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)

Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne usposobljenosti (ISO/IEC/DIS 17043:2022)

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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
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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
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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Reference number
NATIONAL REGULATIONS.
ISO/IEC DIS 17043:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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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
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Email: copyright@iso.org
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Published in Switzerland
© ISO/IEC 2022 – All rights reserved
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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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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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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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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

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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.
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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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