Egyptian Accreditation Council

EGAC

EGAC Policy on Implementation and

Use of Proficiency Testing
PB14G

Prepared by: EGAC Quality General Manager

Reviewed and EGAC Accreditation Director

Aythorized by:

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Table of Modification

Mod. Modification in brief

Proposed by Page No.
No./Date (old/new, added, cancelled )
1.1/Feb 2019 Q G.M 8/26 Clause 8.1
1.2/Mar 2019 Q G.M 4/26, 11/26, - Adding some definitions
12/26 & - Adding general policy for FSP laboratories
13/26
Annual Doc. Quality Manager All Pages Annual revision for this document,
Revision Jan Conducted by Ashraf Saif Quality General Manager.
2021 And no changes needed.
Annual Doc. Quality Manager All Pages Annual revision for this document,
Revision Jan
2022
1.3/Mar 2022 Quality Manager 5&6/33 Adding statement
Annual Doc. in clause 4 , clause 5-1 and Clause5-2
Revision
1.3/Mar 2022 Cal. Manager 5/33 Modification for clarification
1.4/oct2022 Quality Manager 6,14/35 Add new form related toAccredited laboratories
participation in PT programs.
Form F1PB14I G Issue No 1/ Oct 2022
1.5 / Jan 2023 Quality representative 14/35 Canceled Form F1PB14I G and added to WI5M
& Annual Doc. ,WI4TCL & WI12FP
Revision
2/Dec 2023 Quality Manager 5/34 Modification for clarificationn clause 4
2.1/ Nov.2024 Quality representative 10to 18/34 Modification for clarificationn clause 10,11 and 12

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INDEX

1. Scope

2. Definitions

3. Policy

4. Types of accepted proficiency testing

5.1 PT requirements for applicant Lab.

5.2 PT requirements during the Document review and preliminary assessment

5.3 PT requirements during the assessment process

6. Corrective actions and additional measures

7. Additional proficiency tests may be required when:

8. Determination of acceptability criteria

8.1General rules

8.2 Regulatory authorities' criteria

9. Proficiency testing frequency

10. Proficiency Testing Requirements for Medical Laboratories: -

11. General policy for Forensic Services Provider Laboratories

12-General Policy for ISO 20387:2018 Biotechnology Biobanking

13. References
Annex (1) EGAC scope of accreditation for (Testing/Calibration / Medical)

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SCOPE.

This document defines the policy for EGAC’s implementation of Proficiency Testing, It is applied
for the assessment of all accredited testing, calibration, medical laboratories and forensic service
providers.

Note (1): According to ISO/IEC 17025.

The laboratory shall monitor its performance by comparison with results of other laboratories, where
available and appropriate. This monitoring shall be planned and reviewed and shall include, but not
be limited to, either or both of the following:
a) participation in proficiency testing;
b) participation in interlaboratory comparisons other than proficiency testing.

2. Definitions

2.1. Proficiency Testing (PT):

evaluation of participant performance against pre-established criteria by means of
interlaboratory comparisons
.
Note (2):
Some providers of proficiency testing in the medical area use the term “External Quality
Assessment (EQA)”

2.2. Proficiency Testing Scheme:

Proficiency testing designed and operated in one or more rounds for a specific area of testing,
measurement, calibration or inspection.

2.3. Inter-laboratory Comparison (ILC):

Organization, performance and evaluation of measurements or tests on the same or similar items by
two or more laboratories in accordance with predetermined conditions.

3. POLICY

EGAC considers proficiency testing as an important tool in assessment of the laboratory’s

performance. It provides a basis for improving the quality of laboratories.

EGAC requires its applicant(s) / accredited laboratories to develop a plan for "Four years of"
participation in Proficiency Testing schemes, relevant to their scope. EGAC will review this plan
and its implementation by the Laboratory

It is EGAC’s policy to encourage Laboratories to participate in PT schemes that are being

operated in their areas, also encouraging the formation of a new proficiency testing scheme was
considered necessary for the laboratories.

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Regionally, EGAC also encourages its accredited laboratories for achieving some proficiency testing
schemes by subscribing to these CABs in the framework of cooperation with the regional
accreditation bodies (AFRAC, ARAC, APAC, ………) in the fields of calibration , testing and
medical laboratories, EGAC nominates the required number of required accredited CABs and send
the nomination to the region and then receives the samples to be distributed on the selected CABs,
EGAC follow the process for the participated CABs until it is completed with its results.

4. Types of accepted proficiency testing (for ISO/IEC 17025):

For the accreditation process: the acceptable types of proficiency testing in the following order
according to availability are:
1. Accredited Proficiency testing provider according to (ISO/IEC 17043).
2. Intralaboratory Comparison designed primarily by EGAC after reviewing and accepting the
programs from the accreditation manager relevant to the Scheme and technical assessor relevant
to the activity.
3. Measurement audit: in case of impossibility implementing with any of the above, by EGAC after
review and accept the programs from accreditation manager relevant to Scope and technical
assessor relevant to activity.

4. Unaccredited PT provider but after review and accept the programs from accreditation manager
relevant of Scheme.

* If not found Accredited Proficiency testing the CAB shall take approval from EGAC before
implementing alternatives in item 2 or item 3 or last one item 4.

5.1 PT requirements for applicant (for ISO/IEC 17025).

a) Applicant Lab shall provide proficiency testing, at least one PT in sub-Discipline for Each Group
within the same code (Annex 1) according to EGAC scope of accreditation for the (testing /
calibration) laboratory.

b) The applicant also shall provide a plan of proficiency testing to cover the rest of the CAB
accredited scope (testing / calibration) according to EGAC Sub-Discipline activities for Each Group
within the same code (Annex 1) to implement it during its accreditation cycle (four years)

c) The required frequency of participation in the proficiency testing should be relevant to the
technical scope as will be assessed by EGAC however it should not less than the frequent time
explained in clause (9) below (within the period between two subsequent reassessments) for each
sub- discipline of the laboratory’s scope of accreditation.

d) Disciplines may need to be divided into more sub disciplines to clarify their PT schemes; this
will be advised by EGAC assessors / experts. Disciplines and sub disciplines as illustrated in (Annex
I) and are published on EGAC’s website.

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e) For calibration laboratories.

 At initial assessment visit the date of issue PT Report not exceed 18 months during submit
application.
 At extension or re-assessment visit the PT Report must be valid one year before conduct the visit

5.2 PT requirements during the Document review and preliminary assessment

(for ISO/IEC 17025)
The assessment and the system documentation allow for a correct evaluation of the proficiency
testing report.
Assessors shall check the following before starting the assessment:
 The plan for the participation of the laboratory in the PT schemes, along with its justifications.
 The successful execution of this plan, according to the laboratory’s success report.
 The results achieved in proficiency tests are adequately documented in the laboratories before
they can be considered as part of an accreditation procedure.
 Accredited laboratories are maintaining their own records of performance in all types of
proficiency testing, including the outcomes of investigations of any unsatisfactory results and any
subsequent corrective actions, If the CABs have PT Report with all unsatisfactory results the
CAB must re-participate in new proficiency testing.
 The period for keeping the records of proficiency testing results and other documentation is at
least (Previous and Current) accreditation cycle, to establish the competence and stability of the
accredited laboratory.
 Accredited laboratories shall have a written procedure covering participation in proficiency
testing, including how the performance in proficiency testing is used to demonstrate the
laboratory's competence and procedures followed in the event of unsatisfactory performance.
 Assessors shall check the conformity of the frequency and regularity of the laboratory’s
participation in the proficiency testing with regard to EGAC policy.

5.3 PT requirements during the assessment process

- During the assessment, the assessment team will obtain the laboratory’s plan which participation
in the proficiency testing schemes and a report on the participation of the laboratory in proficiency
tests.
- This report of proficiency tests shall always be part of the documentation of the laboratory's
accreditation or sequential assessment procedure. Such a report should contain:
 Plan for the participation of the laboratory in the PT schemes.
 Reporting the success of this plan.
 Dates of proficiency tests already carried out.

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 Organizer of PT scheme.
 Test materials, measured quantities, parameters, artifacts and calibration equipment.
 Matrices (where applicable).
 Acceptability criteria.
 Results (satisfactory/questionable/unsatisfactory)
 Corrective actions and follow -ups, where required.

- If the laboratory submits a greater number of proficiency tests, then the assessment team should
limit its assessment to a sufficient number chosen in a representative way.
- From the survey on proficiency tests and considering the above-mentioned main points,
proficiency tests that are to be checked on-site are to be selected by the assessment team

-The laboratory shall be prepared to justify non-participation in readily available proficiency testing
schemes, where one or more appropriate schemes exist.

6- Corrective actions and additional measures

According to :
 Data from monitoring activities shall be analyzed and used to control and, improve the
laboratory's activities if applicable.
 If the results of the analysis of data from monitoring activities are found to be outside pre-
defined criteria, appropriate action shall be taken to prevent incorrect results from being
reported. (ISO/IEC 17025)
 CAB should make analysis for PT report results (Satisfactory/ questionable / Unsatisfactory),
EGAC will accept the PT provider’s acceptance criteria if available based on Laboratory
analysis, otherwise it will set one according to the PT results presented to the laboratory.
 The laboratories are required to make the results available to be analyzed by EGAC. These
results should be adequately documented in the laboratories before they can be considered
as part of an accreditation process.
 The laboratories are required to demonstrate their ability to take the necessary corrective
action when appropriate.
 Records of proficiency testing results should be analyzed and kept, to establish the
competence and stability of the accredited laboratory.
 The general conclusions that have been drawn by the laboratory from the participation in
proficiency tests concerning their work and corrective actions, if necessary, that have been
taken, shall be studied by the assessment team.

If the laboratory doesn’t have satisfactory results, then, the explanations and corrective actions shall
be checked for sufficiency and suitability. The assessment team shall study these actions to gain
information about a laboratory’s competence. These actions may include the following internal

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and/or external quality measures:

 Calibration of measuring devices.
 Use of quality control charts.
 Performance of duplicate/multiple determinations/measurements and appropriate statistical
methods.
 Use of standard methods for calibration/ testing.
 For testing laboratories:
- Regular use of certified reference materials, where appropriate use of purchasable or in-
house calibration and control materials.
- Introduction of “blind” test materials into the laboratory (e.g. by the Quality Manager).
 For calibration laboratories:
-Regular use of cross checks methods, where appropriate and the use of higher-level
calibrations.
-All kinds of proficiency tests already carried out on the laboratory's own initiative.

In any case, if there are doubts concerning the competence after studying the corrective actions, the
technical assessor should find out - in agreement with the laboratory - whether interlaboratory
comparisons with other laboratories or the participation in existing interlaboratory comparison
schemes should be performed. The extent, selected type, the way of performing and evaluating the
proficiency tests shall be explained to the laboratory by the assessment. Other internal as well as
external quality measures may be considered, e.g.:

 To repeat the PT.

 To check internal quality assurance measures.
 To ask for detailed reports on corrective actions.
 To make an on-site surveillance

7. Additional proficiency tests may be required when:

a. A significant Change of personnel / main used std. operating in the accredited scope, which
may affect the technical competence of the laboratory,
b. External quality measures taken for the test methods/types of tests applied in the scope of
accreditation are not sufficient, regarding, e.g.:
- Number of proficiency tests performed in specific scopes
- Extension of the scope of accreditation
- Insufficiently validated and documented in-house methods
- Procedural steps deviating from the test standard
c. A significant ratio result of the proficiency tests submitted by the laboratory is unsatisfactory
as defined by the acceptability criteria.
d. The conclusions drawn and the necessary corrective actions of the laboratory have not been
carried out or documented, or are in-sufficient

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e. Assistance in detecting systematic errors in the laboratory is needed and if the laboratory has
no other means to provide evidence of its technical competence and quality of measurement.

8. Determination of acceptability criteria

8.1General rules

Generally, the assessment team should use the criteria stated by the organizer of the proficiency
testing scheme.
If the organizer of inter-laboratory comparisons does not provide any criteria for acceptance of
results (e.g. inter-laboratory comparisons for validation of procedures and/or certification of
reference substances), then the laboratory, under assessment, shall define its own acceptance limits.
The assessment team will verify the criteria in use (defined either by PTP or by the laboratory) for
suitability.

8.2 Regulatory authorities' criteria.

 If the laboratory is active in a mandatory area, the assessment team should use the criteria
set by the regulatory authority.
 If the laboratory is not active in a mandatory area, but is taking part in the proficiency testing
scheme established by regulatory authority for purposes of internal quality assurance, then
the assessment team should use the criteria defined for the intended use by the laboratory,
after checking the ability of the laboratory to set criteria and their suitability.

Note (3) : The criteria set by the authority or customer should normally have precedence over the
criteria given by the accreditation body.

9. Proficiency Testing frequency

 For Calibration laboratories fields:

EGAC accept PT for its calibration laboratories activities according to each of its Sub-discipline to
be renewed each accreditation cycle (four years) unless there is no change at the laboratory scope.
(Back to Annex 1).

 For Testing laboratories fields:

a) EGAC accept PT for its testing laboratories activities according to its each Sub-discipline
As defined in (Annex I).to be renewed each accreditation cycle unless there is no change at the
laboratory scope
b) For critical sub-discipline (field/s):

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- Biological Testing.
- Environmental Tests.
- Food Tests.

To be renewed each (2 years/Cycle) unless there is no change at the laboratory scope

10. Proficiency Testing Requirements for Medical Laboratories:-

For the Medical laboratories discipline (Tests), its frequency is dictated by the PT provider scheme.
 ISO 15189:2022, clause 7.3.7.3, requires that the laboratory participates in an EQA program
appropriate to the examination and interpretation of examination results, including POCT (Point
of care testing) examination methods. When an EQA programme is either not available, or not
considered suitable, the laboratory shall use alternative methodologies to monitor examination
method performance, including ILCs other than PT;

Note (1): Participation in PT and/or ILCs other than PT, organized by competent providers is, for
an accredited CAB, an integral part of the monitoring of the validity of its results.

 The period for keeping the records of proficiency testing results and other documentation is at
least (Previous and Current) accreditation cycle, to establish the competence and stability of the
accredited laboratory.

10.1. Types of accepted proficiency testing:

For the accreditation process: the acceptable types of proficiency testing are in the following order
according to availability:
a) Accredited PT providers that meet requirements of ISO/IEC 17043.
b) Unaccredited PT providers, approved by the accreditation manager and director following
review of the PT provider plan, homogeneity, stability, traceability of PT samples, and
previous work.
c) According to ILAC P9 and ISO 15189:2022, clause 7.3.7.3, it is required that the laboratory
participates in an EQA program appropriate to the examination and interpretation of
examination results, including POCT (Point of care testing) examination methods. When an
EQA program is either not available, or not considered suitable, the laboratory shall use
alternative methodologies to monitor examination method performance, including ILCs
other than PT, if either (a) or (b) is not available or not suitable, the CAB (CAB; is the
conformity assessment body that performs medical testing) shall propose a suitable
alternative and get approval from the EGAC accreditation manager and director following
discussion and approval by at a technical assessor subcontracted by EGAC in the related

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activity. A written approval will be provided to the CAB before implementing the
alternatives, the acceptable types of alternatives are in the following order according to
availability:
1. Interlaboratory comparison programs comparing the laboratory daily internal quality
control with peer group using the same quality control materials;
2. Participation in sample exchanges with other accredited laboratories accepted by the
EGAC accreditation manager and director following discussion and approval by the
technical assessor(s) relevant to the activity;
Note (2): The accredited laboratories shall successfully participate in the same period
and the reports of their results shall be reviewed by EGAC.
3. When appropriate the medical laboratory use analysis of reference materials under
EGAC supervision;
4. Depending on the scope of medical laboratory they can use participation in sample
exchanges with another more than two competent and accepted labs by the EGAC
accreditation manager and director following discussion and approval with the
technical assessor(s) relevant to the activity.
The laboratory shall have a documented procedure for alternative methodologies and for
exchange of samples with other accredited laboratories including frequency, number of
samples and acceptable performance criteria. Storage, stability and transport conditions
of samples shall be considered to ensure valid results. Results are documented,
reviewed and corrective action is taken in case of unsatisfactory results.

10.2. PT Requirements for Applicant (Labs).

a) The applicant Medical Laboratory provides proficiency testing reports, at least one
successful shipment for each parameter that is updated within the last 6 months from the
date of submitting a new application or expanding the scope before final approval of
laboratory application by EGAC;
b) Provides a plan of proficiency testing to cover the CAB accredited scope to be implemented
during its accreditation cycle (four years). These plans shall be relevant to its scope of tests,
matched with the PT provider programs and the frequency of proficiency testing shall be at
least annually, also the planning is to take into account the risks and opportunities of the
laboratory activity. This includes an evaluation of the level and frequency of participation in
PT and/or ILCs other than PT;
c) The required frequency of participation in the proficiency testing should be relevant to PT
suppliers with a final report provided at the end of the cycle;
d) For special scopes that include preparation, examination, and interpretation processes (e.g.,
pathology, cytogenetic, microbiology, etc.) the lab shall participate in PT program(s) that

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cover(s) all steps of testing processes till reporting of results (whenever available/ possible).
In the situation where the Lab’s PT participation plan is considered not suitable in relation
to the scope of accreditation such as when the examination process is not included in PT/ILC
program the Lab will arrange for another alternative accepted approach from (10.1);
e) The Medical Laboratory shall treat the PT samples in the same manner as the patient samples
and as mentioned in the PT scheme protocol;
f) The applicant Medical Laboratory shall deliver reports that were provided by PT providers
and prove successful participation to EGAC relevant department. Also, during the
assessment visit the technical assessor shall review raw results or printout of the lab results
that were submitted to PT provider;
g) Proficiency testing / ILC reports shall be clear and comprehensive and include at least the
following minimum information:
 Identification of the participants;
 Measurement protocol;
 Measurement results;
 The reference value/s and how these were established;
 Evaluation of the measurement results;
 An indication of the performance of individual participants;
 Minimum acceptance criteria;
 Conclusion.
h) If the lab performs the same test on two or more identical equipment and the PT program
provides only one report for one equipment, the lab can use the PT samples for comparison
with the other equipment, and comparability studies between equipment should be done at
least every six months.
i) The lab shall formulate and implement a policy and procedures related to its participation in
proficiency tests/inter-laboratory comparison programs (ILCs), alternatives when used, and
analyze their results. EGAC Periodicity will consider the risks and opportunities of the
laboratory activity. This includes evaluating the level and frequency of participation in PT
and/or ILCs other than PT.
j) The lab shall review all related policies and procedures periodically, provided that this
review includes all the technical and organizational issues.

10.3. Successful Participation Requirements:

a) For monthly or biweekly provided samples, the lab shall pass at least 75% of a whole PT
annual cycle including acceptable alternative for those shipments that were not received by
the lab. For any unsatisfactory result the lab shall investigate the root cause and take a
corrective action.
b) For programs providing three shipments per year with five samples per shipment, the lab
shall pass at least 75% of a whole PT annual cycle including acceptable alternative for those

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shipments that were not received by the lab. For any unsatisfactory result the lab shall be
investigate the root cause and take a corrective action.
c) For programs providing three shipments per year (with less than 5 samples per shipment),
the lab shall pass successfully in two shipments, and for the unsatisfactory shipment the lab
shall investigate the root cause and take a corrective action. An alternative is required for
any shipment not received by the lab.
d) For programs with two shipments per year, the lab shall pass successfully one of the two
shipments, and for the unsatisfactory shipment, the lab shall investigate the root cause and
take a corrective action. An alternative is required for any shipment not received by the lab.

10.4. Maintenance of accreditation:

a) The lab shall maintain continuous participation and fulfill the previous successful
participation requirements as explained in (10.3);
b) The lab shall send reports of all PT results every 6 months for EGAC medical department;
c) The lab shall send a self-assessment report that includes the lab performance through the past
six months, the root causes, and corrective actions/justifications for failed or
unreported/Late test results. The accepted corrective action is taken in case of
unsatisfactory results/delayed/undelivered PT samples. Actions shall be at the same time as
the PT calendar plan and
d) Failing to regularly send the above-mentioned reports will result in suspension of the
lab scope in this particular sub-discipline/analyte.
e) For an accredited medical laboratory, it will be suspended or partially suspended for six
months at most if there is no evidence of successful participation at the end of the PT
cycle. The lab shall send evidence of satisfactory PT result(s) before the end of the six-month
suspension period, and the lab will be subjected to a reduction of its scope or withdrawal
according to EGAC’s procedures and regulations.

11. General policy for Forensic Services Provider Laboratories

11.1. On Application for Accreditation:
11.1.1 All applicant for forensic testing laboratories and inspection body are required to
participate in appropriate proficiency testing or Inter-laboratory comparisons for the scope
of accreditation required and provide EGAC with the relevant proof on application of
participation and satisfactory performance.
‘Appropriate’ participation can be described as that level of participation which will result
in an acceptable level of risk, i.e. risk that the laboratory may issue reports with results
falling outside of the specified measurement uncertainty stated on the report. The EGAC
policy requires that laboratories undertake proficiency testing or ILC for all items or
parameters listed on their proposed schedule of accreditation covering examination and post

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examination report.
11.1.2. Proficiency Testing:
Forensic testing laboratories and inspection body shall perform proficiency testing in order
to verify the laboratory’s performance. The frequency of proficiency testing shall be at least
annually, in at least one parameter or different matrix and at least one of these PT should be
from a recognized PT provider external to laboratory.
Proficiency –test samples should be representative of the laboratory’s normal casework.
Methodology required to perform proficiency tests should be relevant to the normal
practice in the laboratory.
11.1.3. Proficiency testing activities may include:
i) An external proficiency testing scheme, preferably operated in accordance with
ISO/IEC 17043;
ii) An Inter-laboratory comparison scheme (where two or more laboratories are used);
iii) Suitable alternative to PT/ILC, as agreed to by EGAC, where PT schemes are not
available or are not practical.
11.1.4. For Maintenance the Accreditation
11.1.4.1. All accredited forensic service laboratories should preferably participate in proficiency
testing scheme, in at least one parameter or different matrix, at least once annually that
have been independently shown to comply with the requirements of ISO/IEC 17043.
The laboratory shall satisfy itself on the competence of the PT providers i n whose
schemes it voluntarily participates.
11.1.4.2. Where available and appropriate, forensic agencies are expected to select PT providers
accredited to ISO/IEC 17043 by EGAC, if available, or another accreditation body that is
recognized by ILAC.
11.1.4.3. The Forensic testing laboratories and inspection body shall review their own performance
and investigate all measurement results that fail to meet the minimum acceptance criteria,
including where there is evidence of consistent poor performance, and record the
root cause analysis conducted and all corrective and preventative action(s) taken.
11.1.5. PT/ILC Activity Plan
11.1.5.1. All accredited Forensic service provider shall have available PT / ILC plans for at least
2 years, i.e. the activities conducted for the past years (where possible) and the plan for
the subsequent years.
11.1.5.2. The plan shall cover all activities as specified above and shall be accomplished in a
period not exceeding 1 accreditation cycle.
Note(3): The frequency and extent of participation shall be justified by the laboratory to
EGAC for each accredited method and shall be at least once annually, in at least one

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parameter or different matrix, and included in the plan.

11.1.5.3. The PT / ILC plan shall be subject to review in response to changes in staff, methodology
or instrumentation, revision and approval as described.
11.1.5.4. Forensic testing laboratories and inspection body may incorporate in the plan participation
in any other organized PT or other comparison programs organized nationally, regionally
or internationally.
11.1.5.5. Where no formal PT is practical or available, the Forensic testing laboratories and
inspection body shall indicate suitable alternative means by which performance will be
assessed and monitored. These may include activities such as intra-laboratory
comparisons, the use of reference materials or other comparisons. EGAC will consider
these alternative arrangements as part of the laboratory’s planned activities. It is the
responsibility of forencsic agency to provide the details of the plan and its justification to
obtain approval from EGAC.
11.1.5.6. The PT activity plan should address:
 The parameters for which PT is conducted;
 Proficiency testing type (PT scheme; Inter-laboratory comparison; Intra-laboratory
comparison; Use of a Reference material);
 Identification and number of participants, if available, and/or potential participants for
ILC;
 The name/s and or identification of the PT schemes which the laboratory intends to
participate;
 The minimum acceptance criteria, if available;
 Any issues expected with participating in PT, from previous experience;
 Frequency of participation per time period justified by the laboratory.
11.1.6. During an Assessment
11.1.6.1. Failure of Forensic testing laboratories and inspection body to show effective
participation, or that the use of alternatives to PT has been agreed on by EGAC,
according to the PT plan, could result in suspension of the tests concerned.
11.1.6.2. Forensic testing laboratories and inspection body shall make available to the assessment
team all proficiency testing scheme and ILC reports.
11.1.6.3. Proficiency testing / ILC reports shall be clear and comprehensive and include at least the
following minimum information:
 Identification of the participants;
 Measurement protocol;
 Measurement results;
 The reference value/s and how these were established;
 Evaluation of the measurement results;
 An indication of the performance of individual participants;
 Minimum acceptance criteria;
 Conclusion.

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11.1.6.4. The effectiveness of corrective and preventative action taken will be evaluated during
the assessment, and taken into consideration during the decision making process.

12. General Policy for ISO 20387:2018 Biotechnology Biobanking

12.1. On Application for Accreditation:

12.1.1 All applicant for biobanks is required to participate in appropriate proficiency testing or
Inter-laboratory comparisons for the scope of accreditation required and provide EGAC with
the relevant proof on application of participation and satisfactory performance.
The EGAC policy requires that laboratories undertake proficiency testing or ILC for all
items or parameters listed on their proposed schedule of accreditation covering examination
and post examination report.
12.1.2. Proficiency Testing:
Biobanks shall perform proficiency testing in order to verify the biobank performance. The
frequency of proficiency testing shall be at least annually, in at least one parameter or
different matrix and at least one of these PT should be from a recognized PT provider
external to the biobank organization.
Proficiency test samples should be representative of the biobanks normal casework.
Methodology required to perform proficiency tests should be relevant to the normal
practice in the biobanks.
12.1.3. Types of accepted proficiency testing::
For the accreditation process: the acceptable types of proficiency testing are in the
following order according to availability:
a. Accredited PT providers that meet requirements of ISO/IEC 17043.
b. Unaccredited PT schemes, agreed by the accreditation manager and director following
review of the PT provider plan, homogeneity, stability, traceability of PT samples, and
previous work.
c. If either a or b is not available or not suitable, the Biobank shall propose a suitable
alternative and get approval from EGAC Accreditation manager and director following
discussion and approval by the relevant technical assessor(s). A written approval will
be provided to the CAB before implementing the alternatives which could be:
d. Interlaboratory comparison programs comparing the laboratory of biobank daily internal
quality control with peer group using the same quality control materials when
appropriate.
e. Depending on the scope of biobanks they can use participation in sample exchanges

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with another more than two competent and accepted biobanks by the EGAC
accreditation manager and director following consultation with the technical
assessor(s) relevant to the activity.
The biobank shall have a documented procedure for exchange of samples with other
accredited/ competent competent including frequency, number of samples and
acceptable performance criteria.Storage, stability and transport conditions of samples
shall be considered to ensure valid results. Results are documented, reviewed and
corrective action is taken in case of unsatisfactory results.

f. When appropriate biobank use analysis of reference materials under EGAC supervision.

12.1.4. For Maintenance the Accreditation

12.1.4.1. All accredited biobanks participate in proficiency testing scheme, in at least one parameter
or different matrix, at least once annually that have been independently shown to comply
with the requirements of ISO/IEC 17043. The biobanks shall satisfy itself on the
competence of the PT providers i n whose schemes it voluntarily participates.
12.1.4.2. Where available and appropriate, biobanks organization are expected to select PT providers
accredited to ISO/IEC 17043 by EGAC, if available, or another accreditation body that is
recognized by ILAC.
12.1.4.3. The biobanks shall review their own performance and investigate all measurement results
that fail to meet the minimum acceptance criteria, including where there is evidence
of consistent poor performance, and record the root cause analysis conducted and all
corrective and preventative action(s) taken.
12.1.4.4. According to ISO 20387:2018, clause 7.8.2.9, requires that approaches from the biobanks
to provide objective evidence to demonstrate the comparability of biological material
quality (the processing or testing output) are used, where such approaches are available
and appropriate. Such approaches include EQA schemes, PT schemes and/or ILCs other
than PT;
12.1.5. PT/ILC Activity Plan
12.1.5.1. All accredited biobanks shall have available PT / ILC plans for at least 2 years, i.e. the
activities conducted for the past years and the plan for the subsequent years.
12.1.5.2. The plan shall cover all activities as specified above and shall be accomplished in a
period not exceeding 1 accreditation cycle.
Note(4): The frequency and extent of participation shall be justified by the bibanks to
EGAC for each accredited scope and shall be at least once annually, and included in the
plan.
12.1.5.3. The PT / ILC plan shall be subject to review in response to changes in staff, methodology
or instrumentation, revision and approval as described.
12.1.5.5. Where no formal PT is practical or available, the biobanks shall indicate suitable alternative

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means by which performance will be assessed and monitored. These may include
activities such as intra-laboratory comparisons, the use of reference materials or other
comparisons. EGAC will consider these alternative arrangements as part of the
laboratory’s planned activities. It is the responsibility of biobank to provide the details of
the plan and its justification to obtain approval from EGAC.
12.1.5.6. The PT activity plan should address:
 The parameters for which PT is conducted;
 Proficiency testing type (PT scheme; ILCs; Intra-laboratory comparison; Use of a
Reference material);
 Identification and number of participants, if available, and/or potential participants for
ILC;
 The name/s and or identification of the PT schemes which the laboratory intends to
participate;
 The minimum acceptance criteria, if available;
 Any issues expected with participating in PT, from previous experience;
 Frequency of participation per time period justified by the biobank.
12.1.6. During an Assessment
12.1.6.1. Failure of the biobanks to show effective participation, or that the use of alternatives
to PT has been agreed on by EGAC, according to the PT plan, could result in suspension
of the tests concerned.
12.1.6.2. the biobanks shall make available to the assessment team all proficiency testing scheme
and ILC reports during the visit.
12.1.6.3. Proficiency testing / ILC reports shall be clear and comprehensive and include at least the
following minimum information:
 Identification of the participants;
 Measurement protocol;
 Measurement results;
 The reference value/s and how these were established;
 Evaluation of the measurement results;
 An indication of the performance of individual participants;
 Minimum acceptance criteria;
 Conclusion.
12.1.6.4. The effectiveness of corrective and preventative action taken will be evaluated during
the assessment, and taken into consideration during the decision making process.

13. REFERENCES

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ILAC-P9:01/ 2024
ISO/IEC 17043: 2023
ISO/IEC 17011: 2017
ISO/IEC 17025 :2017
ISO 15189 :2022
ISO 20387:2018
ISO 5725
EA-4/21 INF: 2018
EA-4/18 G: 2021
IAF/ILAC-A2
ASTM Designation E2327-15

Annex 1

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EGAC Scope for Accreditation Schemes:

Discipline Sub- Discipline
No Field
Code Name Code Group Name
1 Calibration A Electrical - DC/ Low 1 A1 Voltage
Frequency 2 A1 Current
( < 1 MHz) 3 A1 Resistance
4 A2 Capacitance
5 A2 Inductance
6 A3 Power
7 A4 Energy
8 A5 Impedance
9 A6 Transformer’s ratio
10 A7 Oscilloscope Functions
11 A8 Process calibrators
12 A9 Logic State Analysis
13 A10 High Voltage quantities
14 A11 AC/DC transfer (voltage)
15 A11 AC/DC transfer (current)
16 A12 Voltage Ratio
17 A13 Dissipation Factor
B Electrical - 1 B1 Modulation (AM)
RF/Microwave & 2 B1 Modulation (FM)
High Frequency 3 B1 Modulation (PM)
(> 1 MHz) 4 B2 Impedance (reflection coefficient)
5 B3 Power
6 B4 Attenuation
7 B5 Adaptors
8 B6 Antennas
9 B7 Signal Generators
10 B8 Spectrum Analysis
11 B9 S-parameters
12 B10 Noise
13 B11 Electric/Magnetic Field quantities
B12 Voltage Standing Wave Ratio
14
(VSWR)
B13 Electrostatic discharge Simulations
15
(ESD)
16 B14 Coupling/Decoupling Networks
17 B15 Line impedance stabilization network
C Magnetism 1 C1 Magnetic Flux Density
2 C2 Magnetic Material properties
D Time and Frequency 1 D1 Time Interval
2 D1 Periodical time
3 D2 Frequency
4 D3 Rise Time
5 D3 Fall Time

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
6 D4 Phase Angle
7 D5 Phase Shift
8 D6 Acceleration
9 D8 Rotational Speed (rpm)
E Dimensions - Laser E1 Frequency stabilized laser vacuum
1 (wavelength; optical frequency
F Dimensions - Length F1 (Laser, length) interferometer (system,
1 optics, refractometer)
Instruments
2 F2 EDM instrument
3 F3 1-D measuring machine (ULM)
4 F4 Height measuring instrument
5 F5 1-D displacement transducer (LVDT)
6 F6 Gauge block comparators
7 F7 Dial-indicator tester
G Dimensions - End 1 G1 Gauge block
Standards 2 G1 Length bar (long gauge block)
3 G1 [Plane] micrometer setting rod
4 G2 [thread] micrometer setting rod
5 G3 Step gauge
6 G4 Feeler (thickness) gauge
H Dimensions - Line 1 H1 Stage micrometer
Standards H2 (Surveyor, engineer, pi) tape, (geodetic)
2 wire
3 H3 Engineer or machinist scale, steel Rule
I Dimensions - 1 I1 External cylinder (plug)
Diameter Standards 2 I1 External cylinder (piston)
3 I1 External cylinder (pin)
4 I1 External cylinder (wire)
5 I2 Internal cylinder (ring)
6 I3 Sphere (ball)
J Dimensions - Angle 1 J1 Angle block gauges
2 J1 90° (steel, granite, try) square
3 J2 Cylinder square
4 J3 Autocollimator
5 J4 Electronic level
6 J5 Clinometers
7 J6 Spirit (bubble) level
8 J7 Theodolite
9 J8 (Bevel) protractor
10 J9 Sine bar – Sine table
Dimensions - Flatness 1 K1 Optical flat
K
Standards 2 K2 optical parallel
K3
3 Surface Plate
L Dimensions - 1 L1 External cylinder
Roundness Standards 2 L1 Internal cylinder

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
3 L2 Sphere – hemisphere
M Dimensions - 1 L1 Straight edge
Straightness Standards 2 L1 Cylindrical straightness standard
N Dimensions - Screw 1 N1 Thread plug, plain & Tapered
Thread 2 N1 Thread ring, plain & Tapered
N1 Internal & External API screw thread
3 gauge
O Dimensions - 2-D, 3- 1 O1 Profile projector
D Instruments 2 O2 Measuring microscope
3 O3 Coordinate measuring Machine (CMM)
P Dimensions - Hand 1 P1 External micrometer
Instruments 2 P1 Micrometer head
3 P1 Caliper
4 P1 Snap gauge (internal, external)
5 P2 Depth micrometer
6 P2 Depth gauge
7 P3 Internal two-point (bore) micrometer
8 P3 Internal three-point (bore) micrometer
9 P4 Dial gauge
Q Force 1 Q1 Universal Testing Machine (UTM)
2 Q1 Tensile testing machine
3 Q1 Compression Testing machine
4 Q2 Shear Testing machine
5 Q3 Bending testing machine
Q4 Force proving Instrument ( load Cell,
6
Proving ring ….etc
R 1 R1 Torque Wrench
Torque 2 R2 Torque Transducer
3 R3 Torque Multiplier
S Impact 1 S1 Impact machine calibrations
T Hardness 1 T1 Hardness calibration
U Pressure 1 U1 Dead weight testers
2 U2 Gauge
3 U3 transducer
U4
4 Transmitter
V Vacuum 1 V1 Dead weight testers
2 V2 Gauge
3 V3 transducer
4 V4 Transmitter
W Absolute Pressure 1 W4 Dead weight testers
2 W4 Gauge
3 W4 transducer
4 W4 Transmitter
5 W5 Data logger/ Recorder

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
X Differential pressure 1 W1 Dead weight testers
P) and Low 2 W2 Gauge
pressure 3 W3 transducer
4 W4 Transmitter
Y 1 Y1 Conventional Mass/ Weight
Mass 2 Y2 True Mass/ Weight
3 Y3 Density of solid
Z Weighing 1 Z1 Balances/Scales
Instruments 2 Z2 Mass Comparators
AA Acoustics 1 AA1 Microphones
2 AA1 Sound Level
3 AA2 Artificial Mastoids
4 AA3 Noise Dosimeters
5 AA4 Vibration
AB Fluid 1 AB1 Liquid Flow Rate
2 AB2 Gas Flow Rate
3 AB3 Quantity
4 AB4 Velocity / Speed Flow
5 AB5 Viscometers
6 AB6 Viscosity
7 AB7 Density
8 AB7 Hydrometer
9 AB7 Specific Gravity
AC Volumetric 1 AC1 Glass ware volumetric apparatus
(One-mark) Pipette, Burette and
flasks.
2 AC1 Glass ware volumetric apparatus
(Graduated) Pipette, Burette and
flasks.
3 AC2 Piston-operated volumetric apparatus
(Single Volume )
Micro Pipette
4 AC2 Piston-operated volumetric apparatus
(Variable volume)
Micro Pipette
5 AC3 Metal ware
AD Photometric 1 AD1 Luminous flux (lumen)
2 AD2 Illuminance (Lux),
3 AD3 Luminous intensity (Candela)
AE Radiometric 1 AE1 Power (watt)
2 AE2 Irradiance (W/m2)
3 AE3 Spectral irradiance (W/m2/nm)
4 AE4 Detector sensitivity (A/W/m2)
5 AE5 Solar irradiance (W/m2)

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
6 AE6 Laser Power (W)
7 AE7 Laser frequency (Hz)
8 AE8 Laser wavelength (nm)
AF Spectrophotometric AF1 Reflectance/ Transmittance/
1
Absorbance, Wavelength
AG Colorimetric 1 AG1 Gloss
2 AG1 Opacity
3 AG1 Whiteness
AH Thermometry- 1 AH1 SPRTs / PRT Without Indicator
Resistance 2 AH1 RTD, Pt-100 Without Indicator
Thermometry 3 AH2 Thermistors Without Indicator
Thermometry- AH2
1 Thermocouple Without Indicator
Thermocouples
AH3 Temperature Indicators Without
Thermometry-
1 Sensors (Source/Measure
Simulation
Simulation)
Thermometry- AH4 PRT With Indicator
1
Temperature (Secondary/Industrial)
Sensor/Transducer/T 2 AH4 RTD / Pt-100 With Indicator
ransmitter with 3 AH5 Thermocouple With Indicator
Indicator AH6 Dial Temperature Gauge (Filled Bulb
(Thermometer With 4
/ Bimetallic)
Indicator) AH7 Temperature Datalogger with
5
External Sensor
AH7 Temperature Recorder with External
6
Sensor
AH7 Temperature Datalogger with internal
7
Sensor
Thermometry- AI1
AI Glass Thermometers 1 Liquid-In-Glass Thermometers

AJ Thermometry- AJ1 Oven (Multi Sensors according to

1
Closed Volume volume)
AJ1 Muffle (Multi Sensors according to
2
volume)
AJ1 Incubator (Multi Sensors according
3
to volume)
AJ1 Temperature Chambers (Multi
4
Sensors according to volume)
AJ1 Autoclave (Multi Sensors according
5
to volume)
AJ1 Liquid Bath(Multi Sensors according
6
to volume)
AJ2 Refrigerator (Multi Sensors
7
according to volume)

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
AJ2 Freezer (Multi Sensors according to
8
volume)
AJ3 Cold Rooms (Multi Sensors
9
according to volume)
AJ4 Oven (Working location) (single
10
Sensor)
AJ4 Muffle (Working location) (single
11
Sensor)
AJ4 Incubator (Working location) (single
12
Sensor)
AJ4 Temperature Chambers (Working
13
location) (single Sensor)
AJ4 Autoclave (Working location) (single
14
Sensor)
AJ4 Liquid Bath (Working location)
15
(single Sensor)
AJ5 Refrigerator (Working location)
16
(single Sensor)
AJ5 Freezer (Working location) (single
17
Sensor)
AJ5 Cold Rooms (Working location)
18
(single Sensor)
19 AJ6 Thermal mapping
AK Thermometry- 1 AK1 Infrared thermometers
Radiation AK2 Radiation Thermometers
2
Thermometry
AL Thermometry- 1 AL1 Dry Block
Thermometer 2 AL1 Liquid Bath
Calibration AL2
Equipment(Temperat 3 Black Body
ure Source)
AM Thermometry- 1 AM1 Humidity Sensor With Indicator
Humidity 2 AM1 Humidity Transducer With Indicator
3 AM1 Humidity transmitter With Indicator
AM2 Hygrometer/Thermohygrometer
4
(Digital/Analog)
5 AM2 Temperature/Humidity Datalogger
AM3 Climatic Chambers
6
(Temperature/Humidity)
AN General - Equipment 1 AN1 NIBP -Non Invasive Blood Pressure
2 AN2 Defibrillator
3 AN3 Electrical Safety Analyzer Measurements
4 AN4 Electrosurgical Unit
AN5 Infant Incubator (Temperature, Relative
5 Humidity, Air Flow and Noise)
6 AN6 Infusion Syringe Pum

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
7 AN7 Ventilator
8 AN8 Phototherapy
AN9 Electrical properties: (Voltage,
9 Earthlings, Leakage …) Medical safety
tool
10 AN10 Particle size analyzer
11 AN11 Particle counter devices
12 AN12 Gas analyzers
13 AN13 Moisture analyzers
14 AN14 PH meter
15 AN15 Conductivity meter
AN16 Automatic Micro Distillation
16
Apparatus
17 AN17 Automatic Freezing Point Meter
18 AN18 Automatic Pour Point Meter
Other Scope (please
specify)

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
2 Testing A Chemical 1 A1 Wet Chemistry
2 A2 Spectroscopy
3 A3 Chromatography
4 A4 Surface Analysis Techniques
5 A5 Electrochemical (pH)
6 A6 Electrochemical (Conductivity)
7 A7 Thermal Analysis
8 A8 Fire and Combustion Tests
9 A9 Corrosion
10 A10 Microscopy (Optical)
11 A11 Microscopy (Electron)
12 A12 Microscopy (Atomic force)
13 A13 Clinical Chemistry
B Physical 1 B1 Density
2 B2 Viscosity
3 B3 Particle size
4 B4 Porosity
5 B5 Colligative properties
6 B6 Geometric Tests (Length measure)
7 B7 Geometric Tests (dimension)
8 B8 Geometric Tests ( thickness)
B9 Optical Properties (Luminance,
9
Refract index, …)
10 B10 Visual Characteristics (Color, …)
11 B11 Washability
12 B12 Fineness
13 B13 Melting point
14 B14 Flash point
15 B15 Melt flow rate
16 B16 Suspended Solids
17 B17 Glow Wire
18 B18 Non-Destructive Testing (NDT)
C Mechanical 1 C1 Tensile
2 C2 Compression
3 C3 Shear
4 C4 Torsion
5 C5 Fracture
6 C6 Impact Resistance
7 C7 Hardness
8 C8 Material properties
9 C9 Metallography
10 C10 Fatigue
11 C11 Pressure (Switches)
12 C12 Pressure ( Safety/relief valves)

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
13 C12 Pressure (valves)
14 C13 Pressure (Pumps )
15 C14 Hydrostatic/Hydraulic Pressure (Hoes)
C14 Hydrostatic/Hydraulic Pressure
16
(vessels)
17 C14 Hydrostatic/Hydraulic Pressure (pipes)
18 C15 Bending
19 C16 Friction
20 C17 Coating Thickness
D Electrical 1 D1 Resistance
2 D2 Current
3 D3 Voltage
4 D4 Electromagnetic Compatibility EMC
E Environmental 1 E1 Potable Water (organisms)
2 E1 Potable Water (organic …)
3 E2 Non-potable (Sea Water)
4 E2 Non-potable (Irrigation …)
5 E3 Mineral Water
6 E4 Waste Water (industrial)
7 E4 Waste Water (agricultural)
8 E5 Water Sediments & Mussels
9 E6 Solid/Hazardous Waste
10 E7 Lead
11 E8 Asbestos
12 E9 Air [Chemical (content]
13 E10 Air [Chemical (contamination)]
14 E11 Air [Physical (particles)]
15 E12 Air [Physical (color)]
16 E13 Air [Physical (density)]
17 E14 Air [Physical (dust)]
18 E15 Light
19 E16 Heat Stress
10 E17 Acoustics
11 E18 Vibration
F Biological 1 F1 Virology
2 F2 Bacteriology
3 F3 Biology
4 F4 Immunology
5 F5 Molecular Biology
6 F6 Parasitology
7 F7 Mycology
G Radioactivity/ 1 G1 Radioactivity Analysis
radiation 2 G2 Radiation Dose Measurement
H 1 H1 Concrete

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
2 H2 Cement
3 H3 Masonry
4 H4 Bituminous Materials
5 H5 Asphalts, Road Oils, & Tars
6 H6 Lime and Limestone
Construction 7 H7 Marble
Material 8 H8 Soils
9 H9 Doors & windows (Frames, Locks …)
10 H10 Gypsum
11 H11 Aggregate
12 H12 Ceramics
I General Products 1 I1 Adhesives and sealants
2 I2 Fasteners
3 I3 Agricultural
4 I4 Animal Products
5 I5 Foods (animal)
6 I6 Foods (vegetal food)
7 I7 Foods ( dietary)
8 I8 Foods (beverages)
9 I9 Animal Feeds
10 I10 Additives & Supplements
11 I11 Fertilizers
I12 Residues in food and agricultural
12
products
13 I13 Herbicides, Insecticides, & Pesticides
14 I14 Seeds & Grains
15 I15 Soil and Plant Analysis
16 I16 Fuels: (Gaseous)
17 I17 Fuels: (Liquid)
18 I18 Fuels: (Solid)
19 I19 Petroleum Products
20 I20 Coal
21 I21 Lubricants
22 I22 Soap & Detergents
23 I23 Drugs
24 I24 Ferrous Metals
25 I25 Non Ferrous Metals
26 I26 Polymers (Plastics, …)
27 I27 Rubber
28 I28 Leather
29 I29 Paints and Varnishes
30 I30 Textile, Fabrics
31 I31 Floor Covering (Carpet, ….)
32 I32 Pharmaceutics

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
33 I33 Paper
34 I34 Cigarettes & Tobacco
35 I35 Wood
36 I36 Glass
37 I37 Ores
38 I38 Coating
39 I39 Cables (Electrical)
40 I40 Cables (Telephone )
41 I41 Cables (LAN)
42 I42 Cables (Fiber Optics)
43 I43 Insulations Cables
44 I44 Car Spare parts
45 I45 Home Appliances
46 I46 Fire Protection Equipment
I47 Telecommunication Equipment (TV &
47 Radio)
48 I48 Air Conditioners
49 I49 Printing Material (Ink, Dye, …)
50 I50 Foam & Packing Materials
51 I51 Cosmetics
52 I52 Fats & Oils
53 I53 Toys
54 I54 Precious Metals
55 I55 Food Contact Materials
56 I56 Meters (Electrical)
57 I57 Meters (Water)
58 I58 Meters (Gas)
59 I59 Transformer
60 I60 Tire & wheel
61 I61 Drinking (Cups, Accessories, bottles, …..)
62 I62 Batteries
63 I63 House holding
64 I64 Switches, plugs and Sockets
65 I65 Lamps
I66 Luminaires & Electrical components
66 (Phototherapy, ….)
67 I67 Circuit Breaker
68 I68 Spark plug
69 I69 Glow Plug
70 I70 Filter (Oil)
71 I71 Filter ( Air)
72 I72 Footwear
73 I73 Motor
74 I74 Magnet Wire
75 I75 Gas Detectors

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Discipline Sub- Discipline

No Field
Code Name Code Group Name
76 I76 Cutlery and Table Houseware
77 I77 Pressure cookers
Other Scope (please
specify)

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No Fields Major Discipline Sub-Discipline

Code Name Code Name
5 Medical 1 Routine Chemistry
Laboratories
2 Blood gases
3 Hormones
4 Vitamin assays
5 Protein electrophoresis
A Clinical Chemistry 6 Special proteins
7 amino acids
8 Drug assay
9 Clinical toxicology
10 Toxic metals
11 Tumor markers
12 Emergency Clinical Chemistry
1 Routine hematology (CBC, HB, TLC.)
2 Specialized Hematology (CBC with Film)
B Hematology
3 Bone marrow examination
4 Immunohematology
1 Coagulation tests
2 Platelet function tests
C Coagulation
3 Coagulation Factors
4 Bleeding and clotting
1 Hemostasis and thrombosis
2 Hemoglobin electrophoresis
Specialized 3 Thalassemia
D
Hematology
4 Hemoglobinopathies
5 Hemoparasites
1 Leukemia and Lymphoma Immunophenotyping
2 Lymphocyte subsets
E Flow cytometry
3 Cell cycle analysis
4 Flowcytometry tests (CDs count)
1 Routine Immunology
2 Immunoglobulin and complement assay
3 Autoantibodies assay
4 Cellular function
F Immunology
5 Immunofixation electrophoresis
6 Isoelectric focusing
7 Tissue typing (HLA)
8 Hepatitis antibodies
5 1 Serology for infectious diseases
2 Serology for parasitic diseases
3 Antibodies to COVID-19
G Serology 4 Antibodies to Measles and mumps
5 Hepatitis
6 Mononucleosis
7 Autoimmune
1 Clinical Bacteriology
2 Mycology
H Microbiology
3 Tuberculosis
4 Mycobacteriology

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5 Virology (Culture)
1 Molecular microbiology
2 Molecular Chemistry
I Molecular Biology
3 Molecular Hematology
4 Molecular Immunology
1 Microarray tests
Molecular 2 Next Generation Sequencing tests
J
Diagnostics 3 DNA sequencing tests
4 Other tests
1 Molecular genetics
2 Immunogenetics
K Genetics 3 Metabolic Genetics
4 General Genetics
5 Pediatric Genetics
6 Prenatal Genetics
1 Histopathology (Processing, H&E stain)
2 Histopathology (Special stains)
3 Intraoperative frozen section
L 4 Cytopathology
5 Gynecologic
Anatomic Pathology 6 Non-gynecologic
7 Fine needle aspiration
8 Immunohistochemistry
9 Molecular Pathology
10 Immuoflorescence
11 Electron microscopic examination
5 Hematopathology
1
M Routine (Processing, H&E stain)
2 Special stains
3 Immunohistochemistry
1 Metabolite analysis
N 2 Enzymology
Metabolic Disorders
3 Newborn screening
4 Phenylketonuria (PKU)
1 Conventional Cytogenetic ( on Blood sample)
2 Conventional Cytogenetic (on Bone marrow
sample)
3 Conventional Cytogenetic (on Amniotic fluid
O sample)
Clinical Cytogenetic
4 Fluorescent In-Situ Hybridisation (Amniotic fluid)
5 Fluorescent In-Situ Hybridisation (Blood & Bone
marrow)
6 Pre-implantation genetic testing
7 Chromosome breakage
1 Drug assay (therapeutic drug monitoring ; TDM)
2 Narcotic Testing (screening & confirmation )
P Clinical Toxicology
3 Pesticide screening
4 Heavy Metal & Trace element assays

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5 Toxicological screen
1 Immunohematology (ABO group and Rh type)
2 Antibody Detection and identification
Q Blood Transfusion 3 Compatibility testing
4 Nucleic acid testing (NAT)
5 Molecular
1 Semen tests
2 Stool analysis
R Parasitology 3 Urine analysis
4 Blood parasites
5 Occult Blood Test (FOBT)
1 Blood gases
2 Blood Glucose
3 Urease
4 Toxicological screen
S Point of care testing
5 Urine strip tests
6 Intra-arterial needle puncture
7 Oxygen saturation tests
8 Hemo-Screen test

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No Fields Code Major Discipline Code Sub- Discipline

10 Forensic A Controlled/non- 1 Botanical material
Examination controlled 2 Controlled pharmaceutical and drugs
Substances 3 Related chemicals and paraphernalia
B Fingerprints 1 Fingerprints and finger marks
2 Palm prints
3 Footprints
C DNA Analysis 1 Animal DNA profiling
2 DNA profiling
3 Parentage testing
4 Body fluid identification
5 Mitochondrial DNA profiling
D Forensic Medicine 1 Cause of death determination
2 Examination of Injuries
3 Odontology
4 Crime Scene Investigators
5 Violence clinic
E Forensic 1 Histopathology
Pathology 2 Immunohistochemical Examination
3 Tissue Sample Selection
4 Toxin- and – Drug Induced Pathologies
5 Histopathology Special Intoxications
6 Alcohol Related Histopathology
Effect of Heat, Fire, Electricity, Lightning,
7
..Radiation and Gases
F Autopsy 1 Post Mortem Examination
2 Characterize The Extent of Disease States
3 Identify of Disease States
Cause and Manner of Death
G Toxicology 1 Alcohol
2 Pharmaceutical products
3 Drugs
4 Cigarettes & Tobacco
5 Poisons
H Trace Evidence 1 Acids
2 Alkalis
3 Botanical material
4 Components of technical or household appliance
5 Dyes and pigments
6 Feeding stuffs and ancillary items
7 Fibers and hair

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8 Soils
9 Plastics
10 Corrosives
11 Arson & fire evidence
12 Corrosives Cosmetics
13 Fertilizers
14 Electrical devices and components
15 Explosives and explosion debris
16 Pyrotechnic devices
17 Food
18 Glass
19 Lubricants and spermicidal agents
20 Pyrotechnic devices
21 Paints
22 Lachrymatory chemicals
23 Oils and greases
24 Light filaments
25 Hydrocarbon fuels
26 Manufacturers marks
27 Firearm discharge residues
28 Clothing/garments
I General Materials 1 Adhesives and sealants
2 Fasteners
3 Agricultural
4 Animal Products
5 Soil and Plant Analysis
J Food Toxicology Foods (animal & vegetal food, dietary,
1
beverages)
2 Animal Feeds
3 Additives & Supplements
4 Fertilizers
5 Residues in food and agricultural products
6 Herbicides, Insecticides, & Pesticides
7 Mineral Water
8 Seeds & Grains
K Fuels 1 Gaseous, Liquid, Solid
2 Petroleum Products
3 Coal
4 Lubricants
5 Oil & Soap
L Metals 1 Ferrous Metals
2 Non Ferrous Metals
3 Plastics & Polymers

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4 Rubber & rubber products

5 Leather
6 Paint
7 Textile
8 Carpet & Floor Covering
9 Paper
M General Materials 1 Wood
2 Glass
3 Coating
4 Electrical Cables & Insulations
5 Car Spare parts
6 Home Appliances
7 Fire Protection Equipment
8 Telecommunication Equipment (TV & Radio)
9 Air Conditioners
10 Lighting
11 Foam & Packing Materials
N Environmental 1 Potable Water (organisms, organic)
Tests 2 Non-potable (Sea Water, Irrigation)
3 Fertilisers Waste Water (industrial, agricultural)
4 Water Sediments & Mussels
5 Radiochemistry
6 Solid/Hazardous Waste
7 Lead
8 Pyrotechnic devices
9 Air [Chemical (content, contamination) &
Physical (particles, color, density)
O Scene 1 Scene of crime investigation
Investigation 2 Fire investigation
3 Blood pattern analysis
4 Bullet trajectory
5 Photography
6 Chemical, Biological, Radioactive, Nuclear
Handwriting and 1 Copiers and copied material
P Document 2 Handwriting
Examination 3 Inks and printing materials
4 Printers and other printed objects
5 Security marks
6 Embossing and embossed materials
7 Indentations paper
8 Rubber stamps
9 Typewriters and typewritten material
Q Firearms and 1 Bullets and cartridges
ballistics 2 Gunshot residue

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3 Entomology, Botany, Archaeology,

Anthropology
4 Firearms
5 Stun Guns
6 Arson – Fire Investigation
7 Distance determination
8 Database (NIBIN, others)
9 Serial number restoration
10 Ammunition
R Digital Analysis 1 Speech, audio and video analysis Biometrics
2 Computers (hardware and software)
3 Image enhancement
4 Recovery of information from electronic
devices and media
5 Automated skull reconstruction and aging
simulation
6 CCTV
7 Facial Mapping
8 Mobile computerized devices (including phone,
GPS, PDA)
S Marks and 1 Damage examination
Impressions 2 Glove marks
3 Shoe marks
4 Tyre mark
5 Fabric impression
6 Non-friction ridge body marks Tool
7 marks and impressions
T Vehicles and 1 Component failures including light bulbs
Vehicle Accident 2 Electrical failures
Investigation 3 Speed calculations
4 Trajectory determination
5 Car immobilizer systems
6 Erased markings
7 Tachograph charts
8 Tyre examination
W Entomology, 1 Entomology, Botany, Archaeology,
Botany, Anthropology
Archaeology,
Anthropology
X Environment. 1 Environmental protection
Safety 2 Wastes
3 Air quality
4 Water quality
5 Soil quality
6 Occupational safety

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7 Safety of machinery
8 Domestic safety
9 Noise
10 Accident and disaster control
11 Protection against fire
12 Explosion protection
13 Protection against pressure
14 Protection against electric shock
15 Radiation protection
16 Prot. against dangerous goods
17 Protection against crime
18 Alarm and warning systems
19 Protective equipment

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