanged)
— AMC No 1 to 21.A.263(c)(2) Procedure for the approval of minor changes to a type
certificate (TC) or minor repairs (unchanged)
— AMC No 2 to 21.A.263(c)(2) Privileges —Organisations designing minor changes to a type
certificate (TC) or minor repairs to products: procedure for the approval of minor changes to
a TC or minor repairs (unchanged)
— GM 21.A.263(c)(3) Issue of information or instructions (unchanged)
— GM 21.A.263(c)(4) Procedure for the approval of minor revisions to the aircraft flight
manual (unchanged)
— AMC 21.A.263(c)(6) Procedure for the approval of the conditions for issue of a permit to fly
(unchanged)
— AMC 21.A.263(c)(7) Procedure for the issue of a permit to fly (unchanged)]

21.A.265 Obligations of the holder

The holder of a design organisation approval shall within the scope of its terms of approval, as
established by the Agency EASA:
(a) maintain the handbook required under point 21.A.243 in conformity with the design
management assurance system;
(b) ensure that this handbook or the relevant procedures included by cross-reference are is used
as a basic working document within the organisation;
(c) determine that the design of products, or changes or repairs thereto thereof, as applicable,
comply with applicable specifications and requirements and have no unsafe feature features;
(d) except for minor changes or repairs approved under the privilege of point 21.A.263, provide to
the Agency EASA with statements and associated documentation confirming compliance with
point (c) except for approval processes carried out in accordance with point 21.A.263(c);

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(e) provide to the Agency EASA data and information or instructions related to required actions
under point 21.A.3B;
(f) where applicable, under the privilege of point 21.A.263(c)(6), determine in accordance with
point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;
(g) where applicable, under the privilege of point 21.A.263(c)(7), establish in accordance with
point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711(b) and (e) before
issuing a permit to fly to an aircraft.;
(h) designate data and information issued under the authority of the approved design
organisation within the scope of its terms of approval as established by the Agency EASA with
the following statement: ‘The technical content of this document is approved under the
authority of the DOA ref. EASA. 21J.[XXXX]’; and
(i) comply with Subpart A of this Annex.
[Note: related AMC/GM:
— AMC 21.A.265(a) Administration of the Handbook (unchanged)
— GM 21.A.265(b) Use of the Handbook (unchanged)]

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SUBPART M — REPAIRS

21.A.447 Record-keeping
For each repair, all relevant design information, drawings, test reports, instructions and limitations
possibly issued in accordance with point 21.A.443, justification for classification and evidence of the
design approval, shall:
(a) be held by the repair design approval holder at the disposal of the Agency; and
(b) be retained by the repair design approval holder in order to provide the information necessary
to ensure the continued airworthiness of the repaired products, parts or appliances.
[Note: related AMC/GM:
— AMC 21.A.433(a) and 21.A.447 Repair design and record-keeping (moved to AMC1 21.A.5(a)
and 21.A.433(a))]

21.A.451 Obligations and EPA marking

(a) Each holder of a major repair design approval shall:
(1). undertake the obligations:
(i) laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.9, 21.A.439, 21.A.441,
21.A.443, 21.A.447 and 21.A.449;
(ii) implicit in the collaboration with the type certificate type-certificate,
supplemental type certificate type-certificate and with the APU ETSO
authorisation holder under point 21.A.433(b), as appropriate.
(2). specify the marking, including EPA letters, in accordance with point 21.A.804(a).
(b) Except for type certificate type-certificate holders or APU authorisation holders for which
point 21.A.44 applies, the holder of a minor repair design approval shall:
(1). undertake the obligations laid down in points 21.A.4, 21.A.447 and 21.A.449; and
(2). specify the marking, including EPA letters, in accordance with point 21.A.804(a).

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SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER

AUTHORISATIONS

21.A.604 ETSO Aauthorisation for an Aauxiliary Ppower Uunit (APU)

With regard to ETSO authorisation for an APU auxiliary power unit:
(a) by way of derogation from points 21.A.603, 21.A.610 and 21.A.615 21.A.9, the following
points shall apply: points 21.A.15, 21.A.16B, 21.A.17A, 21.A.17B, 21.A.20, 21.A.21, 21.A.31,
21.A.33, 21.A.44 21.B.75 and 21.B.80. shall apply by way of derogation from points 21.A.603,
21.A.606(c), 21.A.610 and 21.A.9 21.A.615, except that However an ETSO Authorisation shall
be issued in accordance with point 21.A.606 instead of the type certificate type-certificate;
(b) by way of derogation from point 21.A.611, the requirements of Subpart D shall apply to the
approval of design changes by the APU ETSO authorisation holder and the requirements of or
Subpart E shall apply to is applicable for the approval of design changes by other applicants
way of derogation from point 21.A.611. When Subpart E is used, a separate ETSO
authorisation shall be issued instead of a supplemental type certificate type-certificate.
(c) the requirements of Subpart M shall apply is applicable to the approval of repair designs.

21.A.609 Obligations of holders of ETSO authorisations

The holder of an ETSO authorisation under this Subpart shall:
(a) manufacture each article in accordance with Subpart G or Subpart F that ensures that each
completed article conforms to its design data and is safe for installation;
(b) prepare and maintain, for each model of each article for which an ETSO authorisation has
been issued, a current file of complete technical data and records in accordance with point
21.A.5 21.A.613;
(c) prepare, maintain and update master copies of all manuals required by the applicable
airworthiness specifications for the article;
(d) make available to users of the article and to the Agency EASA on request those maintenance,
overhaul and repair manuals necessary for the usage and maintenance of the article, and
changes to those manuals;
(e) mark each article in accordance with point 21.A.807;
(f) comply with points 21.A.3A, 21.A.3B, and 21.A.4 and 21.A.9;
(g) continue to meet the qualification requirements of point 21.A.602B.

21.A.613 Record-keeping
Further to the record-keeping requirements appropriate to or associated with the quality system, all
relevant design information, drawings and test reports, including inspection records for the article
tested, shall be held at the disposal of the Agency and shall be retained in order to provide the

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information necessary to ensure the continued airworthiness of the article and of the type-
certificated product in which it is fitted.

21.A.615 Inspection by the Agency

Upon a request of the Agency, each applicant for, or holder of an ETSO authorisation for an article
shall allow the Agency to:
(a) witness any tests;
(b) inspect the technical data files on that article.

21.A.619 Duration and continued validity

(a) An ETSO authorisation shall be issued for an unlimited duration. It shall remain valid unless:
(1). the conditions required when the ETSO authorisation was granted are no longer being
observed; or
(2). the obligations of the holder specified in point 21.A.609 are no longer being discharged;
or
(3) the competent authority is prevented by the holder or any of its partners or
subcontractors from performing the investigations in accordance with point 21.A.9; or
(4)3. the article has proved to give rise to unacceptable hazards in service; or
(5)4. the authorisation has been surrendered or revoked under point 21.B.65, or surrendered
the applicable administrative procedures established by the Agency.
(b) Upon surrender or revocation, the certificate shall be returned to the Agency EASA.

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SUBPART P — PERMIT TO FLY

21.A.705 Competent authority

Notwithstanding point 21.1 of this Annex I (Part 21) for the purpose of this Subpart, the ‘competent
authority’ shall be:
(a) the authority designated by the Member State of registry; or
(b) for unregistered aircraft, the authority designated by the Member State which prescribed the
identification marks.

[Note: related AMC/GM:

 GM 21.A.705 Competent authority (moved to GM1 21.1(c))]

21.A.721 Inspections
The holder of, or the applicant for, a permit to fly shall provide access to the aircraft concerned at
the request of the competent authority.

21.A.723 Duration and continued validity

(a) A permit to fly shall be issued for a maximum of 12 months and shall remain valid subject to:
(1). compliance with the conditions and restrictions of point 21.A.711(e) associated with the
permit to fly;
(2) the competent authority is permitted by the holder or any of its partners or
subcontractors to perform the investigations in accordance with point 21.A.9;
(3)2. the permit to fly not being surrendered or revoked under point 21.B.65 or surrendered;
or
(4)3. the aircraft remaining on the same register.
(b) Notwithstanding point (a), a permit to fly issued for the purpose of point 21.A.701(a)(15) may
be issued for unlimited duration.
(c) Upon surrender or revocation, the permit to fly shall be returned to the competent authority.

21.A.729 Record-keeping
(a) All documents produced to establish and justify the flight conditions shall be held by the
holder of the approval of the flight conditions at the disposal of the Agency and competent
authority and shall be retained in order to provide the information necessary to ensure the
continued airworthiness of the aircraft.
(b) All documents associated with the issue of permits to fly under the privilege of approved
organisations, including inspection records, documents supporting the approval of flight
conditions and the permit to fly itself, shall be held by the related approved organisation at

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the disposal of the Agency or the competent authority and shall be retained in order to
provide the information necessary to ensure the continued airworthiness of the aircraft.

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SECTION B PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A — GENERAL PROVISIONS

21.B.5 Scope
(a) This Section establishes the procedure for the competent authority of the Member State
when exercising its tasks and responsibilities concerned with the issuance, maintenance,
amendment, suspension and revocation of certificates, approvals and authorisations referred
to in this Annex I (Part 21).
(b) The Agency shall develop in accordance with Article 19 of Regulation (EC) No 216/2008
certification specifications and guidance material to assist Member States in the
implementation of this Section.
This section establishes the administrative and management system requirements to be followed by
the competent authority that is in charge of the implementation and enforcement of Section A of
this Annex.

21.B.10 Oversight documentation

The competent authority shall provide all the legislative acts, standards, rules, technical publications,
and related documents to the relevant personnel in order to allow them to perform their tasks and
to discharge their responsibilities.

21.B.15 Information to EASA

(a) The competent authority of the Member State shall notify EASA without undue delay if there
are any significant problems with the implementation of Regulation (EU) 2018/1139 and the
delegated and implementing acts adopted on the basis thereof.
(b) The competent authority of the Member State shall provide EASA with any safety-significant
information stemming from the occurrence reports it has received, pursuant to 21.A.3A.

21.B.20 Obligations of the competent authority

Each competent authority of the Member State is responsible for the implementation of Section A,
Subparts F, G, H, I and P only for applicants, or holders, whose principal place of business is in its
territory.

21.B.20 Immediate reaction to a safety problem

(a) Without prejudice to Regulation (EU) No 376/2014 and its implementing acts, the competent
authority of the Member State shall implement a system to appropriately collect, analyse, and
disseminate safety information.

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(b) EASA shall implement a system to appropriately analyse any relevant safety information
received, and without undue delay, provide to Member States and the Commission any
information, including recommendations or corrective actions to be taken, that is necessary
for them to react in a timely manner to a safety problem involving products, parts, appliances,
persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority of
the Member State shall take adequate measures to address the safety problem.
(d) Measures taken under point (c) shall immediately be notified to all persons or organisations
which need to comply with them under Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof. The competent authority of the Member
State shall also notify those measures to EASA and, when combined action is required, to the
other Member States concerned.

[Note: related AMC/GM:

— GM 21.B.20 Responsibility for implementation (moved to 21.1(a)(2) and (3))]

21.B.25 Requirements for the organisation of the competent

authority
(a) General:
The Member State shall designate a competent authority with allocated responsibilities for
the implementation of Section A, Subparts F, G, H, I and P with documented procedures,
organisation structure and staff.
(b) Resources:
1. the number of staff shall be sufficient to perform the allocated tasks;
2. the competent authority of the Member State shall appoint a manager, or managers,
who are responsible for the execution of the related task(s) within the authority,
including the communication with the Agency and the other national authorities as
appropriate.
(c) Qualification and training:
All staff shall be appropriately qualified and have sufficient knowledge, experience and
training to perform their allocated task.

21.B.25 Management system

(a) The competent authority shall establish and maintain a management system, including as a
minimum:
(1) documented policies and procedures to describe its organisation, means and methods
to achieve compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof. The procedures shall be kept up to

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date, and serve as the basic working documents within that competent authority for all
related tasks;
(2) a sufficient number of personnel to perform its tasks and discharge its responsibilities. A
system shall be in place to plan the availability of personnel, in order to ensure the
proper completion of all tasks;
(3) personnel who are qualified to perform their allocated tasks and who have the
necessary knowledge, experience, initial and recurrent training to ensure continuing
competency;
(4) adequate facilities and office accommodation to perform the allocated tasks;
(5) a function to monitor the compliance of the management system with the relevant
requirements, and the adequacy of the procedures, including the establishment of an
internal audit process, and a safety risk management process. Compliance monitoring
shall include a system to feed back audit findings to the senior management of the
competent authority to ensure the implementation of corrective actions as necessary;
and
(6) a person or group of persons ultimately responsible to the senior management of the
competent authority for the compliance monitoring function.
(b) The competent authority shall, for each field of activity, including the management system,
appoint one or more persons with the overall responsibility for the management of the
relevant task(s).
(c) The competent authority shall establish procedures for participation in a mutual exchange of
all necessary information and assistance with any other competent authorities concerned,
including all findings raised and any follow-up actions taken as a result of the oversight of
persons and organisations that carry out activities in the territory of a Member State, but
certified by the competent authority of another Member State, or by EASA.
(d) A copy of the procedures related to the management system of the competent authority of
the Member State and their amendments shall be made available to EASA for the purpose of
standardisation.

[Note: related AMC/GM:

— AMC1 21.B.25 Management system
— AMC2 21.B.25 Management system
— AMC1 21.B.25(a)(1) Management system
— GM1 21.B.25(a)(2) Management system
— AMC1 21.B.25(a)(3) Management system
— AMC2 21.B.25(a)(3) Management system
— AMC3 21.B.25(a)(3) Management system
— AMC1 21.B.25(a)(5) Management system
— GM1 21.B.25(a)(5) Management system
— AMC1 21.B.25(d) Management system]

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21.B.30 Documented procedures

(a) The competent authority of the Member State shall establish documented procedures to
describe its organisation, means and methods to fulfil the requirements of this Annex I
(Part 21). The procedures shall be kept up to date and serve as the basic working documents
within that authority for all related activities.
(b) A copy of the procedures and their amendments shall be available to the Agency.

21.B.30 Allocation of tasks to qualified entities

(a) Tasks related to the initial certification, or to the continuing oversight of persons, or
organisations subject to Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, may be allocated only to qualified entities. When allocating
tasks, the competent authority shall ensure that it has:
(1) put a system in place to initially and continuously assess whether the qualified entity
complies with Annex VI ‘Essential requirements for qualified entities’ referred to in
Article 69 of Regulation (EU) 2018/1139. This system and the results of the assessments
shall be documented;
(2) established a documented agreement with the qualified entity, approved by both
parties at the appropriate management level, which clearly defines:
(i) the tasks to be performed;
(ii) the declarations, reports, and records to be provided;
(iii) the technical conditions to be met in performing such tasks;
(iv) the related liability coverage; and
(v) the protection given to information acquired in carrying out such tasks.
(b) The competent authority shall ensure that the internal audit process and safety risk
management process required by point 21.B.25(a)(5) cover all the certification and continuing
oversight tasks performed on its behalf.

[Note: related AMC/GM:

 GM1 21.B.30 Allocation of tasks to qualified entities]

21.B.35 Changes in the management system organisation and

procedures
(a) The competent authority of the Member State shall notify any significant change in its
organisation and documented procedures to the Agency.
(b) The competent authority of the Member State shall update its documented procedures
relating to any change to regulations in a timely manner to ensure effective implementation.
(a) The competent authority shall have a system in place to identify any changes that affect its
capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU)

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2018/1139 and the delegated and implementing acts adopted on the basis thereof. This
system shall enable it to take action as appropriate to ensure that its management system
remains adequate and effective.
(b) The competent authority shall update its management system to reflect any change to
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof in a timely manner, so as to ensure its effective implementation.
(c) The competent authority of the Member State shall notify EASA of any changes affecting its
capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.

21.B.40 Resolution of disputes

(a) The competent authority of the Member State shall establish a process for the resolution of
disputes within its organisation documented procedures.
(b) Where a dispute, which cannot be resolved, exists between the competent authorities of the
Member States, the competent authorities shall it is the responsibility of the managers as
defined in point 21.B.25(b)(2) to raise the issue with the Agency for mediation.
[Note: related AMC/GM:
— GM 21.B.40 Principles for the resolution of disputes (unchanged)]

21.B.45 Reporting/coordination
(a) The competent authority of the Member State shall ensure coordination as applicable with
other related certification, investigation, approval or authorisation teams of that authority,
other Member States and the Agency to ensure efficient exchange of information relevant for
safety of the products, parts and appliances.
(b) The competent authority of the Member State shall notify any difficulty in the implementation
of this Annex I (Part 21) to the Agency.
[Note: related AMC/GM:
— GM No 1 to 21.B.45 Co-ordination with other related activities (deleted);
— GM No 2 to 21.B.45 Co-ordination (deleted);
— GM No 3 to 21.B.45 Reporting – Information relevant to registers established by EASA
(deleted)]

21.B.55 Record-keeping
The competent authority of the Member State shall keep, or maintain access to, the appropriate
records related to the certificates, approvals and authorisations it has granted in accordance with
the respective national regulations, and for which responsibility is transferred to the Agency, as long
as these records have not been transferred to the Agency.

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(a) The competent authority shall establish a system of record-keeping that allows adequate
storage, accessibility, and reliable traceability of:
(1) the management system’s documented policies and procedures;
(2) the training, qualifications, and authorisation of its personnel;
(3) the allocation of tasks, covering the elements required by point 21.B.30, as well as the
details of tasks allocated;
(4) certification processes and continuing oversight of certified organisations, including:
(i) the application for a certificate, approval, authorisation and letter of agreement;
(ii) the competent authority’s continuing oversight programme, including all
assessments, audits and inspection records;
(iii) the certificates, approvals, authorisations and letters of agreement issued,
including any changes to them;
(iv) a copy of the oversight programme listing the dates when audits are due and
when audits were carried out;
(v) copies of all formal correspondence;
(vi) details of findings, corrective actions, dates of action closures, any exemptions
and enforcement actions;
(vii) any assessment, audit and inspection report issued by another competent
authority pursuant to points 21.B.120(d), 21.B.221(c) or 21.B.431(c);
(viii) copies of all organisation expositions, handbooks or manuals and amendments to
them; and
(ix) copies of any other document approved by the competent authority; and
(5) the evaluation and notification to EASA of any alternative means of compliance
proposed by organisations, and the assessment of any alternative means of compliance
used by the competent authority itself;
(6) safety information and follow-up measures in accordance with point 21.B.15; and
(7) the use of flexibility provisions in accordance with Article 71 of Regulation (EU)
2018/1139.
(b) The competent authority shall maintain a list of all certificates, approvals, authorisations and
letters of agreement that it has issued.
(c) All records referred to in points (a) and (b) shall be kept for a minimum period of 5 years,
subject to applicable data protection law.
(d) All the records referred to in points (a) and (b) shall be made available upon request to a
competent authorities of another Member State or EASA.
(e) For organisations that produce products, parts or appliances without a production
organisation approval according to Subpart F of Section A of this Annex, the competent
authority shall also maintain records of all Statements of Conformity (EASA Form 52, see

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Appendix VIII) and Authorised Release Certificates (EASA Form 1, see Appendix I) that it has
validated.

[Note: related AMC/GM:

— AMC1 21.B.55(a) Record-keeping
— AMC1 21.B.55(a)(1) Record-keeping
— GM1 21.B.55 Record-keeping
— GM1 21.B.55(e) Record-keeping]

21.B.65 Suspension, limitation and revocation

The competent authority shall:
(a) suspend a certificate, approval, permit to fly, authorisation or letter of agreement on
reasonable grounds in the case of a potential safety threat or if there is evidence that any of
the conditions specified in points 21.A.51(a), 21.A.118B(a) 21.A.181(a) or 21.A.211(a),
21.A.619(a), 21A.723(a) is not met;
(b) suspend, revoke or limit a certificate, approval, authorisation or letter of agreement pursuant
to points 21.B.125, 21.B.225 or 21.B.433; or
(c) suspend a certificate, approval, authorisation or letter of agreement if the competent
authority’s inspectors are unable over a period of 24 months to discharge their oversight
responsibilities through on-site audit(s) due to the security situation in the State where the
facilities are located.

[Note: related AMC/GM:

 AMC1 21.B.65 Suspension, limitation and revocation
 AMC1 21.B.65(c) Suspension, limitation and revocation
 GM1 21.B.65 Suspension, limitation and revocation]

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SUBPART F — PRODUCTION WITHOUT PRODUCTION

ORGANISATION APPROVAL

21.B.115 Alternative means of compliance

(a) Alternative means of compliance may be used to establish compliance with Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(b) The competent authority shall establish a system to consistently evaluate that all alternative
means of compliance used by itself or by organisations under its oversight, allow the
establishment of compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) The competent authority shall evaluate all the alternative means of compliance proposed by
an organisation in accordance with point 21.A.124A by analysing the documentation provided
and, if considered necessary, by conducting an inspection of the organisation.
When the competent authority finds that the alternative means of compliance are in
accordance with Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, it shall without undue delay:
(1) notify the applicant that the alternative means of compliance may be implemented and,
if applicable, amend the letter of agreement of the applicant accordingly;
(2) notify EASA of their content, and include copies of all the relevant documentation.
(d) If the competent authority itself uses alternative means of compliance to achieve compliance
with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the
basis thereof, it shall:
(1) make them available to all the organisations and persons under its oversight;
(2) notify EASA without undue delay; and
(3) provide EASA with a full description of the alternative means of compliance, including
any revisions to procedures that may be relevant, as well as an assessment
demonstrating that the requirements of Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on the basis thereof have been met.

[Note: related AMC/GM:

— GM1 21.B.115 and 21.B.215 Alternative means of compliance
— AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance]

21.B.120 Investigation
(a) The competent authority shall appoint an investigation team for each applicant for, or holder
of, a letter of agreement to conduct all relevant tasks related to this letter of agreement,
consisting of a team-leader to manage and lead the investigation team and, if required, one or
more team members. The team-leader shall report to the manager responsible for the
activity, as defined in point 21.B.25(b)(2).

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(b) The competent authority shall perform sufficient investigation activities for an applicant for,
or holder of, a letter of agreement to justify recommendations for the issuance, maintenance,
amendment, suspension or revocation of the letter of agreement.
(c) The competent authority shall prepare procedures for the investigation of applicants for, or
holders of, a letter of agreement as part of the documented procedures covering at least the
following elements:
1. evaluation of applications received;
2. determination of investigation team;
3. investigation preparation and planning;
4. evaluation of the documentation (manual, procedures, etc.);
5. auditing and inspection;
6. follow up of corrective actions; and
7. recommendation for issuance, amendment, suspension or revocation of the letter of
agreement.

21.B.120 Initial certification procedure

(a) Upon receiving an application for the initial issue of a letter of agreement, the competent
authority shall verify the organisation’s compliance with the applicable requirements.
(b) The competent authority shall record all findings, actions (i.e. actions required to close a
finding), and recommendations.
(c) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(d) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a letter of
agreement (EASA Form 65, see Appendix XI) without undue delay.
(e) The letter of agreement shall contain the scope of the agreement, a termination date and,
where applicable, the appropriate limitations related to the authorisation.
(f) The duration of the letter of agreement shall not exceed one year.

[Note: related AMC/GM:

— AMC1 21.B.120(a) Initial certification procedure
— AMC2 21.B.120(a) Initial certification procedure
— AMC3 21.B.120(a)Initial certification procedure
— AMC4 21.B.120(a) Initial certification procedure
— GM1 21.B.120(c) Initial certification procedure
— AMC1 21.B.120(d) Initial certification procedure]

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21.B.125 Findings and corrective actions

(a) When during audits or by other means objective evidence is found by the competent
authority, showing non-compliance of the holder of a letter of agreement with the applicable
requirements of Section A of this Annex, the competent authority shall issue a finding. The
competent authority this finding shall be classified in accordance with point 21.A.125B(a)
classify the findings as follows:
(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable design data which lowers
safety or seriously endangers flight safety.
The level 1 findings shall also include:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of a letter of agreement by falsification the
submitted documentary evidence; and
(3) any evidence of malpractice or of fraudulent use of the letter of agreement.
(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.
(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding
to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(fb) The competent authority shall take the following actions:
(1.) in the case of for level 1 findings:
(i) take immediate and appropriate action shall be taken by the competent authority
to prohibit or limit the activities of the organisation involved, and, if appropriate,
it shall take action to limit, suspend or revoke the letter of agreement or to limit
or suspend it in whole or in part, depending upon the extent of the level 1
finding, until successful corrective action has been completed by the
organisation;
(ii) grant the organisation a corrective action implementation period that is
appropriate to the nature of the finding, which shall not in any case be more than
21 working days. It shall commence from the date of the written communication

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of the finding to the organisation, requesting corrective action to address the

non-compliance identified.
(2.) in the case of for level 2 findings:
(i) , the competent authority shall grant a corrective action implementation period
that is appropriate to the nature of the finding, which in any case that shall
initially not be more than 3 months. The period shall commence from the date of
the written communication of the finding to the organisation, requesting
corrective action to address the non-compliance identified. In certain
circumstances, at At the end of this period, and subject to the nature of the
finding and the past safety performance of the organisation, the competent
authority can may extend the 3-month period provided that a satisfactory
corrective action plan provided by the organisation has been agreed by the
competent authority;.
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them.
(3) in the case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.
(c) Action shall be taken by the competent authority to suspend the letter of agreement in whole
or in part in case of failure to comply within the timescale granted by the competent
authority.

[Note: related AMC/GM:

— GM1 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective actions
— GM1 21.B.125(b) Findings and corrective actions
— GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions
— AMC1 21.B.125(d) Findings and corrective actions]

21.B.130 Issue of letter of agreement

(a) When satisfied that the manufacturer is in compliance with the applicable requirements of
Section A, Subpart F the competent authority shall issue a letter of agreement to the showing
of conformity of individual products, parts or appliances (EASA Form 65, see Appendix XI)
without undue delay.
(b) The letter of agreement shall contain the scope of the agreement, a termination date and,
where applicable, the appropriate limitations relating to the authorisation.

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(c) The duration of the letter of agreement shall not exceed one year.

[Note: related AMC/GM:

— AMC 21.B.130 Issue of the letter of agreement (moved to AMC1 21.B.120(d))
— GM 21.B.130(b) Issue of the letter of agreement (moved to AMC1 21.B.120(d))]

21.B.145 Limitation, suspension and revocation of a letter of

agreement
(a) The limitation, suspension or revocation of the letter of agreement shall be communicated in
writing to the holder of the letter of agreement. The competent authority shall state the
reasons for the limitation, suspension or revocation and inform the holder of the letter of
agreement on its right to appeal.
(b) When a letter of agreement has been suspended it shall only be reinstated after compliance
with Section A Subpart F has been re-established.

21.B.150 Record-keeping
(a) The competent authority shall establish a system of record-keeping that allows adequate
traceability of the process to issue, maintain, amend, suspend or revoke each individual letter
of agreement.
(b) The records shall at least contain:
1. the documents provided by the applicant for, or holder of, a letter of agreement;
2. documents established during investigation and inspection, in which the activities and
the final results of the elements defined in point 21.B.120 are stated;
3. the letter of agreement, including changes; and
4. minutes of the meetings with the manufacturer.
(c) The records shall be archived for a minimum retention period of six years after termination of
the letter of agreement.
(d) The competent authority shall also maintain records of all Statements of Conformity
(EASA Form 52, see Appendix VIII) and Authorised Release Certificates (EASA Form 1, see
Appendix I) that it has validated.

[Note: related AMC/GM:

— GM 21.B.150(d) Record-keeping – Traceability of release certificates (moved to GM1
21.B.55(e))]

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SUBPART G — PRODUCTION ORGANISATION APPROVAL

21.B.215 Alternative means of compliance

(a) Alternative means of compliance may be used to establish compliance with Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(b) The competent authority shall establish a system to consistently evaluate that all alternative
means of compliance used by itself or by organisations under its oversight, allow the
establishment of compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) The competent authority shall evaluate all the alternative means of compliance proposed by
an organisation in accordance with point 21.A.134A by analysing the documentation provided
and, if considered necessary, conducting an inspection of the organisation.
When the competent authority finds that the alternative means of compliance are in
accordance with Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, it shall without undue delay:
(1) notify the applicant that the alternative means of compliance may be implemented and,
if applicable, amend the approval of the applicant accordingly;
(2) notify EASA of their content, including copies of all relevant documentation.
(d) If the competent authority itself uses alternative means of compliance to achieve compliance
with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the
basis thereof, it shall:
(1) make them available to all the organisations and persons under its oversight;
(2) notify EASA without undue delay.
(3) provide EASA with a full description of the alternative means of compliance, including
any revisions to procedures that may be relevant, as well as an assessment
demonstrating that the implementing rules have been met.

[Note: related AMC/GM:

— GM1 21.B.115 and 21.B.215 Alternative means of compliance
— AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance]

21.B.220 Investigation
(a) The competent authority shall appoint a production organisation approval team for each
applicant, or holder of, a production organisation approval to conduct all relevant tasks
related to this production organisation approval, consisting of a team leader to manage and
lead the approval team and, if required, one or more team members. The team leader shall
report to the manager responsible for the activity as defined in point 21.B.25(b)(2).

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(b) The competent authority shall perform sufficient investigation activities for an applicant for,
or holder of, a production organisation approval to justify recommendations for the issuance,
maintenance, amendment, suspension or revocation of the approval.
(c) The competent authority shall prepare procedures for the investigation of a production
organisation approval as part of the documented procedures covering at least the following
elements:
1. evaluation of applications received;
2. determination of production organisation approval team;
3. investigation preparation and planning;
4. evaluation of the documentation (production organisation exposition, procedures, etc.);
5. auditing;
6. follow up of corrective actions;
7. recommendation for issuance, amendment, suspension or revocation of production
organisation approval;
8. continued surveillance.

21.B.220 Initial certification procedure

(a) Upon receiving an application for the initial issue of a production organisation approval
certificate, the competent authority shall verify the organisation’s compliance with the
applicable requirements.
(b) A meeting with the accountable manager of the organisation shall be convened at least once
during the investigation for initial certification to ensure that he or she fully understands the
significance of the certification process, and the reason for signing the statement specified in
point 21.A.143(a)(1).
(c) The competent authority shall record all findings, closure actions (i.e. actions required to close
a finding), and recommendations.
(d) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(e) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a production
organisation approval (EASA Form 55, see Appendix X) without undue delay.
(f) The certificate reference number shall be included on the EASA Form 55 in a manner specified
by EASA.
(g) The certificate shall be issued for an unlimited duration. The privileges and the scope of the
activities that the organisation is approved to conduct, including any limitations as applicable,
shall be specified in the terms of approval attached to the certificate.
[Note: related AMC/GM:

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— AMC1 21.B.220 and 21.B.221 Initial certification procedure

— AMC1 21.B.220 and 21.B.430 Initial certification procedure
— AMC1 21.B.220 Initial certification procedure
— AMC1 21.B.220 Initial certification procedure
— GM1 21.B.220 Initial certification procedure
— GM2 21.B.220 Initial certification procedure
— GM3 21.B.220 Initial certification procedure
— AMC1 21.B.220(d)(1) Initial certification procedure]

21.B.221 Oversight principles

(a) The competent authority shall verify:
(1) compliance with the requirements that are applicable to organisations prior to issuing
of an organisation certificate;
(2) continued compliance with the applicable requirements of the organisations that it has
certified; and
(3) the implementation of appropriate safety measures mandated by the competent
authority as defined in points 21.B.20(c) and (d).
(b) This verification shall:
(1) be supported by documentation specifically intended to provide personnel responsible
for safety oversight with guidance to perform their functions;
(2) provide the organisations concerned with the results of safety oversight activities;
(3) be based on assessments, audits, inspections, and, if needed, unannounced inspections;
and
(4) provide the competent authority with the evidence needed in case further action is
required, including the measures provided for in point 21.B.225.
(c) The scope of the oversight defined in points (a) and (b) shall take into account the results of
past oversight activities and the safety priorities.
(d) If the facilities of an organisation are located in more than one State, the competent authority
as defined in point 21.1 may agree to have oversight tasks performed by the competent
authority(ies) of the Member State(s) where the facilities are located, or by EASA for facilities
that are located in a third country. Any organisation that is subject to such an agreement shall
be informed of its existence and of its scope.
(e) For any oversight activities that are performed at facilities located in a Member State other
than where the organisation has its principal place of business, the competent authority, as
defined in point 21.1, shall inform the competent authority of that Member State before
performing any on-site audit or inspection of the facilities.
(f) The competent authority shall collect and process any information deemed useful for
conducting oversight activities, including unannounced inspections.
[Note: related AMC/GM:
 AMC1 21.B.221(a), (b) and (c) Oversight principles]

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21.B.222 Oversight programme

(a) The competent authority shall establish and maintain an oversight programme covering the
oversight activities required by point 21.B.221(a).
(b) The oversight programme shall be developed taking into account the specific nature of the
organisation, the complexity of its activities, the results of past certification and/or oversight
activities, and it shall be based on the assessment of the associated risks. It shall include,
within each oversight planning cycle:
(1) assessments, audits and inspections, including unannounced inspections and, as
applicable:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the products, parts and appliances that are
under the scope of the organisation;
(iii) sampling of the work performed; and
(2) meetings convened between the accountable manager and the competent authority to
ensure that they both remain informed of any significant issues.
(c) For organisations certified by the competent authority, an oversight planning cycle that does
not exceed 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the
competent authority has established that during the previous 24 months:
(1) the organisation has demonstrated that it can effectively identify aviation safety
hazards and manage the associated risks;
(2) the organisation has continuously demonstrated under point 21.A.147 that it has full
control over all changes;
(3) no level 1 findings have been issued; and
(4) all corrective actions have been implemented within the time period that was accepted
or extended by the competent authority as defined in point 21.B.225.
Notwithstanding point (c), the oversight planning cycle may be further extended to a
maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the
organisation has established, and the competent authority has approved, an effective
continuous system for reporting to the competent authority on the safety performance and
regulatory compliance of the organisation itself.
(e) The oversight planning cycle may be reduced if there is evidence that the safety performance
of the organisation has decreased.
(f) The oversight programme shall include records of the dates when assessments, audits,
inspections and meetings are due, and when assessments, audits, inspections and meetings
have been effectively carried out.

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(g) At the completion of each oversight planning cycle, the competent authority shall issue a
recommendation report on the continuation of the approval, reflecting the results of
oversight.
[Note: related AMC/GM:
— AMC1 21.B.222 and 21.B.432 Oversight programme
— GM1 21.B.222(a) Oversight programme
— AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
— GM1 21.B.222(b) Oversight programme
— AMC1 21.B.222(b)(1) Oversight programme
— GM1 21.B.222(b)(1)(ii) Oversight programme
— AMC1 21.B.222(c) Oversight programme
— AMC1 21.B.222(c) and 21.B.432(c) Oversight programme
— AMC1 21.B.222(d) Oversight programme]

21.B.225 Findings and corrective actions

(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable design data which lowers
safety or seriously endangers flight safety.
The level 1 findings shall also include:
(a) When, during audits or by other means, objective evidence is found by the competent
authority, showing non-compliance of the holder of a production organisation approval with
the applicable requirements of Section A of this Annex, the competent authority shall issue a
finding. The competent authority this finding shall be classified in accordance with
point 21.A.158(a) classify each finding as follows:
(1) level 1 finding:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of the POA certificate by falsification of the
submitted documentary evidence;
(3) any evidence of malpractice or of fraudulent use of the POA certificate; and
(4) the lack of an accountable manager.
(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.
(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding

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to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(fb) The competent authority shall take the following actions:
(1.) in the case of for level 1 findings take immediate and appropriate action shall be taken
by the competent authority to prohibit or limit the activities of the organisation
involved, and, if appropriate, it shall take action to limit, suspend or revoke the
production organisation approval or to limit or suspend it in whole or in part, depending
upon the extent of the level 1 finding, until successful corrective action has been
completed by the organisation;
(2.) in the case of for level 2 findings:
(i) the competent authority shall grant a corrective action implementation period
that is appropriate to the nature of the finding, which in any case that shall
initially not be more than 3 months. The period shall commence from the date of
the written communication of the finding to the organisation, requesting
corrective action to address the non-compliance identified. In certain
circumstances, at At the end of this period, and subject to the nature of the
finding and the past safety performance of the organisation, the competent
authority can may extend the 3-month period provided that a satisfactory
corrective action plan provided by the organisation has been agreed by the
competent authority; and
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them;
(3) in case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.
(c) Action shall be taken by the competent authority to suspend the approval in whole or in part
in case of failure to comply within the timescale granted by the competent authority.

[Note: related AMC/GM:

— GM1 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective actions
— GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions
— AMC1 21.B.225(d) Findings and corrective actions]

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21.B.230 Issue of certificate

(a) When satisfied that the production organisation is in compliance with the applicable
requirements of Section A, Subpart G, the competent authority shall issue a Production
Organisation Approval (EASA Form 55, see Appendix X) without undue delay.
(b) The reference number shall be included on the EASA Form 55 in a manner specified by the
Agency.

[Note: related AMC/GM:

— AMC No 1 to 21.B.230 Issue of the certificate (deleted)]

21.B.235 Continued surveillance

(a) In order to justify the maintenance of the production organisation approval the competent
authority shall perform continued surveillance:
1. to verify that the production organisation approval holder's quality system complies
with Section A Subpart G;
2. to verify that the organisation of the production organisation approval holder operates
in accordance with the production organisation exposition;
3. to verify the effectiveness of the production organisation exposition procedures; and
4. to monitor by sample the standards of the product, part or appliance.
(b) Continued surveillance shall be performed in accordance with point 21.B.220.
(c) The competent authority shall provide through planned continued surveillance that a
production organisation approval is completely reviewed for compliance with this Annex I
(Part 21) during a period of 24 months. The continued surveillance may be made up of several
investigation activities during this period. The number of audits may vary depending upon the
complexity of the organisation, the number of sites and the criticality of the production. As a
minimum the holder of a production organisation approval shall be subject to continued
surveillance activity by the competent authority at least once every year.

[Note: related AMC/GM:

— GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. (moved to
GM1 21.B.222(b)(1)(ii)
— GM 21.B.235(b) Maintenance of the POA —Work allocation within the competent authority
(moved to GM1 21.B.222(a)
— GM 21.B.235(b) and (c) Continued surveillance (moved to GM1 21.B.222(b)
— AMC 21.B.235(c) Continuation of POA (moved to AMC1 21.B.222(b)(1) and 21.B.432(b)(1)]

21.B.240 Amendment of a production organisation approval

(a) The competent authority shall monitor any minor change through the continued surveillance
activities.

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(b) The competent authority shall investigate as appropriate in accordance with point 21.B.220
any significant change of a production organisation approval or application by the holder of a
production organisation approval for an amendment of the scope and terms of approval.
(c) When the competent authority is satisfied that the requirements of Section A, Subpart G
continue to be complied with it shall amend the production organisation approval accordingly.

21.B.240 Changes to a production organisation approval

(a) Upon receiving an application for a change that requires prior approval, the competent
authority shall verify the organisation’s compliance with the applicable requirements before
issuing the approval.
(b) The competent authority shall establish the conditions under which the organisation may
operate during the change, unless the competent authority determines that the production
organisation approval needs to be suspended.
(c) When satisfied that the organisation is in compliance with the applicable requirements, the
competent authority shall approve the change.
(d) Without prejudice to any additional enforcement measures, if the organisation implements
changes that require prior approval without having received the approval of the competent
authority pursuant to point (c), the competent authority shall suspend, limit or revoke the
organisation’s certificate.
(e) For changes do not require prior approval, the competent authority shall include the review of
such changes in its continuing oversight in accordance with the principles set forth in point
21.B.221. If any non-compliance is found, the competent authority shall:
(1) notify the organisation about the non-compliance and request further changes;
(2) in the case of level 1 or level 2 findings, act in accordance with point 21.B.225.

[Note: related AMC/GM:

 AMC1 No 1 to 21.B.240 Changes to a production organisation approval]

21.B.245 Suspension and revocation of a production organisation

approval
(a) In case of a level one or level two finding, the competent authority shall partly or fully limit,
suspend or revoke a production organisation approval as follows:
1. in case of a level one finding the production organisation approval shall be immediately
limited or suspended. If the holder of the production organisation approval fails to
comply with point 21.A.158(c)(1), the production organisation approval shall be
revoked;
2. in case of a level two finding, the competent authority shall decide on any restriction to
the scope of approval by temporary suspension of the production organisation approval
or parts thereof. If the holder of a production organisation approval fails to comply with
point 21.A.158(c)(2), the production organisation approval shall be revoked.

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(b) The limitation, suspension or revocation of the production organisation approval shall be
communicated in writing to the holder of the production organisation approval. The
competent authority shall state the reasons for the suspension or revocation and inform the
holder of the production organisation approval of its right to appeal.
(c) When a production organisation approval has been suspended it shall only be reinstated after
compliance with Section A, Subpart G has been re-established.

[Note: related AMC/GM:

— GM 21.B.245 Continued validity (moved to GM1 21.B.65)
— AMC 21.B.245 Corrective action plan (moved to AMC1 21.B.65)]

21.B.260 Record-keeping
(a) The competent authority shall establish a system of record-keeping that allows adequate
traceability of the process to issue, maintain, amend, suspend or revoke each individual
production organisation approval.
(b) The records shall at least contain:
1. the documents provided by the applicant for, or holder of, a production organisation
approval certificate;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.220 are stated, including findings
established in accordance with point 21.B.225;
3. the continued surveillance programme, including records of investigations performed;
4. the production organisation approval certificate, including changes;
5. minutes of the meetings with the holder of the production organisation approval.
(c) The records shall be archived for a minimum retention period of six years.

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SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED

CERTIFICATES OF AIRWORTHINESS

21.B.330 Suspension and revocation of certificates of airworthiness

and restricted certificates of airworthiness
(a) Upon evidence that any of the conditions specified in point 21.A.181(a) is not met, the
competent authority of the Member State of registry shall suspend or revoke an airworthiness
certificate.
(b) Upon issuance of the notice of suspension and revocation of a certificate of airworthiness or
restricted certificate of airworthiness the competent authority of the Member State of registry
shall state the reasons for the suspension or revocation and inform the holder of the
certificate of its right to appeal.

21.B.345 Record-keeping
(a) The competent authority of the Member State of registry shall establish a system of record-
keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or
revoke each individual airworthiness certificate.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.320(b) are stated; and
3. a copy of the certificate or permit, including amendments.
(c) The records shall be archived for a minimum retention period of six years after leaving that
national register.

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SUBPART I — NOISE CERTIFICATES

21.B.430 Suspension and revocation of a noise certificate

(a) Upon evidence that some of the conditions specified in point 21.A.211(a) are not met, the
competent authority of the Member State of registry shall suspend or revoke a noise
certificate.
(b) Upon issuance of the notice of suspension and revocation of a noise certificate the competent
authority of the Member State of registry shall state the reasons for the suspension and
revocation and shall inform the holder of the certificate on its right to appeal.

21.B.445 Record-keeping
(a) The competent authority of the Member State of registry shall establish a system of record-
keeping with minimum retention criteria that allows adequate traceability of the process to
issue, maintain, amend, suspend or revoke each individual noise certificate.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.420(b) are stated;
3. a copy of the certificate including amendments.
(c) The records shall be archived for a minimum retention period of six years after leaving that
national register.

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SUBPART J — DESIGN ORGANISATION APPROVAL

21.B.430 Initial certification procedure

(a) Upon receiving an application for the initial issue of a design organisation approval certificate,
the competent authority shall verify the organisation’s compliance with the applicable
requirements.
(b) A meeting with the head of the design organisation shall be convened at least once during the
investigation for initial certification to ensure that he or she fully understands the significance
of the certification process, and the reason for signing the statement specified in point
21.A.243(b).
(c) The competent authority shall record all the findings, closure actions (i.e. actions required to
close a finding), and recommendations.
(d) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(e) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a design
organisation approval without undue delay.
(f) The certificate reference number shall be included in the design organisation approval
certificate in a manner specified by EASA.
(g) The certificate shall be issued for an unlimited duration. The privileges and the scope of the
activities that the organisation is approved to conduct, including any limitations as applicable,
shall be specified in the terms of approval attached to the certificate.

[Note: related AMC/GM:

— AMC1 21.B.220 and 21.B.430 Initial certification procedure
— AMC1 21.B.430 and 21.B.431 Initial certification procedure
— AMC1 21.B.430(a) Initial certification procedure
— AMC1 21.B.430(d)(1) Initial certification procedure]

21.B.431 Oversight principles

(a) The competent authority shall verify:
(1) compliance with the requirements that are applicable to organisations prior to issuing
an organisation certificate;
(2) continued compliance with the applicable requirements of the organisations that it has
certified;
(3) the implementation of appropriate safety measures mandated by the competent
authority as defined in points 21.B.20(c) and (d).
(b) This verification shall:

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(1) be supported by documentation specifically intended to provide personnel responsible

for safety oversight with guidance to perform their functions;
(2) provide the organisations concerned with the results of safety oversight activities;
(3) be based on assessments, audits, inspections, and, if needed, unannounced inspections;
(4) provide the competent authority with the evidence needed in case further action is
required, including the measures provided for in point 21.B.433.
(c) The scope of the oversight defined in (a) and (b) shall take into account the results of past
oversight activities and safety priorities.
(d) The competent authority shall collect and process any information deemed useful for
conducting oversight activities, including unannounced inspections.

[Note: related AMC/GM:

— AMC1 21.B.431(a), (b) and (c) Oversight principles]

21.B.432 Oversight programme

(a) The competent authority shall establish and maintain an oversight programme that covers the
oversight activities required by point 21.B.431(a).
(b) The oversight programme shall be developed taking into account the specific nature of the
organisation, the complexity of its activities, the results of past certification and/or oversight
activities, and it shall be based on the assessment of the associated risks. It shall include
within each oversight planning cycle:
(1) assessments, audits and inspections, including unannounced inspections, and, as
applicable:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the products, parts and appliances that are
under the scope of the organisation; and
(iii) sampling of the work performed; and
(2) meetings convened between the head of the design organisation and the competent
authority to ensure that both remain informed of significant issues.
(c) For organisations certified by the competent authority, an oversight planning cycle that does
not exceed 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the
competent authority has established that during the previous 24 months:
(1) the organisation has demonstrated that they it effectively identify aviation safety
hazards and manage the associated risks;
(2) the organisation has continuously demonstrated under point 21.A.247 that it has full
control over all changes;
(3) no level 1 findings have been issued; and

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(4) all corrective actions have been implemented within the time period that was accepted
or extended by the competent authority as defined in point 21.B.433.
Notwithstanding point (c), the oversight planning cycle may be further extended to a
maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the
organisation has established, and the competent authority has approved, an effective
continuous system for reporting to the competent authority on the safety performance and
regulatory compliance of the organisation itself.
(e) The oversight planning cycle may be reduced if there is evidence that the safety performance
of the organisation has decreased.
(f) The oversight programme shall include records of the dates when assessments, audits,
inspections and meetings are due, and when assessments, audits, inspections and meetings
have been effectively carried out.
(g) At the completion of each oversight planning cycle, the competent authority shall issue a
recommendation report on the continuation of the approval, reflecting the results of
oversight.
Note: related AMC/GM:
— AMC1 21.B.222 and 21.B.432 Oversight programme
— AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC1 21.B.432(b)(1) Oversight programme
— AMC1 21.B.432(c) Oversight programme
— AMC2 21.B.222(c) and 21.B.432(c) Oversight programme
— AMC1 21.B.432(d) Oversight programme]

21.B.433 Findings and corrective actions

(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable requirements which
lowers safety or seriously endangers flight safety.
The level 1 findings shall also include:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of the DOA certificate by falsification of the
submitted documentary evidence;
(3) any evidence of malpractice or of fraudulent use of the DOA certificate;

(4) the lack of a head of the design organisation.

(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.

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(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding
to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(d) The competent authority shall:
(1) in the case of level 1 findings take immediate and appropriate action to prohibit or limit
the activities of the organisation involved, and, if appropriate, it shall take action to
revoke the design organisation approval or to limit or suspend it in whole or in part,
depending upon the extent of the level 1 finding, until successful corrective action has
been completed by the organisation;
(2) in the case of level 2 findings:
(i) grant a corrective action implementation period that is appropriate to the nature
of the finding, which in any case shall initially not be more than 3 months. The
period shall commence from the date of the written communication of the
finding to the organisation, requesting corrective action to address the
non-compliance identified. At the end of this period, and subject to the nature of
the finding and the past safety performance of the organisation, the competent
authority may extend the 3-month period provided that a satisfactory corrective
action plan has been agreed by the competent authority; and
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them;
(3) in the case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.

[Note: related AMC/GM:

— GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and corrective actions
— AMC1 21.B.433(d) Findings and corrective actions]

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21.B.435 Changes to a design organisation approval

(a) Upon receiving an application for a change that requires prior approval, the competent
authority shall verify the organisation’s compliance with the applicable requirements before
issuing the approval.
(b) The competent authority shall establish the conditions under which the organisation may
operate during the change, unless the competent authority determines that the design
organisation approval needs to be suspended.
(c) When satisfied that the organisation is in compliance with the applicable requirements, the
competent authority shall approve the change.
(d) Without prejudice to any additional enforcement measures, if the organisation implements
changes that require prior approval without having received the approval of the competent
authority pursuant to point (c), the competent authority shall suspend, limit or revoke the
organisation’s certificate.
(e) For changes that do not require prior approval, the competent authority shall include the
review of those changes in their continuing oversight activities in accordance with the
principles stated in point 21.B.431. In case of any non-compliance, the competent authority
shall:
(1) notify the organisation about the non-compliance and request further changes;
(2) in case of level 1 or level 2 findings, act in accordance with point 21.B.433.

[Note: related AMC/GM:

 AMC1 21.B.435 Changes to a design organisation approval]

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SUBPART P — PERMIT TO FLY

21.B.530 Revocation of permits to fly

(a) Upon evidence that any of the conditions specified in point 21.A.723(a) are not met for a
permit to fly it has issued, the competent authority shall revoke that permit to fly.
(b) Upon issuance of the notice of revocation of a permit to fly the competent authority shall
state the reasons for the revocation and inform the holder of the permit to fly on the right to
appeal.

21.B.545 Record-keeping
(a) The competent authority shall operate a system of record-keeping that provides adequate
traceability of the process for the issue and revocation of each individual permit to fly.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.520(b) are stated; and
3. a copy of the permit to fly.
(c) The records shall be kept for a minimum of six years after the permit ceases to be valid.

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APPENDICES TO ANNEX I

EASA FORMS
Regulation (EU) No 748/2012

When the Forms of this Annex are issued in a language other than English, they shall include an English
translation.

The EASA ('European Union Aviation Safety Agency') Forms referred to in the appendices to this Part
shall have the following obligatory features. Member States shall ensure that the EASA Forms they
issue are recognisable and shall be responsible for having those Forms printed.
Appendix I — EASA Form 1 Authorised release Ccertificate
Appendix II — EASA Form 15a Airworthiness Rreview Ccertificate
Appendix III — EASA Form 20a Permit to Ffly
Appendix IV — EASA Form 20b Permit to Ffly (issued by approved organisations)
Appendix V — EASA Form 24 Restricted Ccertificate of Aairworthiness
Appendix VI — EASA Form 25 Certificate of Aairworthiness
Appendix VII — EASA Form 45 Noise Ccertificate
Appendix VIII — EASA Form 52 Aircraft Sstatement of Cconformity
Appendix IX — EASA Form 53 Certificate of Rrelease to Sservice
Appendix X — EASA Form 55 Production Oorganisation Aapproval Ccertificate
Appendix XI — EASA Form 65 Letter of Aagreement for production without production
organisation approval
Appendix XII — Categories of flight tests and associated flight test crew qualifications 85

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Appendix VIII — Aircraft statement of conformity — EASA Form 52

AIRCRAFT STATEMENT OF CONFORMITY
1. State of manufacture 2. [MEMBER STATE]1 A Member of the European 3. Statement Ref No:
Union2
4. Organisation
5. Aircraft Type 6. Type-certificate Refs:
7. Aircraft Registration Or Mark 8. Manufacturers Identification No
3
9. Engine/Propeller Details
10. Modifications and/or Service Bulletins3
11. Airworthiness Directives
12. Concessions
13. Exemptions, Waivers or Derogations3
14. Remarks
15. Certificate of Airworthiness
16. Additional Requirements
17. Statement of Conformity
It is hereby certified that this aircraft confirms conforms fully to the type-certificated design and to the
items above in boxes 9, 10, 11, 12 and 13.
The aircraft is in a condition for safe operation.
The aircraft has been satisfactorily tested in flight.
18. Signed 19. Name 20. Date (d/m/y)
21. Production Organisation Approval Reference
EASA Form 52 Issue 2.

Instructions for the use of the Aaircraft Sstatement of Cconformity EASA Form 52
1. PURPOSE AND SCOPE
1.1. Use of the aircraft Sstatement of Cconformity issued by a production organisation
manufacturer producing under Part 21 Section A Subpart F is described under point
21.A.130 and the corresponding acceptable means of compliance.
1.2. The purpose of the aircraft Sstatement of Csonformity (EASA Form 52) issued under
Part 21 Section A Subpart G is to enable the holder of an appropriate production
organisation approval to exercise the privilege to obtain an individual aircraft certificate
of airworthiness from the competent authority of the Member State of registry.
2. GENERAL
2.1. The Sstatement of Cconformity must comply with the format attached, including the
block numbers and the location of each block. The size of each block may, however, be
varied to suit the individual application, but not to the extent that would make the

1 Or EASA if EASA is the competent authority.

2 Delete for non-EU Member States or EASA.
3 Delete as applicable.

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Sstatement of Cconformity unrecognisable. If in doubt, consult the competent

authority.
2.2. The Sstatement of Cconformity must either be pre-printed or computer generated, but
in either case, the printing of lines and characters must be clear and legible. Pre-printed
wording is permitted in accordance with the attached model, but no other certification
statements are permitted.
2.3. Completion may be either machine/computer printed or hand-written using block
letters to permit easy reading. English, and where relevant, one or more of the official
language(s) of the issuing Member State are acceptable.
2.4. A copy of the Sstatement and all the referenced attachments are to be retained by the
approved production organisation.
3. COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR
3.1. There should be an entry in all the blocks to make the document a valid statement.
3.2. A Sstatement of Cconformity may not be issued to the competent authority of the
Member State of registry unless the design of the aircraft and its installed products are
approved.
3.3. The information required in blocks 9, 10, 11, 12, 13 and 14 may be by reference to
separate identified documents held on file by the production organisation, unless the
competent authority agrees otherwise.
3.4. This Sstatement of Cconformity is not intended to include those items of equipment
that may be required to be fitted in order to satisfy the applicable operational rules.
However, some of these individual items may be included in block 10 or in the approved
type design. Operators are therefore reminded of their responsibility to ensure
compliance with the applicable operational rules for their own particular operation.
Block 1 Enter the name of the State of manufacture.
Block 2 The competent authority under which authority the Sstatement of Cconformity is
issued.
Block 3 A unique serial number should be pre-printed in this block for statement control and
traceability purposes. An exception is Except that iIn the case of a computer-generated
document, the number need not be pre-printed where the computer is programmed to
produce and print a unique number.
Block 4 The full name and the address of the location of the organisation issuing the statement.
This block may be pre-printed. Logos, etc. are permitted if the logo can be contained
within the block.
Block 5 The aircraft type in full as defined in the type certificate type-certificate and its
associated data sheet.
Block 6 The type certificate type-certificate reference numbers and issue for the subject
aircraft.

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Block 7 If the aircraft is registered, then this mark will be the registration mark. If the aircraft is
not registered, then this will be such a mark that is accepted by the competent
authority of the Member State and, if applicable, by the competent authority of a third
country.
Block 8 The identification number assigned by the production organisation manufacturer for
control and traceability and product support. This is sometimes referred to as a
production organisation manufacturer Sserial No or Cconstructors No.
Block 9 The engine type and the propeller type(s) in full as defined in the relevant type
certificate type-certificate and its associated data sheet. Their production organisation
manufacturer identification No and the associated location should also be shown.
Block 10 Approved design changes to the aircraft definition.
Block 11 A listing of all the applicable airworthiness directives (or equivalent) and a declaration
of compliance, together with a description of the method of compliance of on the
subject individual aircraft, including products and installed parts, appliances and
equipment. Any future compliance requirement time should be shown.
Block 12 Approved unintentional deviation deviations to from the approved type design,
sometimes referred to as concessions, divergences, or non-conformances.
Block 13 Only agreed exemptions, waivers or derogations may be included here.
Block 14 Remarks. Any statement, information, particular data or limitation which may affect the
airworthiness of the aircraft. If there is no such information or data, state; ‘NONE’.
Block 15 Enter ‘Ccertificate of Aairworthiness’, or ‘Rrestricted Ccertificate of Aairworthiness’, or
for the Ccertificate of Aairworthiness requested.
Block 16 Additional requirements such as those notified by an importing country should be
noted in this block.
Block 17 The validity Validity of the Sstatement of Cconformity is dependent on full completion
of all the blocks on the form. A copy of the flight test report, together with any recorded
defects and rectification details, should be kept on file by the POA holder. The report
should be signed as satisfactory by the appropriate certifying staff and a flight crew
member, e.g. the test pilot or the flight test engineer. The flight tests performed are
those defined under the control of the quality management element of the production
system system, as established by point 21.A.139, in particular 21.A.139(d)(1)(vi)
21.A.139(b)(1)(vi), to ensure that the aircraft conforms with to the applicable design
data, and is in condition for safe operation.
The listing of items provided (or made available) to satisfy the safe operation aspects of
this statement should be kept on file by the POA holder.
Block 18 The Sstatement of Cconformity may be signed by the person authorised to do so by the
production approval holder in accordance with point 21.A.145(d). A rubber stamp
signature should not be used.
Block 19 The name of the person signing the certificate should be typed or printed in a legible
form.

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Block 20 The date on which the Sstatement of Cconformity is signed should be given.
Block 21 The competent authority approval reference should be quoted.

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Appendix X — Production organisation approval certificate — EASA

Form 55
Regulation (EU) No 748/2012

Production Oorganisation Aapproval Ccertificates referred to in Subpart G of Annex I (Part 21)

[MEMBER STATE]1

A Member of the European Union2

PRODUCTION ORGANISATION APPROVAL CERTIFICATE

Reference: [MEMBER STATE CODE1].21G.XXXX

Pursuant to Regulation (EU) 2018/1139 Regulation (EC) No 216/2008 of the European Parliament and of the
Council and to Commission Regulation (EU) No 748/2012 [(EC) No 1702/2003] for the time being in force
and subject to the condition specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE] hereby
certifies:

[COMPANY NAME AND ADDRESS]

as a production organisation in compliance with Annex I (Part 21), Section A, Subpart G of Regulation [(EU)
No 748/2012 (EC) No 1702/2003], approved to produce products, parts and appliances listed in the attached
approval schedule and issue related certificates using the above references.

CONDITIONS:
1. This approval is limited to that specified in the enclosed terms of approval, and
2. This approval requires compliance with the procedures specified in the approved production
organisation exposition, and
3. This approval is valid whilst the approved production organisation remains in compliance with Annex
I (Part 21) of to Regulation EU) No 748/2012 [(EC) No 1702/2003].
4. Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited
duration unless the approval has previously been surrendered, superseded, suspended or revoked.

Date of original issue: ………………………………………………………………………………………………………………………………

Date of this revision: ………………………………………………………………………………………………………………………………..

Revision No: …………………………………………………………………………………………………………………………………………….

Signed: …………………………………………………………………………………………………………………………………………………….

For the competent authority: [COMPETENTAUTHORITY IDENTIFICATION 1]

EASA Form 55a issue 2.

1 Or EASA if EASA is the competent authority.

2 Delete for non-EU Member States.

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[MEMBER STATE]1 TA: [MEMBER STATE

Terms of Aapproval
A Member of the European Union2 CODE1].21G.XXXX

This document is part of Pproduction Oorganisation Aopproval Nnumber [MEMBER STATE CODE1].21G.XXXX
issued to:
Company name:

Section 1. SCOPE OF WORK:

PRODUCTION OF PRODUCTS/CATEGORIES

For details and limitations, refer to the Production Organisation Exposition, Section xxx

Section 2. LOCATIONS:

Section 3. PRIVILEGES:

The Production Organisation is entitled to exercise, within its Tterms of Aapproval and in accordance with
the procedures of its Production Organisation Exposition, the privileges set forth defined in 21.A.163,
Subject subject to the following:
[keep only applicable text]
Prior to approval of the design of the product, an EASA Form 1 may be issued only for conformity purposes.
A Sstatement of Cconformity may not be issued for a non-approved aircraft
Maintenance may be performed, until compliance with the maintenance regulations is required, in
accordance with the Production Organisation Exposition Section xxx
Permits to fly may be issued in accordance with the Production Organisation Exposition Section yyy
Date of original issue: Signed:

Date of this revision:

Revision No.: For [COMPETENT AUTHORITY IDENTIFICATION1]

EASA Form 55b Issue 2.

1 Or EASA if EASA is the competent authority.

2 Delete for non-EU Member States.

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Appendix XI — Letter of agreement for production without

production organisation approval — EASA Form 65
Regulation (EU) No 748/2012

Letter of agreement referred to in Subpart F of Annex I (Part 21)

[MEMBER STATE]1
A Member of the European Union2

LETTER OF AGREEMENT FOR PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

[NAME OF THE APPLICANT]

[TRADE NAME (if different)]
[FULL ADDRESS OF THE APPLICANT]
Date (Day, Month, Year)
Reference: [MEMBER STATE CODE2].21F.XXXX

Dear Sirs,Mr/Ms [Name of the Applicant],

Your production inspection system has been evaluated and found to be in compliance with Section A, Subpart
A and Subpart F of Annex I (Part 21) of to Regulation [(EC) No 1702/2003] (EU) No 748/2012.

Therefore, subject to the conditions specified below, we agree that the showing of conformity of the
products, parts and appliances mentioned below may be done under Section A, Subpart F of Annex I (Part 21)
of to Regulation [(EC) No 1702/2003](EU) No 748/2012].

No of Units P/N S/N

AIRCRAFT
PARTS
The following conditions are applicable to this agreement:
(1) It is valid whilst [Company Name] remains in compliance with Section A, Subpart A and Subpart F of
Annex I (Part 21) of to Regulation [(EC) No 1702/2003](EU) No 748/2012.
(2) It requires compliance with the procedures specified in [Company Name] Manual Rref./Issue
date………………………
(3) It terminates on ……………………………..
(4) The Sstatement of Cconformity issued by [Company Name] under the provisions of point 21.A.130 of
the above-mentioned rRegulation shall be validated by the issuing authority of this letter of agreement
in accordance with the procedure ……………………………. of the referenced manual.
(5) [Company Name] shall notify the issuing authority of this letter of agreement immediately of any
changes to the production inspection system that may affect the inspection, conformity, or
airworthiness of the products and parts listed in this letter.
For the competent authority: [COMPETENT AUTHORITY IDENTIFICATION (1)2]
Date and Signature

EASA Form 65, Issue 2.

1 Or EASA if EASA is the competent authority.

2
Delete for non-EU Member States.

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Draft AMC & GM to Annex I (Part 21) to Regulation (EU) No 748/2012 (Draft
EASA Decision)

GM1 Annex I Definitions

For the purpose of the AMC & GM to Part 21, the following definitions are used:

Audit refers to a systematic, independent, and documented process for obtaining

evidence, and evaluating it objectively to determine the extent to which
requirements are complied with.
Note: an audit may include an inspection

Assessment in the context of management system performance monitoring, continuous

improvement and oversight, refers to a planned and documented activity
performed by competent personnel to:

 review provided evidence in combination with demonstrated

behaviour against the concepts and principles of a model or standard,
 analyse the achieved levels of performance in relation to the
organisation’s strategy and objectives, and
 evaluate the ability of the organisation to reach these objectives.
Note: assessment focuses on desirable outcomes and the overall
performance, looking at the organisation as a whole. The main objective of
the assessment is to identify strengths and weaknesses to drive continual
improvement.

Certificate is any certificate, approval, licence, authorisation, attestation or other

document issued as the result of a certification attesting compliance with
the applicable requirements.

Competency is a combination of individual skills, practical and theoretical knowledge,

attitude, training, and experience.

Correction is the action to eliminate a detected non-compliance.

Corrective action is the action to eliminate or mitigate the root cause(s) and prevent the
recurrence of an existing detected non-compliance, or any other undesirable
condition or situation. The proper determination of the root cause(s) is
crucial for defining effective corrective actions to prevent reoccurrences.

Error is an action or inaction by a person that may lead to deviations from the
accepted procedures or regulations.
Note: errors are often associated with occasions when a planned sequence of

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mental or physical activities either fails to achieve its intended outcome, or is

not appropriate with regard to the intended outcome, and when results
cannot be attributed purely to chance.

Hazard is a condition or an object that has the potential to cause or contribute to an

aircraft incident or accident.

Human factors is anything that affects human performance and refers to principles that
apply to aeronautical design, certification, training, operations and
maintenance, and which seek safe interfaces between the human and other
system components by proper consideration of human performance.

Human refers to human capabilities and limitations which have an impact on the
performance safety and the efficiency of aeronautical operations.

Near miss is an event in which an occurrence that has to be mandatorily reported

according to Regulation (EU) No 376/2014 was narrowly averted or avoided.
Example: a staff member, on rechecking his or her work at the end of a task,
realises that one work card step was not properly carried out.

Inspection in the context of compliance monitoring and oversight, refers to an

independent and documented conformity evaluation by observation and
judgement that is accompanied, as appropriate, by measurements, testing or
gauging, in order to verify compliance with applicable requirements.
Note: an inspection may be part of an audit (e.g. a product audit), but may
also be conducted outside the normal audit plan, for example to verify the
closure of a particular finding.

Just Culture Ref. Regulation (EU) No 376/2014, Article 2.

Organisational is a latent condition that affects the effectiveness of safety risk controls,
factor related to culture, policies, processes, resources, and the workplace of an
organisation.

Oversight planning refers to the time frame within which all areas of the approval and all
cycle processes should be reviewed by the competent authority by means of
audits and inspections.

Oversight refers to the detailed oversight schedule that defines the number of audits
programme and inspections, the scope and duration of each audit and inspection,
including details on product audits and locations, as appropriate, to be
performed by the competent authority, and the tentative time frame for
performing each audit and inspection.

Preventive action is the action to eliminate the cause(s) of a potential non-compliance, or any

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other undesirable potential situation.

Risk assessment is an evaluation based on engineering and operational judgement and/or

analysis methods in order to establish whether the achieved or perceived risk
is acceptable or tolerable.

Safety culture is an enduring set of values, norms, attitudes, and practices within an
organisation concerned with minimising the exposure of the workforce and
the general public to dangerous or hazardous conditions. In a positive safety
culture, a shared concern for, commitment to, and accountability for safety
is promoted.

Safety risk refers to the predicted probability and severity of the consequences or
outcomes of a hazard.

 21.1 Competent authority

GM2 Annex I Acronyms

For the purpose of the AMC & GM to Part 21, the following acronyms are used:

AFM Aircraft flight manual

AMC Acceptable means of compliance

CoA Certificate of airworthiness

CRI Certification review item

CS Certification specification

CS-CCD Certification specification – cabin crew data

CS-FCD Certification specification – flight crew data

CS-GEN-MMEL Certification specification – generic master minimum equipment list

CS-MMEL Certification specification – master minimum equipment list

CS-MCSD Certification specification – maintenance certifying staff data

CS-SIMD Certification specification – simulator data

DO Design organisation

DOA Design organisation approval

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ELOS Equivalent level of safety

ESF Equivalent safety finding

ETSO European technical standard order

OP Other party

OSD Operational suitability data

PO Production organisation

POA Production organisation approval

POATL Production organisation approval team leader

POE Production organisation exposition

GM Guidance material

MOC Means of compliance

RCoA Restricted certificate of airworthiness

RTC Restricted type certificate

SC Special condition

SMS Safety management system

STC Supplemental type certificate

TC Type certificate

TCDS Type certificate data sheet

 21.1 Competent authority

GM1 21.1 Competent authority

RESPONSIBILITY FOR IMPLEMENTATION
Each certificate or approval in accordance with Part 21 Section A Subparts F, G, H, I and P will
normally be issued and controlled by the competent authority of the Member State in whose
country the applicant or holder is located. Therefore, to ensure consistency between the competent
authorities of the Member States in issuing certificates and approvals, the implementation of Part 21
should be based on the following three principles:

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(a) The establishment and maintenance of an effective organisation and the corresponding
processes by all competent authorities.
(b) The operation of all the competent authorities in accordance with Part 21 and its acceptable
means of compliance (AMC) and guidance material (GM).
(c) A standardisation process established and operated by EASA to assess the standard achieved,
and to provide timely advice and guidance to the competent authorities of the Member
States.
As a result, the responsibility for implementation consists of the two main objectives:
(a) To ensure that certificates and approvals are only granted to applicants that comply with the
requirements of Part 21; and
(b) To ensure that there is sufficient visibility of the processes to give EASA and the other Member
States the necessary confidence in the certificates or approvals granted.
 21.1 Competent authority

GM1 21.1(c) Competent authority

PERMIT TO FLY
An aircraft registered in a Member State is under the responsibility of this Member State regarding
continuing airworthiness aspects. Consequently, any permit to fly under Part 21 is issued by that
Member State, including any cases in which the aircraft will fly in another State. The permit to fly
contains all the conditions and restrictions to ensure safe flight, but other airspace and operational
rules remain within the competence of the authority of the State where the flight will take place.
The applicant is also therefore required to ensure compliance with the relevant regulations of that
State.
 21.1 Competent authority

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SECTION A TECHNICAL REQUIREMENTS

SUBPART A — GENERAL PROVISIONS

AMC1 No 1 to 21.A.3A(a)(1) Occurrence reporting Collection,

investigation and analysis of data related to Flammability
Reduction Means (FRM) Reliability
COLLECTION, INVESTIGATION AND ANALYSIS OF DATA RELATED TO FLAMMABILITY REDUCTION
MEANS (FRM) RELIABILITY
Applicants for or holders Holders of a TC type-certificate, RTCtype-certificate, STCtype-certificate or
any other relevant approval deemed to have been issued under Part 21 and which have included a
an FRM in their design should assess on an on-going ongoing basis the effects of aeroplane
component failures on FRM reliability. This should be part of the system for the collection,
investigation and analysis of data required by point 21.A.3A(a)(1). The applicant/holder should do
the following:
(a) Demonstrate effective means to ensure collection of FRM reliability data. The means should
provide data affecting FRM reliability, such as component failures.
(b) Unless alternative reporting procedures are approved by the Agency EASA, provide a report to
the Agency EASA every six 6 months for the first five years after service introduction. After
that period, continued reporting every six 6 months may be replaced with other reliability
tracking methods found acceptable to the Agency EASA or eliminated if it is established that
the reliability of the FRM meets, and will continue to meet, the exposure specifications of
paragraph M25.1 of Appendix M to CS-25.
(c) Develop service instructions or revise the applicable aeroplane manual, according to a
schedule approved by the Agency EASA, to correct any failures of the FRM that occur in
service that could increase any fuel tank’s Fleet Average Flammability Exposure to more than
that specified by paragraph M25.1 of Appendix M to CS-25.
 21.A.3A Occurrence reporting

AMC2 No 2 to 21.A.3A(a)(1) Occurrence reporting Collection,

investigation and analysis of data related to ETOPS significant
occurrences
COLLECTION, INVESTIGATION AND ANALYSIS OF DATA RELATED TO ETOPS SIGNIFICANT
OCCURRENCES
(1) Applicants for or holders Holders of a TC type-certificate, RTC type-certificate, STCtype-
certificate or any other relevant approval deemed to have been issued under Part 21 and
which includes extended range operation with two-engined aeroplane (ETOPS) capability
should implement a specific tracking, reporting and resolution system for ETOPS significant
occurrences, suitable to ensure the initial and continued fleet compliance with the applicable

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ETOPS reliability objectives. This system should be part of the system for collection,
investigation and analysis of data required by point 21.A.3A(a).
Appropriate coordination should exist between the engine TC holder, the propeller TC holder,
and the APU ETSO authorisation holder with and the aircraft TC holder to ensure compliance
with the ETOPS reliability objectives.
(2) For the tracking, reporting and resolution of ETOPS significant occurrences, refer to the latest
edition of AMC 20-6 (see the AMC-20 document).
 21.A.3A Occurrence reporting

GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting The system

for collection, investigation and analysis of data
COLLECTING SYSTEM
In the context of this requirement, the word ‘Ccollection’ refers to means the setting up of systems
and procedures which will enable relevant malfunctions, failures and defects to be properly reported
when they occur.
 21.A.3A Occurrence reporting

GM2 21.A.3A(b)(a) and (b) Occurrence reporting

For occurrence reporting, refer to the latest edition of AMC 20-8 (see the AMC-20 document).
 21.A.3A Occurrence reporting

GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting

MANDATORY AND VOLUNTARY OCCURRENCE REPORTING
The list below provides an overview of the main elements of an occurrence reporting system that is
compliant with Regulation (EU) No 376/2014, and provides references to the relevant Articles of
Regulation (EU) No 376/2014.
(a) An occurrence reporting system that caters both for mandatory and voluntary reporting (see
Articles 4 and 5).
Note 1: the mandatory reporting system established under Regulation (EU) No 376/2014 is
also intended for the reporting of those additional items that qualify for mandatory reporting
that are defined in Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof.
Note 2: the voluntary reporting system is intended to facilitate the collection of details of
occurrences that may not be captured by the mandatory system, and of other safety-related
information which is perceived by the reporting organisation as indicating that there is an
actual or potential hazard to aviation safety.
(b) The designation of one or more persons to independently handle the collection, evaluation,
processing, analysis and storage of details of occurrences with regard to data collection and
hazard identification (see Article 6(1)).

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Note 1: in agreement with their competent authority, small organisations may make use of
simplified mechanisms to ensure the collection, evaluation, processing, analysis and storage of
details of occurrences, possibly by sharing those tasks with other similar organisations.
Note 2: an existing internal safety-reporting scheme, which collects safety-relevant data,
proposals and information, including data on potential safety issues that have not resulted in
any occurrence, may serve as a basis for the mandatory and voluntary occurrence reporting
system. From this pool of safety-relevant information and data collected internally, the
organisation will determine whether a mandatory report is required or whether a voluntary
report may be adequate.
(c) The reporting of details of occurrences collected under the mandatory scheme as soon as
possible, and in any event, no later than 72 hours after becoming aware of the occurrence
(see Article 4(8) & (9);
Note 1: the reference to ‘becoming aware of’ an occurrence implies that a person in the
organisation identifies the occurrence as one that falls into the category of a mandatory
occurrence report — usually through being involved in the occurrence or witnessing it, but
also on review or investigation of information reported to the organisation’s safety reporting
scheme. In the case of design or production organisations, the 72-hour period starts at the
point when the unsafe condition is identified.
In the case of automated data collection systems, the 72-hour period starts when the person
responsible for the analysis of the data detected the reportable occurrence.
Note 2: the 72-hour time frame does not apply to the reporting of details of occurrences
which may involve an actual or potential aviation safety risk, or to safety-related information
collected under the voluntary scheme. These are to be reported in a timely manner (see
Article 5 (5) & (6)).
(d) The establishment of data quality checking processes, to ensure that the information initially
collected and the data stored in the database(s) are consistent (see Article 7(3).
Note: it is understood that data quality checking processes should address four main areas:
— errors in data entry;
— the completeness of data, specially referring to mandatory data;
— the proper use of the ADREP taxonomy;
— improving the consistency of data, notably between the information collected initially
and the report stored in the database (see Article 7(3)).
(e) The storage of occurrence reports that qualify for mandatory and voluntary reporting in one
or more databases (see Article 6(5)) using formats that are standardised to facilitate
information exchange and are compatible with the ECCAIRS software and the ADREP
taxonomy (see Article 7(4)).
Note: organisations that are able to report through an ECCAIRs software compatible reporting
system provided by their competent authority are deemed automatically compliant with the
reporting system requirements in Article 7(4) and do not need to have their own ECCAIRS
software compatible reporting system.

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(f) The application of the safety risk management process to occurrences:

(1) identification of the safety hazards associated with identified occurrences or groups of
occurrences reported to the competent authority (see Article 13(1));
(2) analysis of the related risks in terms of the probability and severity of the outcomes, as
well as the assessment of risks in terms of their tolerability;
(3) based on the result of the risk assessment: the determination of the need for mitigation
action, as required to improve aviation safety (see Article 13(2)); and
(4) monitoring the timely implementation and effectiveness of any mitigation action that is
required (see Article 13(2)).
(g) If the organisations identify that no potential aviation unsafe condition exists as a result of
their analysis of occurrences:
(1) they can delay the reporting to EASA up to the issuance of the final report and report
the occurrence as closed on issue (data exchange). In such cases, no follow-up report
should be submitted. However, the report to EASA should include confirmation and
justification that no unsafe condition exists. It is requested that the organisation
provides information on the cause(s) of the occurrence and on the corrective or
preventive actions (if any) put in place by the organisation; or
(2) after an initial report was sent, the closure report should include confirmation and
justification that no unsafe condition exists. It is requested that the organisation
provides information on the cause(s) of the occurrence and on the corrective or
preventive actions (if any) put in place by the organisation.
This way of reporting should not be understood as an accepted deviation from the
requirements of Part 21 or the requirements of Regulation (EU) No 376/2014. If, at any stage
during the course of the investigation, the organisation identifies that a potential unsafe
condition exists, it should be reported to EASA within 72 hours.
(h) If the organisation identifies an actual or potential aviation safety risk as a result of its analysis
of occurrences or group of occurrences, it should transmit the following information to the
competent authority within 30 days from the date of notification of the occurrence to the
authority (see Article 13(4)):
(1) the latest position of the organisation as to whether the (potential) unsafe condition is
confirmed;
(2) the occurrence analysis and first investigation results — including the cause(s) of
occurrence if known;
(3) the containment actions that have already been defined and put in place (if any);
(4) a risk assessment supporting that the product can be operated safely (see
GM 21.A.3B(d)(4) Defect correction — Sufficiency of proposed corrective action or the
relevant DOA procedure) until the corrective actions have been defined and
implemented, or until a more refined risk assessment can be provided.

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Organisations are encouraged to provide a complete analysis and follow-up as soon as

available and, in principle, no later than 3 months after the occurrence notification. It is
recognised that analysing an occurrence may take longer than 3 months, especially in the
event of a complex investigation or where the services of a specialist investigator are required.
The follow-up requirements are not intended to jeopardise the quality and thoroughness of an
occurrence analysis. It may be detrimental to safety if rushed in order to be completed within
the encouraged 3-month period without properly establishing the root cause(s) and
determining the relevant remedial action.
The final (close-out) report shall include:
(1) the final TC holder position as to whether a (potential) unsafe condition exists;
(2) the occurrence analysis and final investigation results — including the cause(s) of
occurrence;
(3) the corrective and preventive actions; and
(4) a risk assessment supporting that these corrective and preventive actions allow the
product to be operated safely (refer to GM 21.A.3B(d)(4) Defect correction —
Sufficiency of proposed corrective action or the relevant DOA procedure).
Note: the legal obligation to provide the initial results of the analysis of the occurrence,
follow-up reports and final results lies with the other organisation that is the source of the
initial report. If an organisation receives a copy of a report from another organisation that
initially reported the occurrence to the competent authority, depending on its contribution to
the actual or potential aviation safety risk that underlies the occurrence, it may, however, be
required to perform its own analysis of the issue reported, and to provide a follow-up report
to the competent authority.
(i) Safety policy and just culture: consultation of staff representatives to ensure that there is
mutual agreement on and adoption of rules that describe how the ‘just culture’ principles are
guaranteed and implemented within the organisation.
Note 1: the purpose of those rules is to ensure that none of the employees and contracted
personnel that report or are mentioned in occurrence reports, either mandatory or voluntary,
are subjected to any prejudice by their employer or any other organisation for which the
services are provided on the basis of the information supplied by the reporter (see
Article 16(9)), unless an exception applies (see Article 16(10)).
Note 2: staff representatives may be nominated either by the union(s) or by the staff
themselves.
(j) Ensuring that employees and contracted personnel are regularly provided with information
concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken
(see Article 13(3)), while ensuring that only anonymised information is distributed.
(k) Ensuring that personal details are only made available to staff members of their organisation
other than the persons designated in accordance with point (c) if this is necessary to
investigate occurrences with a view to enhancing aviation safety.

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(l) Ensuring that reports addressed to the competent authority contain at least the information
listed in Annex I to Regulation (EU) No 376/2014.
 21.A.3A Occurrence reporting

GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting

INTERNAL SAFETY REPORTING SCHEME
The overall purpose of the internal safety reporting scheme is to use reported information to
improve the level of the safety performance of the organisation, and not to attribute blame.
The objectives of the scheme are to:
(a) enable an assessment of the safety implications of each relevant incident (errors), safety issue
and hazard reported, including previous similar issues, so that any necessary action can be
initiated; and
(b) ensure that knowledge of relevant incidents, safety issues and hazards is distributed so that
other persons and organisations may learn from them.
The scheme is an essential part of the overall monitoring function, and it should be complementary
to the normal day-to-day procedures and ‘control’ systems; it is not intended to duplicate or
supersede any of them. The scheme is a tool to identify those instances when routine procedures
have failed or may fail.
All safety reports that are judged to be reportable by the person submitting the report should be
retained, as the significance of such reports may only become obvious at a later date.
Typical occurrences to be reported are those where aviation safety was, or could have been
endangered, or which could have led to an unsafe condition. If, in the view of the reporter, an
occurrence did not endanger aviation safety but, if it was repeated in different but likely
circumstances, would create an unsafe situation that could lead to an accident or a serious incident,
then a report should be made. What is judged to be reportable on one class of product, part, or
appliance may not be the same for another, and the absence or presence of a single factor,
organisational, human, or technical, can transform an occurrence into an accident or serious
incident.
The collection and analysis of timely, appropriate and accurate data will allow the organisation to
react to the information received, and apply the necessary action.

 21.A.3A Occurrence reporting

AMC1 21.A.3A(b)(2)(d) Occurrence reporting Reporting to the

Agency
REPORTING TO EASA
Within the overall limit of 72 hours, the degree of urgency for the submission of a report should be
determined by the level of hazard that is judged to have resulted from the occurrence.
Where If an occurrence is judged by the person identifying the possible unsafe condition to have
resulted in an immediate and particularly significant hazard, the Agency EASA (or the competent

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authority of the Member State as required) expects to should be advised immediately and by the
fastest possible means (telephone, fax, email, telex, etc.) of whatever details are available at that
time. This initial report must be followed up by a full written report within 72 hours. An A typical
example would be an uncontained engine failure resulting in damage to aircraft primary structure.
In all other cases in which the possible unsafe condition does not result Where the occurrence is
judged to have resulted in a less an immediate and less more significant hazard, the report
submission may be delayed up to the maximum of three 3 days in order to provide more details.
 21.A.3A Occurrence reporting

AMC1 21.A.5 Record-keeping

(a) The record-keeping system should ensure that all the records required by point 21.A.5 are
accessible within a reasonable time. These records should be organised in a manner that
ensures that there is traceability and retrievability throughout the required retention period.
(b) The records should remain legible throughout the required retention period and be protected
against damage, alteration and tampering.
(c) The format of the records should be specified in the organisation’s procedures.
(d) Organisations approved according to Subparts G and J of Part 21 should ensure that the
following records related to the management system defined in accordance with 21.A.139 and
21.A.239 are retained as long as the organisation carries out activities related to Part 21:
(1) the relevant records of management system key processes as defined in points
21.A.126A, 21.A.139, 21.A.239; and
(2) contracts, including with partners, subcontractors and suppliers,

(e) The organisation should ensure that copies of all the documents and supporting
information developed:
(1) under the privileges according to points 21.A.163 and 21.A.263; or
(2) for major repairs, major changes, STCs, and RTCs not issued under privileges
according to point 21.A.263,

are retained until 3 years after the date when the organisation ceases to hold the TC, RTC,
STC, ETSO authorisation, major repair design approval, or production organisation approval.
(f) The retention period starts when the record is created or when it was last amended.
(g) If the organisation transfers a certificate or a letter of agreement to another natural or legal
person, the records related to the certificate should be transferred to the new holder.
 21.A.5 Record-keeping

GM1 21.A.5 Record-keeping

For organisations that hold or have applied for a TC, RTC, STC, ETSO authorisation, major repair
design approval, permit to fly, production organisation approval or letter of agreement under Part
21, the relevant design information/data includes at least, as applicable:

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— design data such as type design data as defined in point 21.A.31 and changes to that data,
ETSO design data, and repair design data;
— drawings and test reports, including inspection records for the product tested;
— the certification programme; and
— compliance demonstration data.
For production organisations, the relevant records include at least:
— conformity justification data with a specific focus on the production and inspection phases;
and
— conformity attestation data (e.g. EASA Form 1, EASA Form 52).
— 21.A.5 Record-keeping

AMC1 21.A.5(a) and 21.A.433(a) Record-keeping

REPAIR DESIGN
(a) The relevant substantiation data associated with a new major repair design and
record-keeping should include:
(1) identification of the damage and the source of the report;
(2) the major repair design approval sheet, identifying the applicable specifications and the
references of the justifications;
(3) the repair drawing and/or instructions, and the scheme identifier;
(4) any correspondence with the TC, STC, or APU ETSO authorisation holder, if its advice on
the design has been sought;
(5) the structural justification (static strength, fatigue, damage tolerance, flutter, etc.) or
references to this data;
(6) the effect on the aircraft, engines and/or systems, (performance, flight handling, etc. as
appropriate);
(7) the effect on the maintenance programme;
(8) the effect on the airworthiness limitations, the flight manual and the operating manual;
(9) any change in the weight and moment; and
(10) any special test requirements.
(b) The relevant minor repair documentation includes points (a)(1) and (a)(3). Other elements of
point (a) may be included where necessary. If the repair is outside the approved data, a
justification for the classification is required.
(c) Special consideration should be given to repairs that impose subsequent limitations on the
part, product or appliance (e.g. engine turbine segments that may only be repaired a finite
number of times, the number of repaired turbine blades per set, oversizing of fastener holes,
etc.).

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(d) Special consideration should also be given to life-limited parts and critical parts, notably with
the involvement of the TC or STC holder, when deemed necessary under point 21.A.433(b).
(e) Repairs to engines or to APU critical parts would normally only be accepted with the
involvement of the TC holder.

 21.A.5 Record-keeping

GM1 21.A.5(a) and (b) Record-keeping

RECORDING AND ARCHIVING SYSTEM
Records within a design or production environment satisfy two purposes. Firstly, they are required,
during the:
— design process to ensure that the configuration of products, parts, or appliances is in
compliance with the certification basis; or
— production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle.
Secondly, certain records of milestone events are needed to subsequently provide objective
evidence that all the prescribed stages of the design or production process have been satisfactorily
completed.
Therefore, the approved design or production organisation or natural or legal person who produces
products, parts and appliances under Part 21 Subpart G are required to implement a system for the
compilation and retention of records during all stages of design or production, covering short-term
and long-term records appropriate to the nature of the product and its processes.
The management of such information is subject to the appropriately documented procedures in the
management system required by points 21.A.139, 21.A.239 or in the manual required by point
21.A.125A(b), as appropriate.
All forms of recording media are acceptable (paper, film, magnetic, etc.) provided they can meet the
required duration for archiving under the conditions provided.
The related procedures are required to:
— identify the records to be kept;
— describe the organisation of, and responsibility for, the archiving system (its location,
compilation, format) and the conditions for access to the information (e.g. by product,
subject);
— control access to the data and provide effective protection from deterioration or accidental
damage;
— ensure the continued readability of the records;
— demonstrate to the competent authority the proper functioning of the records system;
— define an archiving period for each type of data subject to the following:

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 production data which supports the conformity of a product, part, or appliance is kept
for not less than 3 years from the issue date of the related statement of conformity or
authorised release certificate.

 design data which supports the compliance of a product, part, or appliance is kept for
not less than 3 years after the surrender or revocation of the TC, RTC, STC, major repair
or ETSO authorisation This may include minor changes and minor repairs to those TCs,
RTCs, STCs, major repairs, or ETSO authorisations; and

 data that is considered essential for continuing airworthiness is kept throughout the
operational life of the product, part or appliance;

 for organisations approved according to Subparts G and J of Part 21, ensure that the recording
and record-keeping system used by the partners, suppliers and subcontractors meet the
record-keeping objectives with the same level of confidence as for their own system. In each
case, it should be defined who is to retain the data record (organisation or partner, supplier or
subcontractor) as well as the method for surveillance of the recording/record-keeping system
of the partners, suppliers or subcontractors; and
 for natural or legal persons who produce items under Part 21 Subpart F, the data related to
supplied parts may be retained by the supplier if the supplier has a system agreed under
Part 21, Section A, Subpart F, by the competent authority. The production organisation
manufacturer, in each case, is required to define the archiving period and satisfy itself and the
competent authority that the recording media are acceptable.

 21.A.5 Record-keeping

AMC1 21.A.5(e) Record-keeping

RECORD OF PERSONNEL INVOLVED IN DESIGN OR PRODUCTION
(a) The following should be the minimum information to be recorded for each person who
exercises the privileges of an organisation approved according to Subparts G and J of Part 21
according to points 21.A.163 or 21.A.263, or who carries out the independent monitoring of
compliance and adequacy according to point 21.A.139(f) and 21.A.239(f):
(1) name
(2) date of birth
(3) basic training and standard attained
(4) specific training and standard attained
(5) continuation training (if appropriate)
(6) experience
(7) scope of the authorisation
(8) date of first issue of the authorisation
(9) expiry date of the authorisation (if appropriate)
(10) identification number of the authorisation

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(b) The record may be kept in any format and should be controlled by an internal procedure of
the organisation. This procedure forms part of the management system.
(c) The person should be given reasonable access on request to his or her own records in respect
of provisions defined by Regulation (EU) 2016/679.
(d) A production organisation should keep the record for at least 3 years after the:
(1) person has ceased employment with the organisation or has changed his or her position
in the organisation, or the withdrawal of the authorisation in the case of certifying staff,
whichever is the sooner.
(2) the organisation surrendered the TC, RTC, STC, ETSO authorisation, major repair
design approval, or production organisation approval.
(e) A design organisation should retain the records as long as it carries out activities related to
Part 21.
 21.A.5 Record-keeping

GM1 21.A.9 Investigations

ARRANGEMENTS
The arrangements made by the applicant for, or holder of a TC, RTC, STC, ETSO authorisation, major
repair design approval, permit to fly, production organisation approval or letter of agreement under
Part 21 are required to allow the competent authority to make investigations that include the
complete organisation including its partners, subcontractors and suppliers, whether they are in the
State of the applicant or not.
The investigations may include audits, enquiries, questions, discussions and explanations,
monitoring, witnessing, inspections, checks, flight and ground tests and inspections of completed
products, parts or appliances designed or produced.
In order to maintain its confidence in the standards achieved by the organisation, the competent
authority may make an investigation of a sample product part or appliance and its associated
records, reports and certifications.
The arrangements are required to enable the organisation to give positive assistance to the
competent authority and cooperate in performing the investigation during both the initial
assessment and for the subsequent surveillance.
Cooperation in performing investigations refers to the competent authority having been given full
and free access to the facilities and to any information relevant to demonstrate compliance with the
Part 21 requirements, and assistance (personnel support, records, reports, computer data, etc. as
necessary).
Assistance to the competent authority includes all the appropriate means associated with the
facilities of the organisation to allow the competent authority to perform these investigations, such
as the availability of a meeting room, office and personnel support, documentation and data, and
communication facilities, all properly and promptly made available as necessary.
The competent authority seeks to have an open relationship with the organisation, and suitable
liaison personnel are required to be nominated to facilitate this, including suitable representative(s)

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to accompany competent authority staff during visits, not only at the organisation’s own facilities,
but also at subcontractors, partners or suppliers.
 21.A.9 Investigations

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SUBPART F — PRODUCTION WITHOUT PRODUCTION

ORGANISATION APPROVAL

AMC1 No1 to 21.A.122 Eligibility — Link between design and

production
LINK BETWEEN DESIGN AND PRODUCTION
An ‘arrangement’ is considered suitable if it is documented and satisfies the competent authority
that co-ordination coordination is satisfactory.
To achieve satisfactory coordination co-ordination, the documented arrangements must at least
define the following aspects, irrespective of whether the design organisation and the person
producing or intending to produce under Part 21 Subpart F are separate legal entities or not:
(a)1 The responsibilities of a design organisation which assure correct and timely transfer of up-to-
date applicable design data (e.g., drawings, material specifications, dimensional data,
processes, surface treatments, shipping conditions, quality requirements, etc.);
(b)2 The responsibilities and procedures of the production organisation manufacturer for
receiving, managing and using the applicable design data provided by the design organisation;.
(c)3 The responsibilities and procedures of the production organisation manufacturer for
developing, where applicable, its own manufacturing data in compliance with the applicable
design data package;.
(d)4 The responsibilities of the production organisation manufacturer to assist the design
organisation in dealing with continuing airworthiness matters and for required actions (e.g.,
traceability of parts in case of direct delivery to users, retrofitting of modifications, traceability
of processes’ outputs and approved deviations for individual parts as applicable, technical
information and assistance, etc.);
(e)5 The scope of the arrangements covering Subpart F requirements, in particular: points
21.A.126(a)(4), and 21.A.129(d) and (f) 21.A.3A and any associated GM or AMC;.
(f)6 The responsibilities of the production organisation manufacturer, in the case of products prior
to type certification, to assist a design organisation in demonstrating compliance with the CS
(access and suitability of production and test facilities for manufacturing and testing of
prototype models and test specimen);
(g)7 The procedures to deal adequately with production deviations and non-conforming parts;
(h)8 The means to achieve adequate configuration control of manufactured parts, to enable the
production organisation manufacturer to make the final determination and identification for
conformity or airworthiness release and eligibility status;
(i)9 The identification of responsible persons/offices who controls control the above; and.
(j)10 The acknowledgment by the holder of the TC/STC/repair or change approval/ETSO
authorisation that the approved design data provided, controlled and modified in accordance
with the arrangement are is recognised as approved.

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In many cases, the person producing or intending to produce under Part 21 Subpart F may receive
the approved design data through an intermediate production organisation. This is acceptable,
provided that an effective link between the design approval holder and the production organisation
can be maintained to satisfy the intent of point 21.A.122.
When the design organisation and the production organisation manufacturer are two separate legal
entities, a Ddirect Ddelivery Aauthorisation should be available for direct delivery to end users in
order to guarantee continued airworthiness control of the released parts and appliances.
Where there is no general agreement for Ddirect Ddelivery Aauthorisation, specific permissions may
be granted (see AMC 21.A.4).

AMC1 21.A.124 Application

An applicant should submit to the competent authority an EASA Form 60 (see below) completed in
all blocks.

EASA Form 60
Application for agreement of production under Part 21 Subpart F

Competent authority
of an EU Member State or
EASA

1. Registered name and address of the applicant:

2. Trade name (if different):

3. Location(s) of manufacturing activities:

4. Description of the manufacturing activities under application

a) Identification (TC, P/N , … as appropriate):

b) Termination (No. of units, Termination date, …):

5. Evidence supporting the application, as per point

21.A.124(b):

6. Links/arrangements with design approval

holder(s)/ design organisation(s) where different
from Block 1. :

7. Human resources:

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8. Name of the person signing the application:

______________________________ ______________________________________
Date Signature

EASA Form 60 Issue 3

Block 1: the name of the applicant should be entered. For legal entities, the name should be as stated in the
register of the National Companies Registration Office. In this case, a copy of the entry in the register of
the National Companies Registration Office should be provided to the competent authority.

Block 2: state the trade name by which the applicant is known to the public if it is different from the
information given in Block 1. The use of a logo may be indicated in this block.

Block 3: state all the locations of the manufacturing activities that are covered by the application. Only those
locations should be stated that are directly under the control of the applicant stated in Block 1.

Block 4: this block should include further details of the manufacturing activities under the approval for the
addresses indicated in Block 3. The ‘Identification’ block should indicate the products, parts or
appliances intended to be produced, while the ‘Termination’ block should address any information on
the limitation of the activity, e.g. by stating the intended number of units to be manufactured or the
expected date of completion of the manufacturing activities.

Block 5: this block should state the evidence that supports the determination of applicability as stated in point
21.A.121. In addition, an outline of the manual required by point 21.A.125A(b) should be provided with
the application.

Block 6: the information entered here is essential for the evaluation of the eligibility of the application.
Therefore, special attention should be given concerning the completion of this block, either directly, or
by reference to supporting documentation in relation to the requirements of point 21.A.122 and
AMC1 21.A.122.

Block 7: the information to be entered here should reflect the number of staff, or in the case of an initial
approval, the intended number of staff, for the manufacturing activities under this application, and
therefore it should also include any associated administrative staff.

Block 8: State the name of the person authorised to sign the application.

GM 21.A.124(a) Application – Application form

EASA Form 60 (see AMC 21.B.120(c)(1)) should be obtained from the competent authority and
completed by the applicant.
An application may be accepted from:
 An individual applying on his or her own behalf, or


In the case of an organisation, an individual with the authority to make agreements on
behalf of the organisation.
The completed form should be forwarded to the competent authority.

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AMC1 21.A.124A Alternative means of compliance

In order to demonstrate that the requirements are met, a risk assessment should be completed and
documented. The result of this risk assessment should demonstrate that the alternative means of
compliance reaches a level of safety that is acceptable to the competent authority.
 21.A.124A Alternative means of compliance

GM No 1 to 21.A.158(a) Uncontrolled non-compliance with

applicable design data
An uncontrolled non-compliance with applicable design data is a non-compliance:

 that cannot be discovered through systematic analysis; or

 that prevents identification of affected products, parts, appliances, or material.

GM No 2 to 21.A.158(a) Examples of level one findings

Examples of level one findings are non-compliances with any of the following points, that could
affect the safety of the aircraft:
21.A.126, 21.A.127, 21.A.128, 21.A.129..
It should be anticipated that a non-compliance with these points is only considered a level one
finding when objective evidence has been found that this finding is an uncontrolled non-compliance
that could affect the safety of the aircraft.

GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings

CAUSAL ANALYIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as fault tree, to
identify the chain of events that led to the non-compliance may not properly reflect the complexity
of the issue, and, it therefore bears the risk that important factors that need to be addressed in
order to prevent reoccurrences will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the non-conformity. A peer review of the results of the causal analysis may
increase its reliability and objectivity.
A system description of the organisation that considers the organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.
 21.A.125B Findings

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GM 21.A.126(b)(6) Production inspection system – Recording and

record keeping
1. Records within a production environment satisfy two purposes. Firstly, they should, during the
production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle. Secondly, certain records of milestone
events are needed to subsequently provide objective evidence that all prescribed stages of
the production process have been satisfactorily completed and that compliance with the
applicable design data has been achieved.
Therefore, the person producing under Part 21 Subpart F should implement a system for the
compilation and retention of records during all stages of manufacture, covering short-term
and long-term records appropriate to the nature of the product and its production processes.
The management of such information should be subject to appropriate documented
procedures in the Manual required by 21.A.125A(b).
All forms of recording media are acceptable (paper, film, magnetic ...) provided they can meet
the required duration for archiving under the conditions provided.
2. The related procedures should:
2.1 Identify records to be kept.
2.2 Describe the organisation of and responsibility for the archiving system (location,
compilation, format) and conditions for access to the information (e.g., by product,
subject).
2.3 Control access and provide effective protection from deterioration or accidental
damage.
2.4 Ensure continued readability of the records.
2.5 Demonstrate to the competent authority proper functioning of the records system.
2.6 Clearly identify the persons involved in conformity determination.
2.7 Define an archiving period for each type of data taking into account importance in
relation to conformity determination subject to the following:
a) Data which supports conformity of a product, part, or appliance should be kept
for not less than three years from the issue date of the related Statement of
Conformity or Authorised Release Certificate.
b) Data considered essential for continuing airworthiness should be kept throughout
the operational life of the product, part or appliance.
2.8 Data related to supplied parts may be retained by the supplier if the supplier has a
system agreed under Part 21 Section A Subpart F by the competent authority. The
manufacturer should, in each case, define the archiving period and satisfy himself or
herself and the competent authority that the recording media are acceptable.

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SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR

PRODUCTS, PARTS AND APPLIANCES

GM 21.A.134 Application – Application form and manner

EASA Form 50 (see AMC 21.B.220(c)) should be obtained from the competent authority, and
completed by the accountable manager of the organisation.
The completed form, an outline of the production organisation exposition, and details of the
proposed terms of approval are to be forwarded to the competent authority.

AMC1 21.A.134 Application

An applicant for a POA should submit to the competent authority an EASA Form 50 (see below)
completed by the applicant.
The completed form, an outline of the production organisation exposition, and details of the
proposed terms of approval should be forwarded to the competent authority

EASA Form 50
Application for a Part 21 production organisation approval

Competent authority
of an EU Member State or
EASA

1. Registered name and address of the organisation:

2. Trade name (if different):

3. Location(s) for which the approval is applied for:

4. Brief summary of proposed activities at the item 3 addresses

a) General:

b) Scope of approval:

c) Nature of privileges:

5. Description of organisation:

6. Links/arrangements with design approval

holder(s)/design organisation(s) where different
from 1.:

7. Approximate number of staff engaged or intended

to be engaged in the activities:

8. Position and name of the accountable manager:

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_____________________________________ ___________________________________
Date Signature of the accountable manager
EASA Form 50

Block 1: the name of the organisation should be entered as stated in the register of the National Companies
Registration Office. For the initial application, a copy of the entry in the register of the National
Companies Registration Office should be provided to the competent authority.

Block 2: state the trade name by which the organisation is known to the public if it is different from the
information given in Block 1. The use of a logo may be indicated in this Block.

Block 3: state all the locations for which the approval is applied for. Only those locations should be stated
that are directly under the control of the legal entity stated in Block 1.
Block 4: this block should include further details of the activities under the approval for the addresses
indicated in Block 4. The ‘General’ block must include overall information, while the ‘Scope of
approval’ Block should address the scope of work and the products/categories following the
principles laid down in GM 21.A.151. The ‘nature of privileges’ block should indicate the requested
privileges as defined in points 21.A.163(b)-(e). For an application for renewal, state ‘not applicable’.

Block 5: this block should provide a summary of the organisation with reference to the outline of the
production organisation exposition, including the organisational structure, functions and
responsibilities. The nomination of the responsible managers in accordance with point
21.A.145(c)(2) should be included as far as possible, accompanied by the corresponding EASA Form
4. For an application for renewal, state ‘not applicable’.

Block 6: the information entered here is essential for the evaluation of the eligibility of the application.
Therefore, special attention should be given concerning the completion of this block, either directly
or by reference to supporting documentation, in relation to the requirements of points 21.A.133(b)
and (c) and the AMC to 21.A.133(b) and (c).

Block 7: the information to be entered here should reflect the number of staff, or in the case of an initial
approval, the intended number of staff for the complete set of activities that are to be covered by
the approval, and it should also therefore include any associated administrative staff.

Block 8: State the position and name of the accountable manager.

AMC1 21.A.134A Alternative means of compliance

(a) In order to demonstrate that the requirements are met, a risk assessment should be
completed and documented. The result of this risk assessment should demonstrate that the
alternative means of compliance reaches a level of safety that is acceptable to the competent
authority.
(b) The result of the risk assessment forms an integral part of the management system records to
be managed in accordance with point 21.A.139.

 21.A.134A Alternative means of compliance

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GM1 21.A.139(c) Production management system

SAFETY MANAGEMENT ELEMENT
Safety management seeks to proactively identify hazards and mitigate the related safety risks before
they result in aviation accidents and incidents. Safety management enables an organisation to
manage its activities in a more systematic and focused manner. When an organisation has a clear
understanding of its role and contribution to aviation safety, it enables the organisation to prioritise
safety risks and more effectively manage its resources for optimal results.
Safety should not be considered the responsibility of a single person or a limited group of people in
the organisation. A safety culture should be developed throughout the organisation that involves all
the personnel as active contributors to the safety of the final product, part or appliance in
accordance with AMC1.21.A.139(c)(1).
The requirements established in points 21.A.3A, 21.A.5, 21.A.139, 21.A.145 and 21.A.147 and the
related AMC constitute the EU production management system framework for aviation safety
management. This framework transposes Appendix 2 to ICAO Annex 19. The EU approach aims at
facilitating the introduction of safety management systems into production organisations by
inserting the components of safety management into Part 21, thus building upon the existing
management systems.
Therefore, the approach aims at encouraging organisations to embed safety management and
risk-based decision-making into all their activities, instead of superimposing another system onto
their existing management system and governance structure. In addition, where the organisation
holds multiple organisation certificates issued under Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on the basis thereof (according to point 21.A.139(h)), the
organisation may choose to implement a single management system to cover all of its activities. An
integrated management system may not only be used to capture multiple certification
requirements, but also to cover other business management systems such as quality, security,
occupational health and environmental management systems. Integration will remove duplication
and exploit synergies by managing safety risks across multiple activities. Organisations may
determine the best means to structure their management systems to suit their business and
organisational needs.
It is important to recognise that safety management will be a continuous activity, as hazards, risks
and the effectiveness of safety risk mitigations will change over time.
The safety management capability of an organisation should be commensurate with the safety risks
to be managed, which can be at the products, parts and appliances level or at the organisational
level:
— If an organisation produces parts that have a limited effect on safety, it may limit the scope of
its safety management system to cover only the areas that contribute to safety (e.g. the
criticality will be different for the production of parts such as safety belts, or major elements
such as an autopilot system).
— The risks that are inherent in a complex structure require a robust safety risk management
process (e.g. a complex supply chain may induce hazards that are complex to mitigate, or the
rate of production, when stretched to the limit, will require more efficient safety barriers).

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As a consequence, scalability should be a function of the inherent safety risk capability of the
organisation. For instance:
— the risk assessment model used may be very simple in small organisations where the
identified hazards are easy to mitigate;
— expert judgement might be sufficient to measure the efficiency of safety barriers;
— the collection of data, safety information and occurrences might be very limited;
— there might be no need for software and tools to manage the SMS;
— the communication policy might be limited.
However, small organisations that are involved in activities that entail significant aviation safety risks
might require greater SMS resources.

 21.A.139 Production management system

AMC1 21.A.139(c) Production management system

SAFETY MANAGEMENT ELEMENT
An organisation that has a safety management element, compliant with the SMS Industry Standard
‘Implementing a Safety Management System in Design, Manufacturing and Maintenance
Organizations’ SM001 Issue A - September 17th, 20181, should be considered compliant with the EU
framework for aviation safety management as described in GM1 21.A.139(c), provided that
compliance with the following additional topics, as appropriate, is demonstrated.
Paragraph of SMS Industry Standard
Point Additional topics
SM001 Issue A - September 17th, 2018
§6.1.1.1 Safety Policy
Reporting to EASA as per 21.A.3A (b)(3)
§6.2.1 Hazard identification
(refer to AMC 20-8 and AMC1 21.A.3A(d)
§6.2.2 Safety Risk Assessment and as acceptable means of compliance)
21.A.3A Mitigation
Compliance with Regulation (EU)
§6.3 Safety Assurance No 376/2014 (refer to GM1 21.A.3A(a)(1)
and (b)(1) as a summary of the
§6.4.2 Safety Communication
requirements)
§7 Interfaces between organizations
Record-keeping (refer to the AMC and
21.A.5 Not available GM related to 21.A.5 as acceptable
means of compliance and guidance)
§6.1.2 Safety Accountability and
Responsibilities
§6.1.3 Appointment of Key Safety
21.A.139 (b) none
Personnel
§6.2 Safety Risk Management (system
description)

1
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§6.3.2 Management of Change

§6.3.3 Continuous Improvement of
the SMS
§6.4.1 Training and Education
§1 Introduction
§6.1.1.1 Safety Policy
Human factors in the safety policy (refer
§6.1.1.2 Safety Objectives to AMC1 21.A.139(c)(1) as acceptable
§6.1.2 Safety Accountability and means of compliance)
Responsibilities Functions of safety review board & safety
§6.1.3 Appointment of Key Safety action group (refer to
Personnel AMC1 21.A.139(c)(2) and
GM1 21.A.139(c)(2) for acceptable means
§6.2 Safety Risk Management
of compliance and guidance)
§6.2.1 Hazard identification
Interface risk management in case of
§6.2.2 Safety Risk Assessment and subcontracts (refer to
(c) Mitigation AMC1 21.A.139(c)(3) for acceptable
means of compliance)
§6.3 Safety Assurance
Systematic management of all changes,
§6.3.1 Safety Performance Monitoring
not limited to those having substantive
and Measurement
impact on safety management (refer to
§6.3.2 Management of Change AMC1 21.A.139(c)(4)(ii) for acceptable
§6.3.3 Continuous Improvement of means of compliance)
the SMS More structured safety training (refer to
§6.4 Safety Promotion AMC1 21.A.139(c)(5)(i) for acceptable
means of compliance)
§6.4.1 Training and Education
§6.4.2 Safety Communication
§7 Interfaces between organizations
§6.1.5 SMS Documentation
(e) None
§6.4.2 Safety Communication
Independency of the monitoring of
§6.3.1 Safety Performance Monitoring
compliance and adequacy as per
(f) and Measurement (paragraph title:
21.A.139(f). Refer to AMC1 21.A.139(f)
Need for additional measurement)
for acceptable means of compliance)

(g) §7.3 Corporate SMS approach None

21.A.143 §6.1.5 SMS Documentation None

§6.1.1.1 Safety Policy Identification of managers responsible for
the essential functions (refer to
§6.1.2 Safety Accountability and
AMC1 21.A.145(c)(2) for acceptable
21.A.145(c) Responsibilities
means of compliance)
§6.1.3 Appointment of Key Safety
Definition of competency of personnel
Personnel
(refer to AMC2 21.A.145(c)(2) for

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§6.4.1 Training and Education acceptable means of compliance)

Systematic management of all changes,
not limited to those having substantive
21.A.147 §6.3.2 Management of Change impact on safety management (refer to
AMC1 21.A.139(c)(4)(ii) for acceptable
means of compliance)
 21.A.139 Production management system

AMC1 21.A.139(c)(1) Production management system

SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic
management, including the promotion of a positive safety culture;
(2) include internal reporting principles, and encourage personnel to report
production-related errors, incidents and hazards;
(3) be endorsed by the accountable manager;
(4) be communicated, with visible endorsement, throughout the organisation; and
(5) be periodically reviewed to ensure that it remains relevant and appropriate to the
organisation.
(b) The safety policy should include commitments to:
(1) comply with all the applicable legislation, meet all the applicable requirements, and
adopt practices that work towards improving safety standards;
(2) provide the necessary resources for its implementation;
(3) apply human factors principles;
(4) enforce safety as a primary responsibility of all managers; and
(5) apply ‘just culture’ principles, and, in particular, to not make available or use any
personal information on occurrences:
(i) to attribute blame or liability for actions, omissions or decisions taken by
personnel that are commensurate with their experience and training; or
(ii) for any purpose other than the improvement of aviation safety.
(c) Senior management should continuously promote the safety policy to all personnel, and
demonstrate their commitment to it and provide the necessary human and financial resources
for its implementation.
(d) Taking due account of its safety policy, the organisation should define safety objectives. The
safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
(2) reflect the organisation’s commitment to maintain or continuously improve the overall
effectiveness of the management system;

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(3) be communicated throughout the organisation; and

(4) be periodically reviewed to ensure that they remain relevant and appropriate to the
organisation.

 21.A.139 Production management system

GM1 21.A.139(c)(1) Production management system

SAFETY POLICY
The safety policy is the means for the organisation to state its intention to maintain and, where
practicable, improve safety levels in all its activities, and to minimise its contribution to the risk of an
aircraft accident or serious incident as far as is reasonably practicable. It reflects the management’s
commitment to safety and the organisation’s philosophy of safety management. It is the foundation
on which the organisation’s management system is built and serves as a reminder of ‘how we do
business here’. The creation of a positive safety culture begins with the issuance of a clear,
unequivocal policy statement.
The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules
that describe how ‘just culture’ principles are guaranteed and implemented.
For organisations that have their principal place of business in a Member State, Regulation (EU)
No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11)
of that Regulation).
 21.A.139 Production Management System

AMC1 21.A.139(c)(2) Production management system

SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
(a) The management system should encompass safety by defining a structure that is able to
administrate and maintain the processes and functions of the safety management system as
described in point 21.A.139(c). The accountable manager should establish and maintain
functions which act as:
(1) the safety manager; and
(2) a high-level committee that considers matters of strategic safety, sometimes referred to
as the ‘safety review board’, depending on the size of the organisation and the nature
and complexity of its activities, and subject to a risk assessment that is agreed by the
competent authority.
(b) The safety review board function should monitor:
(1) the safety performance against the safety policy and objectives;
(2) whether any safety action is taken in a timely manner; and
(3) the effectiveness of the organisation’s management system processes.
(c) The accountable manager may also establish and maintain a function, referred to as the
‘safety action group’, in support of the two functions above.
 21.A.139 Production management system

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GM1 21.A.139(c)(2) Production management system

SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
The organisation may define its structure in the manner that best fits its needs. The following is an
example of a possible organisation that complies with the safety management element of the
production management system.
The role of the person who assumes, or persons who assume, the function of safety manager should
include, but not be limited, to:
— support of the accountable manager in ensuring that the activities described in point
21.A.139(c) are performed;
— advice to the accountable manager on safety matters; and
— provision of periodic reports on safety performance to the accountable manager and to the
safety review board.
Regardless of the organisational set-up, it is important for the safety manager or a designated
person to remain the unique focal point for the development, administration, and maintenance of
the organisation’s safety management system.
When established by the accountable manager, the function of the safety review board is to:
— ensure that appropriate resources are allocated to achieve the established safety objectives;
— review the results of compliance monitoring; and
— monitor the implementation of the related corrective and preventive actions.
It is composed of heads of functional areas, and it is chaired by the accountable manager.
The role of the safety action group is to:
— analyse specific events;
— assess mitigation measures;
— monitor the safety performance of the organisation;
— define actions to control risks to an acceptable level;
— assess the impact of organisational changes on safety;
— ensure that safety actions are implemented within the agreed timescales; and
— review the effectiveness of previous safety actions and safety promotion.
— 21.A.139 Production management system

AMC1 21.A.139(c)(3) Production management system

SAFETY RISK MANAGEMENT — INTERFACES BETWEEN ORGANISATIONS
(a) Safety risk management processes should specifically address the planned implementation of,
or participation of the organisation in, any complex arrangements (such as when the PO
subcontracts work to multiple organisations).

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(b) Hazard identification and risk assessment should start with the identification of all the parties
involved in the arrangement, including independent experts and non-approved organisations.
This extends to the overall control structure, assessing in particular the following elements
across all subcontract levels and all parties within these arrangements:
(1) coordination and interfaces between the different parties;
(2) applicable procedures;
(3) communication between all the parties involved, including the reporting and feedback
channels;
(4) task allocation, responsibilities and authorities; and
(5) the qualifications and competency of key personnel with reference to point 21.A.145.
(c) Safety risk management should focus on the following aspects:
(1) clear assignment of accountability and allocation of responsibilities;
(2) only one party should be responsible for a specific aspect of the arrangement, with no
overlapping or conflicting responsibilities, in order to eliminate coordination errors;
(3) the existence of clear reporting lines, both for occurrence reporting and progress
reporting; and
(4) the possibility for staff to directly notify the organisation of any hazard that suggests
that there is an obviously unacceptable safety risk as a result of the potential
consequences of this hazard.
(d) Regular communication should be ensured between all the parties to discuss work progress,
risk mitigation actions, changes to the arrangements, as well as any other significant issues.
(e) For subcontracted activities, interfaces and communication channels are also needed for the
purposes of the internal safety reporting scheme (point 21.A.3A).
 21.A.139 Production management system

AMC1 21.A.139(c)(3) and (4) Production management system

SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Hazard identification should be based on a combination of reactive and proactive
methods.
(2) The organisation should in particular focus on the hazards that may generate a
non-conformity of the product, part or appliance that is produced.
(b) Safety risk management processes
(1) A safety risk management process should be developed and maintained that ensures
that the safety risks are:
(i) analysed (in terms of their probability and the severity of the consequences of
hazards and occurrences);

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(ii) assessed (in terms of their tolerability); and

(iii) controlled (in terms of the mitigation of risks to an acceptable level).
(2) Within the safety risk management process, the organisation should specify who has
the authority to make decisions regarding the tolerability of safety risks, in accordance
with (b)(1)(ii).
(c) Regardless of the approval status of the subcontracted organisations, the production
organisation is responsible for ensuring that all subcontracted activities are subject to hazard
identification and safety risk management, as required by point 21.A.139(c)(3), and for
monitoring of their compliance and adequacy, as required by point 21.A.139(f).
(d) Internal investigation
(1) In line with its just culture policy, the organisation should define how to investigate
incidents such as errors or near misses, in order to understand not only what happened,
but also how it happened, to prevent or reduce the probability and/or consequences of
any future recurrences (refer to AMC3 21.A.3A(a)(1) and (b)(1)).
(2) The scope of internal investigations should extend beyond the scope of the occurrences
that are required to be reported to the competent authority in accordance with point
21.A.3A.
(e) Safety performance monitoring and measurement
(1) The organisation should establish, implement and maintain a process by which the
safety performance of the organisation is continuously verified against the safety policy
and safety objectives.
(2) This process may include, as appropriate to the size, nature and complexity of the
organisation:
(i) safety reporting that also addresses the status of compliance with the applicable
requirements;
(ii) safety reviews, including trend reviews, which would be conducted during
introduction and deployment of new products and their components, new
equipment/technologies, the implementation of new or changed procedures, or
in situations of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management
system, and periodically assess the status of safety risk controls; and
(iv) safety surveys that examine particular elements or procedures of a specific area,
such as the problem areas identified, or any bottlenecks in daily production
management activities, the perceptions and opinions of the production
management personnel, and any areas of dissent or confusion.
(f) Management of change
The organisation should manage any safety risks that are related to a change. The
management of change should be a documented process to identify any external or internal

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change that may have an adverse effect on safety. It should make use of the organisation’s
existing hazard identification, risk assessment and risk mitigation processes.
(g) Continuous improvement
The organisation should continuously seek to improve its safety performance and the
effectiveness of its management system. Continuous improvement may be achieved through:
(1) compliance monitoring and audits carried out by external organisations;
(2) assessments, including assessments of the effectiveness of the safety culture and
management system, in particular to assess the effectiveness of the safety risk
management processes;
(3) staff surveys, including cultural surveys, that can provide useful feedback on how
engaged personnel are with the management system;
(4) monitoring incidents and their recurrences;
(5) evaluating safety performance indicators and reviewing all the available safety
performance information; and
(6) identifying the lessons learned.
 21.A.139 Production management system

GM1 21.A.139(c)(4)(ii) Production management system

MANAGEMENT OF CHANGE
Unless properly managed, changes in the organisational structure, facilities, scope of work,
personnel, documentation, policies and procedures, etc. can result in the inadvertent introduction of
new hazards, which can expose the organisation to new or greater risks. Effective organisations seek
to improve their processes, with conscious recognition that changes can expose the organisation to
potentially latent hazards and risks if they are not properly and effectively managed.
The process for the management of change typically provides principles and a structured framework
for managing all aspects of changes. Disciplined application of change management can maximise
the effectiveness of the change, engage staff, and minimise the risks inherent in change.
A change may have the potential to introduce new human factor issues, or to exacerbate pre-
existing ones. For example, changes in computer systems, equipment, technology, personnel
changes, including changes in management personnel, procedures, the work organisation, or work
processes are likely to affect performance.
Effective management of change is supported by the following:
— Implementation of a process for formal hazard identification/risk analysis and assessment for
major operational changes, major organisational changes, changes in key personnel, and
changes that may affect the way in which production management is carried out.
— Identification of changes that are likely to occur in business, which would have a noticeable
impact on:
 resources — material and human;

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 management direction — policies, processes, procedures, training; and

 management control.
— Safety cases/risk assessments that are aviation-safety focused.
— The involvement of key stakeholders in the change management process as appropriate.
— 21.A.139 Production management system

AMC1 21.A.139(c)(4)(ii) Production management system

MANAGEMENT OF CHANGE
(a) Regardless of the magnitude of a change, large or small, there should always be proactive
consideration of the safety implications. This is primarily the responsibility of the team that
proposes or implements the change. However, a change can only be successful if all the
personnel affected by the change are engaged and involved, and they participate in the
process. The magnitude of a change, its safety criticality, and its potential impact on human
performance should be assessed in any change management process.
(b) Special consideration, including human factor issues, should be given to the transition period
during which the change will become effective. In addition, the activities utilised to manage
these issues should be integrated into the change management plan. The purpose of
integrating human factors into the management of change is to minimise the potential risks by
specifically considering the impact of the change on the people within a system.
(c) During the process for the management of a change, previous risk assessments and existing
hazards should be reviewed for their possible effects.

 21.A.139 Production management system

AMC1 21.A.139(c)(5) Production management system

SAFETY COMMUNICATION
(a) The organisation should establish communication with its personnel, as appropriate for their
safety responsibilities, about safety matters that:
(1) ensures that all the personnel are aware of the safety management activities;
(2) conveys safety-critical information, especially related to assessed risks and analysed
hazards;
(3) explains why particular actions are taken; and
(4) explains why safety procedures are introduced or changed.
(b) Regular meetings with personnel, as appropriate for their safety responsibilities, during which
information, actions, and procedures are discussed, may be used to communicate safety
matters.
 21.A.139 Production management system

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GM1 21.A.139(c)(5) Production management system

SAFETY PROMOTION
Safety training, combined with safety communication and information sharing, is a part of safety
promotion.
Safety promotion activities are intended to:
— support the organisation’s policies;
— encourage a positive safety culture;
— create an environment that is favourable to the achievement of the organisation’s safety
objectives;
— support organisational learning;
— support the implementation of an effective safety reporting scheme; and
— support the development of a just culture.
Depending on the particular safety issue, safety promotion may also constitute or complement risk
mitigation actions.
 21.A.139 Production management system

AMC1 21.A.139(c)(5)(i) Production management system

SAFETY TRAINING
(a) The production staff, as described in points 21.A.145(c)(2) and (3), should receive initial and
recurring safety training, as appropriate for their responsibilities, to ensure their continued
competency, including safety management principles, the associated safety objectives and
human factors. The organisation should assess the category of staff for which this training
should be provided.
(b) Adequate records of all the safety training provided should be kept in accordance with point
21.A.5.
(c) Initial training that is compliant with the organisation’s training standards should be provided
to each member of the personnel within 6 months of joining the organisation, unless their
competency assessment justifies that there is no need for such a training. Personnel who are
recruited from another organisation and temporary staff should be assessed for whether they
need to receive any additional safety management training.
(d) Recurrent safety training should be delivered either as a dedicated course, or else integrated
within other training. It should be of an appropriate duration in each 2-year period, in relation
to the relevant compliance monitoring audit findings and any other internal/external sources
of information that are available to the organisation on safety, and in production.
 21.A.139 Production management system

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GM1 21.A.139(c)(5)(i) Production management system

SAFETY TRAINING
The main purpose of the safety training programme is to:
— support safety management policies and processes, including human factors training; and
— ensure that personnel at all levels of the organisation develop and maintain their competency
to fulfil their safety roles.
Each organisation should adapt the syllabus to its own needs. Typically, at least the following items
should be included:
— The organisational roles and responsibilities related to safety, including the hazard
identification and risk management processes, and to fostering a positive safety culture;
— Safety objectives and the associated safety performance indicators;
— Human factors principles, including human performance and limitations;
— Legislation, where applicable;
— Safety reporting systems and investigations; and
— Safety issues.
The purpose of the recurrent safety training is:
— primarily to ensure that staff remain current, notably on changes to SMS principles, processes
and procedures; and
— also to share feedback on safety issues that are relevant to the organisation or lessons
learned.
The training staff should have sufficient knowledge and experience to teach the topics at the
required level, with the skills to influence attitudes and behaviours.
 21.A.139 Production management system

AMC1GM No1 to 21.A.139(d)(a) Production management system

Quality system
QUALITY SYSTEM ELEMENT
The quality system is an organisational structure, included in the production management system,
with responsibilities, procedures, processes, and resources which implement a management
function to determine and enforce quality principles.
The quality system should be documented in such a way that the documentation can be made easily
available to personnel who need to use the material for performing their normal duties, in
particular:
— procedures, instructions, data to cover the issues of point 21.A.139(d)(2)(b)(1) are available in
a written form,;
— distribution of relevant procedures to offices/persons is made in a controlled manner,;

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— procedures which identify persons responsible for the prescribed actions are established,; and
— the updating process is clearly described.
The manager responsible for ensuring that the quality system is implemented and maintained
should be identified.
The competent authority will verify on the basis of the exposition and by appropriate investigations
that the production organisation has established and can maintain their documented quality system.
 21.A.139 Production management system

AMC1 GM 21.A.139(d)(2)(b)(1) Production management system

Quality System – Elements of the quality system
QUALITY SYSTEM — ELEMENTS OF THE QUALITY SYSTEM
(1). The control procedures covering the elements of point 21.A.139(d)(2)(b)(1) should document
the standards to which the production organisation intends to work.
(2). An organisation having a Qquality system designed to meet a recognised Standard such as
ISO 9001 (relevant to the scope of approval being requested) should expand it to include at
least the following additional topics, as appropriate, in order to demonstrate compliance with
the requirements of Part 21 Subpart G:
— Mandatory and voluntary Ooccurrence Rreporting as required by point 21.A.3A and
continued airworthiness as required by point 21.A.165(e)
— Control of work occasionally performed (outside the POA facility by POA personnel)
— Co-ordination Coordination with the applicant for, or holder of, an approved design as
required by points 21.A.133(b) and (c) and 21.A.165(g)
— Issue of certifications within the scope of approval for the privileges of point 21.A.163
— Incorporation of airworthiness data in production and inspection data as required in
points 21.A.133(b) and (c) and 21.A.145(b)
— When applicable, ground test and/or production flight test of products in accordance
with procedures defined by the applicant for, or holder of, the design approval
— Procedures for traceability including a definition of clear criteria of which items need
such traceability. Traceability is defined as a means of establishing the origin of an
article by reference to historical records for the purpose of providing evidence of
conformity
— Personnel training and qualification procedures especially for certifying staff as required
in point 21.A.145(d).
(3). An organisation having a quality system designed to meet a recognised aerospace quality
standard will still need to ensure compliance with all the requirements of Subpart G of Part
21. In all cases, the competent authority will still need to be satisfied that compliance with
Part 21 Subpart G is established.
 21.A.139 Production management system

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GM1 No 2 to 21.A.139(d)(1)(a) Production management system

Quality System – Conformity of supplied parts or appliances
CONFORMITY OF SUPPLIED PARTS OR APPLIANCES
The POA holder is responsible for determining and applying acceptance standards for physical
condition, configuration status and conformity of supplied products, parts or appliances, whether to
be used in production or delivered to customers as spare parts. This responsibility also includes BFE
(Buyer Furnished Equipment) items.
To discharge this responsibility the quality system needs an organisational structure and procedures
to adequately control suppliers. Elements of the quality system for the control of suppliers may be
performed by other parties provided that the conditions of AMC No 1 or No 2 to point
21.A.139(d)(2)(ii)(b)(1)(ii) are met.
Control can be based upon use of the following techniques (as appropriate to the system or product
orientation necessary to ensure conformity):
— qualification and auditing of the supplier’s quality system;,
— evaluation of supplier capability in performing all the manufacturing activities, inspections and
tests necessary to establish the conformity of parts or appliances to the type design;,
— first article inspection inspections, including destruction if necessary, to verify that the article
conforms to the applicable data for a new production line or a new supplier;,
— incoming inspections and tests of supplied parts or appliances that can be satisfactorily
inspected on receipt;,
— identification of incoming documentation and data relevant to the showing of conformity to
be included in the certification documents;,
— a vendor rating system which gives confidence in the performance and reliability of this
supplier; and,
— any additional work, tests or inspection which may be needed for parts or appliances which
are to be delivered as spare parts and which are not subjected to the checks normally
provided by subsequent production or inspection stages.
The POA holder may rely on the results of inspection inspections /tests performed by the supplier if
it can establish that:
— the personnel responsible in charge of for these tasks satisfy the competency standards of the
POA quality system;,
— quality measurements are clearly identified; and,
— the records or reports showing evidence of conformity are available for review and audit.
The control of suppliers holding a POA for the parts or appliances to be supplied can be reduced, to a
level at which a satisfactory interface between the two quality systems can be demonstrated. Thus,
for the purpose of showing conformity, a POA holder can rely upon documentation for parts or
appliances released under a suppliers in accordance with the supplier’s privileges defined in point
21.A.163 privileges.

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A supplier who does not hold a POA is considered as to be a sub-contract subcontract or under the
direct control of the POA quality system.
The POA holder retains direct responsibility for inspections/tests carried out either at its own
facilities or at the supplier’s facilities.

 21.A.139 Production management system

AMC No 1 to 21.A.139(d)(2)(ii)(b)(1)(ii) Production management

system Vendor and sub-contractor assessment, audit and control –
Production Organisation Approval (POA) holder using documented
arrangements with other parties for assessment and surveillance of
a supplier.
VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION
ORGANISATION APPROVAL (POA) HOLDER USING DOCUMENTED ARRANGEMENTS WITH OTHER
PARTIES FOR ASSESSMENT AND SURVEILLANCE OF A SUPPLIER
1. General
Note:
For the purpose of this AMC, vendors and sub-contractors are hereafter referred to as
‘suppliers’, regardless of whether or not they hold a POA and audit and control is hereafter
referred to as ‘surveillance’.
The production organisation is required by Part 21 point 21.A.139(d) to demonstrate that it
has established and maintains a quality system that enables the organisation to ensure that
each item produced conforms to the applicable design data and is in a condition for safe
operation. To discharge this responsibility, the quality system should have, among other
requirements, procedures to adequately carry out the assessment and surveillance of
suppliers.
The use of Oother Pparties (OP OPs), such as a consulting firm or quality assurance company,
for supplier assessment and surveillance does not exempt the POA holder from its obligations
under point 21.A.165. The supplier assessment and surveillance, corrective action and follow-
up activity conducted at any of its supplier’s facilities may be performed by OP OPs.
The purpose of using an OP cannot be to replace the assessment, audit and control of the POA
Hholder. It is to allow an element (i.e. the assessment of the quality system) to be delegated
to another organisation under controlled conditions.
The use of OP OPs to perform supplier assessments and surveillance should be part of the
production organisation quality system and fulfil the conditions of this AMC.
This AMC is applicable to a method whereby a POA holder has a documented arrangement
with an OP for the purpose of assessing and/or surveying a POA's supplier.
2. Approval by the competent authority Reserved
Implementing or changing procedures for using OP for supplier assessment and surveillance is
a significant change to the quality system and requires approval in accordance with 21.A.147.

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3. Conditions and criteria for the use of OP OPs to perform supplier assessment and surveillance
(a) The POA holder should include the use of OP OPs for supplier assessment and
surveillance in the POA holders’ quality system to demonstrate compliance with the
applicable requirements of Part 21.
(b) The Pprocedures required for using OP OPs for supplier assessment and surveillance
should be consistent with other procedures of the POA holders’ quality system.
(c) The Pprocedures of the POA holder that uses OP OPs to perform supplier assessment
and surveillance should include the following:
(1) Identification of the OP that will conduct the supplier assessment and
surveillance.
(2) A listing of suppliers under surveillance by the OP. This listing should be
maintained by the POA holder and made available to the competent authority
upon request.
(3) The method used by the POA holder to evaluate and monitor the OP. The method
should include the following as a minimum:
(i) Verification that standards and checklists used by the OP are acceptable for
the applicable scope.
(ii) Verification that the OP is appropriately qualified and have has sufficient
knowledge, experience and training to perform their its allocated tasks.
(iii) Verification that the frequency with which the OP carry out surveillance
frequency of the suppliers is commensurate with the complexity of the
product and with the surveillance frequency established by the POA
holder’s suppliers control programme.
(iv) Verification that the assessment and surveillance of the suppliers’ suppliers
assessment and surveillance is conducted on-site by the OP.
(v) Verification that the OP has access to the applicable proprietary data to the
level of detail necessary to survey suppliers functions.
Where the POA holder uses an OP accredited by a signatory to the European
cooperation for Accreditation (EA) Multilateral Agreement and working works in
accordance with an aviation standard (e.g. EN 9104 series of requirements) that
describes requirements for the other party assessment and surveillance by the
other party, the items (ii) and (iv) shall be deemed to be complied with.
(4) A definition that states to what scope extent the OP will conduct surveillance of
the suppliers surveillance on behalf of the POA holder. If the OP replaces
surveillance in part, the POA holder should identify the functions that will
continue to be surveyed by the POA holder.
(5) The procedures used by the OP to notify the POA holder of any non-conformities
discovered at the supplier’s facility, and of the corrective action and follow-up.

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(d) The POA should make arrangements that allow the competent authority to make
investigation investigations in accordance with point 21.A.9 21.A.157to include OP
activities.

 21.A.139 Production management system

AMC No 2 to 21.A.139(d)(2)(ii) (b)(1)(ii) Production management

system Vendor and sub-contractor assessment, audit and control -
Production Organisation Approval (POA) holder using other party
supplier certification
VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION
ORGANISATION APPROVAL (POA) HOLDER USING OTHER PARTY SUPPLIER CERTIFICATION
1. General
Note:
For the purpose of this AMC, vendors and sub-contractors are hereafter referred to as
‘suppliers’, regardless of whether or not they hold a POA and audit and control is hereafter
referred to as ‘surveillance’.
Other party supplier certification is a method whereby a supplier contracts with an
appropriately recognised or accredited Other Party (OP) for the purpose of obtaining a
certification from that OP. Certification indicates that the supplier has satisfactorily
demonstrated to meet that it meets the applicable standard on a continuing basis. OP
certification results in placing the supplier on the OP list of certified organisations, or in the
supplier receiving a certificate identifying the requirements that have been met. Periodic
follow-up evaluations are conducted by the OP to verify continued compliance with the
requirements of the applicable standard.
The production organisation is required by Part 21 point 21.A.139(d) to demonstrate that it
has established and maintains a quality system that enables the organisation to ensure that
each item produced conforms to the applicable design data and is in a condition for safe
operation. To discharge this responsibility, the quality system should have, among other
requirements, procedures to adequately carry out the assessment and surveillance of
suppliers.
The assessment and surveillance of suppliers by an OP should be deemed to satisfy the
requirements of point 21.A.139(b)(1)(ii) when the conditions of this AMC are satisfied. The
assessment and surveillance of suppliers by OP as part of supplier certification does not
exempt the POA holder from its obligations under point 21.A.165. The supplier assessment
and surveillance, corrective action and follow-up activity conducted at any of its supplier’s
facilities may be performed by OP.
The purpose of using an OP cannot be to replace the assessment, audit and control of the POA
Hholder. It is to allow an element (i.e. the assessment of the quality system) to be delegated
to another organisation under controlled conditions.
The use of suppliers that are certified by OP in accordance with this AMC should be part of a
production organisation quality system.

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2. Approval by the competent authority Reserved

Implementing or changing procedures for using suppliers that are certified by an OP is a
significant change to the quality system and requires approval in accordance with 21.A.147.
3. Conditions and criteria for using supplier certification for the supplier assessment and
surveillance
(a) The POA holder should include the use of supplier certification for the supplier
assessment and surveillance in the POA holder’s quality system to demonstrate
compliance with the applicable requirements of Part 21.
(b) The procedures Procedures required for use of supplier certification for the supplier
assessment and surveillance should be consistent with the other procedures of the POA
holders’ quality system.
(c) The procedures Procedures of the POA holder that uses supplier certification for the
supplier assessment and surveillance should include the following:
(1) A listing Listing of the OPs OP that have certified or will certify suppliers and will
conduct supplier assessment and surveillance or the scheme under which the
accreditation of the OP is controlled. This listing should be maintained by the POA
holder and made available to the competent authority upon request.
(2) A listing of the certified suppliers that are under surveillance by the OP and that
are used by the POA holder. This listing should be maintained by the POA holder
and made available to the competent authority upon request.
(3) The method used by the POA holder to evaluate and monitor the certification
process of any OP certification body or OP certification scheme used. This applies
not only to new suppliers, but also to any decision by the POA holder to rely on
OP certification of current suppliers. The method should include the following as
a minimum:
(i) Verification that certification standards and checklists are acceptable and
applied to the applicable scope.
(ii) Verification that the OP is appropriately qualified and has sufficient
knowledge, experience and training to perform its allocated tasks.
(iii) Verification that the frequency with which the OP carries out surveillance
frequency of the suppliers is commensurate with the complexity of the
product and with the surveillance frequency established by the POA
holder’s suppliers control programme.
(iv) Verification that the surveillance of the suppliers’ surveillance is conducted
on-site by the OP.
(v) Verification that the surveillance report will be made available to the
competent authority upon request.
(vi) Verification that the OP continues to be recognised or accredited.

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(vii) Verification that the OP has access to the applicable proprietary data to the
level of detail necessary to survey suppliers’ suppliers functions.
Where the POA holder uses an OP accredited by a signatory to the European cooperation for
Accreditation (EA) Multilateral Agreement and working works in accordance with an aviation
standard (e.g. EN 9104 series of requirements) that describes the requirements for the OP
certification, the items (ii), (iv) and (v) shall be deemed to be complied with:
(4) A definition that states to what scope extent the OP will conduct suppliers
supplier surveillance on behalf of the POA holder. If the OP partly replaces
surveillance by the POA holder in part, the POA holder should identify the
functions that will continue to be surveyed by the POA holder.
(5) Procedures that ensure that the POA is aware of the loss of an existing
certification.
(6) Procedures that ensure that the POA holder is aware of any non-conformities and
has access to detailed information of on these non-conformities.
(7) Procedures to evaluate the consequences of non-conformities and take
appropriate actions.
(d) The POA should make arrangements that allow the competent authority to make
investigation investigations in accordance with point 21.A.9 21.A.157to include OP
activities.

 21.A.139 Production management system

GM1 21.A.139(d)(2)(ii) Production management system

VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL
For the purposes of AMC1 21.A.139(d)(2)(ii) and AMC2 21.A.139(d)(2)(ii), vendors and
subcontractors are referred to as ‘suppliers’, regardless of whether or not they hold POAs, and audit
and control is hereafter referred to as ‘surveillance’. Implementing or changing procedures to use an
OP for supplier assessment and surveillance is a significant change to the quality system, and it
requires approval in accordance with point 21.A.147.

 21.A.139 Production management system

AMC1 21.A.139(e) Production management system

DOCUMENTATION
(a) The manual or the exposition that is used to document the management system, should be
the key instrument used by an organisation to internally communicate its approach to
management systems.
(b) The organisation may document its safety policy, safety objectives and all the safety
management system key processes (as required in point 21.A.139(a)(1)) in a separate manual
(e.g. a safety management manual or a management system manual) or in its exposition.
Organisations that hold multiple organisation approvals, issued on the basis of Regulation (EU)

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2018/1139 and the delegated and implementing acts adopted on the basis thereof, may
prefer to have separate manuals in order to avoid duplication.
(a) The organisation may also choose to place in separate documents (e.g. policy documents,
procedures) some of the information that is required to be documented.
(b) If any required information is placed in a separate document, the manual or the exposition
should contain adequate references to that document. Any such referenced documents
should be considered integral parts of the production management system documentation.
 21.A.139 Production management system

AMC1 21.A.139(f) Production management system

INDEPENDENT MONITORING OF COMPLIANCE AND ADEQUACY
(a) The function that carries out independent monitoring of the compliance and adequacy of the
documented procedures of the production management system should ensure that:
(1) the activities of the organisation are monitored for their adequacy and compliance with
the applicable requirements and with any additional requirements as established by the
organisation, and that these activities are carried out properly under the supervision of
the nominated persons referred to in point 21.A.145(c)(2);
(2) an objective review of the complete set of production-management-related activities is
provided through independent audits;
(3) the independence of an audit is established by always ensuring that audits and
inspections are carried out by personnel who are not responsible for the function,
procedure or products that they audit or inspect;
(4) an audit plan is established to show when and how often the activities required by
Part 21 will be audited;
(5) the audit cycle is determined through a risk assessment agreed by the competent
authority and that does not exceed the applicable audit planning cycle according to
point 21.B.222. That determination should consider at least:
(i) the criticality of the items checked during the audit; and
(ii) the safety performance of the organisation, including any previous findings and
root causes;
(6) when a non-compliance is found, the root cause(s) and contributing factor(s) are
identified and corrective actions are defined. The feedback part of the compliance
monitoring function should define who is required to address any non-compliance in
each particular case, and the procedure to be followed if the corrective action is not
completed within the defined time frame;
(7) the compliance monitoring function that ensures the aspects above performs the
planned continuing and systematic evaluations or audits of the factors that affect the
conformity (and, where required, the safe operation) of the products, parts or
appliances to the applicable design. This evaluation should include all the elements of
the production management system in order to demonstrate compliance with Part 21.

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 21.A.139 Production management system

GM No 1 to 21.A.139(b)(2) Quality System – Independent quality

assurance function
The quality assurance function which is part of the organisation is required to be independent from
the functions being monitored. This required independence relates to the lines of reporting,
authority and access within the organisation and assumes an ability to work without technical
reliance on the monitored functions.

GM1 No 2 to 21.A.139(f)(b)(2) Production management system

Quality System – Adequacy of procedures and monitoring function
ADEQUACY OF PROCEDURES AND MONITORING FUNCTION
Adequacy of procedures means that the production management system, through the use of the
procedures as set forth defined, is capable of meeting the conformity objectives identified in point
21.A.139(d)(1)(a).
The quality assurance function to ensure the above should perform planned continuing and
systematic evaluations or audits of factors that affect the conformity (and, where required, safe
operation) of the products, parts or appliances to the applicable design. This evaluation should
include all elements of the quality system in order to demonstrate compliance with Part 21 Subpart
G.

 21.A.139 Production management system

GM1 21.A.143 Exposition – Production Organisation Exposition

(POE)
(a) The purpose of the production organisation exposition (POE) is to set forth state in a concise
document documented format the organisational relationships, responsibilities, terms of
reference, and the associated authority, procedures, means and methods of the organisation.
The information to be provided is specified in point 21.A.143(a). Where this information is
documented and integrated in manuals, procedures and instruction instructions, the POE
should provide a summary of the information and an appropriate cross-reference.
(b) The document does not require approval in itself, but it will be considered as such approved
by virtue of the approval of the organisation.
(c) When changes to the organisation occur, according to point 21.A.143(b), the POE is required
to be kept up to date. This should be done as per a procedure, laid down in the POE. If the
changes are significant, Significant changes to the organisation shall not amend the exposition
before the competent authority has approved the change in accordance with point 21.A.147.
(as defined in GM 21.A.147(a)) should be approved by the competent authority prior to
update of the POE.
When an organisation is approved against any other implementing rule containing a requirement for
an exposition, a supplement covering the differences may suffice to meet the requirements of Part

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21 Subpart G except that the supplement should have an index identifying where those parts missing
from the supplement are covered. Those items then formally become part of the POE. In any
combined documents the POE should be easily identifiable.

 21.A.143 Exposition

AMC1 21.A.143(a)(1) Exposition

(a) All personnel should be familiar with those parts of the POE that are relevant to their tasks.
(b) A paragraph in the POE should provide the description of the organisation, the safety policy
and the objectives as required by point 21.A.139(c)(1).
(c) The POE should include a statement, signed by the accountable manager (and countersigned
by the chief executive officer, if different), confirming that the POE and any associated
manuals will be complied with at all times.
This statement should read as follows, or embrace the intent of the following paragraph.
‘This exposition defines the organisation and procedures upon which the competent
authority’s* production organisation approval is based.
These procedures are approved by the undersigned, and must be complied with, as applicable,
in order to ensure that all production activities are carried out on time and to an approved
standard.
It is understood that the approval of the production organisation is based on the continuous
compliance of the organisation with the applicable requirements of Part 21, and with the
organisation’s procedures described in this exposition. The competent authority* is entitled to
limit, suspend, or revoke the approval if the organisation fails to fulfil the obligations imposed
by Part 21, or any conditions according to which the approval was issued.
Signed .....................................
Dated ......................................
Accountable manager and ... (quote position)
Chief executive officer …
For and on behalf of ... (quote organisation’s name)’
*Where ‘competent authority’ is stated, please insert the actual name of the approving
competent authority organisation or administration granting the POA approval.
The statement should be re-issued at the earliest opportunity, whenever the accountable
manager is changed.
(d) The POE should include the description of the internal safety reporting scheme that is
required by point 21.A.3A(a)(1)(ii);
(e) If the organisation holds one or more additional organisation certificates within the scope of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof, so that the organisation is required to establish another exposition, the organisation
may combine the documents by establishing a separate manual or supplement that covers the

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differences between the production organisation exposition and that other exposition. In such
a case, the supplement should identify where in the other exposition the remaining
information on the production organisation is covered. That remaining information then
formally becomes part of the exposition.

 21.A.143 Exposition

AMC1 21.A.145(a) Resources

(a) The organisation’s equipment and tools should enable all the specified tasks to be
accomplished in a repeatable manner without any detrimental effects. The calibration control
of the equipment and tools which affect the critical dimensions and values of products should
demonstrate compliance with, and be traceable to, national or international standards.
(b) Sufficient personnel means that according to the nature of the work and the production rate
of each function, the organisation has a sufficient quantity of qualified personnel to
accomplish all the specified manufacturing tasks and to attest their conformity. The number of
personnel should be such that the relevant airworthiness considerations may be applied in all
areas without any undue pressure.
(c) An evaluation of the competence of the personnel is performed as part of the quality system.
This should include, where appropriate, verification that specific qualification standards have
been implemented, for example for NDT, welding, etc. Training should be organised to
establish and maintain the competence of the personnel at the levels determined to be
necessary by the organisation.

 21.A.145 Resources

GM1 21.A.145(a) Resources Approval Requirements

A facility is a working area where the working conditions and the environment are controlled as
appropriate in respect of: cleanliness, temperature, humidity, ventilation, lighting, space/access,
noise, and air pollution.
Equipment and tools should be such as to enable all specified tasks to be accomplished in a
repeatable manner without detrimental effect. Calibration control of equipment and tools which
affect critical dimensions and values should demonstrate compliance with, and be traceable to,
national or international standards.
Sufficient personnel means that the organisation has for each function according to the nature of
the work and the production rate, a sufficient quantity of qualified personnel to accomplish all
specified manufacturing tasks and to attest the conformity. Their number should be such that
airworthiness consideration may be applied in all areas without undue pressure.
An evaluation of the competence of personnel is performed as part of the quality system. This
should include, where appropriate, verification that specific qualification standards have been
implemented, for example NDT, welding, etc. Training should be organised to establish and maintain
the personal competence levels determined by the organisation to be necessary.
 21.A.145 Resources

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GM1 21.A.145(b)(2) Resources Approval Requirements –

Airworthiness, noise, fuel venting and exhaust emissions
/production data procedures
AIRWORTHINESS, NOISE, FUEL VENTING AND EXHAUST EMISSIONS/PRODUCTION DATA
PROCEDURES
1 When a POA holder/ or an applicant for a POA is developing its own manufacturing data, such
as computer based data, from the design data package delivered by a design organisation,
procedures are required to demonstrate the right correct transcription of the original design
data.
2 Procedures are required to define the manner in which airworthiness, noise, fuel venting and
exhaust emissions data is used to issue and update the production/quality data, which
determines the conformity of products, parts and appliances. The procedure must also define
the traceability of such data to each individual product, part or appliance for the purpose of
certifying their condition for safe operation and issuing a Sstatement of Cconformity or EASA
Form 1.
 21.A.145 Resources

AMC1 21.A.145(c)(1) Resources

ACCOUNTABLE MANAGER
The accountable manager should:
(a) have sufficient knowledge and authority to be able to respond to the competent authority
regarding major issues of the production approval, and to implement any necessary
improvements;
(b) promote the quality and safety policies of the organisation; and
(c) demonstrate a basic understanding of this Regulation.
 21.A.145 Resources

GM1 21.A.145(c)(1) Resources Approval Requirements –

Accountable manager
ACCOUNTABLE MANAGER
Accountable manager refers to means the manager who is responsible, and has corporate authority
for ensuring that all production work is carried out to the required standard. This function may be
carried out by the Chief Executive chief executive officer or by another person in the organisation,
nominated by him or her the chief executive officer to fulfil the function, provided that the his or her
position and authority of the person in the organisation permits permit him or her to discharge the
attached responsibilities.
The manager is responsible for ensuring that all necessary resources are available and properly used
in order to produce under the production approval in accordance with Part 21 Section A Subpart G.

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The manager needs to have sufficient knowledge and authority to enable him or her to respond to
the competent authority regarding major issues of the production approval and implement
necessary improvements.
The manager needs to be able to demonstrate that he or she is fully aware of and supports the
quality policy and maintains adequate links with the quality manager.
 21.A.145 Resources

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AMC1 GM 21.A.145(c)(2) Resources Approval Requirements –

Responsible managers
RESPONSIBLE MANAGERS
(a) The person or group of persons nominated in accordance with 21.A.145(c)(2) should
represent the management structure of the organisation and be responsible for all the
functions as specified in Part 21. Section A Subpart G. It therefore follows that, depending
Depending on the size of the Part 21 Section A Subpart G approved production organisation,
the functions may be subdivided under individual managers (and in fact may be further
subdivided) or combined in a variety of ways.
(b) The organisation should nominate a person or a group of persons who are responsible for:
(1) monitoring the adequacy of the organisation and its compliance with Part 21;
(2) ensuring the effectiveness of the safety management system,
and they should be able to request other managers or the accountable manager to carry out
any necessary and appropriate remedial action. They should have direct access to the
accountable manager.
(c) The competent authority requires the Each nominated managers manager to should be
identified and their credentials submitted on an EASA Form 4 (see EASA Form 4 for Production
Organisations on the EASA website under: http://easa.europa.eu/certification/application-
forms.php) to the competent authority in order so that they may be seen to be appropriate in
terms of their relevant knowledge and satisfactory experience related to the nature of the
production activities as performed by the Part 21 Section A Subpart G approved production
organisation.
(d) The responsibilities and the tasks of each individual manager are required to should be clearly
defined, in order to prevent any uncertainties about the relations, within the organisation. In
the case of organisation organisational structures where staff-members staff members are
responsible to more than one person, as, for instance, in matrix and project organisations, the
responsibilities of the managers should be defined in such a way that all the responsibilities
are covered.
(e) Where a Part 21 Section A Subpart G an approved production organisation chooses to appoint
managers for all or for any combination of the functions identified in Part 21 functions
because of the size of the undertaking, it is necessary that these managers should ultimately
report ultimately to the accountable manager. In cases where a manager does not directly
report to the accountable manager, he or she should have a formally established direct access
to the accountable manager formally established.
(f) The organisation should have a system in place to plan the availability of staff to ensure that
the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect
and monitor the organisation’s activities in accordance with the terms of approval.
(g) The organisation should establish and control the competency of the personnel involved in
production, compliance monitoring, safety management, and, if applicable, in issuing permits
to fly, in accordance with a procedure and to a standard agreed by the competent authority.
In addition to the necessary expertise related to the job function, the competency of each

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person should include an understanding of the safety management and human factors
principles that are appropriate to the person’s function and responsibilities in the
organisation.
(h) The person or group of persons responsible for the monitoring of compliance and adequacy
should:
(1) not be one of the persons referred to in point 21.A.145(c)(2);
(2) be able to demonstrate their relevant knowledge, background and appropriate
experience related to the activities of the organisation, including knowledge and
experience in compliance monitoring; and
(3) have access to all parts of the organisation, and as necessary, to any supplier.
(i) If any of the functions related to compliance monitoring or safety management are combined
with other duties, the organisation should ensure this does not result in any conflicts of
interest.
(j) Subject to a risk assessment and agreement by the competent authority, with due regard to
the size of the organisation and the nature and complexity of its activities, the functions of the
compliance monitoring manager and the safety manager may be exercised by the accountable
manager provided that he or she has demonstrated the related level of competence.
One such manager, normally known as the quality manager is responsible for monitoring the
organisation’s compliance with Part 21 Section A Subpart G and requesting remedial action as
necessary by the other managers or the accountable manager as appropriate. He or she should have
a direct access to the accountable manager.
 21.A.145 Resources

AMC2 21.A.145(c)(2) Resources

COMPETENCY OF PERSONNEL
(a) To assist in the assessment of competency and to perform the training needs analysis, the
organisation should establish job descriptions for all the job functions in the organisation.
These job descriptions should contain sufficient criteria to enable the competency of each
person to be assessed.
(b) The organisation should provide initial and recurrent training, to the persons or group of
persons nominated in accordance with point 21.A.145(c)(2), which is adequate to their job
function, and which ensures that their continued competency is maintained throughout the
duration of their employment/contract.
(c) The organisation should record the training provided in accordance with point (a).
(d) All prospective members of the production management staff should be assessed for their
competency, qualifications, and capabilities related to their intended duties.
(e) All the staff nominated according to point 21.A.145(c)(2) should be able to demonstrate their
knowledge of, and compliance with, the production management organisation procedures
that are applicable to their job function.

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(f) All the staff nominated according to point 21.A.145(c)(2) should be able to demonstrate an
understanding of the safety management principles, human factors and human performance
issues related to their tasks.
(g) The competency of the person who assumes, or persons who assume, the function of safety
manager should include, but not be limited to, the following:
(1) knowledge of the ICAO standards and European requirements for safety management;
(2) an understanding of management systems, including compliance monitoring systems;
(3) an understanding of risk management;
(4) an understanding of safety investigation techniques;
(5) an understanding of human factors;
(6) an understanding of a positive safety culture and its promotion; and
(7) operational experience related to the activities of the organisation.
(h) The organisation should develop a procedure that describes the process for assessing the
competency of the person. The procedure should specify:
(1) the persons responsible for this process;
(2) the means and methods for the initial assessment;
(3) the means and methods for the continuous control of their competency, including
feedback on their performance;
(4) the actions to be taken if the assessment is not satisfactory; and
(5) how to record assessment results.
 21.A.145 Resources

AMC1 21.A.145(d)(1) Resources Approval Requirements – Certifying

staff
CERTIFYING STAFF
(a) Certifying Sstaff should be are nominated by the production organisation to ensure that each
of their products, parts and/or appliances qualify qualifies for a Sstatements of Cconformity or
a Rrelease Ccertificates. The position and number of Ccertifying Sstaff positions and numbers
are to should be appropriate to the complexity of the product and the production rate.
(b) The qualification qualifications of certifying staff is should be based on their knowledge,
background and experience and on a specific training (or testing) established by the
organisation to ensure that it is appropriate to the product, part, or appliance to be released.
(c) Training should must be given to develop a satisfactory level of knowledge of organisation the
organisation’s procedures, safety management systems (including compliance monitoring),
aviation legislation, and the associated regulations implementing rules, CSs CS and GM that
are relevant to the their particular role.

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(d) For that purpose, in addition to the general training policy, the organisation should must
define its own standards for training, including pre-qualification standards, for personnel to be
identified as certifying staff.
(e) The training policy is part of the Quality System management system, and its appropriateness
forms a part of the investigation investigations by the competent authority within the
organisation approval process, and of the subsequent surveillance of the persons proposed by
the managers.
(f) The training must should be updated in response to experience gained and changes in
technology.
(g) A feedback system to ascertain that the required standards are being maintained must should
be put in place to ensure the continuing compliance of personnel to with authorisation
requirements.
(h) For the release of products, parts or appliances, the responsibilities to issue statements of
conformity or/release certificates (EASA Form 1) or permit permits to fly, including the
approval of flight conditions, are allocated to the certifying staff identified in point
21.A.145(d)(2).
(i) The competent authority holds the right to reject those personnel, appointed by the
organisation, if they are found to have inappropriate experience or not to otherwise comply
with its requirements.

 21.A.145 Resources

AMC 21.A.145(d)(2) Approval requirements – Record of certifying

staff
1. The following is the minimum information to be recorded in respect of each certifying person:
(a) Name
(b) Date of Birth
(c) Basic Training and standard attained
(d) Specific Training and standard attained
(e) If appropriate – Continuation Training
(f) Experience
(g) Scope of the authorisation
(h) Date of first issue of the authorisation
(i) If appropriate – expiry date of the authorisation
(j) Identification Number of the authorisation
2. The record may be kept in any format and must be controlled by an internal procedure of the
organisation. This procedure forms part of the quality system.

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3. Persons authorised to access the system must be maintained at a minimum to ensure that
records cannot be altered in an unauthorised manner and that confidential records cannot
become accessible to unauthorised persons.
4. The certifying person must be given reasonable access on request to his or her own records.
5. Under the provision of 21.A.157 the competent authority has a right of access to the data held
in such a system.
6. The organisation must keep the record for at least two years after the certifying person has
ceased employment with the organisation or withdrawal of the authorisation, whichever is
the sooner.

AMC1 21.A.145(d)(2)(3) Resources Approval requirements –

Evidence of authorisation
EVIDENCE OF AUTHORISATION
(1) The authorisation document must should be in a style that makes its scope clear to the
certifying staff and any authorised person who may require to examine the authorisation.
Where codes are used to define the scope, an interpretation document should be readily
available.
(2) Certifying staff are not required to carry the authorisation document at all times, but they
should be able to make it available within a reasonable time after of a request from an
authorised person. Authorised persons include the competent authority.
 21.A.145 Resources

AMC1 21.A.147 Changes to the production management system

APPLICATION FOR VARIATION OF SCOPE AND TERMS OF THE POA
(a) An application for approval should be submitted in writing to the competent authority, and
the production organisation should demonstrate to the competent authority, on the basis of
the submission of any proposed changes to the exposition, and before the implementation of
the change, that it will continue to comply with Part 21 after the implementation.
(b) The approved production organisation should provide to the competent authority an
application for any significant changes, or for a variation in the scope or terms of their POA, on
an EASA Form 51 (see below) completed by the applicant.
 21.A.147 Changes to the production management system

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EASA Form 51

Application for significant changes or a variation of the scope or terms of a Part 21 POA

Competent authority
of an EU Member State or
EASA

1. Name and address of the POA holder:

2. Approval reference number:

3. Location(s) for which changes in the terms of

approval are requested:

4. Brief summary of the proposed changes to the activities at the item 3 addresses:
a) General:
b) Scope of approval:
c) Nature of privileges:

5. Description of organisational changes:

6. Position and name of the accountable

manager or nominee:

_______________________________ __________________________________
Date Signature of the accountable manager (or nominee)

EASA Form 51

Block 1: the name should be entered as written on the current approval certificate. If a change in the name is
to be announced, state the old name and address here, while using Block 5 for the information about
the new name and address. The change of name and/or address should be supported by evidence, e.g.
by a copy of the entry in the register of commerce.

Block 2: state the current approval reference number.

Block 3: state the location(s) for which changes in the terms of approval are requested, or state ‘not
applicable’ here if no change is anticipated.

Block 4: this block should include further details for the variation of the scope of approval for the addresses
indicated in Block 3. The ‘General’ block should include overall information for the change (including

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changes e.g. in workforce, facilities, etc.), while the ‘Scope of approval’ block should address the change
in the scope of work and products/categories following the principles laid down in GM 21.A.151. The
‘nature of privileges’ block should indicate a change in the privileges as defined in points 21.A.163(b)-
(d). State ‘not applicable’ here if no change is anticipated.

Block 5: this block should state the changes to the organisation as it is defined in the current production
organisation exposition, including changes to the organisational structure, functions and
responsibilities. This block should therefore also be used to indicate a change in the accountable
manager in accordance with point 21.A.145(c)(1) or a change in the nomination of the responsible
managers in accordance with point 21.A.145(c)(2). A change in the nomination of the responsible
managers should be accompanied by the corresponding EASA Forms 4. State ‘not applicable’ here if no
change is anticipated.

Block 6: state the position and name of the accountable manager here. Where there is a change in the
nomination of the accountable manager, the information should refer to the nominee for this position.
State ‘not applicable’ here if no change is anticipated.

In case of an application for a change of the accountable manager, EASA Form 51 should be signed by
the new nominee for this position. In all other cases, EASA Form 51 should be signed by the
accountable manager.

 21.A.147 Changes to the production management system

GM1 21.A.147(a) Changes to the approved production

management system organisation — Significant changes
SIGNIFICANT CHANGES
1 Changes to be approved by the competent authority include:
 Ssignificant changes to the production capacity or methods;.
 Cchanges in the organisation’s structure, especially those parts of the organisation in charge
of quality and safety;.
 A a change of the accountable manager or of any other person nominated under point
21.A.145(c)(2);.

 Cchanges in the production or quality in the production management systems that may have
an important impact on the conformity/ or airworthiness of each product, part or appliance
including reporting lines between the personnel nominated in accordance with point
21.A.145(c)(2)), and the accountable manager; and.
 Cchanges in the placement or control of significant sub-contracted subcontracted work or
supplied parts.
2 To ensure that changes do not result in non-compliance with Part 21, Section A Subpart G it is in
the interest of both the competent authority and the approval holder to establish a relationship and
exchange information that will permit the necessary evaluation work to be conducted before the
implementation of a change. This relationship should also permit agreement on the need for
variation of the terms of approval (refer to point 21.A.143(a)(9)).

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3 Where a change of name or ownership results in the issue of a new approval, the investigation will
normally take account of the competent authority’s knowledge and information from the preceding
approval.
4 Changes of location are addressed in point 21.A.148, and changes of ownership in point 21.A.149,
and the change of scope of approval in point 21.A.153.
 21.A.147 Changes to the production management system

GM1 21.A.149 Transferability

Transfer of approval would normally only be agreed in cases where the ownership changes but the
organisation itself remains effectively unchanged. For example:
An acceptable transfer situation could be a change of company name (supported by the appropriate
certificate from the National Companies Registration Office or equivalent) but with no changes to
the site address, facilities, type of work, staff, accountable manager or person nominated under
point 21.A.145.
Alternatively, in the event of receivership (bankruptcy, insolvency or other equivalent legal process),
there may be good technical justification for continuation of the approval, provided that the
company continues to function in a satisfactory manner in accordance with their POE. It is likely that
at a later stage, the approval might be voluntarily surrendered or the organisation transferred to
new owners, in which case the former paragraphs apply. If it does not continue to operate
satisfactorily, then the competent authority could suspend or revoke the approval under point
21.B.65 21.B.245.
In order for the competent authority to agree to a transfer of approval, it will normally prescribe, it
as a condition in accordance with point 21.B.240(b) 21.A.147(b), that the obligations and
responsibilities of the former organisation should be transferred to the new organisation, otherwise
a transfer is not possible and an application for a new approval will be required.

AMC1 21.A.153 Changes to the terms of approval — Application for

a change to the terms of approval
APPLICATION FOR A CHANGE TO THE TERMS OF APPROVAL
EASA Form 51 (see AMC1 21.A.147 AMC No 1 to 21.B.240) must should be obtained from the
competent authority and completed in accordance with the procedures of the POE.
The information entered on the form is the minimum required by the competent authority to assess
the need for a change of to the production organisation approval.
The completed form and an outline of the changed POE, and details of the proposed change to the
POA terms of approval, must be forwarded to the competent authority.

GM 21.A.157 Investigations – Arrangements

The arrangements made by the applicant for, or holder of an approval under Part 21 Section A
Subpart G should allow the competent authority to make investigations that include the complete

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production organisation including partners, sub-contractors and suppliers, whether they are in the
State of the applicant or not.
The investigation may include; audits, enquiries, questions, discussions and explanations,
monitoring, witnessing, inspections, checks, flight and ground tests and inspection of completed
products, parts or appliances produced under the POA.
In order to maintain its confidence in the standards achieved by a POA holder or applicant the
competent authority may make an investigation of a sample product part or appliance and its
associated records, reports and certifications.
The arrangements should enable the organisation to give positive assistance to the competent
authority and co-operate in performing the investigation during both initial assessment and for the
subsequent surveillance to maintain the POA.
Co-operation in performing investigation means that the competent authority has been given full
and free access to the facilities and to any information relevant to demonstrate compliance to
Part 21 Section A Subpart G requirements, and assistance (personnel support, records, reports,
computer data, etc., as necessary).
Assistance to the competent authority includes all appropriate means associated with the facilities
of the production organisation to allow the competent authority to perform these investigations,
such as the availability of a meeting room, office and personnel support, documentation and data,
and communication facilities, all properly and promptly available as necessary.
The competent authority seeks to have an open relationship with the organisation and suitable
liaison personnel should be nominated to facilitate this, including suitable representative(s) to
accompany competent authority staff during visits not only at the organisations own facilities but
also at sub-contractors, partners or suppliers.

GM No 1 to 21.A.158(a) Uncontrolled non-compliance with

applicable design data
An uncontrolled non-compliance with applicable design data is a non-compliance:
 that cannot be discovered through systematic analysis; or
 that prevents identification of affected products, parts, appliances, or material.

GM No 2 to 21.A.158(a) Examples of level one findings

Examples of level one findings are non-compliances with any of the following points, that could
affect the safety of the aircraft:
21.A.139, 21.A.145, 21.A.147, 21.A.148, 21.A.151, 21.A.163, 21.A.165(b), (c), (d), (e), (f) and (g).
It should be anticipated that a non-compliance with these points is only considered a level one
finding when objective evidence has been found that this finding is an uncontrolled non-compliance
that could affect the safety of the aircraft.
In addition, the failure to arrange for investigations under 21.A.157, in particular to obtain access to
facilities, after denial of one written request should be classified as a level one finding.

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GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings

CAUSAL ANALYIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree,
to identify the chain of events that led to the non-compliance, may not properly reflect the
complexity of the issue, and, it therefore bears the risk that important factors that need to be
addressed in order to prevent reoccurrence will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the non-conformity. A peer review of the results of the causal analysis may
increase its reliability and objectivity.
A system description of the organisation that considers organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.

 21.A.158 Findings

GM 21.A.165(d) and (h) Obligations of the holder – Recording and

archiving system
Records within a production environment satisfy two purposes. Firstly, they are required, during the
production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle. Secondly, certain records of milestone events
are needed to subsequently provide objective evidence that all prescribed stages of the production
process have been satisfactorily completed and that compliance with the applicable design data has
been achieved.
Therefore, the approved production organisation should implement a system for the compilation
and retention of records during all stages of manufacture, covering short-term and long-term
records appropriate to the nature of the product and its production processes.
The management of such information should be subject to appropriate procedures in the Quality
System required by 21.A.139.
All forms of recording media are acceptable (paper, film, magnetic, ...) provided they can meet the
required duration for archiving under the conditions provided.
The related organisation procedures should:

 Identify records to be kept.

 Describe the organisation of and responsibility for the archiving system (location, compilation,
format) and conditions for access to the information (e.g., by product, subject).
 Control access and provide effective protection from deterioration or accidental damage.

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 Ensure continued readability of the records.

 Demonstrate to the competent authority proper functioning of the records system.

 Clearly identify the persons involved in conformity determination.
 Define an archiving period for each type of data taking into account importance in relation to
conformity determination subject to the following:
a) Data which supports conformity of a product, part, or appliance should be kept for not
less than three years from the issue date of the related Statement of Conformity or
Authorised Release Certificate.
b) Data considered essential for continuing airworthiness should be kept throughout the
operational life of the product, part or appliance.
 Ensure that the recording and record-keeping system used by the partners, supplier and sub-
contractors meet the objective of conformity of the product, part or appliance with the same
level of confidence as for their own manufacture. They should define in each case who is to
retain the record data (organisation or partner, supplier or sub-contractor). They should also
define method for surveillance of the recording/record keeping system of the partners,
suppliers or sub-contractors.

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SUBPART J — DESIGN ORGANISATION APPROVAL

GM1 21.A.239(c) Design management system

SAFETY MANAGEMENT ELEMENT
Safety management seeks to proactively identify hazards and mitigate the related safety risks before
they result in aviation accidents and incidents. Safety management enables an organisation to
manage its activities in a more systematic and focused manner. When an organisation has a clear
understanding of its role and contribution to aviation safety, it enables the organisation to prioritise
safety risks and more effectively manage its resources for optimal results.
Safety should not be considered the responsibility of a single person or a limited group of people in
the organisation. A safety culture should be developed throughout the organisation that involves all
the personnel as active contributors to the safety of the final product, part or appliance in
accordance with AMC1.21.A.239(c)(1).
The requirements established in points 21.A.3A, 21.A.5, 21.A.239, 21.A.245 and 21.A.247 and the
related AMC constitute the EU design management system framework for aviation safety
management. This framework transposes Appendix 2 to ICAO Annex 19. The EU approach aims at
facilitating the introduction of the safety management system into design organisations by inserting
the components of safety management into Part 21, thus building upon the existing management
systems.
Therefore, the approach aims at encouraging organisations to embed safety management and
risk-based decision-making into all their activities, instead of superimposing another system onto
their existing management system and governance structure. In addition, if the organisation holds
multiple organisation certificates issued under Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof (according to point 21.A.239(h)), the organisation
may choose to implement a single management system to cover all of its activities. An integrated
management system may not only be used to capture multiple certification requirements, but also
to cover other business management systems such as quality, security, occupational health and
environmental management systems. Integration will remove duplication and exploit synergies by
managing safety risks across multiple activities. Organisations may determine the best means to
structure their management systems to suit their business and organisational needs.
It is important to recognise that safety management will be a continuous activity as hazards, risks
and the effectiveness of safety risk mitigations will change over time.
The safety management capability of an organisation should be commensurate with the safety risks
to be managed, which can be at the product level or at the organisational level:
— For instance, the criticality of variants may have no impact on safety, in which case, the safety
management system may not need to address this aspect; however, if a large number of
variants need to be managed, this may generate additional hazards that need to be mitigated.
— The risks that are inherent in a complex structure require a robust safety risk management
process (e.g. complex interfaces with different partners who participate in the design of a

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product may induce hazards that are complex to mitigate, due to the management of
organisational or technical changes).
As a consequence, scalability should be a function of the inherent safety risk capability of the
organisation. For instance:
— the risk assessment model used may be very simple in small organisations where the
identified hazards are easy to mitigate;
— expert judgement might be sufficient to measure the efficiency of safety barriers;
— the collection of data, safety information and occurrences might be very limited;
— there might be no need for software or tools to manage the SMS;
— the communication policy might be limited.
However, small organisations that are involved in activities that entail significant aviation safety risks
might require greater SMS resources.
 21.A.239 Design management system

AMC1 21.A.239(c) Design management system

SAFETY MANAGEMENT ELEMENT
An organisation that has a safety management element that is compliant with the SMS Industry
Standard ‘Implementing a Safety Management System in Design, Manufacturing and Maintenance
Organizations’ SM001 Issue A - September 17th, 2018 1, should be considered compliant with the EU
framework for aviation safety management as described in GM1 21.A.239(c), provided that
compliance with the following additional topics, as appropriate, is demonstrated.
Paragraph of SMS Industry Standard
Point Additional topics
SM001 Issue A - September 17th, 2018
Reporting to EASA as per 21.A.3A (a)(3)
(refer to AMC 20-8 and AMC1 21.A.3A(d)
as acceptable means of compliance)
§6.1.1.1 Safety Policy
Compliance with Regulation (EU)
§6.2.1 Hazard identification
No 376/2014 (refer to GM1 21.A.3A(a)(1)
§6.2.2 Safety Risk Assessment and and (b)(1) as a summary of the
21.A.3A Mitigation requirements)
§6.3 Safety Assurance Collection, investigation and analysis of
data related to flammability reduction
§6.4.2 Safety Communication
means (FRM) reliability
§7 Interfaces between organizations
Collection, investigation and analysis of
data related to ETOPS significant
occurrences
Record-keeping (refer to the AMC and
21.A.5 Not available GM related to 21.A.5 as acceptable
means of compliance and guidance)

1 https://www.asd-europe.org/sites/default/files/atoms/files/SMS%20Standard_final%20issue%20A_20180917.pdf

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§6.1.2 Safety Accountability and

Responsibilities
§6.1.3 Appointment of Key Safety
Personnel
§6.2 Safety Risk Management (system
(b) description) none

§6.3.2 Management of Change

§6.3.3 Continuous Improvement of
the SMS
§6.4.1 Training and Education
§1 Introduction
§6.1.1.1 Safety Policy
Human factors in the safety policy (refer
§6.1.1.2 Safety Objectives to AMC1 21.A.239(c)(1) as acceptable
§6.1.2 Safety Accountability and means of compliance)
Responsibilities Functions of safety review board & safety
§6.1.3 Appointment of Key Safety action group (refer to
Personnel AMC1 21.A.239(c)(2) and
GM1 21.A.239(c)(2) for acceptable means
§6.2 Safety Risk Management
of compliance and guidance)
§6.2.1 Hazard identification
Interface risk management in case of
21.A.239 §6.2.2 Safety Risk Assessment and subcontracts (refer to
(c) Mitigation AMC1 21.A.239(c)(3) for acceptable
means of compliance)
§6.3 Safety Assurance
Systematic management of all changes,
§6.3.1 Safety Performance Monitoring
not limited to those having substantive
and Measurement
impact on safety management (refer to
§6.3.2 Management of Change AMC1 21.A.239(c)(4)(ii) for acceptable
§6.3.3 Continuous Improvement of means of compliance)
the SMS More structured safety training (refer to
§6.4 Safety Promotion AMC1 21.A.239(c)(5)(i) for acceptable
means of compliance)
§6.4.1 Training and Education
§6.4.2 Safety Communication
§7 Interfaces between organizations
§6.1.5 SMS Documentation
(e) None
§6.4.2 Safety Communication
Independency of the monitoring of
§6.3.1 Safety Performance Monitoring
compliance and adequacy as per
(f) and Measurement (paragraph title:
21.A.239(f). Refer to AMC1 21.A.239(f)
Need for additional measurement)
for acceptable means of compliance)

(g) §7.3 Corporate SMS approach None

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21.A.243 §6.1.5 SMS Documentation None

§6.1.1.1 Safety Policy Identification of managers responsible for
the essential functions (refer to
§6.1.2 Safety Accountability and
AMC1 21.A.245(c)(2) for acceptable
Responsibilities
21.A.245(c) means of compliance)
§6.1.3 Appointment of Key Safety
Definition of competency of personnel
Personnel
(refer to AMC2 21.A.245(c)(2) for
§6.4.1 Training and Education acceptable means of compliance)
Systematic management of all changes,
not limited to those having substantive
21.A.247 §6.3.2 Management of Change impact on safety management (refer to
AMC1 21.A.239(c)(4)(ii) for acceptable
means of compliance)
 21.A.239 Design management system

AMC1 21.A.239(c)(1) Design management system

SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic
management, including the promotion of a positive safety culture;
(2) include internal reporting principles, and encourage personnel to report design-related
errors, incidents and hazards;
(3) be endorsed by the head of the design organisation;
(4) be communicated, with visible endorsement, throughout the organisation; and
(5) be periodically reviewed to ensure that it remains relevant and appropriate to the
organisation.
(c) The safety policy should include commitments to:
(1) comply with all the applicable legislation, meet all the applicable requirements, and
adopt practices that work towards improving safety standards;
(2) provide the necessary resources for its implementation;
(3) apply human factors principles;
(4) enforce safety as a primary responsibility of all managers; and
(5) apply ‘just culture’ principles and, in particular, to not make available or use any
personal information on occurrences:
(i) attribute blame or liability for actions, omissions or decisions taken by personnel
that are commensurate with their experience and training; or
(ii) for any purpose other than the improvement of aviation safety.

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(d) Senior management should continuously promote the safety policy to all personnel, and
demonstrate their commitment to it and provide the necessary human and financial resources
for its implementation.
(e) Taking due account of its safety policy, the organisation should define safety objectives. The
safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
(2) reflect the organisation’s commitment to maintain or continuously improve the overall
effectiveness of the management system;
(3) be communicated throughout the organisation; and
(4) be periodically reviewed to ensure that they remain relevant and appropriate to the
organisation.
 21.A.239 Design management system

GM1 21.A.239(c)(1) Design management system

SAFETY POLICY
The safety policy is the means for the organisation to state its intention to maintain and, where
practicable, improve safety levels in all its activities, and to minimise its contribution to the risk of an
aircraft accident or serious incident as far as is reasonably practicable. It reflects the management’s
commitment to safety and the organisation’s philosophy of safety management. It is the foundation
on which the organisation’s management system is built and serves as a reminder of ‘how we do
business here’. The creation of a positive safety culture begins with the issuance of a clear,
unequivocal policy statement.
The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules
that describe how ‘just culture’ principles are guaranteed and implemented.
For organisations that have their principal place of business in a Member State, Regulation (EU)
No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11)
of that Regulation).

 21.A.239 Design management system

AMC1 21.A.239(c)(2) Design management system

SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
(a) The management system should encompass safety by defining a structure that is able to
administrate and maintain the processes and functions of the safety management system as
described in point 21.A.239(c). The head of the design organisation should establish and
maintain functions which act as:
(1) the safety manager; and
(2) a high-level committee that considers matters of strategic safety, sometimes referred to
as the ‘safety review board’, depending on the size of the organisation and the nature

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and complexity of its activities, and subject to a risk assessment that is agreed by the
competent authority.
(b) The safety review board function should monitor:
(1) the safety performance against the safety policy and objectives;
(2) whether any safety action is taken in a timely manner; and
(3) the effectiveness of the organisation’s management system processes.
(c) The head of the design organisation may also establish and maintain a function, referred to as
the ‘safety action group’, in support of the two functions above.
 21.A.239 Design management system

GM1 21.A.239(c)(2) Design management system

SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
The organisation may define its structure in the manner that best fits its needs. The following is an
example of a possible organisation that complies with the safety management elements of the
design management system.
The role of the person who assumes, or persons who assume, the function of safety manager should
include, but not be limited, to:
— support of the head of the design organisation in ensuring the activities described in
AMC1 21.A.239(c) are performed
— advice to the head of the design organisation on safety matters; and
— provision of periodic reports on safety performance to the head of the design organisation
and to the safety review board.
Regardless of the organisational set-up, it is important for the safety manager or a designated
person to remain the unique focal point for the development, administration, and maintenance of
the organisation’s management system.
When established by the head of the design organisation, the function of the high-level committee
(safety review board) is to:
— ensure that appropriate resources are allocated to achieve the established safety objectives;
— review the results of compliance monitoring; and
— monitor the implementation of related corrective and preventive actions.
It is composed of heads of functional areas and it is chaired by the head of the design organisation.
The role of the safety action group is to:
— analyse specific events;
— assess mitigation measures;
— monitor the safety performance of the organisation;
— define actions to control risks to an acceptable level;

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— assess the impact of organisational changes on safety;

— ensure that safety actions are implemented within the agreed timescales; and
— review the effectiveness of previous safety actions and safety promotion.
— 21.A.239 Design management system

AMC1 21.A.239(c)(3) and (4) Design management system

SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Hazard identification should be based on a combination of reactive and proactive
methods.
(2) The organisation should in particular focus on hazards that may result from
non-compliances or errors in the design of the product, part or appliance.
(b) Risk management processes
(1) A safety risk management process should be developed and maintained that ensures
that the safety risks are:
(i) analysed (in terms of their probability and the severity of the consequences of
hazards and occurrences);
(ii) assessed (in terms of their tolerability); and
(iii) controlled (in terms of the mitigation of risks to an acceptable level).
(2) Within the risk management process, the organisation should specify, who has the
authority to make decisions regarding the tolerability of safety risks, in accordance with
(b)(1)(ii).
(c) Regardless of the approval status of the subcontracted organisations, the design organisation
is responsible for ensuring that hazard identification and risk management activities are
conducted on all subcontracted activities, as required by point 21.A.239(c)(3), as well as for
monitoring of their compliance and adequacy, as required by point 21.A.239(f).
(d) Internal investigation
(1) In line with its just culture policy, the organisation should define how to investigate
incidents such as errors or near misses, in order to understand not only what happened,
but also how it happened, and to prevent or reduce the probability and/or
consequences of any future recurrences (refer to AMC3 21.A.3A(a)(1) and (b)(1)).
(2) The scope of internal investigations should extend beyond the scope of the occurrences
that are required to be reported to the competent authority in accordance with point
21.A.3A.
(e) Safety performance monitoring and measurement
(1) The organisation should establish, implement and maintain a process by which the
safety performance of the organisation is continuously verified against the safety policy
and safety objectives.

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(2) This process may include, as appropriate to the size, nature and complexity of the
organisation:
(i) safety reporting that also addresses the status of compliance with the applicable
requirements;
(ii) safety reviews, including trend reviews, which should be conducted during the
introduction and deployment of new products and their components, new
equipment/technologies, the implementation of new or changed procedures, or
in situations of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management
system, and periodically assess the status of safety risk controls; and
(iv) safety surveys that examine particular elements or procedures of a specific area,
such as the problem areas identified, or any bottlenecks in the daily design
management activities, the perceptions and opinions of the design management
personnel, and any areas of dissent or confusion.
(f) Management of change
The organisation should manage any safety risks that are related to a change. The
management of change should be a documented process to identify any external or internal
change that may have an adverse effect on safety. It should make use of the organisation’s
existing hazard identification, risk assessment and mitigation processes.
(g) Continuous improvement
The organisation should continuously seek to improve its safety performance and the
effectiveness of its management system. Continuous improvement may be achieved through:
(1) compliance monitoring and audits carried out by external organisations;
(2) assessments, including assessments of the effectiveness of the safety culture and the
management system, in particular to assess the effectiveness of safety risk
management processes;
(3) staff surveys, including cultural surveys, that can provide useful feedback on how
engaged personnel are with the management system;
(4) monitoring incidents and their recurrences;
(5) evaluating the safety performance indicators and reviewing all the available safety
performance information; and
(6) identifying the lessons learned.
 21.A.239 Design management system

AMC1 21.A.239(c)(3) Design management system -

SAFETY MANAGEMENT ELEMENT — INTERFACES BETWEEN ORGANISATIONS

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(a) The safety risk management processes should specifically address the planned
implementation of, or participation of the organisation in, any complex arrangements (such as
when the DO subcontracts work to multiple organisations).
(b) Hazard identification and risk assessment start with the identification of all the parties
involved in the arrangement, including any independent experts and non-approved
organisations. It extends to the overall control structure, assessing in particular the following
elements across all subcontract levels and all parties within these arrangements:
(1) coordination and interfaces between the different parties;
(2) applicable procedures;
(3) communication between all the parties involved, including the reporting and feedback
channels;
(4) task allocation, responsibilities and authorities; and
(5) the qualifications and competency of key personnel with reference to point 21.A.245.
(c) Safety risk management should focus on the following aspects:
(1) clear assignment of accountability and allocation of responsibilities;
(2) only one party should be responsible for a specific aspect of the arrangement, with no
overlapping or conflicting responsibilities, in order to eliminate coordination errors;
(3) the existence of clear reporting lines, both for occurrence reporting and progress
reporting; and
(4) the possibility for staff to directly notify the organisation of any hazard that suggests an
obviously unacceptable safety risk as a result of the potential consequences of this
hazard.
(d) Regular communication should be ensured between all the parties to discuss work progress,
risk mitigation actions, changes to the arrangements, as well as any other significant issues.
(e) For any subcontracted activities, interfaces and communication channels are also needed for
the purposes of the internal safety reporting scheme (point 21.A.3A).

 21.A.239 Design management system

AMC1 21.A.239(c)(4)(ii) Design management system

MANAGEMENT OF CHANGE
(a) Regardless of the magnitude of change, large or small, there should always be proactive
consideration of the safety implications. This is primarily the responsibility of the team that
proposes or implements the change. However, a change can only be successful if all the
personnel affected by the change are engaged and involved, and they participate in the
process. The magnitude of a change, its safety criticality, and its potential impact on human
performance should be assessed in any change management process.
(b) Special consideration, including human factor issues, should be given to the transition period
during which the change will become effective. In addition, the activities utilised to manage

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these issues should be integrated into the change management plan. The purpose of
integrating human factors into the management of change is to minimise the potential risks by
specifically considering the impact of the change on the people within a system.
(c) During the process for the management of a change, previous risk assessments and existing
hazards should be reviewed for their possible effects.
 21.A.239 Design management system

GM1 21.A.239(c)(4)(ii) Design management system

MANAGEMENT OF CHANGE
Unless properly managed, changes in the organisational structure, facilities, scope of work,
personnel, documentation, policies and procedures, etc. can result in the inadvertent introduction of
new hazards, which can expose the organisation to new, or greater risks. Effective organisations
seek to improve their processes, with conscious recognition that changes can expose the
organisation to potentially latent hazards and risks if they are not properly and effectively managed.
The process for the management of change typically provides principles and a structured framework
for managing all aspects of changes. Disciplined application of change management can maximise
the effectiveness of the change, engage staff, and minimise the risks inherent in change.
A change may have the potential to introduce new human factor issues, or to exacerbate pre-
existing ones. For example, changes in computer systems, equipment, technology, personnel
changes, including changes in management personnel, procedures, the work organisation, or work
processes are likely to affect performance.
Effective management of change is supported by the following:
— Implementation of a process for formal hazard identification/risk analysis and assessment for
major operational changes, major organisational changes, changes in key personnel, and
changes that may affect the way in which design management is carried out.
— Identification of changes that are likely to occur in business, which would have a noticeable
impact on:

 resources — material and human;

 management direction — policies, processes, procedures, training; and
 management control.
— Safety cases/risk assessments that are aviation-safety focused.
— The involvement of key stakeholders in the change management process, as appropriate.
— 21.A.239 Design management system

AMC1 21.A.239(c)(5) Design management system

SAFETY COMMUNICATION
(a) The organisation should establish communication with its personnel, as appropriate for their
safety responsibilities, about safety matters that:

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(1) ensures that all the personnel are aware of the safety management activities;
(2) conveys safety-critical information, especially related to assessed risks and analysed
hazards;
(3) explains why particular actions are taken; and
(4) explains why safety procedures are introduced or changed.
(b) Regular meetings with personnel, as appropriate for their safety responsibilities, during which
information, actions, and procedures are discussed, may be used to communicate safety
matters.
 21.A.239 Design management system

GM1 21.A.239(c)(5) Design management system

SAFETY PROMOTION
Safety training, combined with safety communication and information sharing, is a part of safety
promotion.
Safety promotion activities are intended to:
— support the organisation’s policies;
— encourage a positive safety culture;
— create an environment that is favourable to the achievement of the organisation’s safety
objectives;
— support organisational learning;
— support the implementation of an effective safety reporting scheme; and
— support the development of a just culture.
Depending on the particular safety issue, safety promotion may also constitute or complement risk
mitigation actions.

 21.A.239 Design management system

AMC1 21.A.239(c)(5)(i) Design management system

SAFETY TRAINING
(a) The design management staff, as described in points 21.A.245(a) and (b), should receive initial
and recurring safety training, as appropriate for their responsibilities, to ensure their
continued competency, including safety management principles and the associated safety
objectives. The organisation should assess the category of staff for which this training should
be provided.
(b) Adequate records of all the safety training provided should be kept in accordance with point
21.A.5.
(c) Initial training that is compliant with the organisation’s training standards should be provided
to each member of the personnel within 6 months of joining the organisation, unless their

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competency assessment justifies that there is no need for such a training. Personnel who are
recruited from another organisation and temporary staff should be assessed for whether they
need to receive any additional safety management training.
(d) Recurrent safety training should be delivered either as a dedicated course, or else integrated
within other training. It should be of an appropriate duration in each 2-year period, in relation
to the relevant compliance monitoring audit findings and any other internal/external sources
of information available to the organisation on safety, and in design.
 21.A.239 Design management system.

GM1 21.A.239(c)(5)(i) Design management system

SAFETY TRAINING
The main purpose of the safety training programme is to:
— support safety management policies and processes, including human factors training; and
— ensure that personnel at all levels of the organisation develop and maintain their competency
to fulfil their safety roles.
Each organisation should adapt the syllabus to its own needs. Typically, at least the following items
should be included:
— The organisational roles and responsibilities related to safety, including the hazard
identification and risk management processes, and to fostering a positive safety culture;
— Safety objectives and the associated safety performance indicators;
— Human factors principles, including human performance and limitations;
— Legislation, where applicable;
— Safety reporting systems and investigations; and
— Safety issues.
The purpose of the recurrent safety training is:
— primarily to ensure that staff remain current, notably on changes to SMS principles, processes
and procedures; and
— also to share feedback on safety issues that are relevant to the organisation or lessons
learned.
The training staff should have sufficient knowledge and experience to teach the topics at the
required level, with the skills to influence attitudes and behaviours.
 21.A.239 Design management system

GM No 1 to 21.A.239(d)(a) Design assurance management system

DESIGN ASSURANCE ELEMENT
(a)1. Purpose

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This GM outlines some basic principles and objectives of 21.A.239(a).the design assurance
element.
(b)2. Definitions
2.(1) The design assurance system is includes the organisational structure, responsibilities,
procedures and resources to ensure the proper functioning of the design organisation.
2.(2) The design Design assurance refers to means all those planned and systematic actions
necessary to provide adequate confidence that the organisation has the capability to:
— to design products or parts in accordance with the applicable type
certification basis, the OSD certification basis CS and the environmental
protection requirements;,
— to demonstrate and verify the compliance with these type certification
basis, the OSD certification basis CS and the environmental protection
requirements;, and
— to demonstrate to the Agency EASA this compliance.
2.(3) The ‘Type Iinvestigation’ means refers to the tasks of the organisation in support of the
TCtype-certificate, STCtype-certificate or other design approval processes necessary to
demonstrate and verify and to maintain compliance with the applicable type
certification basis, OSD certification basis CS and environmental protection
requirements.
3. Design Assurance
The complete process, starting with the CS and environmental protection requirements and
product specifications and culminating with the issuing of a type-certificate, is shown in the
diagram on Figure 1. This identifies the relationship between the design, the Type
Investigation and design assurance processes.
Effective design assurance demands a continuing evaluation of factors that affect the
adequacy of the design for intended applications, in particular that the product, or part,
complies with applicable CS and environmental protection requirements and will continue to
comply after any change.
Two main aspects should therefore be considered:

 How the planned and systematic actions are defined and implemented, from the very
beginning of design activities up to continued airworthiness activities;

 How these actions are regularly evaluated and corrective actions implemented as
necessary.

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Figure 1 - RELATIONSHIPS BETWEEN DESIGN, DESIGN ASSURANCE AND TYPE INVESTIGATION

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3.1 Planned and Systematic Actions

For design organisations carrying out Type Investigation of products, the planned and
systematic actions should cover the following tasks and procedures should be defined
accordingly:
3.1.1 General
a. To issue or, where applicable, supplement or amend the handbook in
accordance with 21.A.243, in particular to indicate the initiation of design
activities on a product.
b. To assure that all instructions of the Handbook are adhered to.
c. To conduct Type Investigation.
d. To nominate staff as ‘compliance verification engineers’ responsible to
approve compliance documents as defined in paragraph 3.1.3.
e. To nominate personnel belonging to the Office of Airworthiness
responsible as defined in paragraph 3.1.4.
f. In the case of an applicant for a supplemental type-certificate, to obtain
the agreement of the type-certificate holder for the proposed
supplemental type-certificate to the extent defined in 21.A.115.
g. To ensure full and complete liaison between the type design organisation
and related organisations having responsibility for products manufactured
to the type-certificate.
h. To provide the assurance to the Agency that prototype models and test
specimens adequately conform to the type design (see 21.A.33(b)(1)).
3.1.2 Chief Executive and Head of design organisation (or his or her Deputy)
a. The Chief Executive should provide the necessary resources for the proper
functioning of the design organisation.
b. The Head of the design organisation, or an authorised representative,
should sign a declaration of compliance (see 21.A.20(d) and 21.A.97(a)(3))
with the applicable CS and environmental protection requirements after
verification of satisfactory completion of the Type Investigation. In
accordance with 21.A.20(e) and 21.A.97(a)(4), his or her signature on the
declaration of compliance confirms that the procedures as specified in the
handbook have been followed (see also GM 21.A.265(b)).
c. The functions of Chief Executive and Head of the design organisation may
be performed by the same person.
3.1.3 Compliance Verification
a. Approval by signing of all compliance documents, including test
programmes and data, necessary for the verification of compliance with
the applicable CS and environmental protection requirements as defined in
the certification programme.

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b. Approval of the technical content (completeness, technical accuracy...),

including any subsequent revisions, of the manuals approved by the
Agency (Aircraft Flight Manual, the Airworthiness Limitations section of the
Instructions for Continued Airworthiness and the Certification Maintenance
Requirements (CMR) document, where applicable).
3.1.4 Office of Airworthiness
a. Liaison between the design organisation and the Agency with respect to all
aspects of the certification programme.
b. Ensuring that a handbook is prepared and updated as required in 21.A.243.
c. Co-operation with the Agency in developing procedures to be used for the
type certification process.
d. Issuing of guidelines for documenting compliance.
e. Co-operation in issuing guidelines for the preparation of the manuals
required by the applicable implementing rules, Service Bulletins, drawings,
specifications, and standards.
f. Ensuring procurement and distribution of applicable CS and environmental
protection requirements and other specifications.
g. Co-operating with the Agency in proposing the type-certification basis
h. Interpretation of CS and environmental protection requirements and
requesting decisions of the Agency in case of doubt.
i. Advising of all departments of the design organisation in all questions
regarding airworthiness, operational suitability, environmental protection
approvals and certification.
j. Preparation of the certification programme and co-ordination of all tasks
related to Type Investigation in concurrence with the Agency.
k. Regular reporting to the Agency about Type Investigation progress and
announcement of scheduled tests in due time.
l. Ensuring co-operation in preparing inspection and test programmes
needed for demonstration of compliance.
m. Establishing the compliance checklist and updating for changes.
n. Checking that all compliance documents are prepared as necessary to
demonstrate compliance with all CS and environmental protection
requirements, as well as for completeness, and signing for release of the
documents.
o. Checking the required type design definition documents described in
21.A.31 and ensuring that they are provided to the Agency for approval
when required.

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p. Preparation, if necessary, of a draft for a type-certificate data sheet and/or

type-certificate data sheet modification.
q. Providing verification to the head of the design organisation that all
activities required for Type Investigation have been properly completed.
r. Approving the classification of changes in accordance with 21.A.91 and
granting the approval for minor changes in accordance with 21.A.95(b).
s. Monitoring of significant events on other aeronautical products as far as
relevant to determine their effect on airworthiness or operational
suitability of products being designed by the design organisation.
t. Ensuring co-operation in preparing Service Bulletins and the Structural
Repair Manual, and subsequent revisions, with special attention being
given to the manner in which the contents affect airworthiness and
environmental protection and granting the approval on behalf of the
Agency.
u. Ensuring the initiation of activities as a response to a failure
(accident/incident/in-service occurrence) evaluation and complaints from
the operation and providing of information to the Agency in case of
airworthiness or operational suitability impairment (continuing
airworthiness and continued operational suitability).
v. Advising the Agency with regard to the issue of airworthiness directives in
general based on Service Bulletins.
w. Ensuring that the manuals approved by the Agency, including any
subsequent revisions (the Aircraft Flight Manual, MMEL, the Airworthiness
Limitations section of the Instructions for Continued Airworthiness and the
Certification Maintenance Requirements (CMR) document, where
applicable) are checked to determine that they meet the respective
requirements, and that they are provided to the Agency for approval.
3.1.5 Maintenance and Operating Instructions
a. Ensuring the preparation and updating of all maintenance and operating
instructions (including Services Bulletins) needed to maintain airworthiness
(continuing airworthiness) in accordance with relevant CS. For that
purpose, the applicant should:
 establish the list of all documents it is producing to comply with the
Appendix referred to in CS 23.1529, CS 25.1529, CS 27.1529,
CS 29.1529, CS-E 25 or CS-P 40 (NPA P-3);

 define procedures and organisation to produce and issue these

documents, using where applicable and so elected 21.A.263(c)(3)
privilege.

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b. In accordance with 21.A.57, 21.A.61, 21.A.107, 21.A.119, 21.A.120A and

21.A.449, ensuring that these documents are provided to all affected
operators and all involved authorities.
3.1.6 Operational Suitability Data
a. Ensuring the preparation and updating of all operational suitability data in
accordance with relevant CS. For that purpose, the applicant should:
 establish the list of all documents it is producing to comply with CS-
MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD as
applicable;

 define procedures and organisation to produce and issue these

documents, using where applicable and so elected 21.A.263(c)(3)
privilege.
b. In accordance with 21.A.57, 21.A.62, 21.A.108, 21.A.119 and 21.A.120B,
ensuring that these documents are provided to all affected operators and
training organisations and all involved authorities.
3.2 Continued effectiveness of the design assurance system. The organisation should
establish the means by which the continuing evaluation (system monitoring) of the
design assurance system will be performed in order to ensure that it remains effective.
 21.A.239 Design management system

AMC1 21.A.239(d) Design management system

DESIGN ASSURANCE ELEMENT
(a) Reserved
(b) Reserved
(c) Design assurance system
The complete design process, starting with the type certification basis, OSD certification basis
and environmental protection requirements and product specifications and culminating with
the issuing of a TC, is shown in the diagram on Figure 1. This identifies the relationship
between the design, the type investigation and the design assurance processes.
Effective design assurance demands a continuing evaluation of any factors that affect the
adequacy of the design for the intended applications. In particular, it must be ensured that the
product or part complies with the applicable type certification basis, the OSD certification
basis and the environmental protection requirements, and will continue to comply after any
change.
Two main aspects should therefore be considered:
— How the planned and systematic actions are defined and implemented from the very
beginning of the design activities up to the continued airworthiness activities;
— How these actions are regularly evaluated and corrective actions are implemented as
necessary.

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Figure 1 — RELATIONSHIPS BETWEEN DESIGN, DESIGN ASSURANCE AND TYPE INVESTIGATION

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(1) Planned and systematic actions

For design organisations that carry out type investigations of products, their planned
and systematic actions should cover the following tasks, and the related procedures
should be defined accordingly:
(i) General
(A) To issue or, where applicable, supplement or amend the handbook in
accordance with point 21.A.243, in particular to indicate the initiation of
design activities on a product.
(B) To assure that all the instructions of the handbook are adhered to.
(C) To conduct type investigations.
(D) To nominate staff as ‘compliance verification engineers’ who are
responsible for approving compliance documents as defined in point
(c)(1)(iii).
(E) To nominate personnel who belong to the Office of Airworthiness and are
responsible as defined in point (c)(1)(iv).
(F) In the case of an applicant for a STC, to obtain the agreement of the
TCholder for the proposed STCto the extent defined in point 21.A.115.
(G) To ensure that there is full and complete liaison between the type design
organisation and the related organisations who have responsibility for the
products manufactured to the TC.
(H) To provide assurance to EASA that any prototype models and test
specimens adequately conform to the type design (see point
21.A.33(b)(1)).
(ii) Chief executive officer and head of the design organisation (or his or her deputy)
(A) The chief executive officer should provide the necessary resources for the
proper functioning of the design organisation.
(B) The head of the design organisation, or an authorised representative,
should sign a declaration of compliance (see points 21.A.20(d) and
21.A.97(a)(3)) with the applicable type certification basis, the OSD
certification basis and the environmental protection requirements after
verifying the satisfactory completion of the type investigation. In
accordance with points 21.A.20(e) and 21.A.97(a)(4), his or her signature
on the declaration of compliance confirms that the procedures as specified
in the handbook have been followed (see also GM 21.A.265(b)).
(C) The functions of the chief executive officer and the head of the design
organisation may be performed by the same person.
(iii) Compliance verification
(A) Approval by the signing of all the compliance documents, including test
programmes and data that are necessary for the verification of compliance

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with the applicable type certification basis, the OSD certification basis and
the environmental protection requirements as defined in the certification
programme.
(B) Approval of the technical content (completeness, technical accuracy, etc.),
including any subsequent revisions, of the manuals approved by EASA (the
aircraft flight manual, the airworthiness limitations section of the
instructions for continued airworthiness and the certification maintenance
requirements (CMR) document, where applicable).
(iv) Office of Airworthiness
(A) Liaison between the design organisation and EASA with respect to all
aspects of the certification programme.
(B) Ensuring that a handbook is prepared and updated as required in point
21.A.243.
(C) Cooperation with EASA in developing procedures to be used for the type
certification process.
(D) Issuing of guidelines for documenting compliance.
(E) Cooperation in issuing guidelines for the preparation of the manuals
required by the applicable requirements, service bulletins, drawings,
specifications, and standards.
(F) Ensuring procurement and distribution of the applicable type certification
basis, OSD certification basis and environmental protection requirements
and other specifications.
(G) Cooperating with EASA in proposing the type certification basis
(H) The interpretation of the type certification basis, the OSD certification basis
and the environmental protection requirements and requesting decisions
from EASA in cases of doubt.
(I) Advising all the departments of the design organisation on all questions
regarding airworthiness, operational suitability, environmental protection
approvals and certification.
(J) Preparation of the certification programme and coordination of all the
tasks related to type investigations in concurrence with EASA.
(K) Regular reporting to EASA about the progress of type investigations, and
announcing scheduled tests in due time.
(L) Ensuring cooperation in preparing the inspection and test programmes
needed for demonstrations of compliance.
(M) Establishing the compliance checklist and updating it with any changes.
(N) Checking that all the compliance documents are prepared that are
necessary to demonstrate compliance with the type certification basis, the

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OSD certification basis and the environmental protection requirements, as

well as for completeness, and signing the documents for release.
(O) Checking the required type design definition documents described in point
21.A.31 and ensuring that they are provided to EASA for approval when
required.
(P) Preparation, if necessary, of a draft of a TCDS and/or a modification to a
TCDS.
(Q) Providing verification to the head of the design organisation that all the
activities required for a type investigation have been properly completed.
(R) Approving the classification of changes in accordance with point 21.A.91
and granting approvals for minor changes in accordance with point
21.A.95(b).
(S) Monitoring significant events on other aeronautical products, as far as they
are relevant, to determine their effect on the airworthiness or the
operational suitability of the products designed by the design organisation.
(T) Ensuring that there is cooperation in preparing service bulletins and the
structural repair manual, and any subsequent revisions, with special
attention being given to the manner in which the contents affect
airworthiness and environmental protection, and granting the approval on
behalf of EASA.
(U) Ensuring the initiation of activities as a response to a failure
(accident/incident/in-service occurrence) evaluation and complaints from
the operation, and providing information to EASA if the airworthiness or
the operational suitability are impaired (continuing airworthiness and
continued operational suitability).
(V) Advising EASA on the issuing of airworthiness directives in general based
on Service Bulletins.
(W) Ensuring that the manuals approved by EASA, including any subsequent
revisions (to the aircraft flight manual, the MMEL, the airworthiness
limitations section of the instructions for continued airworthiness and the
certification maintenance requirements (CMR) document, where
applicable) are checked to determine whether they meet their respective
requirements, and that they are provided to EASA for approval.
(v) Maintenance and operating instructions
(A) Ensuring the preparation and updating of all the maintenance and
operating instructions (including instructions for continued airworthiness
and service bulletins) that are needed to maintain airworthiness (i.e.
continuing airworthiness) in accordance with the relevant CSs. For that
purpose, the applicant should:

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— establish the list of all the documents it is producing to comply with

the Appendix referred to in CS 23.1529, CS 25.1529, CS 27.1529,
CS 29.1529, CS-E 20/25 or CS-P 40 (NPA P-3);
— establish a system to collect in-service experience to be used for the
improvement of the instructions;
— define the procedures and the organisation that will produce and
issue these documents, under the obligation of point 21.A.265(h);
the procedures should cover the:
 preparation, including the format and language (available
industrial standards can be referred to and used);

 proofreading (checking for clarity, readability, typos, etc.);

 checking of technical consistency with the corresponding
approved change(s), repair(s) or approved data, including the
effectivity, description, effects on airworthiness and
environmental protection, especially when limitations are
changed;
 checking of feasibility in practical applications; and
 responsibilities and authorised signatories.
(B) In accordance with points 21.A.57, 21.A.61, 21.A.107, 21.A.119, 21.A.120A
and 21.A.449, ensuring that these documents are provided to all known
operators and all the involved authorities.
(vi) Operational suitability data (OSD)
(A) Ensuring the preparation and updating of all OSD in accordance with the
relevant CSs. For that purpose, the applicant should:
— establish the list of all the documents it is producing to comply with
CS-MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD,
as applicable;
— define the procedures and the organisation that will produce and
issue these documents, under the obligation of point 21.A.265(h);
the procedure should cover the aspects described in (c)(1)(v)(A)
above.
(B) In accordance with points 21.A.57, 21.A.62, 21.A.108, 21.A.119 and
21.A.120B, ensuring that these documents are provided to all the affected
operators and training organisations, and all the involved authorities.
(d) Continued effectiveness of the design assurance system
The organisation should establish the means by which the independent monitoring of the
compliance and adequacy of the design assurance system will be performed in order to
ensure that it remains effective.

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 21.A.239 Design management system

AMC2 GM No 2 to 21.A.239(d)(a) Design management system

Design assurance system for minor changes to type design or minor
repairs to products
DESIGN ASSURANCE ELEMENT FOR MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO
PRODUCTS
(a)1. Purpose
This GM AMC outlines some basic principles and objectives in order to comply with
21.A.239(a) the design assurance element for organisations designing only minor changes to
type design or minor repairs to products.
(b)2. Design assurance system
The design assurance system should include the following:
— an organisational structure to:
 control the design;
 demonstrate compliance with the applicable type certification basis, the
OSD certification basis CS and the environmental protection requirements;
 independently check demonstrations of compliance;
 liaise with the Agency EASA;

 continuously evaluate the design organisation; and

 control sub-contractors subcontractors; and
— procedures and responsibilities associated with the functions listed above, taking
due account of Part 21 requirements applicable to design and approval of minor
changes to type design or minor repairs to products.
— 21.A.239 Design management system

AMC 21.A.239(a)(3) Design assurance system – Independent system

monitoring
The system monitoring function required by 21.A.239(a)(3) may be undertaken by the existing
quality assurance organisation when the design organisation is part of a larger organisation.

AMC1 21.A.239(d)(2)(b) Design management assurance system -

Independent checking function of the demonstration of compliance
INDEPENDENT VERIFICATION FUNCTION OF THE DEMONSTRATION OF COMPLIANCE
(a)1. The independent verification checking function of the demonstration of compliance should
consist of the verification by a person who did not creating create the compliance data. Such a
person may work in conjunction with the individuals who prepare compliance data.

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(b)2. The verification should be shown by signing compliance documents, including test
programmes and data.
(c)3. For a product, there is normally only one compliance verification engineer nominated for each
relevant subject. A procedure should cover the non-availability of nominated persons and
their replacement when necessary.
(d)4. For STC cases, when compliance statement and associated documentation are produced by
the TC holder, and when this these data is are approved under the system of the authority of
TC holder, then the STC applicant does not need to provide, within its own DOA, the
independent verification checking function required in point 21.A.239(d)(2)(b) for these this
data.

 21.A.239 Design management system.

GM1 21.A.239(d)(3)(c) Design management system Design

assurance system
DESIGN ASSURANCE ELEMENT
In meeting the requirements of point 21.A.239(d)(3)(c), the applicant for a design organisation
approval under Subpart J may adopt the following policy:
(a)1. The satisfactory integration of the Partner/Sub-contractor partner/subcontractor and
applicant’s design assurance systems should be is demonstrated for the activities covered
under the applicant’s terms of approval.
(b)2. In the event that a Partner/Sub-contractor partner/subcontractor holds a design organisation
approval (DOA), then in accordance with point 21.A.239(d)(3)(c), the applicant may take this
into account in demonstrating the effectiveness of this integrated system.
(c)3. When any Partner/Sub-contractor partner/subcontractor does not hold a DOA, then the
applicant will need to establish to its own satisfaction and the satisfaction of the Agency EASA,
the adequacy of that partner’s/sub-contractor’ subcontractor’s design assurance system in
accordance with point 21.A.243(b).
 21.A.239 Design management system

AMC1 21.A.239(e) Design management system

DOCUMENTATION
(a) The manual or the handbook that is used to document the management system should be the
key instrument used by an organisation to internally communicate its approach to
management systems.
(b) The organisation may document its safety policy, safety objectives and all the safety
management system key processes (as required in point 21.A.239(a)(1)) in a separate manual
(e.g. a safety management manual or management system manual) or in its handbook.
Organisations that hold multiple organisation approvals, issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, may
prefer to have a separate manual in order to avoid duplication.

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(c) The organisation may also choose to place in separate documents (e.g. policy documents,
procedures) some of the information that is required to be documented.
(d) If any required information is placed in a separate document, the manual or the handbook
should contain adequate references to that document. Any such referenced documents
should be considered integral parts of the organisation’s management system documentation.
 21.A.239 Design management system

AMC1 21.A.239(f) Design management system

INDEPENDENT MONITORING OF COMPLIANCE AND ADEQUACY
(a) The function that carries out independent monitoring of the compliance and adequacy of the
documented procedures of the design management system should ensure that:
(1) the activities of the organisation are monitored for their adequacy and compliance with
the applicable requirements and with any additional requirements as established by the
organisation, and that these activities are carried out properly under the supervision of
the nominated persons referred to in point 21.A.245(b);
(2) all subcontracted design activities are monitored;
(3) an objective review of the complete set of design management related activities is
provided through independent audits;
(4) the independence of the audit is established by always ensuring that audits and
inspections are carried out by personnel who are not responsible for the function,
procedure or products that they audit or inspect;
(5) an audit plan is established to show when and how often the activities required by
Part 21 will be audited; and
(6) the audit cycle should be determined through a risk assessment agreed by the
competent authority and that it does not exceed the applicable audit planning cycle
according to 21.B.432. That determination should consider at least the following
aspects:
(i) the criticality of the items checked during the audit; and
(ii) the safety performance of the organisation, including any previous findings and
root causes;
(7) when a non-compliance is found, the root cause(s) and contributing factor(s) are
identified and corrective actions are defined. The feedback part of the compliance
monitoring function should define who is required to address any non-compliance in
each particular case, and the procedure to be followed if the corrective action is not
completed within the defined time frame.
(c) The independent monitoring of compliance and adequacy required by point 21.A.239(f) may
be undertaken by the existing quality assurance organisation if the design organisation is part
of a larger organisation.
 21.A.239 Design management system

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AMC1 No 1 to 21.A.243(a) Data requirements Handbook

(a) Personnel should be familiar with those parts of the handbook that are relevant to their tasks.
(b) The handbook should provide the following information for each product covered by the
design organisation approval.
(1). A description of the tasks which can be performed under the approval, according to the
following classification:
(i)a. General areas, like subsonic turbojet aeroplanes, turbopropeller turboprop
aeroplanes, small aeroplanes, rotorcraft.
(ii)b. Technologies handled by the organisation (composite, wood or metallic
construction, electronic systems, etc.)
(iii)c. A list of types and models for which the design approval has been granted and for
which privileges may be exercised, supported by a brief description for each
product.
(iv)d. For repair design, classification and (if appropriate) approval activities it is
necessary to specify the scope of activity in terms of structures, systems, engines,
etc.
(2). A general description of the organisation, its main departments, their functions and the
names of those in charge; a description of the line management and of the functional
relationships between the various departments.
(3). A description of the assigned responsibilities and delegated authority of all parts of the
organisation which, taken together, constitute the organisation’s design assurance
management system, together with a chart indicating the functional and hierarchical
relationship of the design assurance management system to the Mmanagement and to
other parts of the organisation; also the chains of responsibilities within the design
assurance management system, and the control of the work of all partners and sub-
contractors subcontractors.
(4). A general description of the way in which the organisation performs all the design
functions in relation to airworthiness, operational suitability and environmental
protection approvals including:
(i)a. The procedures followed and forms used in the type investigation Type
Investigation process to ensure that the design of, or the change to the design of,
the product, as applicable, is identified and documented, and complies with the
applicable type certification basis, the OSD certification basis CS and the
environmental protection requirements, including specific requirements for
import by importing authorities
(ii)b. The procedures for classifying design changes as ‘major’ or ‘minor’ and for the
approval of minor changes.
(iii)c. The procedures for classifying and approving unintentional deviations from the
approved design data occurring in production (concessions or non-conformities
non-conformance’s).

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(iv)d. The procedure for classifying and obtaining approval for repairs.
(5) A general description of the way in which the organisation performs its functions in
relation to the continuing airworthiness and continued operational suitability of the
product it designs, including co-operation cooperation with the production organisation
when dealing with any continuing airworthiness actions that are related to the
production of the product, part or appliance, as applicable.
(6) A description of the human resources, facilities and equipment, which constitutes the
means for design, and where appropriate, for ground and flight testing.
(7) An outline of a system for controlling and informing the staff Staff of the organisation of
current changes in engineering drawings, specifications and design assurance
management procedures.
(8) A description of the recording system for:
(i)a. The the type design, including relevant design information, drawings and test
reports, including inspection records of test specimens.;
(ii)b. The the means of compliance.; and
(iii)c. The the compliance documentation (compliance checklist check list, reports,
etc....).
(9) A description of the record-keeping system to comply with point 21.A.5 21.A.55 and
21.A.105.
(10) A description of the means by which the organisation monitors and responds to
problems affecting the airworthiness or operational suitability of its product during
design, production and in service in particular to comply with point 21.A.3A (see also
AMC1 21.A.239(d), GM No 1 to 21.A.239(a), paragraphs points (c)(1)(iv)(S) and (U).
(11) The names of the design organisation authorised signatories. Nominated persons with
specific responsibilities such as mentioned in points 21.A.33 and 21.A.35 should be
listed.
(12) (Reserved) The description of the organisation’s safety policy and the objectives of the
organisation as required by point 21.A.239(c)(1).
(13) A clear definition of the tasks, competence and areas of responsibility of the Office of
Airworthiness.
(14) A description of the procedures for the establishment and the control of the
maintenance and operating instructions (see points 21.A.57, 21.A.61, 21.A.107,
21.A.119, 21.A.120A and 21.A.449).
(15) A description of the means by which the continuing evaluation (system monitoring) of
the design assurance management system will be performed in order to ensure that it
remains effective.
(16) A description of the procedures for the establishment and the control of the operational
suitability data (see points 21.A.57, 21.A.62, 21.A.108, 21.A.119 and 21.A.120B).

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(17) A description of the internal safety reporting scheme as required by point

21.A.3A(a)(1)(ii);
(18) A statement, signed by the head of the design organisation (and countersigned by the
chief executive officer, if different), confirming that the design management handbook
and any associated manuals will be complied with at all times.
This statement should read as follows, or embrace the intent of the following
paragraph:
‘This handbook defines the organisation and procedures upon which EASA’s design
organisation approval is based.
These procedures are approved by the undersigned, and must be complied with, as
applicable, in order to ensure that all design activities are carried out on time and to an
approved standard.
It is understood that the approval of the design organisation is based on the continuous
compliance or the organisation with the applicable requirements of Part 21, and with
the organisation’s procedures described in this handbook. EASA is entitled to limit,
suspend, or revoke the approval, if the organisation fails to fulfil the obligations imposed
by Part 21, or any conditions according to which the approval was issued.
Signed .....................................
Dated ......................................
Head of the design organisation and ... (quote position)
Chief executive officer…
For and on behalf of ... (quote organisation’s name)
The statement should be re-issued, at the earliest opportunity, whenever the head of
the design organisation is changed.
 21.A.243 Handbook

AMC2 No 2 to 21.A.243(a) Data requirements – Model content of

handbook for organisations designing minor changes to type design
or minor repairs to products Handbook
MODEL CONTENT OF HANDBOOK FOR ORGANISATIONS DESIGNING MINOR CHANGES TO TYPE
DESIGN OR MINOR REPAIRS TO PRODUCTS
Part 1. Organisation
1.1 Objective of the handbook and binding statement
1.2 Responsible person for administration of the handbook
1.3 Amendment procedure
1.4 List of effective pages
1.5 Distribution list

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1.6 Presentation of the design organisation (including locations)

1.7 Scope of work (with identification of type and models of products)
1.8 Organisation charts
1.9 Human resources
1.10 Management staff
1.11 Certifying personnel (see GM No 2 to 21.A.243(d), paragraph 2)
1.12 Independent system monitoring
Part 2. Procedures
2.1 Management of changes to type design and design of repairs

 configuration control
 classification
 approval of minor changes to type design and minor repairs
2.2 Control of design sub-contractors subcontractors
2.3 Collecting/Investigating of failures, malfunctions and defects
2.4 Co-ordination Coordination with production
2.5 Documentation control
 in relations relation with the changes and repairs
 in relation with failures/malfunctions and defects (i.e. Services Bulletins)
2.6 Record-keeping
 21.A.243 Handbook

AMC1 21.A.243(d) Handbook

STATEMENT OF QUALIFICATIONS AND EXPERIENCE
(a) The following statements should be provided:
(1) Other management staff
The person nominated represents, or persons nominated represent, the management
structure of the organisation and is, or are, responsible through the head of the design
organisation to the chief executive officer for the execution of all the functions specified
in Subpart J of Part 21. Depending on the size of the organisation, the functions may be
subdivided under individual managers.
The nominated managers should be identified, and their relevant knowledge and
satisfactory experience related to the nature of the design activities that they perform
should be demonstrated. For each nominated manager, the organisation should provide
this data to EASA on EASA Form 4-DOA (see EASA website:
http://easa.europa.eu/certification/application-forms.php) to show that they are

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suitable in terms of their relevant knowledge and satisfactory experience related to the
nature of the design activities performed by the organisation.
The responsibilities and the tasks of each individual manager should be clearly defined,
in order to prevent any uncertainties about the relations within the organisation. The
responsibilities of the managers should be defined in a way that all responsibilities are
covered.
(2) The personnel who make decisions that affect airworthiness, operational suitability and
environmental protection
For these personnel, no individual statements are required. The organisation should
demonstrate that there is a system to select, train, maintain and identify them for all
the tasks for which they are needed.
(b) The personnel defined in (a) should be identified in the handbook or in a document linked to
the handbook. This, and the corresponding procedures, should enable them to carry out the
assigned tasks and to properly discharge the associated responsibilities.
(c) The number of these personnel who are needed to sustain the design activities should be
identified by the organisation.
(d) The personnel defined in (a) should be chosen on the basis of their knowledge, background
and experience.
(e) When necessary, complementary training should be established, to ensure that personnel
have sufficient background and knowledge in the scope of their authorisation. The minimum
standards for new personnel to qualify in the functions should be established. The training
should lead to a satisfactory level of knowledge of the procedures that are relevant for each
particular role.
(f) Training policy forms a part of the design management system, and its appropriateness forms
a part of investigation by EASA within the organisation approval process and the subsequent
surveillance of the persons proposed by the organisation.
(g) This training should be adapted in response to experience gained within the organisation
(h) The organisation should maintain a record of the personnel defined in (a) as defined in
AMC 21.A.5(d).

 21.A.243 Handbook

GM1 No 1 to 21.A.243(d) Handbook Statement of qualifications and

experience
STATEMENT OF QUALIFICATIONS AND EXPERIENCE
1. Purpose
This GM provides guidelines on the following points:
 Who are the persons covered by 21.A.243(d)?
 What is requested from the applicant for these persons?

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2. Who are the persons?

Three different types of functions are named or implicitly identified in the requirements of
Part 21 Subpart J or in the associated AMC and GM, using qualified and experienced
personnel:

 the Chief Executive chief executive officer [see GM No 1 to 21.A.239(a)

AMC1 21.A.239(d), point (c)(1)(ii) para. 3.1.2, GM 21.A.249, GM 21.A.265(b)]

 the other management staff:

 the Head head of the design organisation [see GM No 1 to 21.A.239(a)

AMC1 21.A.239(d), point (c)(1)(ii) para.3.1.2, GM No 1 21.A.245 AMC1 21.A.245,
point (d)(1)4.1, GM 21.A.265(b)]
 the Chief of the Office of Airworthiness, or [see GM No 1 21.A.245 AMC1
21.A.245, point (d)(2) 4.2]

 the Chief of the independent monitoring function of the design assurance

system [see point 21.A.239(a)(3) and AMC1 No 1 to 21.A.243(a), point (b)(2)
para.2]

 the safety manager function [see AMC1 21.A.239(c)(2)]

 the safety review board function, depending on the size of the organisation, the
nature and complexity of its activities [see AMC1 21.A.239(c)(2)]
 the personnel making decisions affecting airworthiness, operational suitability
and environmental protection:
 compliance verification engineers [see AMC1 to 21.A.239(d), para.3.1.3;
AMC 21.A.239(b) AMC1 21.A.239(d)(2)]
 personnel of the Office of Airworthiness making decisions affecting
airworthiness, operational suitability and environmental protection, especially
those linked with the point 21.A.263 privileges (signing documents for release,
approving classification of changes and repairs, and granting the approval of
minor changes and minor repairs, granting the approval of SBs, and minor
revisions to the aircraft flight manual) [see AMC1 to 21.A.239(d), para. 3.1.4].
 A statement of the qualifications and experience of the chief executive officer is not
required.
3. Kind of statement
3.1 Chief Executive
The Chief Executive should provide the necessary resources for the proper functioning
of the design organisation.
A statement of the qualification and experience of the Chief Executive is normally not
required.
3.2 Other management staff

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The person or persons nominated should represent the management structure of the
organisation and be responsible through the Head of design organisation to the Chief
Executive for the execution of all functions as specified in Part 21, Subpart J. Depending
on the size of the organisation, the functions may be subdivided under individual
managers.
The nominated managers should be identified and their credentials furnished to the
Agency on EASA Form 4-DOA (see EASA website:
http://easa.europa.eu/certification/application-forms.php) in order that they may be
seen to be appropriate in terms of relevant knowledge and satisfactory experience
related to the nature of the design activities as performed by the organisation.
The responsibilities and the tasks of each individual manager should be clearly defined,
in order to prevent uncertainties about the relations, within the organisation.
Responsibilities of the managers should be defined in a way that all responsibilities are
covered.
3.3 Personnel making decisions affecting airworthiness, operational suitability and
environmental protection
For these personnel, no individual statement is required. The applicant should show to
the Agency that there is a system to select, train, maintain and identify them for all
tasks where they are necessary.
The following guidelines for such a system are proposed:

 These personnel should be identified in the handbook, or in a document

linked to the handbook. This, and the corresponding procedures, should enable
them to carry out the assigned tasks and to properly discharge associated
responsibilities.
 The needs, in terms of quantity of these personnel to sustain the design
activities, should be identified by the organisation.
 These personnel should be chosen on the basis of their knowledge,
background and experience.
 When necessary, complementary training should be established, to ensure
sufficient background and knowledge in the scope of their authorization. The
minimum standards for new personnel to qualify in the functions should be
established. The training should lead to a satisfactory level of knowledge of the
procedures relevant for the particular role.
 Training policy forms part of the design assurance system and its
appropriateness forms part of investigation by the Agency within the organisation
approval process and subsequent surveillance of persons proposed by the
organisation.
 This training should be adapted in response to experience gained within
the organisation

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 The organisation should maintain a record of these personnel which

includes details of the scope of their authorisation. The personnel concerned
should be provided with evidence of the scope of their authorisation.

 The following minimum information should be kept on record:

a) Name
b) Date of birth
c) Experience and training
d) Position in organisation
e) Scope of the authorisation
f) Date of first issue of the authorisation
g) If appropriate, date of expiry of the authorisation
h) Identification number of the authorisation.
The record may be kept in any format and should be controlled.
 Persons authorised to access the system should be maintained at a
minimum to ensure that records cannot be altered in an unauthorised manner or
that such confidential records do not become accessible to unauthorised persons.
 Personnel should be given access to their own record.
 Under the provision of 21.A.257 the Agency has a right of access to the
data held in such a system.
 The organisation should keep the record for at least two years after a
person has ceased employment with the organisation or withdrawal of the
authorisation, whichever is the sooner.
 21.A.243 Handbook

GM No AMC2 to 21.A.243(d) Handbook Data requirements – –

Statement of the qualification and experience – Organisations
designing minor changes to type design or minor repairs to
products
STATEMENT OF THE QUALIFICATION AND EXPERIENCE — ORGANISATIONS DESIGNING MINOR
CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
For organisations designing minor changes to type design designs or minor repairs to products, the
statement of the qualifications and experience required by point 21.A.243(d) should be addressed as
follows:
(a)1. The nominated managers should be identified and their relevant knowledge and satisfactory
experience related to the nature of the design activities that they perform should be
demonstrated. For each nominated manager, the organisation should provide evidence of
competency credentials submitted to the Agency EASA on EASA Form 4 - DOA (see EASA

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website: http://easa.europa.eu/certification/application-forms.php) in order that they may be

seen to be appropriate in terms of relevant knowledge and satisfactory experience related to
the nature of the design activities as performed by the organisation.
(b)2. The persons responsible to for:

 classify classifying changes to type design designs or repairs;

 verify verifying compliance [point 21.A.239(b)];

 approve approving minor changes to type design designs and minor repairs [point
21.A.263(c)(2)]; and
 issue issuing information or instructions [point 21.A.263(c)(3)],
should be selected by the organisation in accordance with a procedure and criteria agreed
with the Agency EASA.

 21.A.243 Handbook

AMC GM No 1 to 21.A.245 Requirements for approval Resources

See 21.A.245
(a)1. General. The data handbook submitted in accordance with point 21.A.243 should show that
sufficient skilled personnel are available, and suitable technical and organisational provisions
have been made for carrying out the type investigation Type Investigation defined by GM No 1
to 21.A.239(a)(d), point (b)(3) paragraph 2.3.
(b)2. Personnel. The applicant organisation should show that the personnel available to comply
with point 21.A.245(a)(c)(1) are, due to their special qualifications and number numbers, able
to provide assurance of the design or modification of a product, as well as the compilation and
verification of all data needed to meet the applicable type certification basis, OSD certification
basis CS and environmental protection requirements while taking into account the present
state of the art and new experience.
(c)3. Technical. The applicant should have access to:
(1)a. Wworkshops and production facilities which are suitable for manufacturing prototype
models and test specimens; and.
(2)b. Aaccommodation and test facilities which are suitable for carrying out the tests and
measurements needed to demonstrate compliance with the type certification basis,
OSD certification basis CS and environmental protection requirements. The test facilities
may be subjected to additional technical conditions related to the nature of tests
performed.
(d)4. Organisation. The data handbook submitted in accordance with point 21.A.243 should show
that:
4.(1) the The Head head of the design organisation for which an application for approval has
been made, has the direct or functional responsibility for all departments of the
organisation which are responsible for the design of the product. If the departments
responsible for design are functionally linked, the Head head of the design organisation

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still carries the ultimate responsibility for the compliance of the organisation with Part
21 Subpart J.
4.(2) an An Office of Airworthiness, or equivalent function, has been established and staffed
on a permanent basis to act as the focal point for co-ordinating coordinating
airworthiness, operational suitability and environmental protection matters (see GM No
1 to 21.A.239(a) AMC1 21.A.239(d) point (c)(1)(iv) paragraph 3.1.4); it reports directly to
the head Head of the design organisation or is integrated into an independent quality
assurance organisation reporting to the Head head of the design organisation.
4.(3) [Reserved]
4.(4) The responsibilities Responsibilities for all the tasks related to Tyype Iinvestigations are
assigned in such a way that gaps in authority are excluded.
4.(5) The responsibility for a number of tasks as in point (c)(4) paragraph 4.4 may be assigned
to one person, especially in the case cases of simple projects.
4.(6) Co-ordination Coordination between technical departments and the persons in charge
of the system monitoring required by point 21.A.239(f)(a)(3) has been established to:
(i)a. to ensure the quick and efficient reporting and resolution of difficulties
encountered using the handbook and associated procedures;
(ii)b. to maintain the design assurance management system; and
(iii)c. to optimise auditing activities.

 21.A.245 Resources

AMC GM No 2 to 21.A.245 Resources Requirements for approval –

Organisations designing minor changes to type design or minor
repairs to products
ORGANISATIONS DESIGNING MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
The data handbook submitted in accordance with point 21.A.243 should show that:
(a)1. The the manager responsible for design has the direct or functional responsibility for all the
departments of the organisation which are involved in the design of minor changes to type
design designs or minor repairs to products;.
(b)2. a person has, or persons have, Person(s) have been nominated to liaise with the Agency EASA
and to coordinate co-ordinate airworthiness, operational suitability and environmental
protection matters. Their position in the organisation should allow them to direcly direct
report to the manager responsible for design;.
(c)3. the responsibilities Responsibilities for all tasks related to the design and approval of minor
changes to type design designs or minor repairs to products are assigned to ensure that all
areas are covered; and.
(d)4. the The responsibility for a number of tasks as in point (c) paragraph 3 may be assigned to one
person, especially in the case cases of simple projects.

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 21.A.245 Resources

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AMC1 21.A.245(a) Resources

HEAD OF THE DESIGN ORGANISATION
The head of the design organisation should:
(a) have sufficient knowledge and authority to enable him or her to respond to the competent
authority regarding major issues of the design approval, and to implement necessary
improvements;
(b) promote the safety policy specified in AMC1 21.A.239(c)(1); and
(c) demonstrate a basic understanding of this Regulation.
 21.A.245 Resources

AMC1 21.A.245(b) Resources

RESPONSIBLE MANAGERS
(a) The person or group of persons nominated in accordance with point 21.A.245(b) should
represent the management structure of the organisation and be responsible for all the
functions as specified in Part 21. Depending on the size of the design organisation, the
functions may be subdivided under individual managers (and further subdivided), or
combined.
(b) The nominated managers should be identified in accordance to GM1 21.A.243(d).
(c) The responsibilities and the tasks of each individual manager should be clearly defined, in
order to prevent uncertainties about the relations within the organisation. For organisations
with structures in which staff-members are responsible to more than one person, as, for
instance, in matrix and project organisations, the responsibilities of the managers should be
defined in such a way that all the responsibilities are covered.
(d) If an approved design organisation chooses to appoint managers for all or any combination of
the functions identified in Part 21 because of the size of the undertaking, these managers
should ultimately report to the head of the design organisation. If a manager does not directly
report to the head of design organisation, he or she should have direct access to the head of
the design organisation formally established.
(e) The organisation should have a system in place to plan the availability of staff to ensure that
the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect
and monitor the organisation’s activities in accordance with the terms of approval.
(f) The organisation should establish and control the competency of personnel involved in design,
compliance monitoring and safety management and, if applicable, issuing permits to fly, in
accordance with a procedure and to a standard agreed by the competent authority. In
addition to the necessary expertise related to the job function, the competency of the
personnel should include an understanding of safety management and human factors
principles that is appropriate to the person’s function and responsibilities in the organisation.
(g) The chief of the function for the independent monitoring of compliance and adequacy should:
(1) not be one of the persons referred to in point 21.A.245(b);

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(2) be able to demonstrate relevant knowledge, background and appropriate experience

related to the activities of the organisation, including knowledge and experience in
compliance monitoring; and
(3) have access to all parts of the organisation, and as necessary, any subcontracted
organisations.
(h) If functions related to compliance monitoring or safety management are combined with other
duties, the organisation should ensure that this does not result in any conflicts of interest.
(i) Subject to a risk assessment and agreement by the competent authority, with due regard to
the size of the organisation and the nature and complexity of its activities, the compliance
monitoring manager function and the safety manager function may be exercised by the head
of the design organisation provided that he or she has demonstrated the related competence.

 21.A.245 Resources

AMC2 21.A.245(b) Resources

COMPETENCY OF PERSONNEL
(a) To assist in the assessment of competency and to perform the training needs analysis, the
organisation should establish job descriptions for all the job functions in the organisation.
These job descriptions should contain sufficient criteria to enable the competency of each
person to be assessed.
(b) The organisation should provide initial and recurrent training, to the persons or group of
persons nominated in accordance with point 21.A.245(b), which is adequate to their job
function, and which ensures that their continued competency is maintained throughout the
duration of their employment/contract.
(c) The organisation should record the training provided in accordance with point (a).
(d) All prospective members of the design management staff should be assessed for their
competency, qualifications, and capabilities related to their intended duties.
(e) All the staff nominated according to point 21.A.245(b) should be able to demonstrate their
knowledge of, and compliance with, the design management organisation procedures that are
applicable to their tasks.
(f) All the staff nominated according to point 21.A.245(b) should be able to demonstrate an
understanding of the safety management principles, human factors and human performance
issues related to their tasks.
(g) The competency of the person who assumes, or persons who assume, the function of safety
manager should include, but not be limited to, the following:
— knowledge of the ICAO standards and European requirements for safety management;
— an understanding of management systems, including compliance monitoring systems;
— an understanding of risk management;
— an understanding of safety investigation techniques;
— an understanding of human factors;

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— an understanding of a positive safety culture and its promotion; and

— operational experience related to the activities of the organisation.
(h) The organisation should develop a procedure that describes the process for assessing the
competency of the person. The procedure should specify:
(1) the persons responsible for this process;
(2) the means and methods for the initial assessment;
(3) the means and methods for the continuous control of their competency, including
feedback on their performance;
(4) the actions to be taken if the assessment is not satisfactory; and
(5) how to record assessment results.

 21.A.245 Resources

AMC1 21.A.247 Changes to the design management system

APPLICATION FOR A SIGNIFICANT CHANGE OR A VARIATION OF SCOPE AND TERMS OF THE DOA
An application for a significant change or a variation of scope should be submitted in writing to the
competent authority, and the design organisation should demonstrate to the competent authority,
on the basis of the submission of the proposed changes to the handbook, and before the
implementation of the change, that it will continue to comply with Part 21 after the implementation.
 21.A.247 Changes to the design management system

GM1 21.A.247 Changes to in the design management assurance

system
In addition to a change in ownership (see point 21.A.249), the following changes to the design
assurance management system should be considered as ‘significant’ to for the demonstration of
compliance, or to for the airworthiness, operational suitability or environmental protection of the
products:
(a)1. Organisation
 Relocation to new premises (see also GM 21.A.249);
 A change Change in the industrial organisation (partnership, subcontractors suppliers,
design work sharing), unless it can be shown that the independent verification checking
function of the demonstration of compliance is not affected;
 A change Change in the parts of the organisation that contribute directly to the
airworthiness, operational suitability or environmental protection (independent
verification checking function, Office of Airworthiness office of airworthiness [or
equivalent])

 A change Change to the independent monitoring principles of compliance and adequacy

(see point 21.A.239(f)(a)(3))

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(b)2. Responsibilities

 Change of the management staff

 the head Head of the design organisation [GM No 1 to 21.A.239(a)
AMC1 21.A.239(d), point (c)(1)(ii) para.3.1.2, GM No 1 to 21.A.245 AMC1
21.A.245, point (d)(1) para.4.1, GM 21.A.265(b)]

 the Chief of the Office of Airworthiness [GM No AMC1 to 21.A.245, point

(d)(2)para. 4.2]
 the Chief of the independent monitoring function of compliance and
adequacy of the design management assurance system [point 21.A.239(f)(a)(3)
and AMC No 1 to 21.A.243(a), para.2 point (b)(2)]
 Reporting lines between the personnel nominated in accordance with point
21.A.245(b), and the head of the design organisation;

 New distribution Allocation of responsibilities affecting safety, airworthiness,

operational suitability or environmental protection; and

 For organisations designing minor changes to type design designs or minor

repairs to products, change of the persons identified in GM No 2 to 21.A.243(d).
(c)3. Procedures
Change to the principles of procedures related to:
 the type certification;,

 the classification of changes and repairs as ‘major’ or ‘minor’ [point

21.A.263(c)(1)];,
 the treatment handling of major changes and major repairs, ;
 the approval of the design of minor changes and minor repairs [point 21.A.263(c)(2)], ;
 the issue issuing of information and instructions under the privilege of point
21.A.263(c)(3), ;

 the approval of minor revisions to the Aaircraft Fflight Mmanual [point 21.A.263(c)(4)], ;
 the approval approvals of the design designs of major repairs [point 21.A.437 or
21.A.263(c)(5)], ;
 continued airworthiness or continued operational suitability (see point 21.A.3B), ;

 the configuration control, when airworthiness, operational suitability or

environmental protection is affected, ; and
 the acceptability of design tasks undertaken by partners or sub-contractors
subcontractors [point 21.A.239(d)(3)(c)].
(d)4. Resources
 A substantial Substantial reduction in the number and/or experience of staff (see point
21.A.245(d)(1)(a)).

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 21.A.247 Changes to the design management system

GM 21.A.257(a) Investigations
Arrangements that allow the Agency to make investigations include the complete design
organisation including partners, sub-contractors and suppliers, whether they are in the State of the
applicant or not, assisting and co-operating with the Agency in performing inspections and audits
conducted during initial assessment and subsequent surveillance.
Assistance to the Agency includes all appropriate means associated with the facilities of the design
organisation to allow the Agency to perform these inspections and audits, such as a meeting room
and office support.

GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings

CAUSAL ANALYSIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree,
to identify the chain of events that led to the non-compliance, may not properly reflect the
complexity of the issue, and, it therefore bears the risk that important factors that need to be
addressed in order to prevent reoccurrences will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the nonconformity. A peer review of the results of the causal analysis may increase
its reliability and objectivity.
A system description of the organisation that considers organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.
 21.A.258 Findings

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SUBPART M — REPAIRS

AMC 21.A.433(a) and 21.A.447 Repair design and record keeping

1. Relevant substantiation data associated with a new major repair design and record keeping
should include:
a. damage identification and reporting source,
b. major repair design approval sheet identifying applicable specifications and references
of justifications,
c. repair drawing and/or instructions and scheme identifier,
d. correspondence with the TC, STC, or APU ETSO authorisation holder, if its advice on the
design has been sought,
e. structural justification (static strength, fatigue, damage tolerance, flutter etc.) or
references to this data,
f. effect on the aircraft, engines and/or systems, (performance, flight handling, etc., as
appropriate)
g. effect on maintenance programme,
h. effect on Airworthiness limitations, the Flight Manual and the Operating Manual,
i. weight and moment change,
j. special test requirements.
2. Relevant minor repair documentation includes paragraphs 1(a) and (c). Other points of
paragraph 1 may be included where necessary. If the repair is outside the approved data,
justification for classification is required.
3. Special consideration should be given to repairs that impose subsequent limitations on the
part, product or appliance, (e.g., engine turbine segments that may only be repaired a finite
number of times, number of repaired turbine blades per set, oversizing of fastener holes,
etc.).
4. Special consideration should also be given to Life Limited parts and Critical Parts, notably with
the involvement of the type-certificate or STC holder, when deemed necessary under
21.A.433(b).
5. Repairs to engine or APU critical parts would normally only be accepted with the involvement
of the TC holder.

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SUBPART P — PERMIT TO FLY

GM 21.A.705 Competent authority

An aircraft registered in a Member State is under the responsibility of this Member State for
continuing airworthiness aspects. Consequently, any permit to fly under Part 21 should be issued by
that Member State including cases where the aircraft will fly in another State. The permit to fly
contains all the conditions and restrictions to ensure safe flight but other airspace and operational
rules remain the competence of the authority of the State where the flight will take place. The
applicant should therefore also ensure compliance with the relevant regulations of that State.

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SECTION B PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A — GENERAL PROVISIONS

GM 21.B.20 Responsibility for implementation

Each certificate or approval in accordance with Part 21 Section A Subparts F, G, H, I and P will
normally be issued and controlled by the competent authority of the Member State in whose
country the applicant or holder is located. Therefore, to ensure consistency between the competent
authorities of the Member States in issuing certificates and approvals, implementation of Part 21
should be based on the following three principles:
a) The establishment and maintenance of an effective organisation and corresponding processes
by all competent authorities.
b) The operation of all competent authorities in accordance with Part 21 and its Acceptable
Means of Compliance (AMC) and guidance material (GM).
c) A standardisation process established and operated by the Agency to access the standard
achieved, and to provide timely advice and guidance to the competent authorities of the
Member States.
As a result the responsibility for implementation comprises of the two main objectives:
a) To ensure that certificates and approvals are only granted to applicants that comply with the
requirements of Part 21; and
b) To ensure sufficient visibility of the processes to give the Agency and the other Member States
the necessary confidence in the certificates or approvals granted.

AMC1 21.B.25 Management system

GENERAL
(a) In deciding upon the required airworthiness organisational structure, the competent authority
should review:
(1) the number of certificates, approvals, authorisations and letters of agreement to be
issued,
(2) the number, complexity and sizes of the organisations under its oversight obligations;
(3) the possible use of qualified entities and of the resources of the competent authorities
of other Member States to fulfil the continuing oversight obligations;
(4) the complexity of the aviation industry, taking into consideration the diversity of the
products, parts and appliances; and
(5) the potential growth of activities in the field of civil aviation.
(b) The competent authority should retain effective control of the important inspection functions
and not delegate them in such a way that organisations, in effect, regulate themselves in
airworthiness matters.

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(c) The set-up of the organisational structure should ensure that the various tasks and obligations
of the competent authority do not solely rely on individuals. The continuous and undisturbed
fulfilment of these tasks and obligations of the competent authority should also be
guaranteed in cases of illness, accidents or leave of individual employees.

 21.B.25 Management system

AMC2GM 21.B.25(a) Organisation Management system

GENERAL
(a) The competent authority designated by each Member State should have an organisation in
such a way that:
a)(1) there is specific and effective management authority in the conduct of all the relevant
activities,;
b)(2) the functions and processes described in Part 21 and its AMC and GM may be properly
implemented, ;
c)(3) the competent authority of the Member State’s policy policies, organisation and
operating procedures for the implementation of Part 21 are properly documented and
applied,;
d)(4) all the personnel of the competent authority of the Member State personnel involved in
the related activities are provided with training where necessary,;
e)(5) specific and effective provision is made for the communication and interface as
necessary with the Agency EASA and the competent authorities of the Member States,;
and
f)(6) all the functions related to the implementation of Part 21 are adequately described and
shown (Standardisation).
(b) A general policy in respect of Part 21 the activities related to the applicable requirements of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof should be developed, sponsored promoted and implemented by the manager at the
highest appropriate level, for example, the top of the functional area of the competent
authority of the Member State that is responsible for the related matters.
(c) Appropriate steps should be taken to ensure that the policy is known and understood by all
the personnel staff involved, and all the necessary steps should be taken to implement and
maintain the policy.
(d) The general policy, Whilst whilst also satisfying also the additional national regulatory
responsibilities, the general policy should, in particular, take into account:
(1) the provisions of the Regulation (EU) 2018/1139 (EC) No 216/2008;
(2) the provisions of the applicable requirements and their Part 21 and its AMC and GM;
(3) the needs of industry; and
(4) the needs of the Agency and of the other competent authorities of the Member States.

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(d) The policy should define specific objectives for the key elements of the organisation and
processes for the implementation of the related Part 21 activities, including the corresponding
control procedures and the measurement of the achieved standard.

 21.B.25 Management system

GM 21.B.25(b) Resources
(a) The organisation for related Part 21 activities should be clearly defined within the general
organisation of the competent authority of the Member State, with the hierarchical and
functional links, and the names of the senior staff. Although final responsibility should be
placed at the top of the functional area that is responsible for the related Part 21 activities as
a whole, all subordinate levels of management should be suitably resourced and empowered
to fulfil their delegated tasks.
(b) The definition of an organisation for the implementation of related Part 21 activities should
include the specification of
(1) a manager responsible for the specific Part 21 activity acting as internal and external
focal point. The responsibility is best placed with the manager who is in control of the
day-to-day functions concerning the specific Part 21 activity, although he may delegate
specific tasks to other individuals;
(2) individual or group responsibilities, duties and associated reporting lines;
(3) the resources, human and material;
(4) the documented procedures to be operated in respect of the relevant Part 21 activities.
(c) The various tasks and responsibilities of the personnel involved in the related Part 21 activities
should be clearly identified. The authority attached to the responsibilities should be enough to
ensure that the activities will be performed correctly.
(d) These responsibilities include among others:
(1) the management of the organisation
(2) the management of investigation teams
(3) the team leadership/membership
(4) the investigation and surveillance activities
(5) the administrative management of certificates and approvals, , including record
keeping;
(6) the external and internal interface activities including feedback to the Agency;
(7) the control and distribution of documentation
The definition of the organisation should include means to ensure continued effectivity of the
organisation. The means should provide for a regular assessment of the organisation and its related
activities as well as a feedback system for the follow up of necessary corrective actions (e.g., through
the implementation of a quality system, internal audit system, etc.).

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GM 21.B.25(c) Qualification and training

The competent authority of the Member State should ensure appropriate and adequate training of
its personnel to meet the standard that is considered by the Agency necessary to perform the work.
Arrangements should be made for initial and continuation training as required.
It is understood that the basic competence of the competent authority of the Member State staff is
a matter of recruitment and normal management functions in selection of staff for particular duties.
Moreover, it is understood that the competent authority of the Member State provides training in
the basic skills as required for those duties.
However, to avoid differences in understanding and interpretation, it is considered important that
all personnel involved in Part 21 activities should be provided with further training specifically
related to the relevant Part 21 activity up to the common Agency standard.
The competent authority of the Member State should provide training through its own training
organisation with qualified trainers or through another qualified training source (e.g., training
provided by other competent authorities, the Agency or qualified entities).

AMC1 21.B.25(a)(1) Management system

DOCUMENTED POLICIES AND PROCEDURES

(a) The various elements of the organisation for the activities related Regulation (EU) 2018/1139
and the delegated and implementing acts adopted on the basis thereof should be
documented in order to establish a reference source for the establishment and maintenance
of this organisation.
(b) The documented procedures should be established in a way that it will facilitate their use.
They should be clearly identified, kept up-to-date and made readily available to all the
personnel involved in the relevant activities.
(c) The documented procedures should cover, as a minimum, the following aspects:
(1) policies and objectives;
(2) the structure of the organisation;
(3) responsibilities and the associated authority;
(4) procedures and processes;
(5) internal and external interfaces;
(6) internal control procedures;
(7) the training of personnel;
(8) cross-references to associated documents; and
(9) assistance from other competent authorities or EASA (where required).
(d) The information may be held in more than one document or in a series of documents, in
which case suitable cross-reference information should be provided. For example, the
organisational structure and the job descriptions are not usually in the same documentation

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as the detailed working procedures. In such cases, it is recommended that the documented
procedures should include an index of cross-references to all such other related information,
and the related documentation should be readily available when required.

 21.B.25 Management system

GM1 21.B.25(a)(2) Management system

PERSONNEL
(a) This GM on the determination of the required personnel is limited to the performance of
certification and oversight tasks, excluding any personnel who are required to perform tasks
subject to any national regulatory requirements.
(b) The elements to be considered when determining the required personnel and planning their
availability may be divided into quantitative and qualitative elements and there should be, at
least:
(1) quantitative elements in accordance with AMC1 21.B.25; and
(2) the following qualitative elements:
(i) the size, nature, and complexity of the activities of certified organisations, taking
into account:
(A) the privileges of the organisation;
(B) the type of the approval, the scope of the approval;
(C) the possible use of industry certification standards;
(D) the number of personnel; and
(E) the structure of the organisational;
(ii) the safety priorities identified;
(iii) the results of past oversight activities, including audits, inspections and reviews,
in terms of risks and regulatory compliance, taking into account the:
(A) number and the levels of findings;
(B) time frame for the implementation of corrective actions; and
(C) maturity of the management systems implemented by the organisation,
and its ability to effectively manage safety risks; and
(iv) the size and complexity of the aviation industry under its oversight, and the
potential growth of activities in the field of civil aviation, which may be an
indication of the number of new applications, and of changes to existing
certificates, approvals, authorisations and letters of agreement to be expected.
(c) Based on existing data from previous oversight planning cycles, and taking into account the
situation within the Member State’s aviation industry, the competent authority may estimate:
(1) the standard working time required for processing applications for new certificates,
approvals, authorisations or letters of agreement;

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(2) the number of new certificates, approvals, authorisations or letters of agreement to be

issued for each planning period; and
(3) the number of changes to existing certificates, approvals, authorisations or letters of
agreement to be processed for each planning period.
(d) In line with the competent authority’s oversight policy, the following planning data should be
determined:
(1) the standard number of audits to be performed per oversight planning cycle;
(2) the standard duration of each audit;
(3) the standard working time for audit preparation, on-site auditing, reporting, and
follow-up, per inspector;
(4) the standard number of unannounced inspections to be performed;
(5) the standard duration of inspections, including the preparation, reporting, and follow-
up, per inspector; and
(6) the minimum number and required qualifications of inspectors for each
audit/inspection.
(e) Standard working time could be expressed either in working hours per inspector, or in working
days per inspector. All planning calculations should, then, be based on the same units (hours
or working days).
(f) It is a good practice to use a spreadsheet application to process the data defined under (c) and
(d), to assist in determining the total number of working hours/days per oversight planning
cycle required for certification, oversight and enforcement activities. This application could
also serve as a basis for implementing a system for planning the availability of personnel.
(g) The number of working hours/days per planning period for each qualified inspector that may
be allocated for certification, oversight and enforcement activities should be determined,
taking into account:
(1) purely administrative tasks not directly related to certification and oversight;
(2) training;
(3) participation in other projects;
(4) planned absences; and
(5) the need to include a reserve for unplanned tasks or unforeseeable events.
(h) The determination of working time available for certification, oversight and enforcement
activities should also consider, if applicable:
(1) the use of qualified entities;
(2) cooperation with other competent authorities for approvals that involve more than one
Member State; and
(3) oversight activities under a bilateral aviation safety agreement.
(i) Based on the elements listed above, the competent authority should be able to:

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(1) monitor the dates when audits and inspections are due, and when they were carried
out;
(2) implement a system to plan the availability of personnel; and
(3) identify possible gaps between the number and the qualifications of personnel and the
required volume of certification and oversight.
Care should be taken to keep planning data up to date in line with changes in the underlying
planning assumptions, with a particular focus on risk-based oversight principles.
 21.B.25 Management system

AMC1 21.B.25(a)(3) Management system

QUALIFICATIONS AND TRAINING — GENERAL
(a) It is essential that the competent authority has the full capability to adequately assess the
compliance and performance of an organisation by ensuring that the whole range of activities
is assessed by appropriately qualified personnel.
(b) For each inspector, the competent authority should:
(1) define the competencies required to perform the allocated certification and oversight
tasks;
(2) define the associated minimum required qualifications;
(3) establish initial and recurrent training programmes in order to maintain and to enhance
competency at the level necessary to perform the allocated tasks; and
(4) ensure that the training provided meets the established standards and is regularly
reviewed and updated whenever necessary.
(c) The competent authority may provide training through its own training organisation with
qualified trainers, or through another qualified training source.
(d) When training is not provided through an internal training organisation, adequately
experienced and qualified persons may act as trainers, provided that their training skills have
been assessed. If required, an individual training plan should be established that covers
specific training skills. Records should be kept of such a training, and of the assessment, as
appropriate.
 21.B.25 Management system

AMC2 21.B.25(a)(3) Management system

QUALIFICATIONS AND TRAINING — TECHNICAL PERSONNEL INCLUDING INSPECTORS
(a) Competent authority technical personnel should have:
(1) practical experience and expertise in the application of aviation safety standards and
safe operating practices;
(2) comprehensive knowledge of:
(i) relevant parts of the implementing rules, AMC, CSs and GM;

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(ii) the competent authority’s procedures;

(iii) their rights and obligations;
(iv) systems based on the EU management system requirements (including
compliance monitoring) and on ICAO Annex 19; and
(v) design- or production-, as applicable, related human factors and human
performance principles;
(3) a relevant engineering degree or an aircraft maintenance technician qualification with
additional education. ‘Relevant engineering degree’ means an engineering degree from
aeronautical, mechanical, electrical, electronic, avionic or other studies relevant to the
design and production of aircraft/aircraft components; and
(4) knowledge of design or production standards, as applicable.
(b) In addition, competent authority inspectors should have:
(1) training on auditing techniques and on assessing and evaluating management systems
and safety risk management processes; and
(2) 5 years of relevant work experience to be allowed to work independently as an
inspector. This may include experience gained during training to obtain the
qualifications described in point (a)(2).
(c) In addition to their technical competency, the technical personnel should have a high degree
of integrity, be impartial in carrying out their tasks, be tactful, and have a good understanding
of human nature.
(d) A programme for recurrent training should be developed to ensure that technical personnel
remain competent to perform their allocated tasks. As a general policy, it is not desirable for
the technical personnel to obtain technical qualifications from those entities that are under
their direct regulatory oversight.
 21.B.25 Management system

AMC3 21.B.25(a)(3) Management system

INITIAL AND RECURRENT TRAINING — INSPECTORS
(a) Initial training programme:
The initial training programme for inspectors should include, as relevant to their role, current
knowledge, experience and skills in at least all of the following:
(1) aviation legislation, organisation, and structure;
(2) the Chicago Convention, the relevant ICAO annexes and documents;
(3) Regulation (EU) No 376/2014 on the reporting, analysis and follow-up of
occurrences in civil aviation;
(4) an overview of Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, and the related AMC, CSs, and GM;

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(5) specific knowledge of Regulation (EU) No 748/2012, its related AMC, GM and CSs, as
well as any other applicable requirements;
(6) management systems, including the assessment of the effectiveness of a management
system, in particular hazard identification and risk assessment, and non-punitive
reporting techniques in the context of the implementation of a ‘just culture’;
(7) auditing techniques;
(8) competent authority procedures relevant to the inspectors’ tasks;
(9) human factors principles;
(10) the rights and obligations of inspecting personnel of the competent authority;
(11) ‘on-the-job’ training relevant to the inspector’s tasks; and
(12) technical training appropriate to the role and tasks of the inspector, in particular for
those areas that require approvals.
NOTE: the duration of the on-the-job training should take into account the scope and
complexity of the inspector’s tasks. The competent authority should assess whether the
required competence has been achieved before an inspector is authorised to perform a
task without supervision.
(b) Recurrent training programme
Once qualified, the inspector should undergo training periodically, as well as whenever it is
deemed necessary by the competent authority, in order to remain competent to perform the
allocated tasks. The recurrent training programme for inspectors should include, as
appropriate to their role, at least the following topics:
(1) changes in aviation legislation, the operational environment and technologies;
(2) competent authority procedures that are relevant to the inspector’s tasks;
(3) technical training appropriate to the role and tasks of the inspector; and
(4) results from past oversight.
(c) Assessments of an inspector’s competency should take place at regular intervals that do not
exceed 3 years. The results of these assessments, as well as any actions taken following these
assessments, should be recorded.

 21.B.25 Management system

AMC1 21.B.25(a)(5) Management system

SAFETY RISK MANAGEMENT PROCESS
(a) The safety risk management process required by point 21.B.25 should be documented. The
following should be defined in the related documentation:
(1) the means used for hazard identification and the related data sources, taking into
account data that comes from other competent authorities with which the competent
authority interfaces in the State or from the competent authorities of other Member
States;

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(2) risk management steps including:

(i) analysis (in terms of the probability and severity of the consequences of hazards
and occurrences);
(ii) assessment (in terms of their tolerability); and
(iii) control (in terms of the mitigation of risks to an acceptable level);
(3) who holds the responsibilities for hazard identification and risk management;
(4) who holds the responsibilities for the follow-up of risk mitigation actions;
(5) the levels of management who have the authority to make decisions regarding the
tolerability of risks;
(6) the means to assess the effectiveness of risk mitigation actions; and
(7) the link with the compliance monitoring function.
(b) To demonstrate that the safety risk management process is operational, competent
authorities should be able to provide evidence that:
(1) the persons involved in internal safety risk management activities are properly trained;
(2) hazards that could impact the authority’s capabilities to perform its tasks and discharge
its responsibilities have been identified, and the related risk assessment is documented;
(3) regular meetings take place at appropriate levels of management of the competent
authority to discuss the risks identified and to decide on the risk tolerability and
possible risk mitigations;
(4) in addition to the initial hazard identification exercise, the risk management process is
triggered as a minimum whenever changes occur that may affect the competent
authority’s capability to perform any of the tasks required by Part 21;
(5) a record of the actions taken to mitigate risks is maintained, showing the status of each
action and the owner of the action;
(6) there is follow-up on the implementation of all risk mitigation actions;
(7) risk mitigation actions are assessed for their effectiveness; and
(8) the results of risk assessments are periodically reviewed to check whether they remain
relevant (e.g. are the assumptions still valid? Is there any new information?).

 21.B.25 Management system

GM1 21.B.25(a)(5) Management system

SAFETY RISK MANAGEMENT PROCESS
The purpose of safety risk management as part of the management system framework for
competent authorities is to ensure the effectiveness of the management system. As for any
organisation, hazard identification and risk management are expected to contribute to effective
decision-making, to guide resource allocation and contribute to organisational success.

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The safety risk management process required by point 21.B.25 is intended to address safety risks
that are directly related to the competent authority’s organisation and processes, and which may
affect its capability to perform its tasks and discharge its responsibilities. This process is not intended
as a substitute for the State safety risk management SARPs defined in ICAO Annex 19, Chapter 3,
component 3.3. This does not mean, however, that the competent authority may not use
information and data obtained through its SSP, including oversight data and information, for the
purpose of safety risk management as part of its management system.
The safety risk management process is also to be applied to the management of changes (point
21.B.35), which is intended to ensure that the management system remains effective whenever
changes occur.

 21.B.25 Management system

AMC1 21.B.25(d) Management system

PROCEDURES AVAILABLE TO EASA
(a) Copies of the procedures related to the management system of the competent authority of
the Member States, and their amendments, that should be made available to EASA for the
purpose of standardisation, should provide at least the following information:
(1) the competent authority’s organisational structure for the continuing oversight
functions that it undertakes, with a description of the main processes. This information
should demonstrate the allocation of responsibilities within the competent authority,
and that the competent authority is capable of carrying out the full range of tasks
regarding the size and complexity of the Member State’s aviation industry. It should
also consider the overall proficiency and the scope of authorisation of the competent
authority personnel;
(2) for personnel who are involved in oversight activities, the minimum professional
qualification requirements and experience, and the principles that guide their
appointment (e.g. assessment);
(3) how the following are carried out: the assessment of applications and evaluations of
compliance, the issuance of certificates, approvals, authorisations and letters of
agreement, the performance of continuing oversight, the follow-up of findings,
enforcement measures and the resolution of safety concerns;
(4) the principles used to manage exemptions and derogations;
(5) the processes that are in place to distribute applicable safety information for timely
reaction to a safety problem;
(6) the criteria for planning continuing oversight activities (i.e. an oversight programme),
including the adequate management of interfaces when conducting continuing
oversight activities; and
(7) an outline of the initial training of newly recruited oversight personnel (taking future
activities into account), and the basic framework for the recurrent training of oversight
personnel.

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(b) As part of the continuous monitoring of a competent authority, EASA may request details of
the working methods used, in addition to a copy of the procedures of the competent
authority’s management system (and amendments). These additional details are the
procedures and related guidance material that describe the working methods for the
competent authority personnel who conduct oversight activities.
(c) Information related to the competent authority’s management system may be submitted in
an electronic format.
 21.B.25 Management system

AMC 21.B.30(a) Documented procedures

The various elements of the organisation for the related Part 21 activities must be documented in
order to establish a reference source for the establishment and maintenance of this organisation.
The documented procedures must be established in a way that it will facilitate its use. They must be
clearly identified, kept up-to-date and made readily available to all the personnel involved in the
relevant activities.
The documented procedures must cover, as a minimum, the following aspects:
a) policy and objectives,
b) organisation structure,
c) responsibilities and attached authority,
d) procedures and processes,
e) internal and external interfaces,
f) internal control procedures,
g) training of personnel,
h) cross-references to associated documents,
i) assistance from other competent authorities or the Agency (where required).
Except for smaller competent authorities, it is likely that the information is held in more than one
document or series of documents, and suitable cross-reference information must be provided. For
example, organisational structure and job descriptions are not usually in the same documentation as
the detailed working procedures. In such cases it is recommended that the documented procedures
include an index of cross-references to all such other related information, and the related
documentation must be readily available when required.

GM1 21.B.30 Allocation of tasks to qualified entities

CERTIFICATION TASKS
The tasks that may be performed by a qualified entity on behalf of the competent authority include
those that are related to the initial certification and the continuing oversight of persons and
organisations as defined in the Regulation (EU) No 748/2012.
 21.B.30 Allocation of tasks to qualified entities

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AMC 21.B.35(a) Changes

Standardisation is based on the assessment of the organisation and procedures of the competent
authorities of the Member States and their implementation and suitability by the Agency.
Consequently, a significant change in the competent authority of the Member State organisation
and documented procedures validated by the Agency needs a reassessment to maintain the
confidence in the standardisation process.
Examples of significant changes include changes in the organisation hierarchy, decision making
levels, number and qualification of personnel, etc.
The competent authority of the Member State must notify any of these changes to the Agency and
must be prepared to provide any further explanation/information requested by the Agency. The
Agency may decide to review the documented organisation and procedures of the competent
authority of the Member State and request any clarification or changes. This might also apply when
a change in the regulations takes place and the Agency decides that a specific
assessment/monitoring of the competent authorities related to that change is necessary.

GM No 1 to 21.B.45 Co-ordination with other related activities

The purpose of co-ordination with other related activities is to
a) harmonise the effects of various approval and certification teams especially when dealing with
one organisation / applicant to prevent conflicts of conclusions,
b) ensure efficient flow of information between the various approval and certification teams to
facilitate the execution of their duties
c) optimise the use of the Agency and the competent authorities resources to minimise
disruption and cost.
Therefore, for a given organisation / applicant the responsible person(s) of the Agency or competent
authorities of the Member State should arrange for exchange of information with, and provide
necessary assistance, as appropriate, to the relevant competent authority of the Member State or
Agency teams or staff - e.g.:
a) the appropriate certification teams;
b) the design organisation approval team;
c) the production organisation approval team;
d) the maintenance organisation approval team; or
e) other approval or certification teams as appropriate.

GM No 2 to 21.B.45 Co-ordination
An exchange of information should especially take place in accordance with Article 15 of the
Regulation (EC) No 216/2008:
(a) an immediate reaction of a competent authority of the Member State to a safety problem

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(b) granting of exemptions by the competent authority of the Member State from the substantive
requirements of the Regulation (EC) No 216/2008 and its implementing rules (for a period of
more than two months or when the exemptions become repetitive)
(c) granting of approvals on an equivalent level of protection by the competent authority of the
Member State by derogation from the Part 21 requirements

GM No 3 to 21.B.45 Reporting – Information relevant to registers

established by the Agency
When so requested by the Agency, the competent authority of the Member State should notify any
certificate or approval issued, changed or revoked including details of the scope of that certificate or
approval to the Agency for inclusion in a central register managed by the Agency.

AMC1 21.B.55(a) Record-keeping

GENERAL
(a) The record-keeping system should ensure that all records are accessible whenever needed
within a reasonable time. These records should be organised in a manner that ensures that
there is traceability and retrievability throughout the required retention period.
(b) All records that contain sensitive data regarding applicants or organisations should be stored
in a secure manner with controlled access to ensure their confidentiality.
(c) Records should be kept in paper form, or in an electronic format, or a combination of the two.
Records that are stored on microfilm or optical discs are also acceptable. The records should
remain legible and accessible throughout the required retention period. The retention period
starts when the record is created or was last amended.
(d) Paper systems should use robust material which can withstand normal handling and filing.
Computer systems should have at least one backup system, which should be updated within
24 hours of any new entry. Computer systems should include safeguards against any
unauthorised personnel from altering the data.
(e) All the computer hardware used to ensure data backup should be stored in a different
location from the one that contains the working data, and in an environment that ensures the
data remains in a good condition. When hardware or software changes take place, special
care should be taken that all the necessary data continues to be accessible at least throughout
the full period specified in point 21.B.25(d).

 21.B.55 Record-keeping

AMC1 21.B.55(a)(1) Record-keeping

COMPETENT AUTHORITY MANAGEMENT SYSTEM
Records related to the competent authority’s management system should include, as a minimum
and as applicable:
(a) the documented policies and procedures;

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(b) the personnel files of the competent authority personnel, with the supporting documents
related to their training and qualifications;
(c) the results of the competent authority’s internal audits and safety risk management
processes, including audit findings, and corrective, preventive and risk mitigation actions; and
(d) the contract(s) established with qualified entities that perform certification or oversight tasks
on behalf of the competent authority.
 21.B.55 Record-keeping

GM1 21.B.55 Record-keeping

FOR DESIGN APPROVALS TRANSFERRED TO EASA
Record-keeping related to design approvals, for which the responsibility is transferred to the Agency
EASA, will remain initially with the competent authority of the Member State that has granted the
approvals, at the disposal the Agency EASA. This GM specifies the administrative documents to be
kept for the various kinds of design approvals. It does not repeat the requirements put on holders of
design approvals to keep records (ref. 21.A.5, 21.A.55, 21.A.105, 21.A.118A(a)(1), 21.A.447,
21.A.605).
(a)1. Type-certificate Type certificate
(a)(1) Copy of the type-certificate TC
b) (2) Copy of the type-certificate TCDS
c) (3) Environmental protection approval data
d) (4) Documents defining the type-certification basis including information to justify special
conditions, equivalent safety findings and exemptions (Certification Review Items or
equivalent)
e) (5) List of approved modifications,
f) (6) List of the competent authority’s approved publications (Flight Manual, Repair Manual,
Airworthiness Limitations, Certification Maintenance Requirements)
g) (7) Airworthiness directives
h) (8) Master Minimum Equipment List
i) (9) Maintenance Review Board Report
(b)2. Supplemental type certificate
- (1) Copy of STC
- (2) Environmental protection approval data
- (3) Documents defining the certification basis including information to justify special
conditions, equivalent safety findings and exemptions (Certification Review Items or
equivalent)
- (4) List of the competent authority’s approved documents
- (5) Airworthiness directives

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(c)3. JTSOETSO Aauthorisation

- (1) Copy of JTSO the ETSO authorisation letter
- (2) Copy of Declaration of Design and Performance
- (3) Statement of compliance with applicable standards
- (4) Airworthiness directives
(d)4. Other part or appliance approvals
a(1) Copy of the approval letter,
b(2) Copy of Declaration of Design and Performance or equivalent
c(3) Statement of compliance with applicable standards
d(4) Airworthiness Ddirectives
(e)5. Changes from non TC or STC holders
a(1) Modification approval sheet, or equivalent document
b(2) Documents required by point 21.A.5 21.A.105, or equivalent national requirement
Note: Not applicable to minor design changes approved under a DOA privilege, for which
record-keeping is under the DOA holder responsibility.
(f)6. Repair design approvals
a(1) Repair approval sheet
b(2) Documents listed in point 21.A.5 21.A.447, or equivalent national requirement
Note: Not applicable to repair design approved under a DOA privilege, for which record-
keeping is under the DOA holder responsibility.

 21.B.55 Record-keeping

GM1 21.B.55(e) Record-keeping

TRACEABILITY OF RELEASE CERTIFICATES
The record-keeping for those EASA Forms 52 and 1 that have been validated by the competent
authority should allow the verification of that validation by the parties concerned, including the
recipients of the release certificates.

 21.B.55 Record-keeping

AMC1 21.B.65 Suspension, limitation and revocation

CORRECTIVE ACTION PLAN
It is expected that any established organisation approved according to Subparts G or J will move
quickly to re-establish compliance with Part 21 and will not risk the possibility of their approval being
suspended. Therefore, the corrective action period granted by the competent authority should be
appropriate to the nature of the finding, and in any case, it should not initially be more than 3
months. In certain circumstances and subject to the nature of the finding, the competent authority

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may vary the 3-month period provided that a satisfactory corrective action plan has been agreed by
the competent authority.
If the organisation fails to comply within the time period agreed by the competent authority, a
provisional suspension of the approval, in whole or in part, should proceed.

 21.B.65 Suspension, limitation and revocation

AMC1 21.B.65(c) Suspension, limitation and revocation

INFORMATION ON SECURITY SITUATION
(a) The European Commission Security Directorate generally advises against any non-essential
travel to a country where hostile conditions, or a combination of the following conditions,
reduce the level of security, and pose a high level of threat to personnel, as follows:
(1) international or internal armed conflict with frequent armed confrontation taking place,
numerous casualties, and/or serious damage to infrastructures;
(2) a situation that could lead to war, or characterised by high internal or external tension
that could escalate into instability in the short term; very poorly functioning institutions;
(3) relatively frequent terrorist attacks due to the presence of active terrorist groups, either
domestic or transnational, and state authorities that are unable to ensure a satisfactory
level of security; and
(4) frequent criminal violence that also targets non-nationals. State authorities have a
limited ability to counter criminal activities and ensure security.
(b) Countries where the above conditions apply should not be considered compatible with the
performance of on-site audits by the competent authority.
 21.B.65 Suspension, limitation and revocation

GM1 21.B.65 Suspension, limitation and revocation

(a) GENERAL
Decisions on the suspension or revocation of a certificate, approval, authorisation or letter of
agreement will always be actioned in such a way as to comply with any applicable national
laws or regulations related to appeal rights and the conduct of appeals.
(b) LIMITATION
A limitation is an amendment to the certificate, approval, authorisation or letter of agreement
that partially limits the privileges of the organisation .
(c) SUSPENSION
A suspension is a temporary withdrawal of all the privileges of an organisation’s approval. The
approval remains valid, but no activities that invoke the approval can be made while the
suspension is in force. Approval privileges may be re-instated when the circumstances that
caused the suspension are corrected and the organisation can once again demonstrate full
compliance with the requirements.

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(d) REVOCATION
A revocation is a permanent cancellation of the whole of an approval. All the rights and
privileges of the organisation under the approval are withdrawn, and, after revocation, the
organisation cannot perform activities that invoke the approval, and must remove all
references to the approval from its company documentation.
 21.B.65 Suspension, limitation and revocation

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SUBPART F — PRODUCTION WITHOUT PRODUCTION

ORGANISATION APPROVAL

GM1 21.B.115 and 21.B.215 Alternative means of compliance

Alternative means of compliance that are used by a competent authority, or by a person or
organisation under its oversight, may be used by other competent authorities, persons, or
organisations only if they are processed again in accordance with points 21.B.115(d) and (e) or
21.B.215(d).

 21.B.115 Alternative means of compliance

AMC1 21.B.115(d) and 21.B.215(d) Alternative means of

compliance
DEMONSTRATION OF COMPLIANCE
In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.

 21.B.115 Alternative means of compliance

AMC1 21.B.120(a) Initial certification procedure

INVESTIGATION TEAM
(a) The competent authority should appoint a team for each applicant for, or holder of, a letter of
agreement. This team is responsible for conducting all the relevant tasks related to the
issuance of the letter of agreement. The team should consist of a team leader to manage and
lead the approval team, and, if needed, one or more team members. The team leader should
report to the manager who is responsible for the activities of the competent authority as
defined in point 21.B.25(a).
(b) The competent authority should perform sufficient investigation activities for an applicant for,
or holder of, a letter of agreement, to justify the recommendations for the issuance,
maintenance, amendment, suspension or revocation of the letter of agreement.
(c) The competent authority should prepare procedures for the investigation of applicant for, or a
holder of, a letter of agreement, as part of the documented procedures that cover at least the
following elements:
(1) evaluation of the applications received;
(2) appointment of the investigation team;
(3) preparation and planning of the investigation;
(4) evaluation of the documentation (manual, procedures, etc.);
(5) auditing;
(6) follow-up of corrective actions; and

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(7) recommendations for the issuance, amendment, suspension or revocation of a letter of

agreement.
 21.B.120 Initial certification procedure

AMC2 21.B.120(a) Initial certification procedure Investigation team

– Qualification criteria for the investigation team members
QUALIFICATION CRITERIA FOR THE INVESTIGATION TEAM MEMBERS
The competent authority must should ensure that the team leader and team members have
received appropriate training in the relevant Subpart Subparts of Part 21 and in the related
competent authority documentation before performing investigations in accordance with AMC2
21.B.25(a)(3). They must should also have knowledge and experience at the appropriate level in
aviation production and inspection activities relative related to the particular application for a letter
of agreement.
 21.B.120 Initial certification procedure

AMC3 21.B.120(a)(c)(1) Initial certification procedure

EVALUATION OF APPLICATIONS
(a)1. General
When applying Part 21 Section A, Subpart F and Section B, Subpart F, the competent authority
should must consider that these Subparts are only an alternative way alternatives for
production to Part 21 Section A, Subpart G and Section B, Subpart G. To meet the ICAO
airworthiness obligations and to issue a Ccertificate of Aairworthiness for an individual aircraft
in a practical and efficient way, the competent authority must should use a system of approval
of production organisations (POA) under Part 21 Section A, Subpart G and Section B,
Subpart G, providing to the competent authority the necessary confidence in the technical
standards. The consistent standards of these approvals will also support the standardisation
efforts by the Agency EASA. Nevertheless, it is recognised that it is not always practical,
economical and/or advisable to use the POA.
Considering the ICAO airworthiness obligations as well, Part 21 Section A, Subpart F and
Section B, Subpart F is are provided for such a case on the basis of the following principles:
(1)a) Subpart F should must be considered as an alternative option for particular cases.
(2)b) Its adoption should must be done on an individual basis, as a consequence of an
assessment by the competent authority (see point 21.A.121, 21.A.133(a) and its their
associated CS AMC and GM).
(b)2. Application
The competent authority should must receive an application for a letter of agreement on an
EASA Form 60 (see below) completed by the applicant. The eligibility of the application should
be verified in relation to the competent authority procedures, based on point 21.A.121 and its
associated AMC CS and GM. The applicant should be advised accordingly about the
acceptance or rejection of the application.

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An application may be accepted from:

— an individual applying on his or her own behalf; or
— in the case of an organisation, an individual with the authority to make agreements on
behalf of the organisation.
(c)3. Location of the applicant
The location of the applicant seeking acceptance for production under Part 21 Section A
Subpart F determines which competent authority is responsible for issuing the letter of
agreement.
 21.B.120 Initial certification procedure

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EASA Form 60
Application for agreement of production under Part 21 Subpart F

Competent authority
of an EU Member State or
EASA

1. Registered name and address of the applicant:

2. Trade name (if different):

3. Location(s) of manufacturing activities:

4. Description of the manufacturing activities under application

a) Identification (TC, P/N , … as appropriate):

b) Termination (No. of units, Termination date, …):

5. Evidence supporting the application, as per

21.A.124(b):

6. Links/arrangements with design approval

holder(s)/ design organisation(s) where different
from Block 1. :

7. Human resources:

8. Name of the person signing the application:

______________________________ ______________________________________
Date Signature

EASA Form 60 Issue 3

Block 1: The name of the applicant must be entered. For legal entities the name must be as stated in the
register of the National Companies Registration Office. In this case a copy of the entry in the register of
the National Companies Registration Office must be provided to the competent authority.

Block 2: State the trade name by which the applicant is known to the public if different from the information
given in Block 1. The use of a logo may be indicated in this Block.

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Block 3: State all locations of manufacturing activities that are covered by the application. Only those locations
must be stated that are directly under the control of the applicant stated in Block 1.

Block 4: This Block must include further details of the manufacturing activities under the approval for the
addresses indicated in Block 3. The Block ‘Identification’ must indicate the products, parts or appliances
intended to be produced, while the Block ‘Termination’ must address any information on the limitation
of the activity, e.g., by stating the intended number of units to be manufactured or the expected date of
completion of the manufacturing activities.

Block 5: This Block must state evidence supporting the determination of applicability as stated in 21.A.121. In
addition an outline of the manual required by 21.A.125A(b) must be provided with the application.

Block 6: The information entered here is essential for the evaluation of eligibility of the application. Therefore
special attention must be given concerning the completion of this Block either directly or by reference
to supporting documentation in relation to the requirements of 21.A.122 and AMC No 1 to 21.A.122.

Block 7: The information to be entered here must reflect the number of staff, or in case of an initial approval
the intended number of staff, for the manufacturing activities under this application and therefore must
include also any associated administrative staff.

Block 8: State the name of the person authorised to sign the application.

AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure

Investigation preparation and planning
INVESTIGATION PREPARATION AND PLANNING
Following acceptance of an application for a letter of agreement and before commencing an
investigation, the competent authority should:
--(a) identify the site locations that they needing need to investigate investigation;
--(b) liaise with the competent authority of another a Member State where the investigation of the
organisation should include a there is seen to be a need to visit a production facility in that
Member State for one of the following reasons:
(1)a) where a manufacturer production organisation has contracted part of the production to
another organisation holding a production organisation approval and a need arises to
ensure that the contract has the same meaning for all the parties to the contract, and
the local competent authority of the Member State agrees;
(2)b) to inspect a product (or part or appliance) under production where the sub-contractor
subcontractor is does not hold holding a POA.
--(c) co-ordinate coordinate with the competent authority of a third country and/or the Agency
EASA where the investigation of the organisation should include there is seen to be a need to
visit a production a facility in that country for one of the following reasons:
(1)a) where a manufacturer production organisation has contracted part of the production to
another organisation holding a production organisation approval issued by the Agency
EASA or accepted through an recognition agreement in accordance with Article 68 of
the Basic Regulation (EU) 2018/1139, and a need arises to ensure that the contract has
the same meaning for all the parties to the contract, and the Agency EASA and/or the
competent authority agrees;

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to inspect a product (or part or appliance) under production where the sub-contractor
subcontractor is does not holding hold a POA.
 21.B.120 Initial certification procedure

GM1 21.B.120(c)(5) and (6) Initial certification procedure Auditing

and investigation findings
AUDITING AND INVESTIGATION FINDINGS
During its investigation process, the competent authority may make findings which should then be
recorded. These may be non-conformities to the requirements, the manual as supplied by the
production organisation manufacturer describing its inspection procedures or non-conformities
related to the items under inspection. The manner in which the findings will be handled by the
competent authority before and during the validity of the letter of agreement, should be detailed in
its procedures.
 21.B.120 Initial certification procedure

AMC1 21.B.120(d) Initial certification procedure

ISSUE OF THE LETTER OF AGREEMENT
(a) Unless otherwise agreed by the competent authority, no production before the issue of the
letter of agreement may be accepted under Part 21 Section A, Subpart F.
(b) The agreement should include or reference a pre-defined plan of inspection points established
as part of the production inspection system and agreed with the competent authority to be
used as a basis for the inspections described in points 21.A.129 and 21.B.120(a) and their
associated AMC and GM. The plan should clearly identify the inspection points, places,
inspection subjects (materials, processes, tooling documentation, human resources, etc.), as
well as the focal points and the method of communication between the production
organisation and the competent authority.
(c) The competent authority should detail the method by which it will assure itself that the
production organisation is working in accordance with the manual and the agreed inspection
procedures during the validity period of the agreement. For a renewal of this validity period,
the procedure as defined in point 21.B.140 should be used.
(d) Any conditions under which the agreement will expire (such as the termination date and/or
number of units to produce) should be clearly stated in the letter of agreement.
 21.B.120 Initial certification procedure

GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings

and corrective actions Objective evidence
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;

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(b) examination of equipment/products; and

(c) information from interview questions and observations of production or design activities, as
applicable.

 21.B.120 Initial certification procedure

GM1 21.B.125(b) Findings and corrective actions

EXAMPLES OF LEVEL 1 FINDINGS
Examples of level 1 findings are non-compliances with any of the following points that could affect
the safety of the aircraft are found under points:
— 21.A.126;
— 21.A.127;
— 21.A.128; and
— 21.A.129.
It should be anticipated that a non-compliance with these points is only considered a level 1 finding
if there is objective evidence that this finding is an uncontrolled non-compliance that could affect
the safety of the aircraft.
 21.B.125 Findings and corrective actions

GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective

actions
UNCONTROLLED NON-COMPLIANCE WITH APPLICABLE DESIGN DATA
An uncontrolled non-compliance with applicable design data is a non-compliance that:
(a) cannot be discovered through systematic analysis; or
(b) prevents the identification of the affected products, parts, appliances, or material.

 21.B.125 Findings and corrective actions

AMC1 21.B.125(d) Findings and corrective actions

NOTIFICATION OF FINDINGS
In the case of a level 1 finding, confirmation should be obtained in a timely manner that the
accountable manager has taken note of the finding and its details.
Level 1 and level 2 findings require timely and effective oversight by the competent authority to
ensure the completion of the corrective action. This oversight may include intermediate
communication, such as letters as necessary, to remind the approval holder to verify that the
corrective action plan is followed.
 21.B.125 Findings and corrective actions

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AMC 21.B.130 Issue of the letter of agreement

Unless otherwise agreed by the competent authority no production before the issue of the letter of
agreement may be accepted under Part 21 Section A Subpart F.

GM 21.B.130(b) Issue of the letter of agreement

The agreement should include or reference a pre-defined plan of inspection points established as
part of the production inspection system and agreed with the competent authority to be used as a
basis for the inspections described in 21.A.129 and 21.B.120(c)(5) and its associated CS and GM. The
plan should clearly identify inspection point, places, inspection subjects (materials, process, tooling
documentation, human resources, etc.), as well as the focal points and the method of
communication between the manufacturer and the competent authority.
The competent authority should detail a method how it will assure itself that the manufacturer is
working in accordance with the manual and the agreed inspection procedures during the validity
period of the agreement. For renewal of this validity period the procedure as defined in 21.B.140
should be used.
Any conditions under which the agreement will expire (such as termination date and/or number of
units to produce), should be clearly stated in the letter of agreement.

AMC1 21.B.140 Amendment of a letter of agreement

The competent authority must should be satisfied that any change affecting a letter of agreement
comply complies with the shows of Section A Subpart F before implementation can start. A plan for
the change should be agreed with the applicant in accordance with AMC1 21.B.120(d)21.B.130. If
the change affects the content of the letter of agreement, a new application should be filed, and an
amended/revised letter of agreement should be obtained subsequently.

GM 21.B.150(d) Record keeping – Traceability of release certificates

The recordkeeping for those EASA Forms 52 and 1 that have been validated by the competent
authority should allow verification of such validation by concerned parties including the recipients of
the release certificates.

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SUBPART G — PRODUCTION ORGANISATION APPROVAL

GM1 21.B.115 and 21.B.215 Alternative means of compliance

Alternative means of compliance that are used by a competent authority, or by a person or
organisations under its oversight, may be used by other competent authorities, persons, or
organisations only if they are processed again in accordance with points 21.B.115(d) and (e) or
21.B.215(d).
 21.B.215 Alternative means of compliance

AMC1 21.B.115(d) and 21.B.215(d) Alternative means of

compliance
DEMONSTRATION OF COMPLIANCE
In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.

 21.B.215 Alternative means of compliance

AMC1 21.B.220 and 21.B.221 Initial certification procedure

INVESTIGATION TEAM
(a) The competent authority should appoint a production organisation investigation team for
each applicant for, or holder of, a production organisation approval. This team is responsible
for conducting all the relevant tasks related to the approval. The team should consist of a
team leader to manage and lead the approval team and, if needed, one or more team
members. The team leader should report to the manager who is responsible for the activities
of the competent authority as defined in point 21.B.25(c).
(b) The competent authority should perform sufficient investigation activities for an applicant for
a production organisation approval, or a holder of one, to justify the recommendations for the
issuance, maintenance, amendment, suspension or revocation of the approval.
(c) The competent authority should prepare procedures for the investigation of a production
organisation approval as part of the documented procedures that cover at least the following
elements:
(1) evaluation of the applications received;
(2) appointment of the organisation approval team;
(3) preparation and planning of the investigation;
(4) evaluation of the documentation (production organisation exposition, procedures, etc.);
(5) auditing;
(6) follow-up of corrective actions;

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(7) recommendation for the issuance, amendment, suspension or revocation of a

production organisation approval; and
(8) continued surveillance.

 21.B.220 Initial certification procedure

AMC1 21.B.220 and 21.B.430 Initial certification procedure

VERIFICATION OF COMPLIANCE
(a) In order to verify the organisation’s compliance with the applicable requirements, the
competent authority should conduct an audit of the organisation, including interviews of the
personnel, and inspections carried out at the organisation’s facilities.
(b) The competent authority should only conduct such an audit if it is satisfied that the
application and supporting documentation are in compliance with the applicable
requirements.
(c) The audit should focus on the following areas:
(1) the detailed management structure, notably its adequacy;
(2) the personnel: the adequacy of the number of staff, and of their qualifications and
experience with regard to the intended terms of approval and the associated privileges;
(3) the processes used for safety risk management and compliance monitoring;
(4) the facilities and their adequacy regarding the organisation’s scope of work; and
(5) the documentation based on which the approval should be granted.
(d) If an application for an approval is refused, the applicant should be informed of the right of
appeal that exists under national law.
 21.B.220 Initial certification procedure

AMC1 GM No 1 to 21.B.220(c) Procedures for investigation–

Investigation preparation and planning Initial certification
procedure
INVESTIGATION PREPARATION AND PLANNING
Following the acceptance of the application for a production organisational approval and before
commencing an investigation, the competent authority should, for the preparation and planning of
the investigation:
-(a) identify the site locations needing investigation taking into account the scope of any other
POA issued by a Member State according to Part 21, which are valid in the circumstances;
-(b) when EASA is not the competent authority, liaise with the Agency EASA for the appointment
of any necessary observer(s) for standardisation purposes and seek any necessary advice and
guidance from EASA;
-(c) establish any necessary liaison arrangement with other competent authorities;

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-(d) agree the size and composition of the POAT investigation team and any specialist tasks likely
to be covered and to select suitable team members from all involved competent authorities;
and
- seek any necessary advice and guidance from the Agency
-(e) liaise with the competent authority of the other a Member State where the investigation of
the organisation should include a there is seen to be a need to visit a production approval
holder facility in that Member State for one of the following reasons:
(1) where a production organisation manufacturer has subcontracted production to
another organisation and therefore a need arises to ensure that contract has the same
meaning for all the parties to the contract, and the competent authority of the Member
State agrees
(2) to inspect a product, part, appliance, or material under production for its own, Member
States or non-EU register.
 21.B.220 Initial certification procedure

AMC2GM 21.B.220(a) Initial certification procedure Investigation

team
INVESTIGATION TEAM
(a)1. Type of Team team
Where the applicant is located in a Member State, the competent authority should appoint a
production organisation approval team (POAT) leader and members appropriate to the nature
and scope of the applicant’s organisation.
If EASA is not the competent authority and Where the facilities of the applicant are located in
more than one Member State, the competent authority of the country of manufacture should
liaise with the other involved competent authorities to agree and appoint a production
organisation approval team POAT leader and members appropriate to the nature and scope of
the applicant’s organisation.
(b)2. Team leader selection
The team leader should satisfy all of the criteria for a team member and will be selected by
considering the following additional criteria:
(1)a) the capability to lead and manage a team;
(2)b) the capability to prepare reports and be diplomatic;
(3)c) experience in approval team investigations (not necessarily only Part 21 Section A,
Subpart G) ; and
(4)d) a knowledge of production and quality systems for aircraft and related products and
parts.
(c)3. Team member selection

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The team leader should agree with the The competent authority should determine on the size
of the POA team and the specialisations to be covered taking into account the scope of work
and the characteristics of the applicant. Team members should be selected by considering the
following criteria:
(a) training, which is mandatory, for Part 21 Section A, Subpart Subparts A and G and
Section B, Subpart Subparts A and G;
(b) education and experience, to cover appropriate aviation knowledge, audit
practices and approval procedures; and
(c) the ability to verify that an applicant’s organisation conforms to its own POA
procedures, and that its key personnel are competent.

 21.B.220 Initial certification procedure

AMC 21.B.220(c) Procedures for investigation – Evaluation of

applications
The competent authority must receive an application for POA on an EASA Form 50 (see below)
completed by the applicant. The eligibility and appropriateness of the application must be evaluated
in accordance with 21.A.133 at that time and the applicant must be advised about acceptance or
rejection of its application in writing accordingly.

EASA Form 50
Application for Part 21 production organisation approval

Competent authority
of an EU Member State or
EASA

1. Registered name and address of the organisation:

2. Trade name (if different):

3. Locations for which the approval is applied for:

4. Brief summary of proposed activities at the item 3 addresses

a) General:

b) Scope of approval:

c) Nature of privileges:

5. Description of organisation:

6. Links/arrangements with design approval

holder(s)/design organisation(s) where different
from 1.:

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7. Approximate number of staff engaged or intended

to be engaged in the activities:

8. Position and name of the accountable manager:

_____________________________________ ___________________________________
Date Signature of the accountable manager
EASA Form 50

Block 1: The name of the organisation must be entered as stated in the register of the National Companies
Registration Office. For the initial application a copy of the entry in the register of the National
Companies Registration Office must be provided to the competent authority.

Block 2: State the trade name by which the organisation is known to the public if different from the
information given in Block 1. The use of a logo may be indicated in this Block.

Block 3: State all locations for which the approval is applied for. Only those locations must be stated that are
directly under the control of the legal entity stated in Block 1.

Block 4: This Block must include further details of the activities under the approval for the addresses
indicated in Block 4. The Block ‘General’ must include overall information, while the Block ‘Scope of
approval’ must address the scope of work and products/categories following the principles laid
down in the GM 21.A.151. The Block ‘nature of privileges’ must indicate the requested privileges as
defined in 21.A.163(b)-(e). For an application for renewal state ‘not applicable’.

Block 5: This Block must state a summary of the organisation with reference to the outline of the production
organisation exposition, including the organisational structure, functions and responsibilities. The
nomination of the responsible managers in accordance with 21.A.145(c)(2) must be included as far
as possible, accompanied by the corresponding EASA Forms 4.

For an application for renewal state ‘not applicable’.

Block 6: The information entered here is essential for the evaluation of eligibility of the application.
Therefore special attention must be given concerning the completion of this Block either directly or
by reference to supporting documentation in relation to the requirements of 21.A.133(b) and (c)
and the AMC to 21.A.133(b) and (c).

Block 7: The information to be entered here must reflect the number of staff, or in case of an initial approval
the intended number of staff, for the complete activities to be covered by the approval and
therefore must include also any associated administrative staff.

Block 8: State the position and name of the accountable manager.

GM1 No 2 to 21.B.220(c) Initial certification procedure Procedures

for investigation — GeneralROCEDURES FOR INVESTIGATION
ORGANISATION APPROVAL — GENERAL
(a)1. Purpose of the Pprocedures

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The purpose of the procedures is to investigate the applicant’s production organisation for
compliance with Part 21 Subpart G in relation to the requested terms of approval. When
appropriate, this procedure these procedures should also be used to investigate significant
changes or applications for variation variations of in the scope of approval.
The following procedure assumes that the application has been accepted and that an
investigation team has been selected.
(b)2. Initiation
The POA Tteam Lleader initiates the procedure by:
2.(1) arranging a meeting with the POAT team members to review the information provided
in accordance with the application (according to point 21.A.134) and to take account of
any other information available within the competent authority about the applicant.
knowledge that the POAT members have regarding the production standards of the
applicant;
2.(2). obtaining collecting information from other teams of a competent authorities authority
of the Member State or the Agency EASA on the functioning of the applicant’s
organisation (see GM No 1 GM1 21.B.25(c) to 21.B.45);
2.(3) arranging a meeting with the applicant in order to:
(i) enable the applicant to make a general presentation of its organisation and
products, parts or appliances;
(ii) ensure that the accountable manager understands the reason for signing the
statement specified in point 21.A.143(a)(1);
(iii) enable the investigation team POAT to describe the proposed investigation
process; and
(iv) enable the investigation team POAT to confirm to the applicant the identity of
those managers nominated in accordance with Part 21 Subpart G who need to
complete an EASA Form 4 (See EASA Form 4 for Production Organisations on
EASA website: http://easa.europa.eu/certification/application-forms.php). The
applicant should provide a completed copy of EASA Form 4 for each of the key
management staff identified by Part 21 Subpart G. The EASA Form 4 is a
confidential document and will be treated as such.
(c)3. Preparation
The investigation team POAT:
3.(1) studies the information gathered in the initiation phase;
3.(2) establishes an investigation plan which:
(i) takes account of the location of the POA applicant’s facility as identified
per GM3 No 3 to 21.B.65220(c);
(ii) defines areas of coverage and work-sharing between team POAT members
taking account of their individual expertise;

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(iii) defines areas where more detailed investigation is considered necessary;

(iv) establishes the need for external advice to team POAT members where
expertise may be lacking within the team;
(v) includes completion of a comprehensive plan for the investigation in order
to present it to the applicant; and
(vi) recognises the need to:
(A) review the documentation and procedures;
(B) verify compliance and implementation; and
(C) audit a sample of products, parts, and appliances;
3.(3) co-ordinates coordinates with the appropriate Part 21 Section A, Subpart J design
organisation approval Tteams sufficiently for both parties to have confidence in the
applicants co-ordination coordination links with the holder of the approval of the design
(as required by point 21.A.133) ; and
3.(4) establishes liaison with the applicant to plan mutually suitable dates and times for visits
at each location that need investigation needs to be investigated, and also to agree the
investigation plan and approximate time scales with the applicant.
(d)4. Investigation
The investigation team POAT:
4.(1) makes a check of the exposition POE for compliance with Part 21; Subpart G
4.(2) audits the organisation, its organisational structure, and its procedures for compliance
with Part 21 Subpart G, using EASA Form 56 as a guide during the investigation, and as a
checklist at the end of it;
4.(3). generates compliance checklists for investigations of working processes and procedures
on site as required;
4.(4) accepts or rejects each EASA Form 4 completed by the key nominated personnel in
accordance with point 21.A.145(c)(2) ;
4.(5) checks that the exposition production organisation exposition (POE) standard reflects
the organisation, its procedures, practices and the requirements defined in point
21.A.143. Having checked and agreed a an exposition POE issue or subsequent
amendment, the competent authority should have a clear procedure to indicate its
acceptance or rejection;
4.(6) makes sample audits at working level to verify that:
(i) work is performed in accordance with the system described in the exposition
POE;
(ii) products, parts, appliances or material produced by the organisation are in
conformity with the applicable design data (see GM 21.B.235(b)(4));

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(iii) facilities, working conditions, equipment and tools are in accordance with the
exposition POE and appropriate for the work being performed;
(iv) competence competency and numbers of personnel is are appropriate for the
work being performed; and
(v) co-ordination coordination between production and design is satisfactory; and
4.(7) at an advanced stage of the investigation, conducts an interim team review of audit
results and matters arising, in order to determine any additional areas requiring
investigation.
Each investigation team should be accompanied during the process by company
representatives who are knowledgeable of the applicant’s organisation and procedures. This
will ensure that the organisation is aware of the audit progress and problems as they arise.
Access to information will also be facilitated.
The team leader POATL should co-ordinate coordinate the work of the team POAT members
for an efficient investigation process, which will provide a consistent and effective
investigation and reporting standards.
(e)5. Conclusions
5.(1) The team leader POATL holds a team meeting to review the findings and observations
so as to produce a final agreed report of findings.
5.(2) The team leader POATL, on completion of the investigation, holds a meeting to verbally
presents present the report to the applicant.
The team leader POATL should be the chairman of this meeting, but individual team
members may present their own findings and observations.
5.(3) The meeting should agree the findings, corrective action time scales, and preliminary
arrangements for any follow-up that may be necessary.
5.(4) Some items may as a result of this meeting be withdrawn by the team leader POATL but
if the investigation has been correctly performed, at this stage there should be no
disagreement over the facts presented.
5.(5) Inevitably there will be occasions when the team POAT member carrying out the audit
may find situations in the applicant or POA approval holder where he or she it is unsure
about compliance. In this case, the organisation is informed about possible non-
compliance at the time and advised that the situation will be reviewed within the
competent authority before a decision is made. The organisation should be informed of
the decision without undue delay. Only if the decision results in a confirmation of non-
compliance, this is recorded in Part 4 of EASA Form 56.
5.(6) The team leader POATL will transmit the final signed report on EASA Form 56 together
with notes of the final meeting with the applicant to the competent authority of the
country in which where the applicant is located, or to EASA according to the
competence defined in point 21.1. The report will include recommendations and
significant findings, together with appropriate conclusions and corrective actions. In

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particular, it should indicate if whether the exposition POE is acceptable, or changes are
required.
5.(7) Completion of EASA Form 56 includes the need to record in Part 4 comments, criticisms,
etc., and this must should reflect any problems found during the visit and must should
be the same as the comments, criticisms made to the organisation during the debrief.
Under no circumstances should additional comments, criticisms, etc., be included in
Part 4 of the report unless the applicant or POA approval holder has previously been
made aware of such comments.
Many applicants Applicants may need to take corrective action and amend the
proposed exposition before the competent authority is able to conclude its
investigation. Such corrective actions should be summarised in Part 4 of the EASA Form
56 and a copy always given to the applicant, so that there is a common understanding
of the actions necessary before approval can be granted.
The intention of the EASA Form 56 Part 4 is to provide a summary report of
findings and outstanding items during initial investigation and major changes. The
competent authority will need to operate a supporting audit system to manage
corrective action monitoring, closure, etc. While the EASA Form 56 Part 4 format may
be used for monitoring purposes, it is not adequate on its own to manage such a
system.
5.(8) If the findings Findings made during the investigation mean that approval
recommendation will not or cannot be issued, then it is essential that such findings are
confirmed in writing to the organisations within two weeks of the visit. The reason for
confirmation in writing is that many organisations take a considerable time to establish
compliance. As a result, it is too easy to establish a position of confusion where the
organisation claims it was not aware of the findings that prevented the issue of an
approval.
(f)6. Management Involvement
The investigation team shall see the accountable manager will be seen at least once during the
investigation process and preferably twice, because he or she is ultimately responsible for
ensuring compliance with the requirements for the initial grant granting and subsequent
maintenance of the production organisation approval. Two Twice is the preferred number of
visits to the accountable manager, with one being conducted at the beginning of the audit to
explain the investigation process, and the second, at the end, to debrief on the results of the
investigation.
 21.B.220 Initial certification procedure

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Competent authority
of an EU Member State or
EASA

RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL

ISSUE / CONTINUATION / VARIATION / SIGNIFICANT CHANGE

PART ONE OF FIVE PARTS: BASIC DETAILS OF THE ASSESSMENT

Name of the organisation:

Approval reference: ___________

Address(es) of the facilities surveyed:

Main Part 21 Subpart G activities at facilities surveyed:

Date(s) of survey:

Names and positions of the organisation's senior management attended during survey:

Names of the competent authority staff:

Office: EASA Form 56 completion date:

Note: If it is determined that a recommendation for issue/continuation/variation/significant change of

approval cannot be made because of a non-compliance with Part 21 Subpart G, the reasons for the
non-compliance need to be identified in PART 4 of the report. A copy of PART 1 and PART 4, or at
least the information included in these parts, must be given to the organisation to ensure that the
organisation, in failing to obtain Part 21 Subpart G approval, even if only temporarily, has the same
information as is on the files of the competent authority.
EASA Form 56 Issue 3 – POAT Recommendation Audit Report - Part 1 of 5, Page 1 of 1 MONTH YEAR

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Competent authority
of an EU Member State or
EASA

RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G ISSUE /

CONTINUATION / VARIATION/SIGNIFICANT CHANGE

PART TWO OF FIVE PARTS: Part 21 SUBPART G COMPLIANCE

Name of organisation:

Approval of organisation:

Approval reference: ___________ Survey reference:

Note A: This form has been compiled according to those points of Part 21 Subpart G which are relevant to an organisation
trying to demonstrate compliance.

Note B: The right-hand part of each box must be completed with one of the following three indicators:

1. a tick () which means compliance;

2. NR which means that the requirement is Not Relevant to the activity at the address surveyed; (the reason for NR
should be stated in Part 4 of the report, unless the reason is obvious)
3. a number relating to a comment which must be recorded in Part 4 of the report.
The left-hand part of each box is optional for use by the competent authority.

21.A.3A Failures, malfunctions and defects

(a) N/A

(b) Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons who hold or have
applied for a production approval under Subpart G, or who produce a product, part or appliance
under Subpart F, shall:

(1) establish and maintain a system for collecting and assessing internal mandatory and
voluntary occurrence reports, including reports on internal errors, near misses, and hazards,
in order to identify any adverse trends or to address any deficiencies, and extract reportable
occurrences. This system shall include the evaluation of relevant information related to
occurrences, and the promulgation of the related information;

(2) report to the holder of the type certificate, restricted type certificate or design approval, all
cases in which products, parts or appliances have been released by the production
organisation and subsequently identified to have deviations from the applicable design data,
and investigate with the holder of the type certificate, restricted type certificate or design
approval to identify those deviations which could lead to an unsafe condition;

(3) report to EASA and the competent authority of the Member State the deviations that were
identified according to point (2) which could lead to an unsafe condition; and

(4) if the production organisation acts as a supplier to another production organisation, also
report to that other organisation all cases in which it has released products, parts or
appliances to that organisation and subsequently identified them to have possible deviations
from the applicable design data.

(c) The reports defined in points (a) and (b) shall appropriately safeguard the confidentiality of the
reporter and of the persons mentioned in the report and be made in a form and manner

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established by the competent authority, as soon as practicable and in any case dispatched not later
than 72 hours after the identification of the possible unsafe condition, unless exceptional
circumstances prevent this.

(d) Without prejudice to Regulation (EU) No 376/2014, if an occurrence reported under points (a)(3) or
(b)(3) results from a deficiency in the design, or a production deficiency, the holder of the type
certificate, restricted type certificate, supplemental type certificate, major repair design approval,
ETSO authorisation, or any other relevant approval deemed to have been issued under this Annex,
or the production organisation as appropriate, shall investigate the reason for the deficiency and
report to EASA the results of its investigation and any action it is taking or proposes to take to
correct that deficiency.

(e) If the competent authority finds that an action is required to correct the deficiency, the holder of
the type certificate, restricted type certificate, supplemental type certificate, major repair design
approval, ETSO authorisation, or any other relevant approval deemed to have been issued under
this Annex, or the production organisation as appropriate, shall submit the relevant data to the
competent authority.

21.A.5 Record-keeping

All natural or legal persons who hold or who have applied for a type certificate, restricted type certificate,
supplemental type certificate, ETSO authorisation, major repair design approval, permit to fly, production
organisation approval or letter of agreement under this Annex shall:

(a) N/A

(b) when producing a product, part or appliance:

(1) maintain the relevant records produced under the production system that was used to
justify the conformity of the products, parts or appliances, and retain them in order to
provide the information necessary to ensure the continued airworthiness of the product,
part or appliance; and

(2) for production organisations approved in accordance with Subpart G, record all details of
work carried out and establish a record-keeping system that incorporates the requirements
imposed on its partners, suppliers and subcontractors, and ensures the conservation of the
data used to justify the conformity of the products, parts or appliances. This data shall be
held at the disposal of the competent authority and be retained in order to provide the
information necessary to ensure the continuing airworthiness of the products, parts or
appliances;

(c) regarding permits to fly:

(1) maintain documents produced to establish and justify the flight conditions, and retain them
at the disposal of EASA and the competent authority in order to provide the information
necessary to ensure the continued airworthiness of the aircraft; and

(2) when issuing a permit to fly under the privilege of approved organisations, maintain the
documents associated with it, including inspection records, documents that support the
approval of flight conditions and the permit to fly itself, retain them at the disposal of EASA
or the competent authority, in order to provide the information necessary to ensure the
continued airworthiness of the aircraft;

(d) retain records of competence and the qualifications of personnel who are involved in design or
production, in independent monitoring of compliance and adequacy, and in safety management if
required by points 21.A.139, 21.A.145, 21.A.239 or 21.A.245; and

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(e) when employing personnel who exercise the privileges of the approved organisation according to
points 21.A.163 or 21.A.263, or who carry out the independent monitoring of compliance and
adequacy according to points 21.A.139(f) and 21.A.239(f), retain the records of their authorisation.

21.A.9 Investigation

(a) All organisations who hold or who have applied for a type certificate, restricted type certificate,
supplemental type certificate, ETSO authorisation, major repair design approval, permit to fly,
design organisation approval, production organisation approval or letter of agreement under this
Annex, shall make arrangements that allow the competent authority to make any investigations,
including investigations of partners, suppliers and subcontractors, that are necessary to determine
the compliance and the continued compliance of the organisation with the applicable requirements
of this Annex.

(b) Design and production organisations and applicants for, or holders of, permits to fly or of ETSO
authorisations shall allow the competent authority to review any report and make any inspection
and perform or witness any test that is necessary to check the compliance of the organisation with
this Annex, and to inspect the technical data files.

21.A.133 Eligibility

Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this
Subpart. The applicant shall:

(a) justify that, for a defined scope of work, an approval under this Subpart is appropriate for the
purpose of showing conformity with a specific design; and

(b) hold or have applied for an approval of that specific design; or

(c) have ensured, through an appropriate arrangement with the applicant for, or holder of, an approval
of that specific design, satisfactory co-ordination coordination between production and design.

21.A.134 Application

Each application for a production organisation approval shall be made to the competent authority in a
form and manner established by that authority, and shall include an outline of the information required by
point 21.A.143 and the terms of approval requested to be issued under point 21.A.151.
EASA Form 56 Issue 3 - POAT Recommendation Report POA Audit Report - Part 2 of 5, Page 1 of 5 MONTH YEAR

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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:

21.A.139 Quality System Production management system

(a) The production organisation shall establish, implement, and maintain a production management
system that includes a safety management system and a quality system with clear lines of
responsibility and accountability throughout the organisation demonstrate that it has established
and is able to maintain a quality system.

(b) The production management system shall:

(1) correspond to the size of the organisation, and to the nature and complexity of its activities,
taking into account the hazards and associated risks inherent in these activities; and

(2) be established under the direct accountability of a single accountable manager according to
point 21.A.145(c)(1).

(c) As part of the safety management element of the production management system, the production
organisation shall:

(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;

(2) appoint key safety personnel to execute the safety policy in accordance with point
21.A.145(c)(2);

(3) establish, implement and maintain a safety risk management process that includes:

(i) hazard identification in all domains of the organisation and its production activities,
resulting from analysis of occurrences collected according to point 21.A.3A; and

(ii) safety risk assessment and mitigation;

(4) establish, implement and maintain a safety assurance process including:

(i) the measurement and monitoring of safety performance;

(ii) the management of changes in accordance with points 21.A.143(b) and 21.A.147; and

(iii) principles for continuous improvement of the safety management system; and

(5) promote safety in the organisation through:

(i) training and education; and

(ii) communication.

(d) As part of the quality management element of the production management system, the production
organisation shall:

(1) The quality system shall be documented. This quality system shall be such as to enable the
organisation to ensure that each product, part or appliance produced by the organisation or
by its partners, or supplied from or subcontracted to outside parties, conforms to the
applicable design data and is in condition for safe operation, and thus exercise the privileges
set forth as defined in point 21.A.163.;
(2) The quality system shall contain establish, implement, and maintain, as applicable, within
the scope of approval, control procedures for:

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(i) document issue, approval, or change;

(ii) vendor and subcontractor assessment, audit and control;

(iii) verification that incoming products, parts, materials, and equipment, including items
supplied new or used by buyers of products, are as specified in the applicable design
data;

(iv) identification and traceability;

(v) manufacturing processes;

(vi) inspection and testing, including production flight tests;

(vii) calibration of tools, jigs, and test equipment;

(viii) non-conforming item control;

(ix) airworthiness co-ordination coordination with the applicant for, or holder of, a design
approval;

(x) records the completion and retention of records;

(xi) personnel the competence and qualification qualifications of personnel;

(xii) the issue of airworthiness release documents;

(xiii) handling, storage and packing;

(xiv) internal quality audits and the resulting corrective actions;

(xv) work within the terms of approval performed at any location other than the approved
facilities;

(xvi) work carried out after the completion of production but prior to delivery, to maintain .
the aircraft in a condition for safe operation; and

(xvii) issue issuance of permits to fly and approval of associated flight conditions.;

(3) The control procedures need to include specific provisions for any critical parts in the control
procedures for any critical parts.

(e) The production organisation shall document in accordance with point 21.A.143 all production
management system key processes, and maintain a process for:

(1) amending that documentation; and

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(2) making personnel aware of their responsibilities under the production management system.

(f) The production organisation shall include in the production management system An independent
quality assurance function to monitor monitoring of compliance with, and the adequacy of, the
production management system and its documented procedures of the quality system. This
monitoring shall include a feedback system to the person or group of persons referred to in point
21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as
necessary, corrective action.

(g) If the organisation holds other organisation certificates issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production
organisation may integrate the production management system with the management system that
is required for the issuance of the other certificate(s).
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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:

21.A.143 Exposition
(a) As part of the production management system, the The organisation shall establish submit to the
competent authority a production organisation exposition that provides providing directly or by
cross reference the following information: (see Part 3 of this Form)

(b) The production organisation exposition shall be amended as necessary to remain an up-to-date
description of the organisation, and copies of any amendments shall be supplied to the competent
authority.

21.A.145 Approval requirements Resources

The production organisation shall demonstrate, on the basis of the information submitted in accordance
with point 21.A.143 that:

(a) with regard to general approval requirements, facilities, working conditions, equipment and tools,
processes and associated materials, number and competence of staff, and general organisation are
adequate to discharge the obligations under point 21.A.165;

(b) with regard to all necessary airworthiness, noise, fuel venting and exhaust emissions data:

(1) the production organisation is in receipt of such data from the Agency EASA, and from
the holder of, or applicant for, the type certificate type-certificate, restricted type certificate
type-certificate or design approval to determine conformity with the applicable design data;

(2) the production organisation has established a procedure to ensure that airworthiness,
noise, fuel venting and exhaust emissions data are correctly incorporated in its production
data; and

(3) such data is are kept up to date and made available to all personnel who need access
to such data to perform their duties;

(c) with regard to management and staff:

(1) a an accountable manager has been nominated by the production organisation, and is
accountable to the competent with authority to ensure that, His or her responsibility within
the organiszation, shall consist of ensuring that all production is performed to the required
standards and that the production organisation is continuously in compliance with the
requirements of the management system referred to in point 21.A.139, and the data and the
procedures identified in the exposition referred to in point 21.A.143.

(2) the accountable manager shall nominate a person or a group of persons have been
nominated by the production organisation to ensure that the organisation is in compliance
with the requirements of this Annex I (Part 21), and are identified, together with the extent
of their authority. Such a person (or persons) shall act under the direct authority of the
accountable manager referred to in point (1). The knowledge, background and experience of
the persons nominated shall be appropriate to discharge their responsibilities; and

(3) staff at all levels have been given appropriate authority to be able to discharge their
allocated responsibilities and that there is full and effective co-ordination coordination
within the production organisation in respect of airworthiness, noise, fuel venting and
exhaust emission data matters;

(d) with regard to certifying staff, authorised by the production organisation to sign the documents
issued under point 21.A.163 under the scope or terms of approval:

(1) the knowledge, background (including other functions in the organisation), and

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experience of the certifying staff are appropriate to discharge their allocated responsibilities;
and

(2) the production organisation maintains a record of all certifying staff which shall
include details of the scope of their authorisation;

(2) certifying staff are provided with evidence of the scope of their authorisation.

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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:

21.A.147 Changes to the approved production management system organisation
After the issue of a production organisation approval, each change to the approved production
management system organisation that is significant to the showing demonstration of conformity or to
the airworthiness and characteristics of noise, fuel venting and exhaust emissions of the product, part
or appliance, particularly changes to the quality system, shall be approved by the competent authority
before being implemented. Before the implementation of the change, an An application for approval
shall be submitted in writing to the competent authority, and the organisation shall demonstrate, to
the competent authority before implementation of the change, that it will continue to comply with this
Subpart Annex after the implementation.

The competent authority shall establish the conditions under which a production organisation approved
under this Subpart may operate during such changes unless the competent authority determines that the
approval should be suspended.

21.A.148 Changes of location

A change of the location of the manufacturing facilities of the approved production organisation shall
be deemed of significance and therefore shall comply with point 21.A.147.

21.A.149 Transferability

Except as a result of a change in ownership, which is deemed significant for the purposes of point
21.A.147, a production organisation approval is not transferable.

21.A.151 Terms of approval

The terms of approval shall identify the scope of work, the products or the categories of parts and
appliances, or both, for which the holder is entitled to exercise the privileges under point 21.A.163.

Those terms shall be issued as part of a production organisation approval.

21.A.153 Changes to the terms of approval

Each change to the terms of approval shall be approved by the competent authority. An application for
a change to the terms of approval shall be made in a form and manner established by the competent
authority. The applicant shall comply with the applicable requirements of this Subpart.

21.A.157 Investigations

A production organisation shall make arrangements that allow the competent authority to make any
investigations, including investigations of partners and sub-contractors, necessary to determine
compliance and continued compliance with the applicable requirements of this Subpart.

21.A.163 Privileges

Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation
approval may:

(a) perform production activities under this Annex; I (Part 21).

(b) in the case of complete aircraft and upon presentation of a statement of conformity (EASA Form 52)
under point 21.A.174, obtain an aircraft certificate of airworthiness and a noise certificate without
further showing;

(c) in the case of other products, parts or appliances, issue authorised release certificates (EASA Form
1) under point 21.A.307 without further showing;

(d) maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form

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53) in respect of that maintenance;

(e) under procedures agreed with its competent authority for production, for an aircraft it has
produced, and when the production organisation itself is controlling under its POA the
configuration of the aircraft and is attesting conformity with the design conditions approved for the
flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight
conditions in accordance with point 21.A.710(b).

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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:

21.A.165 Obligations of the holder

The holder of a production organisation approval shall:

(a) ensure that the production organisation exposition furnished in accordance with point 21.A.143 and
the documents to which it refers, are used as basic working documents within the organisation;

(b) maintain the production organisation in conformity with the data and procedures approved for the
production organisation approval;

(c) (1) determine that each completed aircraft conforms to the type design and is in condition for
safe operation prior to submitting statements of conformity to the competent authority; or

(2) determine that other products, parts or appliances are complete and conform to the
approved design data and are in a condition for safe operation before issuing an EASA Form
1 to certify conformity to approved design data and in a condition for safe operation, and
additionally in the case of engines, determine according to data provided by the engine type-
certificate holder that each completed engine is in compliance with the applicable emissions
requirements as defined in point 21.A.18(b), current at the date of manufacture of the
engine, to certify emissions compliance; or

(3) additionally, in the case of engines, determine that the completed engine is in compliance
with the applicable emissions requirements on the date of manufacture of the engine;

(4) determine that other products, parts or appliances conform to the applicable data before
issuing EASA Form 1 as a conformity certificate;

(d) comply with Subpart A of this Annex record all details of work carried out;

(e) establish and maintain an internal occurrence reporting system in the interest of safety, to enable
the collection and assessment of occurrence reports in order to identify adverse trends or to
address deficiencies, and to extract reportable occurrences. This system shall include evaluation of
relevant information relating to occurrences and the promulgation of related information;

(f) (1) report to the holder of the type-certificate or design approval, all cases where products,
parts or appliances have been released by the production organisation and subsequently
identified to have possible deviations from the applicable design data, and investigate with
the holder of the type-certificate or design approval in order to identify those deviations
which could lead to an unsafe condition;

(2) report to the Agency and the competent authority of the Member State, or both, the
deviations which could lead to an unsafe condition identified according to point (1). Such
reports shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;

(3) where the holder of the production organisation approval is acting as a supplier to
another production organisation, report also to that other organisation all cases where it has
released products, parts or appliances to that organisation and subsequently identified them
to have possible deviations from the applicable design data;

(e) provide assistance to the holder of the type certificate type-certificate or design approval in dealing
with any continuing airworthiness actions that are related to the products parts or appliances that
have been produced;

(h) establish an archiving system incorporating requirements imposed on its partners, suppliers and
sub-contractors, ensuring conservation of the data used to justify conformity of the products, parts

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or appliances. Such data shall be held at the disposal of the competent authority and be retained in
order to provide the information necessary to ensure the continuing airworthiness of the products,
parts or appliances;

(f) where, under its terms of approval, the holder issues a certificate of release to service, determine
that each completed aircraft has been subjected to necessary maintenance and is in condition for
safe operation, prior to issuing the certificate;

(g) where applicable, under the privilege of point 21.A.163(e), determine the conditions under which a
permit to fly can be issued;

(h) where applicable, under the privilege of point 21.A.163(e), establish compliance with points
21.A.711(c) and (e) before issuing a permit to fly to an aircraft;.

(i) comply with Subpart A of this Annex.

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Competent authority
of an EU Member State or
EASA

RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G ISSUE / CONTINUATION /

VARIATION/SIGNIFICANT CHANGE

PART THREE OF FIVE PARTS: Part 21 SUBPART G EXPOSITION COMPLIANCE

Name of organisation:

Approval of organisation:

Approval reference: ___________ Survey reference:

Note A: Each box must be completed with one of the three following indicators:
1. a tick () which means compliance;
2. NR which means the requirement is NOT RELEVANT to the activity at the address
surveyed; (The reason for NR should be stated in Part 4 of the report unless the reason is
obvious.);
3. a number relating to a comment which must be recorded in Part 4 of the report.
Note B: The exposition may be compiled in any subject order as long as all applicable subjects are covered.
Note C: If the organisation holds another Part approval requiring an exposition or handbook, it is
acceptable to use this index as a supplement to the existing exposition or handbook and to cross-
refer each subject to the position in the existing exposition or handbook.
Production organisation exposition
Revision Status:
(Content as required by point 21.A.143(a))

(1) A statement signed by the accountable manager confirming that the production organisation
exposition and any associated manuals which define the approved organisation’s compliance with
this Annex Subpart will be complied with at all times;

(2) the title(s) and names of the managers accepted by the competent authority in accordance with
point 21.A.145(c)(2);

(3) the accountabilities duties and responsibilities of the manager(s) as required by point 21.A.145(c)(2)
including matters on which they may deal directly with the competent authority on behalf of the
organisation.

(4) an organisational chart showing the associated chains of accountability and responsibility of the
managers as required by points 21.A.145(c)(1) and (c)(2);

(5) a list of certifying staff as referred to in point 21.A.145(d)

[Note : a separate document may be referenced]

(6) a general description of man-power resources;

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PART THREE OF FIVE (CONTINUED): SURVEY REFERENCE:

(7) a general description of the facilities located at each address specified in the production
organisation’s certificate of approval.

(8) a general description of the production organisation’s scope of work that is relevant to the terms of
approval;

(9) the procedure for the notification of organisational changes to the competent authority;

(10) the amendment procedure for the production organisation exposition;

(11) a description of the quality production management system and the policy, processes and the
procedures as required by point 21.A.139(b)(1);

(12) a list of those outside parties referred to in point 21.A.139 (a) (d)(1); and

[Note : a separate document may be referenced]

(13) if flight tests are to be conducted, a flight test operations manual defining the organisation’s
policies and procedures in relation to flight test.

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Competent authority
of an EU Member State or
EASA

RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL ISSUE / CONTINUATION /

VARIATION/SIGNIFICANT CHANGE

PART FOUR OF FIVE PARTS: FINDINGS ON Part 21 SUBPART G COMPLIANCE STATUS

Name of organisation:

Approval reference: _______________ Survey reference: _______________

Note A: Each finding must be identified by number and the number must cross-refer to the same number
in a box in Parts 2 or 3 of the Part 21 Subpart G survey report.
Note B: As stated in Part 1, any comments recorded in this Part 4 should be copied to the organisation
surveyed, together with Part 1.
Note C: In the case of a partial clearance of a finding with some outstanding actions remaining, these
actions have to be identified.
CLEARANCE
NO: FINDING LEVEL OUTSTANDING ACTION
DATE REP.REF.

NAME & SIGNATURE OF INSPECTOR: Date:

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PART FOUR OF FIVE (CONTINUED): Sheet ___ of ___

SURVEY REFERENCE:
CLEARANCE
NO: FINDING LEVEL OUTSTANDING ACTION
DATE REP.REF.

NAME & SIGNATURE OF INSPECTOR: Date:

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Competent authority
of an EU Member State or
EASA

RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL ISSUE / CONTINUATION /

VARIATION/SIGNIFICANT CHANGE

PART FIVE OF FIVE PARTS: Part 21 SUBPART G APPROVAL RECOMMENDATION

Name of organisation:

Approval reference: _______________ Survey reference: _______________

Recommendation for issue / variation of approval/significant change:

The following Part 21 Subpart G Tterms of approval are recommended for the above organisation at the
address(es) specified in Part 1 of this report:

or

Recommendation for continuation of existing approval:

It is recommended that the Part 21 Subpart G Tterms of approval identified in EASA Form 55 referenced

_______________ be continued.

 Reporting performed according to the procedure for authority surveillance of suppliers of a POA holder
located in other Member States, if applicable. (Strict confidentiality to be observed)

Name of the competent authority inspector making the recommendation:

Signature of the competent authority inspector:

Competent authority office: Date:

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 21.B.220 Initial certification procedure

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GM2 No 3 to 21.B.220(c) Initial certification procedure - Procedures

for investigation – POA applications received from organisations
with facilities/partners/ suppliers/sub-contractors located in a third
country
APPLICATION RECEIVED FROM ORGANISATIONS WITH FACILITIES/PARTNERS/
SUPPLIERS/SUBCONTRACTORS LOCATED IN A THIRD COUNTRY
The obligations of the applicant are totally independent from the surveillance exercised by the
competent authority. It is not acceptable that the applicant relies on the surveillance activities of the
competent authority to simplify its tasks.
Facilities located in a third country
When any part of the production facilities of an applicant for POA is located outside the Member
States, then the location will be treated in all aspects as part of the applicant’s POA organisation.
Therefore, the investigating competent authority will include the facilities outside the Member
States:
(a) include the facilities outside the Member States fully in their investigation and surveillance
activities for the applicant for, or holder of, the POA;
(b) include the facilities outside the Member States in the terms of approval of the EASA Form 55
(see Annex I Part 21 Appendix X) when issuing the POA.
Partners/suppliers/subcontractors sub-contractors located in a third country
The competent authority should define on the basis of Part 21 and, its associated CS and GM, a clear
procedure on supplier control. This procedure should include the control of
partners/suppliers/subcontractors sub-contractors of the applicant for, or holder of, a POA that are
located outside the Member States.
In respect of the applicant for, or holder, of the POA, the competent authority should:
(1) investigate, for the initial approval and consequent continued surveillance, the production
organisation, and its partners/suppliers/subcontractors sub-contractors at the necessary level,
to ensure that the organisation can comply with the requirements of Part 21;,
(2) in accordance with the competent authority procedure, assess and accept the documented
procedure for supplier control as part of the POA holder’s quality system, and changes to that
procedure prior to implementation; and,
(3) in accordance with competent authority procedure, assess the necessary level of surveillance
to be exercised by the production organisation on partners / suppliers / subcontractors sub-
contractors and check the audit plan of the production organisation against this level.
The level of co-operation cooperation between the competent authority and the competent
authority of the third country where a partner/supplier/subcontractor sub-contractors or of the
production organisation is located may influence the authorities’ activities concerning this
partner/supplier/ subcontractor subcontractors. Co-operation Cooperation with the competent
authority of the third country should be based on the capability and goodwill of that authority, and a
complete interchange of necessary information.

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The involvement of this competent authority of the third country in the surveillance of the
partner/supplier/ sub contractors sub-contractors will be based on the following principles:
(a) When a recognition agreement under Article 68 of Regulation (EU) 2018/1139 covering
production subjects has been concluded:
a(1) The competent authority in accordance with GM1 No 2 to 21.A.139(a) (d)(1) may decide
that direct surveillance of the POA holder activities at the foreign location may not be
necessary.
b(2) In any other case, the provisions of the recognition agreement on the subject apply
(technical assistance, etc....).
(b) If a recognition agreement has not been concluded, or it does not cover production subjects, it
may be necessary that the competent authority of the Member State, the Agency EASA, and
the competent authority of a third country enter into a specific working arrangement
addressing the following matters:
a(1) acceptance by the competent authority of the third country of conducting
manufacturing surveillance of the relevant production activities on behalf of the
competent authority, under the respective quality standards defined by the competent
authority;.
b(2) tasks to be performed; and
c(3) practical methods.
These arrangements are between authorities and do not relieve the applicant of its
obligations.
— In all cases, even though surveillance tasks are delegated to the competent authority of
the third country, the competent authority remains the responsible authority and may
consequently exercise direct surveillance if necessary.
— If in case that it is not possible to delegate surveillance tasks to the competent authority
of the third country, the competent authority will have to establish a direct surveillance
programme in accordance with its procedure concerning supplier control as part of the
overall surveillance of the POA holder.
— 21.B.220 Initial certification procedure

GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures

for investigation — Competent authority surveillance of suppliers
of a POA holder located in other Member States
COMPETENT AUTHORITY SURVEILLANCE OF SUPPLIERS OF A POA HOLDER LOCATED IN OTHER
MEMBER STATES
(a)1. The aviation legislation identifies specific State obligations in relation to complete products.:
The State of manufacture, as used in ICAO Annex 8, normally identifies the country where the
final assembly and the final determination of airworthiness is made. However, sub-assemblies
and parts may be produced by POA holders in other countries and the EASA Form 1 -

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Authorised Release Certificate will identify those countries as the locations location for
production.
Among Member States, the obligations of the State of manufacture may be discharged
through the use of the Part 21 POA system.
According to Part 21 Subpart G, each POA holder must have established and documented in
its POE a system for its own control of suppliers/supplies. Surveillance of this system is part of
the responsibility of the competent authority of the POA holder wherever the suppliers are
located.
This surveillance may be exercised through the POA holder and/or at supplier level especially
in the cases where the supplier would be eligible for its own POA.
The purpose of this procedure is to ensure the completeness of the chain of responsibilities
chain so that no separate technical agreement between these national authorities is
necessary, and when necessary, to establish a means of communication between the involved
competent authorities of the Member States.
(b)2. Principle to organise competent authority supplier surveillance between Member States.:
In order to avoid duplication and to take the best advantage of Regulation (EC) No 216/2008
that establishes under Article 11 mutual recognition of certificates issued by production
organisations approved in accordance with Part 21 Section A Subpart G by a an Member State,
the principle for the competent authority surveillance of the suppliers of a POA holder located
in other Member States is for the responsible competent authority to delegate surveillance
activity activities to the other competent authority of the supplier.
This applies between Member States and for to suppliers holding a Part 21 POA.
Delegation of surveillance tasks does not imply a delegation of the overall responsibility,
therefore the competent authority of the POA contractor always retains the right of direct
supervision at the supplier location, especially when serious quality problems are
encountered. In such a case, co-ordination there will be coordination will be organised
between both competent authorities.
This delegation of surveillance is to be considered automatic as soon as the supplier holds a
Part 21 POA, provided that the intended supply is included in the approved scope of work.
Evidence of that approval will normally be found through the release of the supplied parts
with an EASA Form 1. In addition, the competent authority of the supplier should immediately
inform the competent authority of the contractor in any case of a serious quality problem.
In the cases where the competent authority of the contractor considers that it is necessary to
establish closer ties with the competent authority of the supplier (i.e., critical or significant
parts), the exchange of information between the competent authorities should be organised
as follows:
2.(1) Tasks of the competent authority of the POA contractor
The competent authority of the contractor should inform in writing the
competent authority of the sub-contractor subcontractor with of the following:
(i)a. The identification Identification (and location) of the contractor;

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(ii)b. The identification Identification (and location) of the sub-contractor

subcontractor;
(iii)c. The identification Identification of the subcontracting (parts, contract No N°,
etc.);
(iv)d. Reference A reference to the quality requirements attached to the contract;
(v)e. The name Name and address of the competent authority office/person in charge
of the POA;
(vi)f. Whether Ddirect Ddelivery Aauthorisation (DDA) applies;
(vii)g. Any specific action item/requirement from the competent authority; and
(viii)h. Request A request for a bi-annual reporting (both ways).
EASA Form 58A is provided for the convenience of the competent authority for this
purpose.
The competent authority of the contractor should require that the contract/order from
the contractor to the sub-contractor subcontractor should to indicate that it is placed
under the surveillance of its competent authority on behalf of the competent authority
of the contractor, and should address the subject to the payment of the possible
surveillance fees.
2.(2) Tasks of the competent authority of the supplier (sub-contractor subcontractor)
On receipt of the information from the competent authority of the contractor,
the competent authority of the sub-contractor subcontractor should:
–(i) Vverify that the scope of work of the POA of the supplier covers the intended
supply (or envisage to extend extending it in liaison with the supplier);.
–(ii) Vverify that the specific quality requirements for the parts have been introduced
in into the quality system of the supplier;.
–(iii) Cconfirm to the competent authority of the contractor that the procurement is
included in the POA of the supplier and that their surveillance will cover this
activity; and.
–(iv) Iindicate the name and address of the competent authorities office/person in
charge of the POA.
If the supplier has no POA under Part 21, or does not want to extend it, and/or if
its competent authority cannot conduct surveillance on behalf of the other competent
authority, the competent authority of the supplier will inform the competent authority
of the contractor in order for it to decide on the appropriate actions.
2.(3) Exchange of information between the competent authorities
This information should normally take two forms:
— Immediate exchange of information between both competent authorities
in case of serious quality problems;

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— A bi-annual exchange of information at a given date in order to guarantee

proper on going ongoing control of the subcontract by both competent
authorities.
This information should cover in a concise form:
a(i) Ffor the competent authority of the contractor:
— A a résumé resume of the quality problems encountered by the contractor,
on receipt inspection, on installation on aircraft or on in service aircraft;
and
— A a status of the reference documents.
b(ii) For the competent authority of the sub-contractor subcontractor:
A résumé resume of at least the following subjects:
— Changes in organisation and qualification of the sub-contractor
subcontractor (in case of impact on the procurement);,
— Quality problems encountered during manufacture;,
— Corrective actions following problems encountered earlier on in the
procurement;,
— Findings from national authorities’ surveillance that may have an impact on
the procurement; and,
— Quality problems related to the contractor procurement (materials,
documentation, procedures, processes).
Any exchange Exchange of information between competent national authorities according to
this procedure is strictly confidential and should not be disclosed to other parties.
It is recommended to plan at least every 5 years a meeting between industry and the two
competent national authorities to review each major subcontract to verify that there is proper
management by the various parties involved.
3. Miscellaneous
a) Release documentation
The release Release of parts by the POA sub-contractor subcontractor to the contractor
will be accompanied by an « ‘Authorised Release Certificate EASA Form 1»’ issued for
«’Airworthiness »’ or for «’Conformity»’ as appropriate.
b) Sub-subcontracting Subsubcontracting
If the sub-contractor subcontractor wants itself to subcontract, it is up to the
competent authority of the sub-contractor subcontractor to verify that this is done in
accordance with the conditions of the contract, to organise as necessary the related
authority surveillance and to inform the competent authority of the contractor.
c) Language

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Except if it is agreed otherwise, it is recommended to use the English language for the
exchange of information between the competent authorities.

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Competent authority
of an EU Member State or
EASA

REQUEST FOR REPORTING ON SUB-CONTRACTOR SUBCONTRACTOR SURVEILANCE

Document reference number: <REQUEST REF. NO.>

As competent authority which issued a POA to: <CONTRACTOR COMPANY>

With approval reference: <CONTRACTOR POA REF. NO..>

The <COMPETENT AUTHORITY> has determined that there

<SUB-CONTRACTOR COMPANY>
is a need for direct authority supplier surveillance of:

With approval reference: <SUB-CONTRACTOR POA REF.NO.>

Which is situated in: <COUNTRY OF SUB-CONTRACTOR COMPANY>

As part of the surveillance as required for the Part 21 Section A Subpart G approved production
organisation, according to GM3 No. 4 to 21.B.220(c), the competent authority of the sub-contractor
subcontractor is requested to perform authority surveillance on the specific sub-assembly sub-assembly and
parts as details and requirements are defined below.

Identification of subcontracting (parts, contract No., etc.…):

Reference to the quality requirements attached to the
contract between contractor and sub-contractor
subcontractor:
Name and address of the requesting competent authority
office/person in charge of the POA:

Direct Ddelivery Aauthorisation (DDA) applies:  Yes  No

Specific action item/requirement from the competent

authority of the contractor:

Request and details required for a bi-annual reporting (both

ways) according to GM3 No. 4 to 21.B.220(c)
(Strict confidentiality to be observed):
Name and signature of the competent authority person making the
request:

Competent authority office: Date:

EASA Form 58A – Request for reporting on sub-contractor subcontractor surveillance, Page x of x

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Competent authority
of an EU Member State or
EASA

REPORT ON SUB-CONTRACTOR SUBCONTRACTOR SURVEILLANCE

Document reference number: <REPORT REF. NO.>

Reporting request reference number: < REQUEST REF. NO >

As responsible competent authority, the <COMPETENT
AUTHORITY> issued a POA to and is performing direct <SUB-CONTRACTOR COMPANY>
authority surveillance of:
With approval reference: <SUB-CONTRACTOR POA REF. NO..>

Which is a subcontracted supplier of: <CONTRACTOR COMPANY>

With approval reference: <CONTRACTOR POA REF.NO.>

Which is situated in: <COUNTRY OF CONTRACTOR COMPANY>
According to GM3 No. 4 to 21.B.220(c) and on request of the competent authority of the contractor
company, the <COMPETENT AUTHORITY> reports on the results of its authority surveillance on the specific
parts and appliances defined below:

Identification of subcontracting (parts, contract No., etc. …):

Identification of attachments to this report (if needed):

Date and identification of the previous report:

Resume of surveillance results:

Changes in organisation and qualification of the sub-
contractor subcontractor (in case of impact on the
procurement):
Quality problems encountered during manufacture:
Corrective actions following problems encountered earlier
on in the procurement:
Findings from competent authority surveillance that may
have an impact on the procurement:
Quality problems related with the contractor procurement
(materials, documentation, procedures, processes):
Note: the exchange Exchange of information between national authorities according to this procedure is
strictly confidential and should not be disclosed to other parties.

Name and signature of the competent authority person reporting:

Competent authority office: Date:

EASA Form 58B – Report on sub-contractor subcontractor surveillance, Page x of x

 21.B.220 Initial certification procedure

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AMC1 21.B.220(d)(1) Initial certification procedure

ISSUE OF THE CERTIFICATE
(a) The competent authority should base its decision to issue or amend a POA on the
recommendation report (EASA Form 56, see GM1 21.B.220) of the investigation team
submitted by the POA team leader. EASA Form 56 includes a proposal by the investigation
team for the scope and terms of approval that define the products, parts and appliances for
which the approval is to be granted, with appropriate limitations.
(b) When the competent authority issues the approval, a final controlled copy of an acceptable
exposition for the organisation should be supplied to the competent authority.
(c) In some cases, it may be acceptable for some findings to not be fully closed because corrective
actions are still in progress. The competent authority may decide according to the following
principles:
(1) Findings should be equivalent to level 2, which do not need to be rectified as a matter
of urgency within less than 3 months, and should normally not exceed three in number.
(2) A corrective action plan, including timescales, should have been accepted and should
not require an additional and specific follow-up audit by the competent authority.
(d) A record should be kept by the competent authority and should upon request be brought to
the attention of EASA for standardisation purposes.
 21.B.220 Initial certification procedure

AMC1 21.B.221(a), (b) and (c) Oversight principles

MANAGEMENT SYSTEM ASSESSMENT
As part of the initial certification of an organisation in accordance with point 21.B.220, the
competent authority should assess the organisation’s management system and its processes to
make sure that all the required enablers of a functioning management system are present and
suitable.
As part of the continuing oversight, the competent authority should remain satisfied as to the
presence of the required enablers, and assess the effectiveness of the organisation’s management
system and its processes.
When significant changes take place in the organisation, the competent authority should determine
whether the existing assessment needs to be reviewed to ensure that it is still appropriate.
 21.B.221 Oversight principles

AMC1 21.B.222 and 21.B.432 Oversight programme

ANNUAL REVIEW
(a) The oversight planning cycle and the related oversight programme for each organisation
should be reviewed annually to ensure they remain adequate regarding any changes in the
nature, complexity or safety performance of the organisation.

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(b) When reviewing the oversight programme and the oversight planning cycle, the competent
authority should also consider any relevant information collected in accordance with points
21.A.3A and 21.B.215(d) for production organisations or point 21.B.431(d) for design
organisations.

 21.B.222 Oversight programme

GM1 21.B.222(a) Oversight programme

MAINTENANCE OF THE POA — WORK ALLOCATION WITHIN THE COMPETENT AUTHORITY
After the issue of the approval, the competent authority should appoint a suitable member of its
technical staff as the POATL to be in charge of the approval for the purpose of continued
surveillance.
Where the POA holder facilities are located in more than one Member State, the competent
authority of the State of manufacture will liaise with the competent authorities of the various
members to ensure appropriate continued surveillance.
 21.B.222 Oversight programme

AMC1 21.B.222(b) and 21.B.432(b) Oversight programme

SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT
When determining the oversight programme, including the relevant sample of product, parts and
appliances under the scope of the organisation as the product audits, the competent authority
should consider in particular the following elements, as applicable:
(a) the effectiveness of the organisation’s management system in identifying and addressing
non-compliances and safety hazards;
(b) the implementation by the organisation of any industry standards that are directly relevant to
the organisation’s activity subject to Part 21;
(c) any specific procedures implemented by the organisation that are related to any alternative
means of compliance used;
(d) the number of approved locations and the activities performed at each location;
(e) the number and type of any subcontractors who perform production or design tasks as
appropriate; and
(f) the volume of activity for each product, parts or appliance.
 21.B.222 Oversight programme

AMC2 21.B.222(b) and 21.B.432(b) Oversight programme

SUBCONTRACTED ACTIVITIES
If a Part 21 organisation subcontracts some tasks, the competent authority should determine
whether the subcontracted organisations needs to be audited and included in the oversight
programme, taking into account the specific nature and complexity of the subcontracted activities,

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the results of previous oversight activities of the organisation approved according to Subparts G or J,
and based on the assessment of the associated risks.
For such an audit, the competent authority inspector should ensure that he or she is accompanied
throughout the audit by a senior technical member of the Part 21 organisation.

 21.B.222 Oversight programme

GM1 21.B.222(b) Oversight programme

The oversight programme consists of:
(a) planned continued surveillance, in which the total surveillance actions are split into several
audits, which are carried out at planned intervals during the validity period of the production
organisation approval. Within the continued surveillance, one aspect may be audited once or
several times, depending upon its importance; and
(b) unplanned POA reviews, which are specific additional investigations of a POA holder related to
surveillance findings or external needs. The competent authority is responsible for deciding
when a review is necessary, taking into account any changes in the scope of work, changes in
personnel, reports on the organisation’s performance submitted by other EASA or competent
authorities teams, and reports on the in-service product.
 21.B.222 Oversight programme

AMC1 21.B.222(b)(1) Oversight programme

AUDIT
(a) The oversight programme should indicate which aspects of the certificate will be covered by
each audit.
(b) A part of each audit should concentrate on the organisation’s audit reports produced by the
compliance monitoring function to determine whether the organisation is identifying and
correcting its problems.
(c) At the conclusion of the audit, an audit report should be completed by the auditing inspector,
identifying the areas and processes that were audited and including all the findings that were
raised.
(d) At the completion of each oversight planning cycle, the POATL responsible for the POA should
complete an EASA Form 56 (see GM1 21.B.220) as a summary report for the continued
surveillance, including the recommendation for a continuation of the POA, as applicable.
EASA Form 56 should be countersigned by the person responsible within the competent
authority for the acceptance. At this stage, there is no limitation on the number of level 2
findings that may be open, provided that they are within the time limits of the respective
corrective action plans.

 21.B.222 Oversight programme

GM1 21.B.222(b)(1)(ii) Oversight programme

GUIDE TO THE CONDUCT OF MONITORING PRODUCTION STANDARDS

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(a) Point 21.B.222(b)(1)(ii) identifies the need for a sample investigation of products, parts or
appliances, their associated conformity determinations and the certifications made by a POA
holder. For this to be performed effectively and efficiently, the competent authority should
integrate a sampling plan as part of the planning of the investigation and continued
surveillance activities that are appropriate to the scope and size of the relevant applicant.
(b) The sample investigation could, for example, include:
(1) a modification (or change);
(2) the installation, testing, or operation of a major part or system;
(3) the accuracy and generation of the flight test report data;
(4) the accuracy and generation of the weighing report data;
(5) an engine test bed run;
(6) the traceability of records;
(7) the accuracy and generation of the statement of conformity data and the
associated safe operation determination; and
(8) the accuracy and generation of EASA Form 1 data.
(c) The sampling plan should be flexible so as to:
(1) accommodate changes in the production rate;
(2) make use of the results from other samples;
(3) make use of the results from other POA investigations; and
(4) provide the competent authorities with the maximum degree of confidence.
(d) To be effective, this product sample requires that the individual investigator(s):
(1) have a good practical knowledge of the product, part or appliance;
(2) have a good practical knowledge of the manufacturing processes;
(3) have up-to-date knowledge of the production organisation’s production
programme;
(4) use an appropriate and up-to-date sample plan and compliance checklists;
(5) have a suitable recording system for the results;
(6) have a properly operating system to provide feedback to their competent
authority’s organisation for the POA and the production organisation;
(7) maintain an effective working relationship with the production organisation and
its staff; and
(8) be able to communicate effectively.
 21.B.222 Oversight programme

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AMC1 21.B.222(c) Oversight programme

OVERSIGHT PLANNING CYCLE AUDIT AND INSPECTION
(a) When determining the oversight planning cycle and defining the oversight programme, the
competent authority should assess the risks related to the activity of each organisation and
adapt the oversight to the level of risk identified and to the effectiveness of the organisation’s
management system, in particular its ability to effectively manage safety risks.
(b) The competent authority should establish a schedule of audits and inspections that is
appropriate to each organisation. The planning of audits and inspections should take into
account the results of the hazard identification and risk assessment conducted and
maintained by the organisation as part of the organisation’s management system. Inspectors
should work in accordance with the schedule provided to them.
(c) When the competent authority, having regard to the level of risk identified and the
effectiveness of the organisation’s management system, varies the frequency of an audit or
inspection, it should ensure that all the aspects of the organisation’s activities are audited and
inspected within the applicable oversight planning cycle.
 21.B.222 Oversight programme

AMC1 21.B.222(c) and 21.B.432(c) Oversight programme

OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation approved by the competent authority, all the processes should be
completely audited at periods that do not exceed the applicable oversight planning cycle. The
beginning of the first oversight planning cycle is normally determined by the date of issue of
the first approval. If the competent authority wishes to align the oversight planning cycle with
the calendar year, it should shorten the first oversight planning cycle accordingly.
(b) Audits should include at least one on-site audit within each oversight planning cycle. For
organisations that exercise their regular activity at more than one site, the determination of
the sites to be audited should consider the results of past oversight, the volume of activity at
each site, as well as the main risk areas identified.
(c) For organisations that hold more than one approval, the competent authority may define an
integrated oversight schedule to include all the applicable audit items. In order to avoid any
duplication of audits, credit may be granted for any specific audit items already completed
during the current oversight planning cycle, subject to the following conditions:
(1) the specific audit item should be the same for all the approvals under consideration;
(2) there should be satisfactory evidence on record that the specific audit items were
carried out and that all corrective actions have been implemented to the satisfaction of
the competent authority;
(3) the competent authority should be satisfied that there is no evidence that standards
have deteriorated in respect of those specific audit items for which credit is granted;
and

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(4) the interval between two audits for the specific item for which credit is granted should
not exceed the applicable oversight planning cycle.
 21.B.222 Oversight programme.

AMC1 21.B.222(d) Oversight programme

EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) If the competent authority applies an oversight planning cycle that exceeds 24 months, it
should perform, at a minimum, one inspection of the organisation within each 12-month
segment of the applicable oversight planning cycle to validate the oversight programme.
(b) If the results of this inspection indicate a decrease in the safety performance of the
organisation, the competent authority should revert to a 24-month (or shorter) oversight
planning cycle and review the oversight programme accordingly.
(c) In order to be able to apply an oversight planning cycle of up to 36 months, the competent
authority should determine the format and contents of the regular reports to be made by the
organisation on its safety performance.
(d) To enable the competent authority to apply an oversight planning cycle of up to 48 months,
the competent authority should establish, implement and maintain a methodology to
evaluate the safety performance of the organisation, focusing on the organisation’s ability to
effectively identify aviation safety hazards and manage the associated risks.
 21.B.222 Oversight programme

GM1 21.B.225(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings

and corrective actions Objective evidence
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;
(b) examination of equipment/products; and
(c) information from interview questions and observations of POA an organisation’s activities.
 21.B.225 Findings and corrective actions

GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective

actions
UNCONTROLLED NON-COMPLIANCE WITH APPLICABLE DESIGN DATA
An uncontrolled non-compliance with applicable design data is a non-compliance that:
(a) cannot be discovered through systematic analysis; or
(b) prevents the identification of the affected products, parts, appliances, or material.
 21.B.225 Findings and corrective actions

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AMC1 21.B.225(d)(a) Findings and corrective actions Notification of

findings
NOTIFICATION OF FINDINGS
In case of a level 1 one finding, confirmation must should be obtained in a timely manner that the
accountable manager has taken note of the finding and its details received the letter containing
details of the level one finding and the approval suspension details.
A level two finding requires timely and effective handling oversight by the competent authority to
ensure the completion of the corrective action. This oversight may includes intermediate
communication, including reminding letters as necessary, with to remind the POA approval holder to
verify that the corrective action plan is followed.
The competent authority should grant the organisation a corrective action implementation period
that is appropriate to the nature of the finding, which should not in any case be more than 21
working days, commencing from the date of the written communication of the finding to the
organisation, requesting corrective action to address the non-compliance identified.
 21.B.225 Findings and corrective actions

AMC No 1 to 21.B.230 Issue of the certificate

The competent authority should base its decision to issue or amend a POA on the recommendation
report (EASA Form 56, see GM No 2 to 21.B.220(c)) of the POAT submitted by the POA team leader.
The EASA Form 56 includes a proposal by the POAT for the scope and terms of approval defining the
products, parts and appliances for which the approval is to be granted, with appropriate limitations.
When the competent authority issues the approval a final controlled copy of an acceptable
exposition for the organisation should have been supplied to the competent authority.
In some cases it may be accepted that some findings are not fully closed because corrective actions
are still in progress. The competent authority may decide according to the following principles:
1) Findings should be equivalent to level two, which do not need to be rectified as a matter of
urgency within less than three months, and should normally not exceed three in number.
2) Corrective action plan, including timescales, should have been accepted and should not
require an additional and specific follow-up audit by the competent authority.
A record should be kept by the competent authority and should be brought to the attention of the
Agency on request for standardisation purposes.

GM 21.B.235(a)(4) Guide to the conduct of monitoring production

standards.
1. 21.B.235(a)(4) identifies a need for a sample investigation of products, parts or appliances,
their associated conformity determinations and certifications made by a POA holder. For this
to be performed effectively and efficiently, the competent authority should integrate a
sampling plan as part of the planning of the investigation and continued surveillance activities
appropriate to the scope and size of the relevant applicant.

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2. The sampling plan could, for example, investigate:

(a) a modification (or change)
(b) the installation, testing, or operation of a major part or system
(c) the accuracy and generation of the Flight Test report data
(d) the accuracy and generation of the Weighing report data
(e) an engine test bed run
(f) records traceability
(g) the accuracy and generation of the Statement of Conformity data and the
associated safe operation determination
(h) the accuracy and generation of EASA Form 1 data.
The sampling plan should be flexible so as to:
(i) accommodate changes in production rate
(j) make use of results from other samples
(k) make use of results from other POA Investigations
(l) provide the maximum national authorities confidence
To be effective this product sample requires that the individual investigator(s):
(m) have a good practical knowledge of the product, part or appliance
(n) have a good practical knowledge of the manufacturing processes
(o) have an up to date knowledge of the manufacturers production programme
(p) use an appropriate and up to date sample plan and compliance check lists
(q) have a suitable recording system for the results
(r) have a properly operating feedback system to their national authorities
organisation for POA and the manufacturer
(s) maintain an effective working relationship with the manufacturer and his staff
(t) be able to communicate effectively

GM 21.B.235(b) Maintenance of the POA - Work allocation within

the competent authority
After issue of the approval the competent authority should appoint a suitable member of its
technical staff as the POATL to be in charge of the approval for the purpose of continued
surveillance.
Where the POA holder facilities are located in more than one Member State the competent
authority of the State of manufacture will liaise with the competent authorities of the various
partners/members to ensure appropriate continued surveillance.

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GM 21.B.235(b) and (c) Continued surveillance

Continued surveillance consists of:
1. Planned continued surveillance, in which the total surveillance actions are split into several
audits, which are carried out at planned intervals during the validity period of the production
organisation approval. Within the continued surveillance one aspect may be audited once or
several times depending upon its importance.
2. Unplanned POA reviews, which are specific additional investigation of a POA holder related to
surveillance findings or external needs. The competent authority is responsible for deciding
when a review is necessary taking into account changes in the scope of work, changes in
personnel, reports on the organisation performance submitted by other EASA or national
authorities teams, reports on the in service product.

AMC 21.B.235(c) Continuation of POA

At the end of the 24 months continued surveillance cycle the POATL responsible for the POA should
complete an EASA Form 56 (see GM No 2 to 21.B.220(c)) as a summary report for the continued
surveillance including the recommendation for continuation of the POA as applicable. The
EASA Form 56 should be countersigned by the person responsible within the competent authority
for his acceptance. At this stage there is no limitation to the number of level two findings that may
be open, provided they are within the time limits of the respective corrective action plans.

AMC1 No 1 to 21.B.240 Changes to a production organisation

approval Application for significant changes or variation of scope
and terms of the POA
APPLICATION FOR SIGNIFICANT CHANGES OR A VARIATION OF SCOPE AND TERMS OF THE POA
(a) The competent authority should have adequate control over any changes to the personnel
specified in points 21.A.145(c)(1) and (2). Such changes in personnel will require an
amendment to the exposition.
(b) When an organisation submits the name of a new nominee for any of the personnel specified
in points 21.A.145(c)(1) and (2), the competent authority may require the organisation to
produce a written résumé of the proposed person's qualifications. The competent authority
should reserve the right to interview the nominee or call for additional evidence of his or her
suitability before deciding upon his or her acceptability.
(c) For changes that require prior approval, in order to verify the organisation's compliance with
the applicable requirements, the competent authority should conduct an audit of the
organisation, limited to the extent of the changes, and determine whether the organisation
needs to provide a safety risk assessment.
(d) If a safety risk assessment is deemed necessary, the competent authority should inform the
organisation accordingly.

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(e) If the competent authority considers that it is necessary to review the safety risk assessment
performed by the organisation, it should request the assessment from the organisation and
assess its results.
(f) If required for verification, the audit may conduct interviews and inspections carried out at
the organisation’s facilities.
(g) The competent authority should receive an application for any significant changes or for a
change to the terms of approval of the DOA on an EASA Form 51 completed by the applicant.
The competent authority must receive an application for significant changes or variation of scope
and terms of the POA on an EASA Form 51 (see below) completed by the applicant.

 21.B.240 Changes to a production organisation approval

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EASA Form 51

Application for significant changes or variation of scope and terms of Part 21 POA

Competent authority
of an EU Member State or
EASA

1. Name and address of the POA holder:

2. Approval reference number:

3. Locations for which changes in the terms of

approval are requested:

4. Brief summary of proposed changes to the activities at the item 3 addresses:

a) General:
b) Scope of approval:
c) Nature of privileges:

5. Description of organisational changes:

6. Position and name of the accountable

manager or nominee:

_______________________________ __________________________________
Date Signature of the accountable manager (or nominee)

EASA Form 51

Block 1: The name must be entered as written on the current approval certificate. Where a change in the name
is to be announced state the old name and address here, while using Block 5 for the information about
the new name and address. The change of name and/or address must be supported by evidence, e.g.
by a copy of the entry in the register of commerce.

Block 2: State the current approval reference number.

Block 3: State the locations for which changes in the terms of approval are requested or state ‘not applicable’ if
no change is to be anticipated here.

Block 4: This Block should include further details for the variation of the scope of approval for the addresses
indicated in Block 3. The Block ‘General’ must include overall information for the change (including

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changes e.g. in workforce, facilities etc.), while the Block ‘Scope of approval’ must address the change in
the scope of work and products/categories following the principles laid down in the GM 21.A.151. The
Block ‘nature of privileges’ must indicate a change in the privileges as defined in 21.A.163(b)-(d). State
‘not applicable’ if no change is anticipated here.

Block 5: This Block must state the changes to the organisation as defined in the current production
organisation exposition, including changes the organisational structure, functions and responsibilities.
This Block must therefore also be used to indicate a change in the accountable manager in accordance
with 21.A.145(c)(1) or a change in the nomination of the responsible managers in accordance with
21.A.145(c)(2). A change in the nomination of responsible managers must be accompanied by the
corresponding EASA Forms 4. State ‘not applicable’ if no change is anticipated here.

Block 6: State the position and name of the accountable manager here. Where there is a change in the
nomination of the accountable manager, the information must refer to the nominee for this position.
State ‘not applicable’ if no change is anticipated here.

In case of an application for a change of the accountable manager the EASA Form 51 must be signed by
the new nominee for this position. In all other cases the EASA Form 51 must be signed by the
accountable manager.

GM 21.B.245 Continued validity

1. GENERAL
Decisions on restriction, surrender, suspension or revocation of POA will always be actioned in
such a way as to comply with any applicable national laws or regulations relating to appeal
rights and the conduct of appeals, unless the decision has been taken by the Agency. In such
case, the Agency appeal procedures will apply.
2. RESTRICTION is temporary withdrawal of some of the privileges of a POA under 21.A.163.
3. SURRENDER is a permanent cancellation of a production organisation approval by the
competent authority upon formal written request by the accountable manager of the
organisation concerned. The organisation effectively relinquishes its rights and privileges
granted under the approval and, after cancellation, may not make certifications invoking the
approval and must remove all references to the approval from its company documentation.
4. SUSPENSION is temporary withdrawal of all the privileges of a production organisation
approval under 21.A.163. The approval remains valid but no certifications invoking the
approval may be made while the suspension is in force. Approval privileges may be re-instated
when the circumstances causing the suspension are corrected and the organisation once again
can demonstrate full compliance with the Requirements.
5. REVOCATION is a permanent and enforced cancellation of the whole of an approval by the
competent authority. All rights and privileges of the organisation under the approval are
withdrawn and, after revocation, the organisation may not make any certifications or other
statements invoking the approval and must remove all references to the approval from its
company documentation.

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AMC 21.B.245 Corrective action plan

It is expected that any established POA holder will move quickly to re-establish compliance with
Part 21 and not risk the possibility of approval suspension. Therefore, the corrective action period
granted by the competent authority must be appropriate to the nature of the finding but in any case
initially must not be more than six months. In certain circumstances and subject to the nature of the
finding the competent authority can vary the six months period subject to a satisfactory corrective
action plan agreed by the competent authority.
Failure to comply within time scale agreed by the competent authority means that provisional
suspension of the POA in whole or in part must proceed.

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SUBPART J — DESIGN ORGANISATION APPROVAL

AMC1 21.B.220 and 21.B.430 Initial certification procedure

VERIFICATION OF COMPLIANCE
(a) In order to verify the organisation’s compliance with the applicable requirements, the
competent authority should conduct an audit of the organisation, including interviews of the
personnel, and inspections carried out at the organisation’s facilities.
(b) The competent authority should only conduct such an audit if it is satisfied that the
application and supporting documentation are in compliance with the applicable
requirements.
(c) The audit should focus on the following areas:
(1) the detailed management structure, notably its adequacy;
(2) the personnel: the adequacy of the number of staff, and of their qualifications and
experience with regard to the intended terms of approval and the associated privileges;
(3) the processes used for safety risk management and compliance monitoring;
(4) the facilities and their adequacy regarding the organisation’s scope of work; and
(5) the documentation based on which the approval should be granted.
(d) If an application for an approval is refused, the applicant should be informed of the right of
appeal that exists under national law.
 21.B.430 Initial certification procedure

AMC1 21.B.430 and 21.B.431 Initial certification procedure

INVESTIGATION TEAM
(a) The competent authority should appoint a design organisation investigation team for each
applicant for, or each holder of, a design organisation approval. This team is responsible for
conducting all the relevant tasks related to the approval. The team should consist of a team
leader to manage and lead the approval team and, if needed, one or more team members.
The team leader should report to the manager who is responsible for the activities of the
competent authority as defined in point 21.B.25(c).
(b) The competent authority should perform sufficient investigation activities for an applicant for,
or a holder of, a DOA to justify the recommendations for the issuance, maintenance,
amendment, suspension or revocation of the approval.
(c) The competent authority should prepare procedures for the investigation of a DOA as part of
the documented procedures that cover at least the following elements:
(1) the evaluation of the applications received;
(2) the appointment of the organisation approval team;
(3) the preparation and planning of the investigation;

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(4) the evaluation of the documentation (design organisation handbook, procedures, etc.);
(5) the auditing;
(6) the follow-up of corrective actions;
(7) any recommendation for the issuance, amendment, suspension or revocation of a
design organisation approval; and
(8) continued surveillance.
 21.B.430 Initial certification procedure

AMC1 21.B.430(a) Initial certification procedure

ORGANISATION APPROVAL TEAM
(a) Team leader selection
The team leader should satisfy all of the criteria for a team member and will be selected by
considering the following additional criteria:
(1) the capability to lead and manage a team;
(2) the capability to prepare reports and be diplomatic;
(3) experience in approval team investigations (not necessarily only Part 21 Section A
Subpart J); and
(4) relevant knowledge of the design management system.
(b) Team member selection
The competent authority should determine the size of the team and the specialisations to be
covered, taking into account the scope of work and the characteristics of the applicant. Team
members should be selected by considering the following criteria:
(1) training, which is mandatory, for Part 21 Section A, Subparts A and J, and Section B,
Subparts A and J;
(2) education and experience, to cover the appropriate aviation knowledge, audit
practices and approval procedures; and
(3) the ability to verify that an applicant’s organisation conforms to its own
procedures, and that its key personnel are competent.

 21.B.430 Initial certification procedure

AMC1 21.B.430(d)(1) Initial certification procedure

ISSUE OF THE CERTIFICATE

(a) The competent authority should base its decision to issue or amend a DOA on the
recommendation in the DOA investigation report (for an initial investigation) or the significant
change report (for significant changes) submitted by the DOA team leader. The report includes
a proposal by the DOAT for the terms of approval that define the products, technical scope
and privileges for which the approval is to be granted, with appropriate limitations.

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(b) When the competent authority issues the approval, a final controlled copy of an acceptable
handbook for the organisation should be supplied to the competent authority.
(c) In some cases, it may be acceptable for some actions to not be fully closed because work is
still in progress. The competent authority may decide according to the following principles:
(1) The findings should be of level 2 or 3, which do not need to be rectified as a matter of
urgency within less than 3 months, and should normally not exceed three in number.
(2) A corrective action plan, including timescales, should have been accepted, and should
not require an additional specific follow-up audit by the competent authority.
 21.B.430 Initial certification procedure

AMC1 21.B.431(a), (b) and (c) Oversight principles

MANAGEMENT SYSTEM ASSESSMENT
As part of the initial certification of an organisation in accordance with point 21.B.430, the
competent authority should assess the organisation’s management system and its processes to
make sure that all the required enablers of a functioning management system are present and
suitable.
As part of their continuing oversight, the competent authority should remain satisfied as to the
presence of the required enablers, and assess the effectiveness of the organisation’s management
system and processes.
When significant changes take place in the organisation, the competent authority should decide
whether it needs to review the existing assessment to ensure it is still appropriate.
 21.B.431 Oversight principles

AMC1 21.B.222 and 21.B.432 Oversight programme

ANNUAL REVIEW
(a) The oversight planning cycle and the related oversight programme for each organisation
should be reviewed annually to ensure they remain adequate regarding any changes in the
nature, complexity or safety performance of the organisation.
(b) When reviewing the oversight programme and the oversight planning cycle, the competent
authority should also consider any relevant information collected in accordance with points
21.A.3A and 21.B.215(d) for production organisations, or point 21.B.431(d) for design
organisations.
 21.B.432 Oversight programme

AMC1 21.B.222(b) and 21.B.432(b) Oversight programme

SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT
When determining the oversight programme, including the relevant sample of design activities
under the scope of the organisation as product audits, the competent authority should consider in
particular the following elements, as applicable:

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(a) the effectiveness of the organisation’s management system in identifying and addressing
non-compliances and safety hazards;
(b) the implementation by the organisation of any industry standards that are directly relevant to
the organisation’s activity subject to Part 21;
(c) any specific procedures implemented by the organisation that are related to any alternative
means of compliance used;
(d) the number of locations and the activities performed at each location;
(e) the number and type of subcontractors who perform production or design activities as
appropriate; and
(f) the volume of activity for each product, parts or appliance.

 21.B.432 Oversight programme

AMC2 21.B.222(b) and 21.B.432(b) Oversight programme

SUBCONTRACTED ACTIVITIES
If a Part 21 organisation subcontracts some activities, the competent authority should determine
whether the Part 21 organisation needs to be audited on how they control particular subcontracted
activities and include this in the oversight programme, taking into account the specific nature and
complexity of the subcontracted activities, the results of previous oversight activities of the
organisation approved according to Subparts G or J, and based on the assessment of the associated
risks.
For such an audit, the competent authority inspector should ensure that he or she is accompanied
throughout the audit by a senior technical member of the Part 21 organisation.
 21.B.432 Oversight programme

AMC1 21.B.432(b)(1) Oversight programme

AUDIT
(a) The oversight programme should indicate which aspects of the terms of approval will be
covered by each audit.
(b) Audits may be complemented by a review of the compliance monitoring results particular to
the topics of the audit to determine if the organisation is identifying and correcting its
problems.
(c) At the conclusion of the audit, the auditing inspector should complete an audit report that
identifies the areas and processes that were audited and includes all the findings that were
raised.
 21.B.432 Oversight programme

AMC1 21.B.432(c) Oversight programme

OVERSIGHT PLANNING CYCLE AUDIT AND INSPECTION

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(a) When determining the oversight planning cycle and defining the oversight programme, the
competent authority should assess the risks related to the activity of each organisation, and
adapt the oversight to the level of risk identified and to the effectiveness of the organisation’s
management system, in particular its ability to effectively manage safety risks.
(b) The competent authority should establish a schedule of audits and inspections that is
appropriate to each organisation. The planning of audits and inspections should take into
account the results of the hazard identification and the risk assessment conducted and
maintained by the organisation as part of the organisation’s management system.
(c) When the competent authority, having regard to the level of risk identified and the
effectiveness of the organisation’s management system, varies the frequency of an audit or
inspection, it should ensure that all aspects of the organisation’s activity are audited and
inspected within the applicable oversight planning cycle.
 21.B.432 Oversight programme

AMC2 21.B.222(c) and 21.B.432(c) Oversight programme

OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation approved by the competent authority, all the processes should be
completely audited at periods that do not exceed the applicable oversight planning cycle. The
beginning of the first oversight planning cycle is normally determined by the date of issue of
the first approval. If the competent authority wishes to align the oversight planning cycle with
the calendar year, it should shorten the first oversight planning cycle accordingly.
(b) Audits should include at least one on-site audit within each oversight planning cycle. For
organisations that exercise their regular activity at more than one site, the determination of
the sites to be audited should consider the results of past oversight, the volume of activity at
each site, as well as the main risk areas identified.
(c) For organisations that hold more than one approval, the competent authority may define an
integrated oversight schedule to include all the applicable audit items. In order to avoid any
duplication of audits, credit may be granted for any specific audit items already completed
during the current oversight planning cycle, subject to the following conditions:
(1) the specific audit item should be the same for all the approvals under consideration;
(2) there should be satisfactory evidence on record that the specific audit items were
carried out and that all corrective actions have been implemented to the satisfaction of
the competent authority;
(3) the competent authority should be satisfied that there is no evidence that standards
have deteriorated in respect of those specific audit items for which credit is granted;
and
(4) the interval between two audits for the specific item for which credit is granted should
not exceed the applicable oversight planning cycle.

 21.B.432 Oversight programme

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AMC1 21.B.432(d) Oversight programme

EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) If the during an inspection the competent authority finds a decrease in the safety
performance of the organisation, the competent authority should revert to a 24-month (or
shorter) oversight planning cycle and review the oversight programme accordingly.
(b) In order to be able to apply an oversight planning cycle of up to 36 months, the competent
authority should determine the format and contents of the regular reports to be made by the
organisation on its safety performance.
(c) To enable the competent authority to apply an oversight planning cycle of up to 48 months,
the competent authority should establish, implement and maintain a methodology to
evaluate the safety performance of the organisation, focusing on the organisation’s ability to
effectively identify aviation safety hazards and manage the associated risks.
 21.B.432 Oversight programme

GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and

corrective actions
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;
(b) examination of equipment/products; and
(c) information from interview questions and observations of organisation activities.

 21.B.433 Findings and corrective actions

AMC1 21.B.433(d) Findings and corrective actions

NOTIFICATION OF FINDINGS
In the case of a level 1 finding, confirmation should be obtained in a timely manner that the head of
the design organisation has taken note of the finding and its details.
A finding requires timely and effective oversight by the competent authority to ensure the
completion of the corrective action. This oversight may include intermediate communication,
including letters as necessary, to remind the approval holder to verify that the corrective action plan
is followed.
The competent authority should grant the organisation a corrective action implementation period
that is appropriate to the nature of the finding, which should not in any case be more than 21
working days, commencing from the date of the written communication of the finding to the
organisation, requesting corrective action to address the non-compliance identified.
 21.B.433 Findings and corrective actions

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AMC1 21.B.435 Changes to a design organisation approval

APPLICATION FOR SIGNIFICANT CHANGES OR VARIATION OF SCOPE AND TERMS OF THE DOA
(a) The competent authority should have adequate control over any changes in the personnel
specified in points 21.A.245(a) and (b). Such changes in personnel will require an amendment
to the handbook.
(b) When an organisation submits the name of a new nominee for any of the personnel positions
specified in points 21.A.245(a) and (b), the competent authority may require the organisation
to produce a written résumé of the proposed person's qualifications. The competent authority
should reserve the right to interview the nominee or call for additional evidence of his or her
suitability before deciding upon his or her acceptability.
(c) For changes that require prior approval, in order to verify the organisation's compliance with
the applicable requirements, the competent authority should conduct an audit of the
organisation, limited to the extent of the changes, and determine whether the organisation
needs to provide a safety risk assessment.
(d) If a safety risk assessment is deemed necessary, the competent authority should inform the
organisation accordingly.
(e) If the competent authority considers that it is necessary to review the safety risk assessment
performed by the organisation, it should request the assessment from the organisation and
assess its results.
(f) If required for verification, the audit may include interviews and inspections carried out at the
organisation’s facilities.
(g) The competent authority should receive an application for any significant changes or for a
change to the terms of approval of the DOA on an EASA Form 82 completed by the applicant.

 21.B.435 Changes to a design organisation approval

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