Iso 19011 2018
Iso 19011 2018
Iso 19011 2018
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INTERNATIONAL ISO
STANDARD 19011
Third edition
2018-07
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Guidelines for auditing management
systems
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Lignes directrices pour l'audit des systèmes de management
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Reference number
ISO 19011:2018(E)
© ISO 2018
Copyrighted material licensed to SGS SA^SGS Group. No further reproduction or distribution permitted.
Printed / viewed by: [[email protected]] @ 2018-08-31
ISO 19011:2018(E)
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ISO 19011:2018(E)
Contents
Foreword ..........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................ vi
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1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
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͵ ϐ ..................................................................................................................................................................................... 1
4 Principles of auditing ...................................................................................................................................................................................... 5
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5 Managing an audit programme ............................................................................................................................................................. 6
ͷǤͳ
........................................................................................................................................................................................................... 6
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ͷǤʹ
....................................................................................................................... 9
ͷǤ͵ .............................................. 9
ͷǤͶ ..................................................................................................................................... 10
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ͷǤͶǤͳ ȋȌ.. 10
ͷǤͶǤʹ
ȋȌ ...................................................... 11
ͷǤͶǤ͵ .................................................................................................. 11
ͷǤͶǤͶ
.............................................................................................. 12
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ͷǤͷ .......................................................................................................................................... 12
ͷǤͷǤͳ
................................................................................................................................................................................... 12
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ͷǤͷǤͷ .................. 15
ͷǤͷǤ ............................................................................................................. 16
ͷǤͷǤ
................................................................ 16
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Ǥ͵
............................................................................................................................................................ 19
Ǥ͵Ǥͳ
................................................................................ 19
Ǥ͵Ǥʹ ................................................................................................................................................................. 19
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ISO 19011:2018(E)
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ǤʹǤ͵ ................................................................................................................................................ 30
ǤʹǤͶ
......................................................................................................................... 32
ǤʹǤͷ
............................................................................................... 33
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Ǥ͵
......................................................................................................................... 33
ǤͶ
................................................................................................ 33
Ǥͷ
............................................................................................................................................... 33
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Ǥ
................................................................................................... ͵Ͷ
Annex A ȋȌ Additional guidance for auditors planning and conducting audits .....................35
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Bibliography ............................................................................................................................................................................................................................. 46
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ISO 19011:2018(E)
Foreword
ȋȌ
ȋ ȌǤ
Ǥ
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Ǥ
ǡ Ǧǡ ǡ Ǥ
ȋȌ
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Ǥ
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Ȁ
ǡͳǤ
Ǥ
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Ȁ
ǡʹȋwww.iso.org/directives).
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Ǥ
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ϐ
Ȁ
ȋwww.isoǤȀ).
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ȋȌ
ȋȌ
URL: www.iso.org/iso/foreword.html.
Ȁ ͵Ͳʹǡ Guidelines for auditing management
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systems.
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ȋͳͻͲͳͳǣʹͲͳͳȌǡ
revised.
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Ȅ ϐ
ȋDzdzȌǢ
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ϐ
ȋǡ
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ȌǢ
Ȅ
ȋȌ
ǡ
ǡǡ
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ISO 19011:2018(E)
Introduction
ʹͲͳͳǡ
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not limited to:
Ȅ ϐǢ
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ϐǢ
Ȅ ȋȌ
ϐ
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ȋǤǤǡ
ȌǤ
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ǡǤ
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ȋϐ Ȍ
ȋ
ȌǤ
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ǡ
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ǡDzdzǡ
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DzdzDzdzǡDzdzDzdzǤ
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ǡ
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Ǥ
ǡ ǡ
ǦǤ
Ǧ
ϐ
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ϐǤ
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ǯ
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ISO 19011:2018(E)
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Copyrighted material licensed to SGS SA^SGS Group. No further reproduction or distribution permitted.
Printed / viewed by: [[email protected]] @ 2018-08-31
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1 Scope
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ϐ
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2 Normative references
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͵ ϐ
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ǡϐǤ
ǣ
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Ȅ ǣhttps://www.iso.org/obp
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Ȅ
ǣhttp://wwwǤ
.org/
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3.1
audit
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ͳ ǣ ǡ
ϐ ǡ
ǡ ǡ
Ǥ
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ʹǣ
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ǡ
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Ǥ
ǡ
ϐ
Ȁ
Ǥ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳǡϐȄϐȐ
PR
3.2
combined audit
audit (3.1Ȍ
auditee (3.13) on two or more management systems (3.18)
ͳ ǣ
Ǧ
ϐ
Ǥ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤʹǡϐȐ
ISO 19011:2018(E)
3.3
joint audit
audit (3.1Ȍ
auditee (3.13Ȍ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵Ǥ͵Ȑ
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3.4
audit programme
audits (3.1Ȍ
ϐ
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ϐ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͶǡϐȄϐȐ
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3.5
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audit scope
audit (3.1)
ͳǣ
Ǧ
ǡ
ǡ
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ǡ
Ǥ
ʹǣ
Ǧ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͷǡϐȄͳϐǡʹ
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Ȑ
3.6
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audit plan
audit (3.1)
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤȐ
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3.7
audit criteria
set of requirements (3.23Ȍ
objective evidence (3.8Ȍ
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ͳ ǣ
ȋ
Ȍ ǡ
Dz
dzDzǦ
dzϔ (3.10).
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ʹ ǣ
ǡ
ǡ
ǡ ǡ
ǡ
Ǥ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤǡϐȄϐ
ͳ
ʹȐ
RI
3.8
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objective evidence
PR
ͳǣ ǡǡǤ
ʹǣ
audit (3.1Ȍ
ǡ
ǡ
audit criteria (3.7ȌϐǤ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤͺǤ͵Ȑ
3.9
audit evidence
ǡ
ǡ
audit criteria (3.7Ȍ
ϐ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͺȐ
ISO 19011:2018(E)
3.10
ϐ
audit evidence (3.9Ȍaudit criteria (3.7)
ͳǣϐ
conformity (3.20) or nonconformity (3.21).
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ʹǣϐ
ϐ
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͵ ǣ
ǡϐ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͻǡϐȄʹ͵ϐȐ
3.11
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audit conclusion
audit (3.1Ȍǡ
ϔ (3.10)
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳͲȐ
3.12
audit client
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audit (3.1)
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳͳǡϐȄͳȐ
3.13
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auditee
SG
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳʹǡϐȐ
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3.14
audit team
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ʹǣ
ǦǦǤ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳͶȐ
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3.15
auditor
audit (3.1)
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳͷȐ
3.16
technical expert
δε
ϐ
audit team (͵ǤͳͶ)
ͳ ǣ
ϐ
ǡ
ǡ
ǡ
ǡ
ǡ
ǡ
Ǥ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳǡϐȄͳʹϐȐ
ISO 19011:2018(E)
3.17
observer
audit team (͵ǤͳͶȌ
auditor (3.15)
ȏǣͻͲͲͲǣʹͲͳͷǡ͵Ǥͳ͵ǤͳǡϐȐ
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3.18
management system
ǡ
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processes (͵ǤʹͶȌ
ͳ ǣ
ǡ ǤǤ
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ǡϐ
Ǥ
ʹ ǣ ǯ ǡ
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ǡǡǡ
ǡ
ǡǡǡ
Ǥ
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͵ ǣ
ǡ
ϐ
ϐ
ǡ
ϐ
ϐ
ǡ
Ǥ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤͷǤ͵ǡϐȄͶȐ
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3.19
risk
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ʹǣ
ǡǡϐ
ǡ
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ǡǡ
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͵ǣ
ȋϐ
͵ǣʹͲͲͻǡ
͵ǤͷǤͳǤ͵Ȍ
ȋϐ
͵ǣʹͲͲͻǡ͵ǤǤͳǤ͵Ȍǡ
Ǥ
Ͷ ǣ
ȋ
E
Ȍ
ȋϐ
͵ǣʹͲͲͻǡ͵ǤǤͳǤͳȌ
Ǥ
AD
ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͻǡϐȄͷȐ
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3.20
conformity
ϐrequirement (3.23)
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͳͳǡϐȄͳȐ
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3.21
nonconformity
Ǧϐrequirement (3.23)
PR
ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͻǡϐȄͳȐ
3.22
competence
ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤͳͲǤͶǡϐȄȐ
ISO 19011:2018(E)
3.23
requirement
ǡ
ͳ ǣ Dz
dz
Ǥ
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ʹǣ
ϐǡ
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͶǡϐȄ͵ǡͶǡͷȐ
3.24
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process
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤͶǤͳǡϐȄȐ
3.25
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performance
ͳǣ
ϐǤ
IA
ʹ ǣ
ǡ processes (͵ǤʹͶȌǡ
ǡ
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Ǥ
ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͺǡϐȄ͵Ȑ
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3.26
effectiveness
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ȏǣͻͲͲͲǣʹͲͳͷǡ͵ǤǤͳͳǡϐȄͳȐ
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4 Principles of auditing
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ͷ to 7
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Ȅ ǡǤǤǢ
Ȅ ϐ
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Ȍ ǣ
ϐǡ
ϐ
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ISO 19011:2018(E)
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Ȍ ϐǣ
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ϐǤ
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ǡ
ϐ
Ǥ ǡ
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ϐ
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ϐǤ
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ϐϐ
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Ȍ Ǧ
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5.1 General
PR
ǡ
ȋ
ȌǤ
ǡ
ǡ
ǡ
ǡǡ
ȋȌǤ
Ǥ
Ǥ
ISO 19011:2018(E)
Ȁ ȋǤǤ
Ȍǡ
ǡ
ǡǤ
Ǥ
HO
ǡ
ǯǣ
AL
Ȅ
Ǣ
Ȅ Ǣ
AB
Ȅ
Ǣ
TR
Ȅ
ϐǤ
ǡ
ǡ
Ǥ
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ȋȌ
ϐ
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OP
Ǥ
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ϐ
ϐǤ
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Ȍ
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SG
Ȍ
ȋ 5.3Ȍ
Ǣ
Ȍ
ȋǡǡ
Ȍ
Ǣ
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AD
Ȍ
ȋȀȀ
ȌǢ
Ȍ ǡ
Ǣ
ED
Ȍ
Ǣ
Ȍ Ǣ
RI
Ȍ
Ǣ
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Ȍ
Ǥ
PR
Ǥ
(see 5.6Ȍ
Ǥ
ȋ5.7).
Figure 1
ϐǤ
ISO 19011:2018(E)
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ʹ Ȁ Ȁ Ǥ
ͳȄ ϐ
ISO 19011:2018(E)
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ǣ
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Ȍ
ǡǢ
Ȍ
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Ǣ
Ȍ Ǣ
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Ȍ Ǣ
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Ȍ ǯ
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ǡǡǡ
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ǡǤǤϐ
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ISO 19011:2018(E)
Ȍ
ǡǤǤ
Ȁ
Ȁ
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Ȍ ǡ ǤǤ
ǡ
ϐǢ
Ȍ
ǡ ǤǤ
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Ȍ ǡ ǡ ǤǤ
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5.4.1 Roles and responsibilities of the individual(s) managing the audit programme
ȋȌǣ
S
Ȍ
ȋ5.2Ȍ
SG
Ǣ
Ȍ ǡ
ǡ
ǡ
E
ǡǢ
AD
Ȍ
ǡǡǡǢ
ED
Ȍ
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RI
Ȅ
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Ȅ
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ȋȌ
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Ȅ Ǣ
PR
Ȅ
ǡǢ
Ȅ
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Ȅ Ǧ
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Ȅ
ǡǤ
Ȍ
Ǣ
Ȍ
ǡ
Ǣ
ISO 19011:2018(E)
Ȍ ǡǢ
Ȍ
ǡ ǡ
Ǥ
ȋȌ
Ǥ
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5.4.2 Competence of individual(s) managing audit programme
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ȋȌ
AB
ϐ
ǡ
ǣ
Ȍ
ȋͶȌǡ
ȋA.1A.2ȌǢ
TR
Ȍ ǡ
Ȁ
Ǣ
Ȍ
ȋǤǤȀǡ
DE
ǡ
ǡ
ǡ
ȌǢ
Ȍ
IA
Ǥ
OP
ǡǡ
ǡ
ȋȌ
Ǥ
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ȋȌ
Ǥ
S
ȋȌǤ
ȋ5.3).
E
ǡ ̵
ǡ
ȋǤǤ
ȌǤ
AD
ǣ
ED
Ȍ
ǡ
ǡ
ǡ
ǡǢ
RI
Ȍ
Ǣ
OP
Ȍ ǡ
ǡ
ǡ
Ǣ
Ȍ
ϐ
Ǣ
PR
Ȍ
ǡ
ǡ
Ǣ
Ȍ ǡǢ
Ȍ Ǣ
Ȍ ǡ
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Ȍ
ǡ
ǡ Ǧ
ǡ
Ǣ
ISO 19011:2018(E)
Ȍ ϐ
ǯ
Ǣ
Ȍ
ǡ
ȋA.16ȌǢ
Ȍ
ǡ
ǡ
HO
ǡ
ǡ
Ǣ
Ȍ ǡ
Ǥ
AL
5.4.4 Determining audit programme resources
AB
ǡȋȌ
should consider:
TR
Ȍ ϐ
ǡ ǡ
Ǣ
DE
Ȍ ȋA.1ȌǢ
Ȍ
Ǣ
IA
Ȍ ȋͷǤͶǤ͵Ȍȋ5.3ȌǢ
OP
Ȍ
ǡ
Ǣ
-C
Ȍ
Ǣ
Ȍ
ȋǤǤ
ȌǢ
S
SG
Ȍ ǡ
Ǣ
Ȍ
ǡ
ȋA.5ȌǢ
E
Ȍ
ǡ
ȋǤǤ
AD
ǡ
ǡ
ȌǤ
ED
5.5.1 General
RI
ȋͷǤͶǤ͵Ȍ
OP
(see ͷǤͶǤͶȌ
Ǥ
PR
ȋȌǣ
Ȍ
ǡ
ǡ
ǡ
Ǣ
Ȍ ϐ
ǡ
Ǣ
Ȍ
ȋA.1ȌǢ
Ȍ
Ǣ
Ȍ
ȋͷǤͷǤͶȌǢ
ISO 19011:2018(E)
Ȍ
ȋͷǤͶǤͶȌǢ
Ȍ
ǡ
ǡȋǤǤ
Ȍǡ
Ǣ
HO
Ȍ
ȋ5.5.7ȌǢ
AL
Ȍ ϐ
ȋ5.6Ȍ
Ǣ
Ȍ ȋ5.7).
AB
ͷǤͷǤʹ ϐ
ǡ
TR
ϐ
ǡ
Ǥ
Ǥ
DE
ϐ
following:
Ȍ
ǡǡ
IA
Ǣ
OP
Ȍ
Ǣ
-C
Ȍ
Ǣ
Ȍ ϐ
Ǣ
S
SG
Ȍ
Ǣ
Ȍ
E
ǡ
ǡ
AD
Ǥ
Ǥ
ED
ǡ
ǡ
ǡ
Ǥ
RI
Ǥ
ǣ
ǡ
ǡ
ǡ
OP
Ǥ
ǡ
ǡ
ϐ
ǡǤ
ǡ
Ǥ
ϐ
ϐ
Ǥ
ISO 19011:2018(E)
ȋȌ
ϐ
ǡ ϐ
ǡ
Ǥ
HO
Ǧǡ
Ǥ
ǡǡǡ
Ǥ
AL
ǡ
Ǥ
AB
ǡ
Ǥ
TR
5.5.4 Selecting audit team members
ȋȌ ǡ
ϐ
Ǥ
DE
ǡ
ϐ
Ǥǡ
IA
Ǥ
OP
NOTE
Ǥ
ǡǣ
-C
Ȅ ϐ
Ǣ
S
Ȅ
Ǥ
SG
ϐ
ǡ
given to the following:
Ȍ
ǡ
E
Ǣ
AD
Ȍ
Ǣ
ED
Ȍ
Ǣ
Ȍ
Ǣ
RI
Ȍ
ϐ
Ǣ
OP
Ȍ
Ǣ
PR
Ȍ Ȁ ǡ
ǡ ǯ
Ǥ̵
ǡ
Ǣ
Ȍ
Ǥ
ǡȋȌ
Ǥ
ǡ
Ǥ
ǦǦ
ǡ
Ǥ
ISO 19011:2018(E)
ǡ ǤǤ
ϐ
Ǥ
ǡ
ȋǤǤǡȋȌǡ
Ȍ
Ǥ
HO
5.5.5 Assigning responsibility for an individual audit to the audit team leader
ȋȌ
AL
Ǥ
ϐ
ǡ
AB
Ǥ
ǡ
TR
ǣ
Ȍ
Ǣ
Ȍ
Ǣ
DE
Ȍ
ǡ
ϐ
IA
Ǣ
Ȍ
Ǣ
OP
Ȍ
Ǣ
-C
Ȍ
ǡ
ǡ
Ǣ
Ȍ
Ǣ
S
SG
Ȍ ϐ
Ǣ
Ȍ
ȋȌ
E
Ǥ
AD
ǡǣ
Ȅ
ED
ǡǢ
Ȅ Ǣ
RI
Ȅ
ϐ
ǡǢ
OP
Ȅ ǡǢ
PR
Ȅ
Ǣ
Ȅ
Ǣ
Ȅ
ǡǤǤǦ
Ǣ
Ȅ
ǡǤǤ
Ǥ
ǡ
ǡ
ǡ
ϐ
ǡ
Ǥ
ISO 19011:2018(E)
ȋȌ
performed:
Ȍ
Ǣ
HO
Ȍ ϐ
Ǣ
AL
Ȍ
ϐǢ
Ȍ Ǣ
AB
Ȍ
ǦǤ
TR
ǡǣ
Ȅ
ǡ
Ȅ
Ǥ
Ǥ
ϐ
Ǥ
-C
ǣ
Ȍ
ǡ
ǣ
S
Ȅ
Ǣ
SG
Ȅ
Ǣ
Ȅ ǡ
E
Ǣ
AD
Ȅ
Ǥ
ED
Ȍ
ǡ
ǣ
Ȅ Ǣ
RI
Ȅ
ϐǢ
OP
Ȅ
Ǣ
Ȅ
Ǣ
PR
Ȅ ǦǤ
Ȍ
ǣ
Ȅ
Ǣ
Ȅ
Ǣ
Ȅ
Ǥ
Ǥ
ISO 19011:2018(E)
HO
Ȍ
Ǣ
AL
Ȍ Ǣ
Ȍ
ǡǡǡ
Ǣ
AB
Ȍ ϐ
Ǥ
TR
Ǥ
ǣ
Ȅ ϐǢ
DE
Ȅ ǯ
Ǣ
Ȅ
Ǣ
IA
Ȅ
Ǣ
OP
Ȅ ǯǢ
Ȅ ǡ
Ǣ
-C
Ȅ Ǣ
Ȅ ϐ
ϐ
Ǣ
S
Ȅ
ǯǤ
SG
ȋȌ
AD
Ǥ
Ǥ
ED
ȋȌǣ
Ȅ Ǣ
RI
Ȅ ϐ
Ǣ
OP
Ȅ
Ǣ
Ȅ
ǡ
7.6Ǣ
PR
Ȅ
ǡǤ
ǣ
Ȍ Ǣ
Ȍ
Ǣ
Ȍ
Ǣ
Ȍ
Ǣ
ISO 19011:2018(E)
Ȍ Ǣ
Ȍ Ǣ
Ȍ
ǡ
Ǣ
HO
Ȍ
ϐ
Ǥ
AL
6 Conducting an audit
AB
6.1 General
TR
ϐ
Ǥ
Figure 2
Ǥ
ϐ
Ǥ
ȋ
OP
5.5.5Ȍ
ȋ6.6).
ǡ Figure 1
Ǣ ǡ
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ǣ
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E
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AD
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ǡ
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PR
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Ǣ
Ȍ ǡ
ϐ
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Ȍ
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ISO 19011:2018(E)
ϐ
Ǥ
HO
following:
Ȍ ϐ
Ǣ
AL
Ȍ
Ǣ
AB
Ȍ
Ǥ
TR
Ǥ
ǡ
ǡ
Ǥ
ǣ
Ȅ ǯ
-C
ȋǤ͵ǤͶȌǡǤǤ
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S
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SG
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E
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A.5.
ED
Ǧ
OP
Ǥ
ǯ
PR
ǡ
Ǥ
ϐ
Ǥ
ϐ
ǡ
Ǥǡ
consider the following:
Ȍ
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Ȍ
ȋA.6ȌǢ
Ȍ
ϐ
Ǣ
ISO 19011:2018(E)
Ȍ
Ǣ
Ȍ
Ǥ
ϐ
ǯǡǡ
ǡ
ǡ
HO
ȋǤǤ
ȌǤ
ǡ
AL
Ǥ
AB
6.3.2.2 Audit planning details
ǡ ǡ
TR
ǡǤϐ
ϐ
Ǥ
ǣ
Ȍ
Ǣ DE
Ȍ
ǡ
ϐ
ǡ
IA
Ǣ
OP
Ȍ
Ǣ
Ȍ
ȋ
Ȍǡ ǡ
-C
ǡ
ǯǢ
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ȋǤǤ
ȋȌǡ
ȌǢ
S
SG
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E
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AD
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ED
ǡǣ
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ǯȋȌǢ
RI
Ȅ
OP
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PR
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Ǣ
Ȅ
ϐ
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ȋȌǤǤǡ
Ǣ
Ȅ Ǧ
Ǣ
Ȅ
ǡ
Ǥ
ISO 19011:2018(E)
Ǥ
ǡ ǡ
ǡ ȋȌ
Ǥ
HO
ǡ
ǡ
ϐ
ǡ
ǡ
ǡ ǡ
AL
ǦǤ
ǡ
ǡǦǦ
Ǥ
AB
ǡǡ
Ǥ
TR
Ǥ
DE
ǡ Ǥ
IA
ǣ
Ȍ
Ǣ
OP
Ȍ Ǣ
-C
Ȍ Ǥ
ǡ
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S
SG
A.13.
ǡǡ
ǡ
ϐ Ǥ
E
6.6Ǥ
AD
ϐ
Ǥ
ED
6.4.1 General
ϐ
Figure 1Ǥ
OP
ϐ
Ǥ
PR
ǡ
ȀǡǤϐ
Ǥ
ǡ
Ǥ
ǡ
ǡ ǡ ǡ
ϐ
Ǥ
ISO 19011:2018(E)
ǡ ǡ
Ǥ
following:
Ȍ
ϐ
Ǣ
HO
Ȍ
ϐ
Ǣ
AL
Ȍ
Ǧ
ϐ
ǡ ǡ
ǡ
ǡ
ϐ
Ǣ
AB
Ȍ ǡǢ
TR
Ȍ
ϐ
ǡǤ
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Ǣ
OP
Ȍ
Ǥ
-C
ǯ ǡ ǡ
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Ǥ
S
Ǥ
SG
ǡǤǤǡ
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ǡ
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E
Ǥ
AD
ǡǣ
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ǡ
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ED
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RI
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ǡǣ
OP
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PR
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ǡǯǡ
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ϐ
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ISO 19011:2018(E)
Ȅ
ǡǡ
ǡ
Ǣ
Ȅ
Ǥ
ǡǣ
HO
Ȅ ϐ
ǡǢ
Ȅ
Ǣ
AL
Ȅ ϐǢ
AB
Ȅ
ϐ
ǡ
Ǥ
TR
6.4.4 Communicating during audit
ǡ
DE
ǡǡ
ȋǤǤ
Ȍǡ
nonconformities.
IA
ǡ
ǡǤ
OP
ǡ
ǡϐ
ϐ
ǡǤ
-C
ϐ
ǡǡ
Ǥ
ǡ
Ǥ
S
ǡ
SG
Ǥ
ǡ
ǡ
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E
AD
ǡ ǡ ȋȌ
ǡǤ
ED
ϐ
ǡ
ǡ
RI
Ǥ
ϐ
Ǥ
Ǥ
OP
ǡ
Ǥ
ǡ Ȁ Ǥ ǡ
PR
determined (see ǤͳȌǤ
Ǥ ǡ
Ǥ
ǯ
ǣ
Ȅ
ǡ
ǡ
Ǣ
Ȅ
Ǥ
A.5.
ISO 19011:2018(E)
ǡ
Ǥ
ǡ
ȋȌ
Ǥ
ǡ
HO
Ǥ
AL
6.4.7 Collecting and verifying information
ǡ ǡ ǡ
AB
ǡ
ϐǡ
Ǥ
TR
ͳ A.5.
ʹ
A.6.
DE
ϐ
Ǥϐ
Ǥ
IA
ϐ
Ǥ ǡ
ǡ
ǡǡ
OP
Ǥ
Figure 2
ǡ
-C
conclusions.
S
SG
E
AD
ED
RI
OP
PR
ǡǣ
Ȅ Ǣ
ISO 19011:2018(E)
Ȅ Ǣ
Ȅ
Ǥ
͵
ǤͳͶ.
HO
Ͷ
ǯ
A.15.
ͷ
A.17.
AL
ǤͶǤͺ
ϐ
AB
ϐǤ
ϐ
Ǥ
ϐǡ
ϐ
TR
ǡǡ
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Ǥ
DE
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ȋǤǤͳͷȌȋǤǤǡȌǤ
IA
Ǥ
ϐǤ
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OP
ϐǤ
-C
ͳ ϐ ϐA.18.
ʹ
ǡ
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S
SG
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AD
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ǡ
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ED
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RI
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OP
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ǣ
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Ȍ
ǡ
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Ȍ
ǡ
ϐ
Ǣ
Ȍ ϐ
Ǥ
ISO 19011:2018(E)
ϐ ǡ
ǡ
Ǥ
HO
ϐ
Ǥ
ǡ
ǣ
AL
Ȅ
Ǣ
AB
Ȅ
Ǣ
Ȅ Ǣ
TR
Ȅ
ȀǤ
DE
ǡ
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OP
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S
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E
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PR
ϐ
ǡǡǤǡ
Ǥ
ϐ
ǡ
Ǥ
Ǥ
ISO 19011:2018(E)
Ǥ
HO
ǡ
ǡ
ǡ
include or refer to the following:
Ȍ
Ǣ
AL
Ȍ
ǡ
ϐ
ȋ Ȍ
AB
Ǣ
Ȍ ϐ
Ǣ
TR
Ȍ ϐ
ǯ
Ǣ
Ȍ
Ǣ
Ȍ
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IA
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OP
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S
SG
ǡǣ
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E
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ǡ
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AD
Ȅ
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Ǣ
ED
Ȅ
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ϐǡϐ
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RI
Ȅ
ϐǢ
OP
Ȅ
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Ȅ
ǦǡǢ
PR
Ȅ
ϐ
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Ȅ
Ǥ
Ǥǡ
ȋȌǤ
ǡ
ǡǡ
Ǥ
ISO 19011:2018(E)
ϐ
Ǥ
ǡ
ϐ
considered.
HO
6.6 Completing audit
ǡ
AL
ȋǤǤ
ȌǤ
AB
TR
Ǥ
ǡȋȌ
ǡǡ
DE
ǡǡǤ
ǡ
Ǥ
IA
OP
Ǥ
ǡ
ǡ
ǡ
ǡǤ
S
ǤǡȋȌ
SG
Ȁ
Ǥ
ϐǤϐ
Ǥ
E
Ǥ
AD
7.1 General
RI
ϐ
ǡ
Ǥ
OP
ǡ
ǡ
Ǥ
PR
Ǥ
7.2.3
Ǣ
ϐ
Ǥ
Ǥ ǡ
ϐ
Ǥ
ǡ
ǡ
ǡǤ
ǡǣ
Ȍ
ϐǢ
Ȍ
Ǣ
Ȍ
Ǣ
ISO 19011:2018(E)
Ȍ
Ǥ
ǣ
Ȅ
ȋ
ͷǤͷǤͶȌǢ
HO
Ȅ
ȋǤǤȌǢ
Ȅ
Ǥ
AL
ǡ
ȋ7.6).
AB
7.3ǡǤͶ7.5.
TR
7.2.27.2.3
7.1.
ȋȌ
ͷǤͶǤʹ.
ǡ ǯ
following should be considered:
-C
Ȍ ǡǡ
ǡ
ǡ
Ǣ
Ȍ Ǣ
S
Ȍ
Ǣ
SG
Ȍ
Ǣ
Ȍ Ǣ
E
Ȍ
Ǣ
AD
Ȍ
Ǣ
ED
Ȍ ǡ
ǡ
Ǥ
RI
7.2.3.
OP
PR
ͶǤ
Ǥ
ǣ
Ȍ
ǡǤǤǡǡ
ǡ
Ǣ
Ȍ ǦǡǤǤ
Ǣ
Ȍ
ǡǤǤ
Ǣ
Ȍ ǡǤǤ
Ǣ
Ȍ
ǡǤǤǢ
Ȍ ǡǤǤǢ
ISO 19011:2018(E)
Ȍ
ǡǤǤ
Ǣ
Ȍ
ǡǤǤ
Ǣ
Ȍ ǦǡǤǤ
Ǣ
HO
Ȍ
ǡǤǤ
ǡ
Ǣ
AL
Ȍ ǡǤǤǢ
Ȍ
ǡǤǤ
Ǣ
AB
Ȍ
ǡ ǤǤ
ǡ
ǯǤ
TR
7.2.3 Knowledge and skills
7.2.3.1 General
Ȍ
Ǧ
ϐ
Ǥ
-C
Ǥ
S
Ǥ
Ȍ
ǡ
ǣ
E
Ǥ
AD
ǣ
Ȅ
ED
Ǧ
Ǣ
Ȅ
Ǣ
RI
Ȅ
Ǣ
OP
Ȅ
ϐ
Ǣ
Ȅ
ǡ ȋ ǡ
PR
ȌǢ
Ȅ
ǡ ǡ
ǡ
Ǣ
Ȅ
Ǣ
Ȅ
ǯǢ
Ȅ
ϐǡ
ǡǢ
Ȅ
Ǣ
ISO 19011:2018(E)
Ȅ
ϐ ϐ
ϐ
Ǣ
Ȅ
ϐ
Ǣ
Ȅ
ϐǡǢ
HO
Ȅ
ϐ
Ǥ
AL
Ȍ
ǣ
ǡ
ǣ
AB
Ȅ
Ȁ
Ǣ
TR
Ȅ
Ǣ
Ȅ
ȋȌ
Ǣ
DE
Ȅ
Ǣ
Ȅ
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IA
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ǯ
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OP
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-C
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ǡǡ
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ǡ
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S
SG
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Ȍ
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ǡǡǯǤ
E
ϐ
ǯ
ǡ
ǡ
AD
ǣ
Ȅ
Ǣ
ED
Ȅ
Ǣ
Ȅ
Ǥ
RI
OP
Ǥ
ǤʹǤ͵Ǥ͵
Ǧ
ϐ
PR
Ǧ
ϐ
Ǥ
Ǧ
ϐ
ǣ
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ǡ
Ǣ
Ȍ
ȋȌ
ȋȌ
Ǣ
Ȍ
Ǧ
ϐ
ǡ
ǡ
ϐ
ϐ
Ǣ
ISO 19011:2018(E)
Ȍ
ǡ
ǡ
Ǥ
HO
ϐ
competence to:
Ȍ
ϐ
AL
Ǣ
AB
Ȍ
Ǣ
TR
Ȍ
Ǣ
Ȍ
ǡ
ǣ
DE
Ȅ
Ǣ
Ȅ
Ǣ
IA
Ȅ
ǡ
ǡ
Ǣ
OP
Ȅ
Ǣ
-C
Ȅ
ǦǦǢ
Ȅ
ϐ
ǡ
ǡ
Ǥ
S
SG
Ȍ
ȋȌǡ
Ǣ
Ȍ
Ǣ
E
Ȍ
Ǥ
AD
ǡ
Ǥ
RI
Ǥ
OP
Ǥ
PR
ǣ
Ȍ
Ǣ
Ȍ
ǡ
ǡ
ǡ
ǡ ǡ
ǡ
Ǣ
Ȍ
Ȁ
ϐ
Ǣ
ISO 19011:2018(E)
Ȍ
Ǥ
Ǥ
Ǥ
ǡ
Ǥ
HO
7.2.5 Achieving audit team leader competence
AL
described in ǤʹǤ͵ǤͶǤ
Ǥ
AB
7.3 Establishing auditor evaluation criteria
TR
ȋ
ǡ
ǡ
Ȍȋ
ǡ
ǡȌǤ
Ȍ Ǣ
Ȍ Ǣ
-C
Ȍ
ǡ
ǡ
Ǥ
S
SG
ǡ
AD
ǡǡ-
ǡǡ
ǡ-
ED
ǡ
Interview -
ǡ
RI
OP
ISO 19011:2018(E)
ϐ
ǡǡ
ǦǤ
HO
Ǥ
Ǥ
ǡ
AL
ǡǡ
ǡ
ǡ
Ǥ
AB
ȋȌ
Ǥ
TR
ǣ
Ȍ
Ǣ
DE
Ȍ
Ǣ
Ȍ
Ȁ
Ǣ
IA
Ȍ
Ǥ
OP
-C
S
SG
E
AD
ED
RI
OP
PR
ISO 19011:2018(E)
Annex A
ȋȌ
HO
AL
A.1 Applying audit methods
AB
Ǥ
Ǥ
ϐ
TR
ǡ
ǡ
Ǥ
Ǥ
ϐ
DE
Ǥ
Ǥ Ǥͳ
IA
ǡ
ǡ
Ǥ
ǡ Ǧ
OP
Ǥ
A.15.
-C
AD
Ȅ-
- Ǣ
Ȅ
Ǣ
ED
Ȅ
-
Ǥ
RI
No human interaction Conducting document review (e.g. re- Conducting document review (e.g. re-
ǡȌ
ǡȌ
OP
-
ǡ
-
Conducting on-site visit
PR
ȋǤǤ
Ȍ
Ǧ
Ǥ
ǡ
Ǥ
ǯ Ǥ Ǧ
ǡ
Ǥ
ȋȌǤ
Ǥ
ISO 19011:2018(E)
ȋǤǤ
ǡ
ϐ
ǯ
ȌǤ
ǡǦ
ǡ
HO
Ǥ
AL
A.2 Process approach to auditing
Dz
dz
AB
Ȁ
ǡ ͳǡ Ǥ
ǯ
TR
ȋȌǤ
ϐ
Ǥ
Ǥ
Ǥǡ
-C
Ǥ
Ǥ
ǡ
Ǥ
Ǥ
E
AD
ϐ
Ǥ
ED
ǡ
ϐ
ǡ
ǣ
OP
Ȍ
ȋ
ȌǢ
Ȍ
ȋ
ȌǢ
PR
Ȍ
ȋ
ȌǢ
Ȍ
ȋ
ȌǤ
ϐ ϐ
Ǥ
ȋǤǤ ǡ
Ȍǡ
Ǥ
ϐ
ȋ
ǡ
document).
ISO 19011:2018(E)
A.6 Sampling
A.6.1 General
HO
ǡǤǤ
Ǥ
ͳͲͲ Ψ ȋȌ
AL
ǡ
Ǥ
ϐ
AB
Ǥ
TR
Ǥǡ̵
Ǥ
Ǥ
ǣ
Ȍ
Ǣ
DE
IA
Ȍ
Ǣ
OP
Ȍ
Ǣ
Ȍ Ǣ
-C
Ȍ
Ǣ
Ȍ
ǡǡ
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S
SG
ǡ
ǡ
ϐ
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ǡǤǤ
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E
AD
ǡ
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ED
ǦȋA.6.2Ȍ ȋA.6.3).
Ǧ
ȋ).
OP
Ǧǡ
ǣ
Ȍ
Ǣ
PR
Ȍ
ȋ
Ȍ
Ǣ
Ȍ
ǯ
Ǣ
Ȍ
ǡ
Ǣ
Ȍ ϐϐ
Ǣ
Ȍ Ǥ
Ǧ
ϐ
Ǥ
ISO 19011:2018(E)
HO
Ǥ Ǧ
ȋǤǤ
Ȁ
ȀȌǤǦ
AL
Ǥ
AB
Ǧ ǦǤ ǡ
ǡǦ
Ǥ
TR
ǡǦ
Ǥ
ǣ
Ȍ
ǡǡ
Ǣ DE
Ȍ
Ǣ
IA
Ȍ
Ǣ
OP
Ȍ Ǣ
-C
Ȍ
ϐ
Ǣ
Ȍ
Ȁ
Ǥ
S
ǡ
SG
Ǥ
ϐ
Ǥ
ǡ ͷ Ψ
ϐ
ͻͷ ΨǤ
ͷΨ
ͷͳͲͲȋͳʹͲȌ
ϐ
Ǥ
E
AD
ǡ
Ǥ
ǡ
ȋǤǤ
Ȍǡ
ED
ǡǤ
RI
Ȍ
Ǣ
PR
Ȍ
ǡ
Ǣ
Ȍ
Ǥ
ǡ
ǡ
ǣ
ͳȌ
Ǣ
ʹȌ
Ǣ
ISO 19011:2018(E)
͵Ȍ
Ǣ
ͶȌ
Ǣ
ͷȌ
Ǧ
Ǣ
HO
Ȍ
Ǥ
AL
A.8 Auditing context
AB
ǡ
Ǥǡ
Ǥ
TR
ϐ
ǡ
DE
Ǥǡ
ǣ
Ȍ
ȋȌȋȌǢ
IA
Ȍ
ȋȌǢ
OP
Ȍ
ȋȌǢ
Ȍ
Ǣ
-C
Ȍ
ǡǤ
Ǧ
ϐ
S
Ǥ
SG
Ǥ
AD
ϐǤ
ED
Ǥ
RI
Ǧ
Ǥ
ȋ
OP
ǡ
ǡ
ǡ
Ȍ
Ǥ
PR
ϐ
Ǧ
ϐ
ǡ
ǡ
Ǥ
ǡǤ
ISO 19011:2018(E)
HO
Ȅ
Ǣ
AL
Ȅ Ǥ
ǯ
AB
Ǧ
Ǥ
ǡ
Ǥ
ǣ
TR
Ȍ ǡ
ǣ
DE
Ȅ Ǣ
Ȅ
Ǣ
IA
Ȅ ǡ
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sectors.
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ISO 19011:2018(E)
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document.
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ISO 19011:2018(E)
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ISO 19011:2018(E)
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Auditor competence should include:
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following items:
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ISO 19011:2018(E)
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ISO 19011:2018(E)
ǡ
ϐǤ
HO
AL
AB
TR
DE
IA
OP
-C
S
SG
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AD
ED
RI
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PR
ISO 19011:2018(E)
Bibliography
HO
ȏʹȐ ͻͲͲͳǡQuality management systems — Requirements1)
ȏ͵Ȑ
͵ǣʹͲͲͻǡRisk management — Vocabulary
AL
ȏͶȐ Ȁ ͳͲʹͳǦͳǡ Conformity assessment — Requirements for bodies providing audit and
ϔ
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AB
TR
DE
IA
OP
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S
SG
E
AD
ED
RI
OP
PR
HO
AL
AB
TR
DE
IA
OP
-C
S
SG
E
AD
ED
RI
OP
PR
Copyrighted material licensed to SGS SA^SGS Group. No further reproduction or distribution permitted.
Printed / viewed by: [[email protected]] @ 2018-08-31
ISO 19011:2018(E)
HO
AL
AB
TR
DE
IA
OP
-C
S
SG
E
AD
ED
RI
OP
PR
౧Ͳ͵ǤͳʹͲǤʹͲǢͲ͵ǤͳͲͲǤͲ
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