SIST EN ISO/IEC 17043:2023
(Main)Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023)
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.
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern von Eignungsprüfungen (ISO/IEC 17043:2023)
Dieses Dokument legt allgemeine Anforderungen an die Kompetenz und Unparteilichkeit von Anbietern von Eignungsprüfungen(EP) und den konsistenten Ablauf sämtlicher Eignungsprüfungsprogramme fest. Dieses Dokument kann als Grundlage für spezifische technische Anforderungen für bestimmte Anwendungsfelder verwendet werden.
Anwender von Eignungsprüfungsprogrammen, Aufsichtsbehörden, Organisationen und Programme die Begut
achtung unter Gleichrangigen nutzen, Akkreditierungsstellen und andere können diese Anforderungen nutzen, um die Kompetenz von Anbietern von Eignungsprüfungen zu bestätigen oder anzuerkennen.
Évaluation de la conformité - Exigences générales concernant la compétence des organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ugotavljanje skladnosti - Splošne zahteve za usposobljenost ponudnikov preskušanja strokovne usposobljenosti (ISO/IEC 17043:2023)
Ta dokument določa splošne zahteve za usposobljenost in nepristranskost ponudnikov preskušanja strokovne usposobljenosti (PT) ter dosledno delovanje vseh shem za preskušanje strokovne usposobljenosti. Ta dokument je mogoče uporabiti kot osnovo za posebne tehnične zahteve za določena področja uporabe.
Uporabniki shem za preskušanje strokovne usposobljenosti, regulativni organi, organizacije in sheme, ki uporabljajo medsebojno ocenjevanje, akreditacijski organi ter drugi lahko uporabijo te zahteve za potrjevanje ali priznavanje usposobljenosti ponudnikov preskušanja strokovne usposobljenosti.
General Information
Relations
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 17043:2023
01-julij-2023
Nadomešča:
SIST EN ISO/IEC 17043:2010
Ugotavljanje skladnosti - Splošne zahteve za usposobljenost ponudnikov
preskušanja strokovne usposobljenosti (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing
providers (ISO/IEC 17043:2023)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern
von Eignungsprüfungen (ISO/IEC 17043:2023)
Évaluation de la conformité - Exigences générales concernant la compétence des
organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2023
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17043:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17043:2023
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SIST EN ISO/IEC 17043:2023
EUROPEAN STANDARD EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 03.120.20
Supersedes EN ISO/IEC 17043:2010
English version
Conformity assessment - General requirements for the
competence of proficiency testing providers (ISO/IEC
17043:2023)
Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen
concernant la compétence des organisateurs d'essais an die Kompetenz von Anbietern von
d'aptitude (ISO/IEC 17043:2023) Eignungsprüfungen (ISO/IEC 17043:2023)
This European Standard was approved by CEN on 17 April 2023.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2023 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO/IEC 17043:2023 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17043:2023
EN ISO/IEC 17043:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO/IEC 17043:2023
EN ISO/IEC 17043:2023 (E)
European foreword
This document (EN ISO/IEC 17043:2023) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/ JTC
1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17043:2010.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEC 17043:2023 has been approved by CEN-CENELEC as EN ISO/IEC 17043:2023
without any modification.
3
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SIST EN ISO/IEC 17043:2023
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SIST EN ISO/IEC 17043:2023
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
Reference number
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO/IEC 2023 – All rights reserved
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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
7.1.2 PT scheme communication . 8
7.2 Design and planning of a PT scheme . 9
7.2.1 General . 9
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 items . 11
7.3.2 Homogeneity and stability assessment of PT items.12
7.3.3 Handling and storage 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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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
Annex B (informative) Statistical methods for PT .28
Bibliography .36
iv
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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.
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 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 in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
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.
v
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SIST EN ISO/IEC 17043:2023
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
measurement or test results;
d) provision of additional confidence to users of measurement or test results;
e) identification of differences in measurement or test results;
f) education of participating laboratories based on the outcomes of such comparisons;
g) validation of measurement uncertainty claims.
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,
vi
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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.
vii
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SIST EN ISO/IEC 17043:2023
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SIST EN ISO/IEC 17043:2023
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.
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 17034, General requirements for the competence of reference material producers
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
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:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .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.]
1
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SIST EN ISO/IEC 17043:2023
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”
and the Notes to the entry have been added.]
3.5
outlier
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 from the expected population, originate from a different
population, or be the result of an incorrect recording or other gross error.
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
...
SLOVENSKI STANDARD
SIST EN ISO/IEC 17043:2023
01-julij-2023
Nadomešča:
SIST EN ISO/IEC 17043:2010
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/IEC 17043:2023)
Conformity assessment - General requirements for the competence of proficiency testing
providers (ISO/IEC 17043:2023)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern
von Eignungsprüfungen (ISO/IEC 17043:2023)
Évaluation de la conformité - Exigences générales concernant la compétence des
organisateurs d’essais d’aptitude (ISO/IEC 17043:2023)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2023
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17043:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17043:2023
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SIST EN ISO/IEC 17043:2023
EUROPEAN STANDARD EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 03.120.20
Supersedes EN ISO/IEC 17043:2010
English version
Conformity assessment - General requirements for the
competence of proficiency testing providers (ISO/IEC
17043:2023)
Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen
concernant la compétence des organisateurs d'essais an die Kompetenz von Anbietern von
d'aptitude (ISO/IEC 17043:2023) Eignungsprüfungen (ISO/IEC 17043:2023)
This European Standard was approved by CEN on 17 April 2023.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2023 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO/IEC 17043:2023 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17043:2023
EN ISO/IEC 17043:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO/IEC 17043:2023
EN ISO/IEC 17043:2023 (E)
European foreword
This document (EN ISO/IEC 17043:2023) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN-CENELEC/ JTC
1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17043:2010.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEC 17043:2023 has been approved by CEN-CENELEC as EN ISO/IEC 17043:2023
without any modification.
3
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SIST EN ISO/IEC 17043:2023
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SIST EN ISO/IEC 17043:2023
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
Reference number
ISO/IEC 17043:2023(E)
© ISO/IEC 2023
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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
7.1.2 PT scheme communication . 8
7.2 Design and planning of a PT scheme . 9
7.2.1 General . 9
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 items . 11
7.3.2 Homogeneity and stability assessment of PT items.12
7.3.3 Handling and storage 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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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
Annex B (informative) Statistical methods for PT .28
Bibliography .36
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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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.
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 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 in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
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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SIST EN ISO/IEC 17043:2023
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
measurement or test results;
d) provision of additional confidence to users of measurement or test results;
e) identification of differences in measurement or test results;
f) education of participating laboratories based on the outcomes of such comparisons;
g) validation of measurement uncertainty claims.
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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SIST EN ISO/IEC 17043:2023
ISO/IEC 17043:2023(E)
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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SIST EN ISO/IEC 17043:2023
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.
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 17034, General requirements for the competence of reference material producers
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
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:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .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.]
1
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SIST EN ISO/IEC 17043:2023
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”
and the Notes to the entry have been added.]
3.5
outlier
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 from the expected population, originate from a different
population, or be the result of an incorrect recording or other gross error.
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
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17043:2022
01-julij-2022
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/IEC/DIS 17043:2022)
Conformity assessment - General requirements for proficiency testing (ISO/IEC/DIS
17043:2022)
Konformitätsbewertung - Allgemeine Anforderungen an die Kompetenz von Anbietern
von Eignungsprüfungen (ISO/IEC/DIS 17043:2022)
Évaluation de la conformité - Exigences générales concernant les essais d'aptitude
(ISO/IEC/DIS 17043:2022)
Ta slovenski standard je istoveten z: prEN ISO/IEC 17043
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
oSIST prEN ISO/IEC 17043:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEC 17043:2022
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 17043
ISO/CASCO Secretariat: ISO
Voting begins on: Voting terminates on:
2022-04-27 2022-07-20
Conformity assessment — General requirements for the
competence of proficiency testing providers
ICS: 03.120.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/IEC DIS 17043:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO/IEC 2022
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(E)
ISO/IEC DIS 17043-:20XX(E)
ISO/CASCO/WG57
Secretariat: ISO/CASCO
Conformity assessment — General requirements for the
competence of proficiency testing providers
DIS
The text highlighted in grey indicates clauses that contain CASCO/PROC33 text. It contains obligatory
requirements common to all ISO/CASCO documents for "impartiality", "confidentiality", “competence”,
"complaints”, “appeals" and "management system". This text cannot be modified unless a request for
deviation is addressed to CASCO /CPC. This highlighted text is introduced to help with DIS comments and
will be deleted for the final publication.
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8 Page 1 of 43
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(E)
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 4
4.1 Impartiality . 4
4.2 Confidentiality . 4
5 Structural requirements . 5
6 Resource requirements . 6
6.1 General . 6
6.2 Personnel . 6
6.3 Facilities and environmental conditions . 7
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
7.1.2 PT scheme communication . 9
7.2 Design and planning of a PT scheme . 9
7.2.1 General . 9
7.2.2 Statistical design . 10
7.2.3 Determination of assigned values . 11
7.3 Operations related to the production of PT items . 12
7.3.1 Production of PT items . 12
7.3.2 Homogeneity and stability assessment of PT items . 12
7.3.3 Handling and storage of PT items . 13
7.3.4 Packaging, labelling and distribution of PT items . 13
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 . 17
7.5.1 Technical records . 17
7.5.2 Control of data and information management . 17
7.5.3 Surveillance of the processes . 18
7.5.4 Nonconforming work . 18
7.6 Handling of complaints . 19
7.7 Handling of appeals . 19
8 Management system requirements . 20
8.1 General requirements . 20
8.2 Management system documentation . 20
8.3 Control of management system documents . 21
8.4 Control of records . 21
8.5 Actions to address risks and opportunities . 21
8.6 Improvement . 22
8.7 Corrective actions . 22
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(E)
8.8 Internal audits . 23
8.9 Management reviews . 24
Annex A (informative) Types of proficiency testing schemes . 25
A.1 General . 25
A.2 Types of PT schemes . 26
A.3 External quality assessment (EQA) programmes . 27
A.4 Alternative interlaboratory comparisons . 28
Annex B (informative) Statistical methods for proficiency testing . 29
B.1 General . 29
B.2 Demonstration of PT item homogeneity and stability . 29
B.3 Determination of the assigned value and its uncertainty . 30
B.4 Calculation of performance statistics . 32
B.4.1 Performance for quantitative results . 32
B.4.2 Performance for nominal and ordinal results . 34
B.4.3 Combined performance scores . 35
B.5 Evaluation of performance . 35
B.5.1 Performance in current PT round . 35
B.5.2 Monitoring performance over time. 36
Bibliography . 37
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details
of any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents) or the IEC list of patent
declarations received (see http://patents.iec.ch).
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 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 in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO). This second
edition cancels and replaces the first edition (ISO/IEC 17043:2010) which has been technically revised.
The main changes compared to the previous edition are as follows:
— harmonization with the revision of ISO/IEC 17025, including technical requirements and structure;
— harmonization with the revision of ISO 13528 in terms of terminology;
— incorporation of requirements from ISO/CASCO PROC 33;
— inclusion of the requirement that testing activities, calibration activities and PT 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.
© ISO/IEC 2022 – All rights reserved v
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(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 has been developed with the objective of promoting
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 (3.4) and associated notes to the definitions broadens the use
of both terms "laboratories" and " measurements and tests" for the purposes of this document to include
all types of conformity assessment bodies and their activities, respectively.
There are many different purposes for interlaboratory comparison schemes, that can be addressed by
PT, including but not limited to:
a) evaluation of the performance of laboratories for specific measurements, tests, calibrations, or
examinations;
b) identification of problems in laboratories which, for example, may be related to inadequate test or
measurement procedures, effectiveness of training and supervision of personnel, or calibration of
equipment;
c) establishment of the effectiveness of test and measurement procedures and comparability of results;
d) provision of additional confidence to users of test and measurement results;
e) identification of differences in laboratory results;
f) education of participating laboratories based on the outcomes of such comparisons; and
g) validation of measurement uncertainty claims.
For the following types of interlaboratory comparisons the term PT does not usually apply because it is
necessary to establish laboratory competence in advance, in order to assure the validity of tests and
measurements as well as the metrological traceability of assigned values:
h) evaluation of the performance characteristics of a measurement method – often described as
collaborative trials;
i) assignment of values to reference materials; and
j) support for statements of the equivalence of measurements of National Metrology Institutes, or their
Designated Institutes through “key and supplementary comparisons", conducted on behalf of the
International Bureau of Weights and Measures (BIPM) and associated regional metrology
organizations.
It is recognised however, that interlaboratory comparisons for purposes h), i) and j) can be used to
provide independent demonstrations of laboratory competence. The requirements of this document can
be applied to many of the technical planning and operational activities for these 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
vi © ISO/IEC 2022 – All rights reserved
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(E)
negative events. The PT provider is responsible for deciding which risks and opportunities need to be
addressed.
The need for ongoing confidence in laboratory performance is not only essential 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,
assuring validity of results and performance evaluations, confidentiality, and other aspects, as
appropriate.
This document has been prepared to provide a consistent basis for all interested parties to determine the
competence of organizations that provide PT. This document has preserved and updated the principles
for the operation of PT described in the 1st edition of ISO/IEC 17043:2010.
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.
For the purposes of research, users are encouraged to share their views on this document and their
priorities for changes to future editions. Click on the link below to take part in the online survey: XXXX
(to be developed by the Secretariat later)
The survey to be developed at later stage by Secretariat.
The text highlighted in grey indicates clauses that contain CASCO/PROC33 text. It contains obligatory
requirements common to all ISO/CASCO documents for "impartiality", "confidentiality", “competence”,
"complaints”, “appeals" and "management system". This text cannot be modified unless a request for
deviation is addressed to CASCO /CPC. This highlighted text is introduced to help with DIS comments and
will be deleted for the final publication.
© ISO/IEC 2022 – All rights reserved vii
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oSIST prEN ISO/IEC 17043:2022
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oSIST prEN ISO/IEC 17043:2022
ISO/IEC DIS 17043:2022(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
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.
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 17034, General requirements for the competence of reference material producers
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
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://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
assigned value
value attributed to a particular property or characteristic of a proficiency testing item
[SOURCE: ISO 13528:2015, 3.3, modified – Changed “test” to “testing” and words "or characteristic of"
added]
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3.2
consensus value
value derived from a collection of results in an interlaboratory comparison
Note 1 to entry: The phrase ‘consensus value’ is typically used to describe estimates of location and dispersion
derived from participant results in a proficiency testing round, 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 13528:2015, 3.11, modified – Changed "test" to "testing".]
3.3
customer
organization or individual for which a proficiency testing scheme is provided through a contractual
arrangement
Note 1 to entry: The term ‘client’ is an alternative term for ‘customer’ used in parts of this document and 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
[ISO 13528:2015, 3.1, modified – Changed "organization" to "design". The Notes to the entry have been
added.]
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 that are subject to the proficiency testing, 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.
3.5
outlier
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 from the expected population, originate from a different population,
or be the result of an incorrect recording or other gross error.
Note 2 to entry: Many proficiency testing schemes use the term outlier to designate a result that generates an action
signal. However, 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.
[ISO 13528:2015, 3.12, modified – Changed the word "blunder" to "gross error" in Note 1 to entry and
added "proficiency testing" to "schemes" in Note 2 to entry.]
3.6
participant
person or organization that undertakes activities related to proficiency testing and submits their results
for performance evaluation by the proficiency testing provider
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3.7
proficiency testing
(PT)
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons
Note 1 to entry: Further information regarding the design of various proficiency testing schemes 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
3.9
proficiency testing provider
(PT provider)
organization which takes responsibility for all activities in the development and operation of a
proficiency testing scheme
3.10
proficiency testing round
(PT round)
single complete sequence of proficiency testing, including the evaluation and reporting of participants'
performance
3.11
proficiency testing scheme
(PT scheme)
proficiency testing designed and operated in one or more proficiency testing rounds for a specified area
of measurement, testing, calibration, examination, sampling or inspection
Note 1 to entry: A proficiency testing scheme might 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, based on the available
information
Note 1 to entry: This can be interpreted as the population standard deviation of results from a hypothetical
population of participants performing exactly in accordance with requirements.
Note 2 to entry: The standard deviation for proficiency assessment applies only to ratio and interval scale results.
Note 3 to entry: Not all proficiency testing schemes evaluate performance based on the dispersion of results.
[ISO 13528:2015, 3.4, modified – Changed "test" to "testing".]
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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 no
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