INTERNATIONAL ISO/IEC

STANDARD 17043

Second edition
2023-05

Conformity assessment — General

requirements for the competence of
proficiency testing providers
Évaluation de la conformité — Exigences générales concernant la
compétence des organisateurs d’essais d’aptitude

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Reference number
ISO/IEC 17043:2023(E)

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ISO/IEC 17043:2023(E)

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Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction............................................................................................................................................................................................................................... vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 General requirements..................................................................................................................................................................................... 3
4.1 Impartiality................................................................................................................................................................................................ 3
4.2 Confidentiality......................................................................................................................................................................................... 4
5 Structural requirements.............................................................................................................................................................................. 4
6 Resource requirements................................................................................................................................................................................. 5
6.1 General............................................................................................................................................................................................................ 5
6.2 Personnel...................................................................................................................................................................................................... 5
6.3 Facilities and environmental conditions.......................................................................................................................... 6
6.4 Externally provided products and services.................................................................................................................. 7
7 Process requirements..................................................................................................................................................................................... 8
7.1 Establishing, contracting and communicating the PT scheme objectives......................................... 8
7.1.1 Review of requests, tenders and contracts.................................................................................................. 8

7.2 iTeh STANDARD PREVIEW

7.1.2 PT scheme communication........................................................................................................................................ 8
Design and planning of a PT scheme.................................................................................................................................... 9
7.2.1 General......................................................................................................................................................................................... 9
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7.2.2 Statistical design.............................................................................................................................................................. 10
7.2.3 Determination of assigned values.................................................................................................................... 11
7.3 Production and distribution of PT items...................................................................................................................... 11
7.3.1 Production of PT ISO/IEC 17043:2023
items............................................................................................................................................... 11
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7.3.2 Homogeneity and stability assessment of PT items......................................................................... 12
7.3.3 Handling and storage iec-17043-2023
of PT items..................................................................................................................... 12
7.3.4 Packaging, labelling and distribution of PT items............................................................................. 12
7.3.5 Instructions for participants................................................................................................................................. 13
7.4 Evaluation and reporting of PT scheme results...................................................................................................... 14
7.4.1 Data analysis........................................................................................................................................................................ 14
7.4.2 Evaluation of performance...................................................................................................................................... 14
7.4.3 PT reports.............................................................................................................................................................................. 15
7.5 Control of the PT scheme process........................................................................................................................................ 16
7.5.1 Technical records............................................................................................................................................................. 16
7.5.2 Control of data and information management...................................................................................... 16
7.5.3 Surveillance of the processes................................................................................................................................ 17
7.5.4 Nonconforming work................................................................................................................................................... 17
7.6 Handling of complaints................................................................................................................................................................. 18
7.7 Handling of appeals.......................................................................................................................................................................... 19
8 Management system requirements............................................................................................................................................... 19
8.1 General requirements.................................................................................................................................................................... 19
8.2 Management system documentation............................................................................................................................... 20
8.3 Control of management system documents............................................................................................................... 20
8.4 Control of records.............................................................................................................................................................................. 20
8.5 Actions to address risks and opportunities............................................................................................................... 21
8.6 Improvement.......................................................................................................................................................................................... 21
8.7 Corrective actions.............................................................................................................................................................................. 22
8.8 Internal audits...................................................................................................................................................................................... 22
8.9 Management reviews...................................................................................................................................................................... 23
Annex A (informative) Types of PT schemes............................................................................................................................................24

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Annex B (informative) Statistical methods for PT............................................................................................................................. 28

Bibliography.............................................................................................................................................................................................................................. 36

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Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
The procedures used to develop this document and those intended for its further maintenance
are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria
needed for the different types of document should be noted. This document was drafted in
accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
www.iec.ch/members_experts/refdocs).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of
any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC
had not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.

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Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the (standards.iteh.ai)
voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles
ISO/IEC in the Technical Barriers to Trade (TBT) see
17043:2023
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
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This document was prepared by the ISO Committee on Conformity Assessment (CASCO), in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 1, Criteria
for conformity assessment bodies, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/IEC 17043:2010), which has been
technically revised.
The main changes are as follows:
— harmonization with ISO/IEC 17025:2017, including technical requirements and structure;
— harmonization with ISO 13528:2022 in terms of terminology;
— incorporation of requirements from ISO/CASCO PROC 33;
— inclusion of the requirement that testing activities, calibration activities and proficiency testing
item production conform to the relevant requirements of appropriate ISO conformity assessment
standards;
— deletion of Annex C and revision of Annexes A and B.
Any feedback or questions on this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html and
www.iec.ch/national-committees.

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ISO/IEC 17043:2023(E)

Introduction
Proficiency testing (PT) is widely recognized as an essential tool for demonstrating the competence of
conformity assessment bodies. PT can provide evidence of competence and it can be an indicator of an
underlying or emerging problem. This document is intended to promote confidence in the operations
of PT providers. It contains requirements for PT providers to enable them to demonstrate that they
operate competently and can generate valid evaluations of participant performance.
PT involves the use of interlaboratory comparisons for the evaluation of laboratory performance. The
definition of “interlaboratory comparison” (see 3.4) broadens the use of both the terms “laboratories”
and “measurements or tests” for the purposes of this document to include all types of conformity
assessment bodies and their activities, respectively. The term “method” as used in this document can
be considered synonymous with the term “measurement procedure” as defined in ISO/IEC Guide 99.
There are many different purposes for interlaboratory comparisons, which can be addressed by PT
schemes, including but not limited to:
a) evaluation of the performance of laboratories for specific measurements, tests, calibrations,
examinations, inspections or sampling;
b) identification of problems in laboratories that, for example, can be related to measurement or test
methods, effectiveness of training and supervision of personnel, or calibration of equipment;
c) establishment of the effectiveness of measurement or test methods and the comparability of
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measurement or test results;
d) provision of additional confidence to users of measurement or test results;
e)
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identification of differences in measurement or test results;
f) education of participating laboratories based on the
ISO/IEC outcomes of such comparisons;
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g) validation of measurement uncertainty claims.
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For the following types of interlaboratory comparisons, the term PT does not usually apply because
laboratory competence must be established in advance, in order to ensure the validity of measurements
or tests as well as the metrological traceability of assigned values:
h) evaluation of the performance characteristics of a measurement or test method (often described as
collaborative trials);
i) assignment of values to reference materials;
j) support for statements of the equivalence of measurements of National Metrology Institutes (NMIs),
or their Designated Institutes (DIs) through “key and supplementary comparisons”, conducted
on behalf of the International Bureau of Weights and Measures (BIPM) and associated Regional
Metrology Organizations (RMOs).
It is recognized that interlaboratory comparisons for purposes h), i) and j) can contribute to independent
demonstrations of laboratory competence. The requirements of this document can be applied to many
of the technical planning and operational activities for these interlaboratory comparisons.
This document also requires PT providers to plan and implement actions to address risks and
opportunities, based on their experience. Addressing both risks and opportunities establishes a basis
for increasing the effectiveness of the management system, achieving improved results and preventing
negative events. The PT provider is responsible for deciding which risks and opportunities to address.
The need for ongoing confidence in laboratory performance is essential not only for laboratories and
their customers but also for other interested parties, such as regulators, accreditation bodies and other
organizations that specify requirements for laboratories. Most of the requirements in this document
apply to those evolving areas, especially regarding management, planning and design, personnel,

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assuring validity of results and performance evaluations, confidentiality and other aspects, as
appropriate.
This document is intended to provide a consistent basis for all interested parties to determine the
competence of organizations that provide PT.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.

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INTERNATIONAL STANDARD ISO/IEC 17043:2023(E)

Conformity assessment — General requirements for the

competence of proficiency testing providers

1 Scope
This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.

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ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
(standards.iteh.ai)
ISO 17034, General requirements for the competence of reference material producers
ISO/IEC Guide 99, International vocabulary of 17043:2023
ISO/IEC metrology — Basic and general concepts and associated
terms (VIM)
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and
ISO/IEC Guide 99 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
3.1
assigned value
value attributed to a particular property or characteristic of a proficiency testing item (3.8)
[SOURCE: ISO 13528:2022, 3.3, modified — The words "or characteristic" have been added and the
word “test” has been replaced with “testing”.]
3.2
consensus value
value derived from a collection of results in an interlaboratory comparison (3.4)
Note 1 to entry: The phrase “consensus value” is typically used to describe estimates of location and dispersion
derived from participant (3.6) results in a round of a proficiency testing scheme (3.11), but may also be used to
refer to values derived from results of a specified subset of such results or, for example, from a number of expert
laboratories.

[SOURCE: ISO 13528:2022, 3.11.]

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ISO/IEC 17043:2023(E)

3.3
customer
client
organization or individual for which a proficiency testing scheme (3.11) is provided through a contractual
arrangement
Note 1 to entry: The term “client” is an alternative term for “customer” and is used in parts of this document.
These terms are regarded as having the same definition.

3.4
interlaboratory comparison
design, performance and evaluation of measurements or tests on the same or similar items by two or
more laboratories in accordance with predetermined conditions
Note 1 to entry: The term “laboratories” is used in this document to cover all organizations that provide
information on items based on experimental observation, including measurement, testing, calibration,
examination, sampling and inspection.

Note 2 to entry: The term “measurements or tests” is used throughout this document to apply to any activities
undertaken by the proficiency testing participants (3.6) that are subject to the proficiency testing (3.7), whether
quantitative, qualitative or interpretative, unless otherwise qualified.

Note 3 to entry: Interlaboratory comparisons that involve measurements convey more insight regarding
performance when measurement uncertainty is considered.

[SOURCE: ISO 13528:2022, 3.1, modified — The word “organization” has been replaced with “design”
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and the Notes to the entry have been added.]
3.5
outlier (standards.iteh.ai)
member of a set of values which is inconsistent with other members of that set
Note 1 to entry: An outlier can arise by chance ISO/IEC 17043:2023
from the expected population, originate from a different
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population, or be the result of an incorrect recording or other gross error.
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Note 2 to entry: Many proficiency testing schemes (3.11) use the term outlier to designate a result that generates
an action signal. This is not the intended use of the term. While outliers will usually generate action signals, it is
possible to have action signals from results that are not outliers.

[SOURCE: ISO 13528:2022, 3.12, modified — The word “blunder” has been replaced with “gross error”
in Note 1 to entry.]
3.6
participant
person or organization that undertakes activities related to proficiency testing (3.7) and submits their
results for performance evaluation by the proficiency testing provider (3.9)
3.7
proficiency testing
PT
evaluation of participant (3.6) performance against pre-established criteria by means of interlaboratory
comparisons (3.4)
Note 1 to entry: Further information regarding the design of various proficiency testing schemes (3.11) is provided
in Annex A.

3.8
proficiency testing item
PT item
sample, product, artefact, reference material, piece of equipment, measurement standard, object, image,
data set or other information used for proficiency testing (3.7)

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3.9
proficiency testing provider
PT provider
organization which takes responsibility for all activities in the development and operation of a
proficiency testing scheme (3.11)
3.10
proficiency testing round
PT round
single complete sequence of proficiency testing (3.7), including the evaluation and reporting of the
performance of participants (3.6)
3.11
proficiency testing scheme
PT scheme
proficiency testing (3.7) designed and operated in one or more proficiency testing rounds (3.10) for a
specified area of measurement, testing, calibration, examination, sampling or inspection
Note 1 to entry: A proficiency testing scheme can cover a particular type of activity or a number of activity types
within the same area.

3.12
standard deviation for proficiency assessment
measure of dispersion used in the evaluation of results of proficiency testing (3.7), based on the available
information
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Note 1 to entry: The standard deviation for proficiency assessment can be interpreted as the population standard

(standards.iteh.ai)
deviation of results from a hypothetical population of participants (3.6) performing exactly in accordance with
requirements.

Note 2 to entry: The standard deviation for proficiency assessment applies only to ratio and interval scale results.
ISO/IEC 17043:2023
Note 3 to entry: Not all proficiency testing schemes (3.11) evaluate performance based on the dispersion of results.
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4 General requirements

4.1 Impartiality

4.1.1 PT activities shall be undertaken impartially.

4.1.2 The PT provider shall be structured and managed so as to safeguard impartiality.

4.1.3 The PT provider shall be responsible for the impartiality of its PT activities and shall not allow
commercial, financial or other pressures to compromise its impartiality.

4.1.4 The PT provider shall monitor its activities and its relationships to identify threats to its
impartiality. This monitoring shall include the relationships of its personnel.
NOTE A relationship can be based on ownership, governance, management, personnel, shared resources,
finances, contracts or marketing (including branding). Such relationships do not necessarily present a PT
provider with a threat to impartiality.

4.1.5 If a threat to impartiality is identified, its effect shall be eliminated or minimized so that the
impartiality is not compromised.

4.1.6 The PT provider shall have top management commitment to impartiality.

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4.2 Confidentiality

4.2.1 The PT provider shall be responsible, through legally enforceable agreements, for the
management of all information obtained or created during the performance of PT activities. The PT
provider shall inform the client in advance of the information it intends to place in the public domain.
Except for information that the client makes publicly available, or when agreed between the PT provider
and the client, all other information is considered proprietary information and shall be regarded as
confidential.
NOTE The terms “proprietary” and “confidential” do not preclude publication for academic and new insights
of information purposes, provided that neither clients nor participants can be identified, including by inference.

4.2.2 When the PT provider is required by law or authorized by contractual arrangements to release
confidential information, the client concerned shall be notified of the information released, unless
prohibited by law.

4.2.3 Information about the participant or customer from a source other than the participant or
customer (e.g. complainant or regulator) shall be kept confidential by the PT provider. The identity of
the source shall be kept confidential by the PT provider and shall not be shared with the participant or
the customer, unless agreed by the source.

4.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or
persons acting on the PT provider’s behalf, shall keep confidential all information obtained or created
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during the performance of the PT activities.

4.2.5 The identity of participants(standards.iteh.ai)

in a PT scheme shall be confidential and known only to persons
involved in the operation of the PT scheme, unless the participant or the customer waives confidentiality.

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5 Structural requirements
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5.1 The PT provider shall be a legal entity, or a defined part of a legal entity, that is legally responsible
for its PT activities.
NOTE For the purposes of this document, a governmental PT provider is deemed to be a legal entity on the
basis of its governmental status.

5.2 The PT provider shall identify management that has overall responsibility for the PT activities.

5.3 The PT provider shall define and document the PT schemes for which it conforms with this
document. The PT provider shall only claim conformity with this document for those PT schemes.

5.4 The PT provider shall carry out PT activities in such a way so as to meet the requirements of
this document and address the requirements of participants, customers, regulatory authorities, and
organizations providing recognition. These requirements apply to all PT activities performed in its
permanent facilities and any other facility or site.

5.5 The PT provider shall:

a) define its organization and management structure, its place in any parent organization and the
relationships between the management, technical operations and support services;
b) specify the responsibility, authority and interrelationships of all personnel who manage, perform
or verify work affecting the results of its PT activities;
c) document its procedures to the extent necessary to ensure the consistent application and validity
of its PT activities.

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5.6 The PT provider shall have personnel who, irrespective of other responsibilities, have the
authority and resources needed to carry out their duties, including:

a) implementation, maintenance and improvement of the management system;

b) identification of deviations from the management system or from the procedures while performing
the PT activities;
c) initiation of actions to prevent or minimize such deviations;
d) reporting to its management on the performance of the management system and any need for
improvement;
e) ensuring the effectiveness of the PT activities.

5.7 The PT provider management shall ensure that:

a) communication takes place regarding the effectiveness of the management system and the
importance of meeting the requirements of participants, customers, regulatory authorities and
organizations providing recognition;
b) the integrity of the management system is maintained when changes to the management system
are planned and implemented.

6 Resource requirements
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6.1 General
(standards.iteh.ai)
6.1.1 The PT provider shall have access to the personnel, facilities, equipment, systems and support
services necessary to manage and perform its PT
ISO/IEC activities.
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6.1.2 Measurements or tests conducted iec-17043-2023
under the responsibility of the PT provider, related to PT
item characterization or for assessing homogeneity and stability, shall be conducted in accordance with
the relevant requirements of ISO/IEC 17025.
NOTE 1 The relevant requirements are requirements that relate to the validity of the measurement or test
results, which can impact the validity of PT activities (e.g. metrological traceability). They are not intended to
include management system requirements or other requirements unrelated to the PT activities.

NOTE 2 In the medical area, the relevant requirements of ISO 15189 apply in place of ISO/IEC 17025.

6.1.3 Where the PT item is a material that meets the definition of “reference material”, it shall be
produced under conditions that meet the relevant requirements of ISO 17034.
NOTE 1 Such materials include reference materials for quality control (e.g. chemical solutions with or without
reference values) and reference materials with certified property values (CRMs).

NOTE 2 The relevant requirements are requirements that relate to the validity of operations to produce a
reference material that directly impacts the PT activities (e.g. mixing, or handling and storage). They are not
intended to include management system requirements or other requirements not directly related to the PT
activities (e.g. contents of certificates).

NOTE 3 In the medical area, the relevant requirements of ISO 15194 can apply for CRMs in place of ISO 17034,
when applicable.

6.2 Personnel

6.2.1 The PT provider shall have access to a sufficient number of competent personnel to perform its
PT activities.

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