This document is used by the American Accreditation Assosiation (AAA) and applicants for PTP accreditation to conduct an ISO/IEC

17043:2010
document review.

FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
4 Technical Requirements
4.1 General
The development and operation of proficiency testing schemes shall be undertaken by
proficiency testing providers having competence to conduct interlaboratory comparisons
and access to expertise with the particular type of proficiency test items. Proficiency
testing providers or their subcontractors shall also have competence in the measurement
of the properties being determined.
4.2 Personnel
4.2.1 The proficiency testing provider shall have managerial and technical personnel with the
necessary authority, resources and technical competence required to perform their duties.
4.2.2 The proficiency testing provider's management shall define the minimum levels of
qualification and experience necessary for the key positions within its organization and
ensure those qualifications are met.
4.2.3 The proficiency testing provider shall use personnel who are either employed by, or
under contract to it. Where contracted and additional technical and key support personnel
are used, the proficiency testing provider shall ensure that such personnel are supervised
and competent and that they work in accordance with the management system.
4.2.4 The proficiency testing provider shall authorize specific personnel to:
a) select appropriate proficiency test items;
b) plan proficiency testing schemes;
c) perform particular types of sampling;
d) operate specific equipment;
e) conduct measurements to determine stability and homogeneity, as well as assigned
values and associated uncertainties of the measurands of the proficiency test item;
f) prepare, handle and distribute proficiency test items;

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 1 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
g) operate the data processing system;
h) conduct statistical analysis;
i) evaluate the performance of proficiency testing participants;
j) give opinions and interpretations; and
k) authorize the issue of proficiency testing reports.
4.2.5 The proficiency testing provider shall maintain up-to-date records of the relevant
authorization(s), competence, educational and professional qualifications, training, skills
and experience of all technical personnel, including contracted personnel. This
information shall be readily available and shall include the date on which competence to
perform their assigned tasks was assessed and confirmed.
4.2.6 The proficiency testing provider shall formulate the objectives with respect to the
education, training, and skills for each staff member involved with the operation of the
proficiency testing scheme. The proficiency testing provider shall have a policy and
procedures for identifying training needs and providing training of personnel. The
training programme shall be relevant to the present and anticipated needs of the
proficiency testing provider.
4.2.7 The proficiency testing provider shall ensure that staff receive the necessary training to
ensure competent performance of measurements, operation of equipment and any other
activities which affect the quality of the proficiency testing scheme. The effectiveness of
training activities shall be evaluated.
4.3 Equipment, accommodation and environment
4.3.1 The proficiency testing provider shall ensure that there is appropriate accommodation for
the operation of the proficiency testing scheme. This includes facilities and equipment
for proficiency test item manufacturing, handling, calibration, testing, storage and
despatch, for data processing, for communications, and for retrieval of materials and
records.
4.3.2 The proficiency testing provider shall ensure that the environmental conditions do not
compromise the proficiency testing scheme or the required quality of operations.
Particular care shall be taken when operations are undertaken at sites away from the

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 2 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
proficiency testing provider's permanent facilities or are undertaken by subcontractors.
The technical requirements for accommodation and environmental conditions that can
affect the proficiency testing shall be documented.
4.3.3 Access to and use of areas affecting the quality of proficiency testing schemes shall be
controlled. The proficiency testing provider shall determine the extent of control based
on its particular circumstances.
4.3.4 The proficiency testing provider shall identify environmental conditions that can
significantly influence
the quality of the proficiency test items and any testing and calibration carried out,
including conditions that are required by relevant specifications and measurement
procedures. The proficiency testing provider shall control and monitor these conditions,
and shall record all relevant monitoring activities. Relevant proficiency testing activities
shall be stopped when the environmental conditions jeopardize the quality or the
operations of the proficiency testing scheme.
4.3.5 There shall be effective separation between neighbouring areas in which there are
incompatible activities. Action shall be taken to prevent cross-contamination.
4.3.6 Proficiency testing providers shall ensure that performance characteristics of laboratory
methods and equipment used to confirm the content, homogeneity and stability of
proficiency testing items are appropriately validated and maintained.
4.4 Design of proficiency testing schemes
4.4.1 Planning
4.4.1.1 The proficiency testing provider shall identify and plan those processes which directly
affect the quality of the proficiency testing scheme and shall ensure that they are carried
out in accordance with prescribed procedures.
4.4.1.2 The proficiency testing provider shall not subcontract the planning of the proficiency
testing scheme (see 5.5.2).
4.4.1.3 The proficiency testing provider shall document a plan before commencement of the
proficiency testing scheme that addresses the objectives, purpose and basic design of the
proficiency testing scheme, including the following information and, where appropriate,
reasons for its selection or exclusion:
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 3 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
a) the name and address of the proficiency testing provider;
b) the name, address and affiliation of the coordinator and other personnel involved in the
design and operation of the proficiency testing scheme;
c) the activities to be subcontracted and the names and addresses of subcontractors involved
in the operation of the proficiency testing scheme;
d) criteria to be met for participation;
e) the number and type of expected participants in the proficiency testing scheme;
f) selection of the measurand(s) or characteristic(s) of interest, including information on
what the participants are to identify, measure, or test for in the specific proficiency
testing round;
g) a description of the range of values or characteristics, or both, to be expected for the
proficiency test items;
h) the potential major sources of errors involved in the area of proficiency testing offered;
i) requirements for the production, quality control, storage and distribution of proficiency
test items;
j) reasonable precautions to prevent collusion between participants or falsification of
results, and procedures to be employed if collusion or falsification of results is suspected;
k) a description of the information which is to be supplied to participants and the time
schedule for the various phases of the proficiency testing scheme;
l) for continuous proficiency testing schemes, the frequency or dates upon which
proficiency test items are to be distributed to participants, the deadlines for the return of
results by participants and, where appropriate, the dates on which testing or measurement
is to be carried out by participants;
m) any information on methods or procedures which participants need to use to prepare the
test material and perform the tests or measurements;
n) procedures for the test or measurement methods to be used for the homogeneity and
stability testing of proficiency test items and, where applicable, to determine their
biological viability;
o) preparation of any standardized reporting formats to be used by participants;

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 4 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
p) a detailed description of the statistical analysis to be used;
q) the origin, metrological traceability and measurement uncertainty of any assigned values;
r) criteria for the evaluation of performance of participants;
s) a description of the data, interim reports or information to be returned to participants;
t) a description of the extent to which participant results, and the conclusions that will be
based on the outcome of the proficiency testing scheme, are to be made public; and
u) actions to be taken in the case of lost or damaged proficiency test items.
4.4.1.4 The proficiency testing provider shall have access to the necessary technical expertise
and experience in the relevant field of testing, calibration, sampling or inspection, as well
as statistics. This may be achieved, if necessary, by establishing an advisory group
(named as appropriate).
4.4.1.5 Technical expertise shall be used, as appropriate, to determine matters such as the
following:
a) planning requirements as listed in 4.4.1.3;
b) identification and resolution of any difficulties expected in the preparation and
maintenance of homogeneous proficiency test items, or in the provision of a stable
assigned value for a proficiency test item;
c) preparation of detailed instructions for participants;
d) comments on any technical difficulties or other remarks raised by participants in
previous proficiency testing rounds;
e) provision of advice in evaluating the performance of participants;
f) comments on the results and performance of participants as a whole and, where
appropriate, groups of participants or individual participants;
g) provision of advice for participants (within limits of confidentiality), either individually
or within the report;
h) responding to feedback from participants; and
i) planning or participating in technical meetings with participants.
4.4.2 Preparation of proficiency test items
4.4.2.1 The proficiency testing provider shall establish and implement procedures to
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 5 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
ensure that proficiency test items are prepared in accordance with the plan
described in 4.4.1.
4.4.2.2 The proficiency testing provider shall establish and implement procedures to
ensure appropriate acquisition, collection, preparation, handling, storage and,
where required, disposal of all proficiency test items. The procedures shall
ensure that materials used to manufacture proficiency test items are obtained in
accordance with relevant regulatory and ethical requirements.
4.4.2.3 Proficiency test items should match in terms of matrix, measurands and
concentrations, as closely as practicable, the type of items or materials
encountered in routine testing or calibration.
4.4.2.4 In proficiency testing schemes that require participants to prepare or
manipulate, or both prepare
and manipulate, the proficiency test item and submit it to the proficiency testing
provider, the proficiency testing provider shall issue instructions for
preparation, packaging and transport of the proficiency test item.
4.4.3 Homogeneity and stability
4.4.3.1 Criteria for suitable homogeneity and stability shall be established and shall be based on
the effect that inhomogeneity and instability will have on the evaluation of the
participants' performance.
4.4.3.2 The procedures for the assessment of homogeneity and stability shall be documented and
conducted, where applicable, in accordance with appropriate statistical designs. Where
possible, the proficiency testing provider shall use a statistically random selection of a
representative number of proficiency test items from the whole batch of test material in
order to assess the homogeneity of the material.
4.4.3.3 The assessment of homogeneity shall normally be performed after the proficiency test
items have been packaged in the final form and before distribution to participants unless,
for example, stability studies indicate that they should be stored in bulk form.
4.4.3.4 Proficiency test items shall be demonstrated to be sufficiently stable to ensure that they

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 6 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
will not undergo any significant change throughout the conduct of the proficiency
testing, including storage and transport conditions. When this is not possible, the stability
shall be quantified and considered as an additional component of the measurement
uncertainty associated with the assigned value of the proficiency test item, and/or taken
into account in the evaluation criteria.
4.4.3.5 When proficiency test items from previous rounds are retained for future use, the
property values to be determined in the proficiency testing scheme shall be confirmed by
the proficiency testing provider prior to distribution.
4.4.3.6 In circumstances where homogeneity and stability testing is not feasible, the proficiency
testing provider shall demonstrate that the procedures used to collect, produce, package
and distribute the proficiency test items are sufficient for the purpose of the proficiency
testing.
4.4.4 Statistical design
4.4.4.1 Statistical designs shall be developed to meet the objectives of the scheme, based on the
nature of the data (quantitative or qualitative, including ordinal and categorical),
statistical assumptions, the nature of errors, and the expected number of results (see
B.3.2.2).
4.4.4.2 The proficiency testing provider shall document the statistical design and data analysis
methods to be used to identify the assigned value and evaluate participant results, and
shall provide a description of the reasons for their selection and assumptions upon which
they are based. The proficiency testing provider shall be able to demonstrate that
statistical assumptions are reasonable and that statistical analyses are carried out in
accordance with prescribed procedures.
4.4.4.3 In designing a statistical analysis, the proficiency testing provider shall give careful
consideration to the following:
a) the accuracy (trueness and precision) as well as the measurement uncertainty required or
expected for each measurand or characteristic in the proficiency testing;
b) the minimum number of participants in the proficiency testing scheme needed to meet
the objectives of the statistical design; in cases where there is an insufficient number of
participants to meet these objectives or to produce statistically meaningful analysis of
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 7 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
results, the proficiency testing provider shall document, and provide to participants,
details of the alternative approaches used to assess participant performance;
c) the relevance of significant figures to the reported result, including the number of
decimal places;
d) the number of proficiency test items to be tested or measured and the number of repeat
tests, calibrations or measurements to be conducted on each proficiency test item or for
each determination;
e) the procedures used to establish the standard deviation for proficiency assessment or
other evaluation criteria;
f) procedures to be used to identify or handle outliers, or both;
g) where relevant, the procedures for the evaluation of values excluded from statistical
analysis; and
h) where appropriate, the objectives to be met for the design and the frequency of
proficiency testing rounds.
4.4.5 Assigned values
4.4.5.1 The proficiency testing provider shall document the procedure for determining the
assigned values for the measurands or characteristics in a particular proficiency testing
scheme. This procedure shall take into account the metrological traceability and
measurement uncertainty required to demonstrate that the proficiency testing scheme is
fit for its purpose.
4.4.5.2 Proficiency testing schemes in the area of calibration shall have assigned values with
metrological traceability, including measurement uncertainty.
4.4.5.3 For proficiency testing schemes in areas other than calibration, the relevance, needs and
feasibility for metrological traceability and associated measurement uncertainty of the
assigned value shall be determined by taking into account specified requirements of
participants or other interested parties, or by the design of the proficiency testing scheme.
4.4.5.4 When a consensus value is used as the assigned value (see Annex B), the proficiency
testing provider shall document the reason for that selection and shall estimate the
uncertainty of the assigned value as described in the plan for the proficiency testing

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 8 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
scheme.
4.4.5.5 The proficiency testing provider shall have a policy regarding the disclosure of assigned
values. The policy shall ensure that participants cannot gain advantage from early
disclosure.
4.5 Choice of method or procedure
4.5.1 Participants shall normally be expected to use the test method, calibration or
measurement procedure of their choice, which should be consistent with their routine
procedures. The proficiency testing provider may instruct participants to use a specified
method in accordance with the design of the proficiency testing scheme.
4.5.2 Where participants are permitted to use a method of their choice, the proficiency testing
provider shall:
a) have a policy and follow a procedure regarding comparison of results obtained by
different test or measurement methods;
b) be aware of which different test or measurement methods for any measurand are
technically equivalent, and take steps to assess participants' results using these methods
accordingly.
4.6 Operation of proficiency testing schemes
4.6.1 Instructions for participants
4.6.1.1 The proficiency testing provider shall give participants sufficient prior notice before
sending proficiency test items, providing the date on which the proficiency test items are
likely to arrive or to be despatched, unless the design of the proficiency testing scheme
makes it inappropriate to do so.
4.6.1.2 The proficiency testing provider shall give detailed documented instructions to all
participants. Instructions to participants shall include:
a) the necessity to treat proficiency test items in the same manner as the majority of
routinely tested samples (unless there are particular requirements of the proficiency
testing scheme which require departure from this principle);
b) details of factors which could influence the testing or calibration of the proficiency test
items, e.g. the nature of the proficiency test items, conditions of storage, whether the

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 9 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
proficiency testing scheme is limited to selected test methods, and the timing of the
testing or measurement;
c) detailed procedure for preparing or conditioning, or both preparing and conditioning, of
the proficiency test items before conducting the tests or calibrations;
d) any appropriate instructions on handling the proficiency test items, including any safety
requirements;
e) any specific environmental conditions for the participant to conduct tests or calibrations,
or both, and, if relevant, any requirement for the participants to report relevant
environmental conditions during the time of the measurement;
f) specific and detailed instructions on the manner of recording and reporting test or
measurement results and associated uncertainties. If the instructions include reporting of
the uncertainty of the reported result or measurement, this shall include the coverage
factor and, whenever practicable, the coverage probability;
g) the latest date for the provider to receive the proficiency testing or measurement results
for analysis;
h) information on the contact details of the proficiency testing provider for enquiries; and
i) instructions on return of the proficiency test items, when applicable.
4.6.2 Proficiency test items handling and storage
4.6.2.1 The proficiency testing provider shall ensure that proficiency test items are
appropriately identified and segregated and cannot become contaminated or
degraded, from the time of preparation to their distribution to participants.
4.6.2.2 The proficiency testing provider shall provide secure storage areas or stock
rooms, or both, which prevent damage or deterioration of any proficiency test
item between preparation and distribution. Appropriate procedures for
authorizing despatch to, and receipt from, such areas shall be defined.
4.6.2.3 When appropriate, the condition of stored or stocked proficiency test items,
chemicals and materials shall be assessed at specified intervals during their
storage life in order to detect possible deterioration.

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 10 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
4.6.2.4 Where potentially hazardous proficiency test items, chemicals and materials are
used, facilities shall be available to ensure their safe handling, decontamination
and disposal.
4.6.3 Packaging, labelling and distribution of proficiency test items
4.6.3.1 The proficiency testing provider shall control packaging and labelling processes to the
extent necessary to ensure conformity with relevant national, regional, or international
safety and transport requirements.
4.6.3.2 The proficiency testing provider shall specify relevant environmental conditions for the
transport of proficiency test items. Where relevant, the proficiency testing provider shall
monitor the pertinent environmental conditions of the proficiency test item during
transport and assess the impact of environmental influences on the proficiency test item.
4.6.3.3 In proficiency testing schemes where participants are required to transport the
proficiency test items to other participants, documented instructions for this transport
shall be supplied.
4.6.3.4 The proficiency testing provider shall ensure that labels are securely attached to the
packaging of individual proficiency test items and are designed to remain legible and
intact throughout the proficiency testing round.
4.6.3.5 The proficiency testing provider shall follow a procedure to enable the confirmation of
delivery of the proficiency test items.
4.7 Data analysis and evaluation of proficiency testing scheme results
4.7.1 Data analysis and records
4.7.1.1 All data processing equipment and software shall be validated in accordance with
procedures before being brought into use. Computer system maintenance shall include a
back-up process and system recovery plan. The results of such maintenance and
operational checks shall be recorded.
4.7.1.2 Results received from participants shall be recorded and analysed by appropriate
methods. Procedures shall be established and implemented to check the validity of data
entry, data transfer, statistical analysis, and reporting.
4.7.1.3 Data analysis shall generate summary statistics and performance statistics, and associated

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 11 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
information consistent with the statistical design of the proficiency testing scheme.
4.7.1.4 The influence of outliers on summary statistics shall be minimized by the use of robust
statistical methods or appropriate tests to detect statistical outliers.
4.7.1.5 The proficiency testing provider shall have documented criteria and procedures for
dealing with test results that may be inappropriate for statistical evaluation, e.g.
miscalculations, transpositions and other gross errors.
4.7.1.6 The proficiency testing provider shall have documented criteria and procedures to
identify and manage proficiency test items that have been distributed and are
subsequently found to be unsuitable for performance evaluation, e.g. because of
inhomogeneity, instability, damage or contamination.
4.7.2 Evaluation of performance
4.7.2.1 The proficiency testing provider shall use valid methods of evaluation which meet the
purpose of the proficiency testing scheme. The methods shall be documented and include
a description of the basis for the evaluation. The evaluation of performance shall not be
subcontracted (see 5.5.2).
4.7.2.2 Where appropriate for the purpose of the proficiency testing scheme, the proficiency
testing provider shall provide expert commentary on the performance of participants with
regard to the following:
a) overall performance against prior expectations, taking measurement uncertainties into
account;
b) variation within and between participants, and comparisons with any previous
proficiency testing rounds, similar proficiency testing schemes, or published precision
data;
c) variation between methods or procedures;
d) possible sources of error (with reference to outliers) and suggestions for improving
performance;
e) advice and educational feedback to participants as part of the continual improvement
procedures of participants;
f) situations where unusual factors make evaluation of results and commentary on

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 12 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
performance impossible;
g) any other suggestions, recommendations or general comments; and
h) conclusions.
4.8 Reports
4.8.1 Proficiency test reports shall be clear and comprehensive and include data covering the
results of all
participants, together with an indication of the performance of individual participants.
The authorization of the final report shall not be subcontracted (see 5.5.2).
4.8.2 Reports shall include the following, unless it is not applicable or the proficiency testing
provider has valid reasons for not doing so:
a) the name and contact details for the proficiency testing provider;
b) the name and contact details for the coordinator;
c) the name(s), function(s), and signature(s) or equivalent identification of person(s)
authorizing the report;
d) an indication of which activities are subcontracted by the proficiency testing provider;
e) the date of issue and status (e.g. preliminary, interim, or final) of the report;
f) page numbers and a clear indication of the end of the report;
g) a statement of the extent to which results are confidential;
h) the report number and clear identification of the proficiency testing scheme;
i) a clear description of the proficiency test items used, including necessary details of the
proficiency test item's preparation and homogeneity and stability assessment;
j) the participants' results;
k) statistical data and summaries, including assigned values and range of acceptable results
and graphical displays;
l) procedures used to establish any assigned value;
m) details of the metrological traceability and measurement uncertainty of any assigned
value;
n) procedures used to establish the standard deviation for proficiency assessment, or other
criteria for evaluation;

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 13 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
o) assigned values and summary statistics for test methods/procedures used by each group
of participants (if different methods are used by different groups of participants);
p) comments on participants' performance by the proficiency testing provider and technical
advisers;
q) information about the design and implementation of the proficiency testing scheme;
r) procedures used to statistically analyse the data;
s) advice on the interpretation of the statistical analysis; and
t) comments or recommendations, based on the outcomes of the proficiency testing round.
4.8.3 Reports shall be made available to participants within planned timescales. In sequential
proficiency testing schemes, e.g. where the turn-around time may be very long, and in
schemes involving perishable materials, preliminary or anticipated results may be
provided before final results are disclosed.
4.8.4 The proficiency testing provider shall have a policy for the use of reports by individuals
and organizations.
4.8.5 When it is necessary to issue a new or amended report for a proficiency testing scheme,
this shall include the following:
a) a unique identification;
b) a reference to the original report that it replaces or amends; and
c) a statement concerning the reason for the amendment or re-issue.
4.9 Communication with participants
4.9.1 The proficiency testing provider shall make detailed information available about the
proficiency testing scheme. This shall include:
a) relevant details of the scope of the proficiency testing scheme;
b) any fees for participation;
c) documented eligibility criteria for participation;
d) confidentiality arrangements; and
e) details of how to apply.
4.9.2 Participants shall be advised promptly by the proficiency testing provider of any changes
in proficiency testing scheme design or operation.

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 14 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
4.9.3 There shall be documented procedures for enabling participants to appeal against the
evaluation of their performance in a proficiency testing scheme. The availability of this
process shall be communicated to proficiency testing scheme participants.
4.9.4 Relevant records of communications with participants shall be maintained and retained,
as appropriate.
4.9.5 If the proficiency testing provider issues statements of participation or performance, they
shall contain sufficient information to not be misleading.
4.10 Confidentiality
4.10.1 The identity of participants in a proficiency testing scheme shall be confidential and
known only to persons involved in the operation of the proficiency testing scheme,
unless the participant waives confidentiality.
4.10.2 All information supplied by a participant to the proficiency testing provider shall be
treated as confidential.
4.10.3 When an interested party requires the proficiency testing results to be directly provided
by the proficiency testing provider, the participants shall be made aware of the
arrangement in advance of participation.
4.10.4 In exceptional circumstances, when a regulatory authority requires proficiency testing
results to be directly provided to the authority by the proficiency testing provider, the
affected participants shall be notified of this action in writing.
5 Management requirements
5.1 Organization
5.1.1 The proficiency testing provider, or the organization of which it is part, shall be an entity
that is legally identifiable and accountable.
5.1.2 It is the responsibility of the proficiency testing provider to carry out its proficiency
testing operations in such a way as to meet the requirements of this International
Standard and to satisfy the needs of the participants, regulatory authorities and
organizations providing recognition.
5.1.3 The management system shall cover work carried out in the proficiency testing
provider's permanent facilities, at sites away from its permanent facilities, and in

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 15 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
associated temporary facilities.
5.1.4 If the proficiency testing provider is part of an organization performing other activities,
then the proficiency testing provider shall identify the responsibilities of key personnel in
the organization that have an involvement in or could have influence on the proficiency
test activities, in order to identify potential conflicts of interest. Where potential conflicts
of interest are identified, procedures shall be put in place to ensure that all activities of
the proficiency testing provider are conducted with impartiality.
5.1.5 The proficiency testing provider shall:
a) have managerial and technical personnel who, irrespective of other responsibilities, have
the authority and resources needed to carry out their duties, including the
implementation, maintenance and improvement of the management system, and to
identify the occurrence of departures from the management system or from the
procedures for providing proficiency testing schemes, and to initiate actions to prevent or
minimize such departures;
b) have arrangements to ensure that its management and personnel are free from any undue
internal or external commercial, financial and other pressures that may adversely affect
the quality of their work;
c) have policies and procedures to ensure the protection of its participants' confidential
information and proprietary rights, including procedures for their protection during
electronic storage and transmission;
d) have policies and procedures to avoid involvement in any activities that might diminish
confidence in its competence, impartiality, judgement or operational integrity;
e) define the organization and management structure, its place in any parent organization,
and the relationships between quality management, technical operations and support
services;
f) specify the responsibility, authority, interrelationships and required competence of all
personnel who manage, perform or verify work affecting the quality of the operation of
proficiency testing schemes;
g) ensure that the personnel are aware of the relevance and importance of their activities
and how they contribute to the achievement of the objectives of the management system;
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 16 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
h) provide adequate supervision of technical staff, including trainees, by persons familiar
with procedures for each activity;
i) have technical management which has overall responsibility for the technical operations
and the provision
of the resources needed to ensure the required quality of proficiency testing schemes,
including access to the necessary technical expertise and experience in the relevant field
of testing, calibration or inspection, as well as statistics, as indicated in 4.4.1.4;
j) appoint a member of staff as quality manager (named as appropriate) who, irrespective
of other duties and responsibilities, shall have defined responsibility and authority for
ensuring that the management system is implemented and followed at all times; the
quality manager shall have direct access to the highest level of management at which
decisions are taken on the proficiency testing provider's policies or resources; and
k) appoint deputies for key managerial personnel.
5.1.6 Top management shall ensure that appropriate communication processes are established
within the organization and that communication takes place regarding the effectiveness
of the management system.
5.2 Management system
5.2.1 The proficiency testing provider shall establish, implement and maintain a management
system appropriate to its scope of activities, including the type, range and volume of
proficiency testing that it provides.
5.2.2 The proficiency testing provider shall define and document its policies, programmes,
procedures and instructions to the extent necessary to assure the quality of all aspects of
proficiency testing. The system's documentation shall be communicated to, understood
by, available to, and implemented by the appropriate personnel.
5.2.3 The proficiency testing provider's management system policies related to quality,
including a quality policy statement, shall be defined in a quality manual (named as
appropriate). The overall objectives shall be established and reviewed during
management review. The quality policy statement shall be issued under the authority of
top management. It shall include at least the following:
a) the management's commitment to the quality of its proficiency testing services to
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 17 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
participants and other customers;
b) the management's statement of the standard of service;
c) the purpose of the management system related to quality;
d) a requirement that all personnel concerned with the proficiency testing activities
familiarize themselves with the quality documentation and implement the policies and
procedures in their work; and
e) the management's commitment to comply with this International Standard and to
continually improve the effectiveness of the management system.
5.2.4 Top management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness.
5.2.5 Top management shall communicate to the organization the importance of meeting
customer requirements, as well as statutory and regulatory requirements.
5.2.6 The quality manual shall include or make reference to the supporting procedures,
including technical procedures. It shall outline the structure of the documentation used in
the management system.
5.2.7 The roles and responsibilities of technical management and the quality manager,
including their responsibility for ensuring compliance with this International Standard,
shall be defined in the quality manual.
5.2.8 Top management shall ensure that the integrity of the management system is maintained
when changes to the management system are planned and implemented.
5.3 Document control
5.3.1 General
The proficiency testing provider shall establish and maintain procedures to control all
documents that form part of its management system (internally generated, or from
external sources), such as regulations, standards, other normative documents, proficiency
testing scheme protocols, test or calibration methods, or both test and calibration
methods, as well as drawings, software specifications, instructions and manuals.
5.3.2 Document approval and issue

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 18 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
5.3.2.1 All documents issued as part of the management system shall be reviewed and approved
for use by authorized personnel prior to issue. A master list or equivalent document
control procedure identifying the current revision status and distribution of documents in
the management system shall be established and be readily available, in order to prevent
the use of invalid or obsolete documents, or both.
5.3.2.2 The procedures adopted shall also ensure that:
a) authorized editions of appropriate documents are available at all locations where
activities essential to the effective operation of proficiency testing schemes are
performed;
b) documents are periodically reviewed and updated, as necessary, to ensure continuing
suitability and compliance with applicable requirements;
c) invalid or obsolete documents are promptly removed from all points of issue or use, or
otherwise assured against unintended use; and
d) obsolete documents retained for either legal or knowledge preservation purposes are
suitably marked.
5.3.2.3 Management system documents generated by the proficiency testing provider shall be
uniquely identified. Such identification shall include the date of issue or revision
identification, or both, page numbering, the total number of pages or a mark to signify
the end of a document, and the issuing authority/authorities.
5.3.3 Document changes
5.3.3.1 Changes to documents shall be reviewed and approved by the same function that
performed the original review and approval, unless specifically designated otherwise.
The designated personnel shall have access to pertinent background information upon
which to base their review and approval.
5.3.3.2 Where practicable, the altered or new text shall be identified in the document or the
appropriate attachments.
5.3.3.3 If the proficiency testing provider's document control system allows for the amendment
of documents by hand, pending re-issue of the documents, the procedures and authorities
for such amendments shall be defined. Amendments shall be clearly marked, initialled

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 19 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
and dated. A revised document shall be issued as soon as practicable.
5.3.3.4 Procedures shall be established to describe how changes in documents maintained in
computerized systems are made and controlled.
5.4 Review of requests, tenders, and contracts
5.4.1 The proficiency testing provider shall establish and maintain policies and procedures for
the review of requests, tenders and contracts. These reviews shall ensure that:
a) the requirements, including those for test and calibration methods, measuring equipment
and proficiency test items to be used, are adequately defined, documented and
understood;
b) the proficiency testing provider has the capability and resources to meet the
requirements; and
c) the proficiency testing scheme is technically appropriate.
5.4.2 Records of such reviews, including any changes, shall be maintained. Records shall also
be maintained of pertinent discussions with a customer relating to the customer's
requirements, or the results of the work during the period of execution of the contract, or
both.
5.4.3 The review shall cover all aspects of the request, including any work that is
subcontracted by the proficiency testing provider.
5.4.4 The participants and other customers, as appropriate, shall be informed of any deviation
in the contract or agreed proficiency testing scheme design.
5.4.5 If a request or contract is amended after the proficiency testing scheme is underway, the
same review process shall be repeated and any amendments shall be communicated to all
affected personnel.
5.5 Subcontracting services
5.5.1 When a proficiency testing provider subcontracts work, the proficiency testing
provider shall demonstrate that the subcontractors' experience and technical
competence are sufficient for their assigned tasks and that they comply with the
relevant clauses of this International Standard and other appropriate standards.
5.5.2 The proficiency testing provider shall not subcontract the planning of the
ISO/IEC 17043 checklist Document No. F-PT-02
Issue 01

PT providers Accreditation Section Page 20 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
proficiency test scheme (see 4.4.1.2), the evaluation of performance (see
4.7.2.1) or the authorization of the final report (see 4.8.1).
5.5.3 The proficiency testing provider shall inform participants, in advance and in
writing, of services that are, or may be, subcontracted.
5.5.4 The proficiency testing provider shall be responsible to the participants and
other customers for the subcontractor's work, except in the case where a
regulatory authority specifies which subcontractor is to be used.
5.5.5 The proficiency testing provider shall maintain a register of all subcontractors
used in the operation of
proficiency testing schemes, including the scope of subcontracting and a record
of the competence assessment against relevant parts of this International
Standard and other appropriate standards for the work in question.
5.6 Purchasing services and supplies
5.6.1 The proficiency testing provider shall have a policy and procedure(s) for the selection of
services and supplies that it uses and that affect the quality of its proficiency testing
schemes. Procedures shall exist for the purchase, reception and storage of reagents,
proficiency test items, reference materials and other consumable materials relevant for
the proficiency testing schemes.
5.6.2 The proficiency testing provider shall ensure that purchased supplies, equipment and
consumable materials that affect the quality of proficiency testing schemes are not used
until they have been inspected or otherwise verified as complying with specifications or
requirements. Records of actions taken to check compliance shall be maintained.
5.6.3 Purchasing documents for items affecting the quality of proficiency testing schemes shall
contain data describing the services and supplies ordered. These purchasing documents
shall be reviewed and approved for technical content prior to release.
5.6.4 The proficiency testing provider shall evaluate suppliers of critical supplies and services
which affect the quality of proficiency testing schemes. The proficiency testing provider
shall maintain records of these evaluations, and list those suppliers that are approved.

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 21 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
5.7 Service to the customers
5.7.1 The proficiency testing provider shall be willing to cooperate with participants and other
customers in
clarifying customers' requests and in monitoring the proficiency testing provider's
performance in relation to the work performed, provided that the proficiency testing
provider assures confidentiality to its participants.
5.7.2 The proficiency testing provider shall seek feedback, both positive and negative, from its
customers. The feedback shall be used and analysed to improve the management system,
proficiency testing schemes, and customer service.
5.8 Complaints and appeals
The proficiency testing provider shall have a policy and follow a procedure for the
resolution of complaints and appeals received from participants, customers or other
parties. Records shall be maintained of all complaints, appeals, investigations and
corrective actions taken by the proficiency testing provider.
5.9 Control of nonconforming work
5.9.1 The proficiency testing provider shall have a policy and procedure(s) that shall be
implemented when any aspect of its activities does not conform to its own procedures or
the agreed requirements of its customers. The policy and procedure(s) shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting work of ongoing programmes and withholding
reports, as necessary) are defined and taken when nonconforming work is identified;
b) an evaluation of the significance of the nonconforming work is made;
c) a decision on the need for action and timescale is taken immediately, together with any
decision about the acceptability of the nonconforming work;
d) proficiency testing scheme participants and other customers, as appropriate, are informed
and the nonconforming proficiency test items or reports already sent to participants are
recalled or disregarded; and
e) the responsibility for authorization of the resumption of work is defined.
5.9.2 Where the evaluation indicates that nonconforming work could recur or that there is

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 22 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
doubt about the compliance of the proficiency testing provider or subcontractor with
their own policies and procedures, the corrective action procedure in 5.11 shall be
promptly followed.
5.10 Improvement
The proficiency testing provider shall continually improve the effectiveness of its
management system through the use of the quality policy, quality objectives, audit
results, analysis of data, corrective and preventive actions and management review.
5.11 Corrective actions
5.11.1 General
The proficiency testing provider shall establish a policy and procedure(s) and shall
designate appropriatepersonnel for implementing corrective actions when
nonconforming work or departures from the policies and procedures in the management
system or technical operations have been identified.
5.11.2 Cause analysis
The procedure for corrective action shall start with an investigation to determine the root
cause(s) of the problem.
5.11.3 Selection and implementation of corrective actions
5.11.3.1 Where corrective action is needed, the proficiency testing provider shall identify
potential corrective actions. It shall select and implement the action(s) most likely to
eliminate the problem and to prevent recurrence.
5.11.3.2 Corrective actions shall be appropriate to the magnitude and risk of the problem.
5.11.3.3 The proficiency testing provider shall document and implement any required changes
resulting from corrective action investigations.
5.11.4 Monitoring of corrective actions
The proficiency testing provider shall monitor the results to ensure that the corrective
actions taken have been effective.
5.11.5 Additional audits
Where the identification of nonconforming activities or departures from authorized
procedures cast doubts on the compliance of the proficiency testing provider with its own

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 23 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
policies and procedures, or on its compliance with this International Standard, the
proficiency testing provider shall ensure that the appropriate areas of activity are audited
in accordance with 5.14 as soon as possible.
5.12 Preventive actions
5.12.1 Areas for improvements and potential sources of nonconforming work, either technical
or concerning the management system, shall be identified. When improvement
opportunities are identified, or if preventive action is required, action plans shall be
developed, implemented and monitored, to reduce the likelihood of such nonconforming
work and to take advantage of the opportunities for improvement.
5.12.2 Any procedure for preventive action shall include the initiation of such actions and
application of controls to ensure that they are effective.
5.13 Control of records
5.13.1 General
5.13.1.1 The proficiency testing provider shall establish and maintain procedures for
identification, collection, indexing, access, filing, storage, maintenance and disposal of
records. Quality records shall include reports from internal audits and management
reviews, as well as records of corrective and preventive actions.
5.13.1.2 All records shall be legible and shall be stored and retained in such a way that they are
readily retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss. Retention times of records shall be established.
5.13.1.3 All records shall be kept secure and confidential, and in accordance with relevant
regulatory requirements.
5.13.1.4 The proficiency testing provider shall follow procedures to protect and back-up records
stored electronically and to prevent unauthorized access or amendment of these records.
5.13.2 Technical records
5.13.2.1 The proficiency testing provider shall retain records of all technical data relating to each
proficiency testing round for a defined period, including, but not necessarily limited to:
a) results of homogeneity and stability testing;
b) instructions to participants;

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 24 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
c) participants' original responses;
d) collated data for statistical analysis;
e) information required for reports (see 4.8); and
f) final reports (summary or individual, or both).
5.13.2.2 Data entry, checking and calculations shall be recorded at the time they are made and
shall be identifiable to the specific task and to the personnel responsible.
5.13.2.3 When mistakes occur in records and alterations are made, actions shall be taken to:
a) identify the change and date of alteration;
b) avoid loss of original data; and
c) identify the person making the alteration.
5.14 Internal audits
5.14.1 The proficiency testing provider shall conduct internal audits of its activities
periodically, and in accordance with a predetermined schedule and procedure, in
order to verify that its operations continue to comply with the requirements of
the management system and this International Standard. The internal audit
programme shall address all elements of the management system, including the
technical procedures and proficiency test item preparation, storage and
distribution, as well as reporting activities for the operation of a proficiency
testing scheme. It is the responsibility of the quality manager to plan and
organize audits as required by the schedule and requested by management.
Internal audits shall be carried out by trained and qualified personnel who are,
wherever resources permit, independent of the activity to be audited.
5.14.2 When audit findings cast doubt upon the effectiveness of the operations,
including the suitability and
correctness of proficiency test items, procedures, statistical evaluations and data
presentation, the proficiency testing provider shall take timely corrective action
and shall notify its customers or participants, or both, in proficiency testing

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 25 of 26

 FILLED BY LAB FILLED BY AAA

NO. REQUIREMENT PTP DOCUMENT REVIEW AAA REVIEW

(Document Ref./ Clause No.) Y N NOTES
schemes whose activities may have been affected.
5.14.3 The area of audited activity, the audit findings and any corrective actions that
arise from them shall be recorded.
5.14.4 Follow-up audit activities shall verify and record the implementation and
effectiveness of any corrective actions taken.
5.15 Management reviews
5.15.1 In accordance with a pre-determined schedule and procedure, the proficiency testing
provider's top management shall periodically conduct a review of the proficiency testing
provider's management system and proficiency testing activities, in order to ensure their
continued suitability and effectiveness and to introduce any necessary changes or
improvements. The review shall take account of:
a) the suitability of policies and procedures;
b) reports from management and supervisory personnel;
c) the outcome of recent internal audits;
d) corrective and preventive actions;
e) assessments by external bodies;
f) changes in the volume and type of work;
g) customer, advisory group or participant feedback;
h) complaints and appeals;
i) recommendations for improvement; and
j) other relevant factors, such as resources and staff training.
5.15.2 Findings from management reviews, and the actions that arise from them, shall be
recorded. The management shall ensure that those actions are discharged within an
appropriate and agreed timescale.

ISO/IEC 17043 checklist Document No. F-PT-02

Issue 01

PT providers Accreditation Section Page 26 of 26