Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010)

ISO/IEC 17043:2010 specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. These requirements are intended to be general for all types of proficiency testing schemes, and they can be used as a basis for specific technical requirements for particular fields of application.

Konformitätsbewertung - Allgemeine Anforderungen an Eignungsprüfungen (ISO/IEC 17043:2010)

Diese Internationale Norm legt allgemeine Anforderungen an die Kompetenz der Anbieter von Eignungsprüfungsprogrammen
sowie an die Entwicklung und Durchführung von Eignungsprüfungsprogrammen fest.
Diese Anforderungen sind allgemein gehalten für alle Arten von Eignungsprüfungsprogrammen. Sie können
als Grundlage für spezifische technische Anforderungen in bestimmten Anwendungsgebieten genutzt werden.

Évaluation de la conformité - Exigences générales concernant les essais d'aptitude (ISO/IEC 17043:2010)

L'ISO/CEI 17043:2010 spécifie les exigences générales relatives à la compétence des organisateurs de programmes d'essais d'aptitude et à l'élaboration et à l'exécution des programmes d'essais d'aptitude. Ces exigences sont générales pour tous les types de programmes d'essais d'aptitude et on peut les utiliser comme base pour des exigences techniques spécifiques dans des domaines d'application particuliers.

Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne usposobljenosti (ISO/CASCO 17043:2010)

Ta mednarodni standard določa splošne zahteve za usposobljenost ponudnikov shem preskušanja strokovne usposobljenosti in za razvoj in delovanje shem preskušanja strokovne usposobljenosti. Namen teh zahtev je, da so splošne za vse vrste shem preskušanja strokovne usposobljenosti in se lahko uporabljajo kot osnova za posebne tehnične zahteve za določena področja ali uporabo.

General Information

Status
Published
Publication Date
31-Jan-2010
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
01-Feb-2010
Completion Date
01-Feb-2010

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SLOVENSKI STANDARD
SIST EN ISO/IEC 17043:2010
01-april-2010
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/CASCO 17043:2010)
Conformity assessment - General requirements for proficiency testing (ISO/CASCO
17043:2010)
Konformitätsbewertung - Allgemeine Anforderungen an Eignungsprüfungen
(ISO/CASCO 17043:2010)

Évaluation de la conformité - Exigences générales concernant les essais d'aptitude

(ISO/CASCO 17043:2010)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2010
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17043:2010 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO/IEC 17043:2010
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SIST EN ISO/IEC 17043:2010
EUROPEAN STANDARD
EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2010
ICS 03.120.20
English version
Conformity assessment - General requirements for proficiency
testing (ISO/CASCO 17043:2010)

Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen an

concernant les essais d'aptitude (ISO/CASCO 17043:2010) Eignungsprüfungen (ISO/CASCO 17043:2010)

This European Standard was approved by CEN on 30 January 2010.

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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United

Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels

© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17043:2010 E

worldwide for CEN national Members and for CENELEC
Members.
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SIST EN ISO/IEC 17043:2010
EN ISO/IEC 17043:2010 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO/IEC 17043:2010
EN ISO/IEC 17043:2010 (E)
Foreword

This document (EN ISO/IEC 17043:2010) has been prepared by Technical Committee ISO/CASCO

"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/TC 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 August 2010, and conflicting national standards shall be withdrawn at

the latest by August 2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

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, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO/CASCO 17043:2010 has been approved by CEN as a EN ISO/IEC 17043:2010 without any

modification.
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SIST EN ISO/IEC 17043:2010
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SIST EN ISO/IEC 17043:2010
INTERNATIONAL ISO/IEC
STANDARD 17043
First edition
2010-02-01
Conformity assessment — General
requirements for proficiency testing
Évaluation de la conformité — Exigences générales concernant les
essais d'aptitude
Reference number
ISO/IEC 17043:2010(E)
ISO 2010
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)
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electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

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ii © ISO 2010 — All rights reserved
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)
Contents Page

Foreword ............................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 Scope......................................................................................................................................................1

2 Normative references............................................................................................................................1

3 Terms and definitions ...........................................................................................................................1

4 Technical Requirements.......................................................................................................................4

4.1 General ...................................................................................................................................................4

4.2 Personnel ...............................................................................................................................................4

4.3 Equipment, accommodation and environment ..................................................................................5

4.4 Design of proficiency testing schemes...............................................................................................6

4.5 Choice of method or procedure.........................................................................................................10

4.6 Operation of proficiency testing schemes........................................................................................11

4.7 Data analysis and evaluation of proficiency testing scheme results ............................................12

4.8 Reports .................................................................................................................................................13

4.9 Communication with participants......................................................................................................14

4.10 Confidentiality......................................................................................................................................15

5 Management requirements.................................................................................................................15

5.1 Organization.........................................................................................................................................15

5.2 Management system ...........................................................................................................................16

5.3 Document control................................................................................................................................17

5.4 Review of requests, tenders and contracts......................................................................................18

5.5 Subcontracting services.....................................................................................................................19

5.6 Purchasing services and supplies ....................................................................................................19

5.7 Service to the customer......................................................................................................................20

5.8 Complaints and appeals .....................................................................................................................20

5.9 Control of nonconforming work ........................................................................................................20

5.10 Improvement ........................................................................................................................................20

5.11 Corrective actions ...............................................................................................................................21

5.12 Preventive actions...............................................................................................................................21

5.13 Control of records ...............................................................................................................................22

5.14 Internal audits ......................................................................................................................................22

5.15 Management reviews ..........................................................................................................................23

Annex A (informative) Types of proficiency testing schemes .....................................................................24

Annex B (informative) Statistical methods for proficiency testing..............................................................28

Annex C (informative) Selection and use of proficiency testing..................................................................35

Bibliography......................................................................................................................................................39

© ISO 2010 — All rights reserved iii
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(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. In the field of conformity

assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of

International Standards and Guides.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

Draft International Standards are circulated to the national bodies for voting. Publication as an International

Standard requires approval by at least 75 % of the national bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO/IEC 17043 was prepared by the ISO Committee on conformity assessment (CASCO).

It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both

organizations.

This first edition of ISO/IEC 17043 cancels and replaces ISO/IEC Guide 43-1:1997 and

ISO/IEC Guide 43-2:1997, which have been technically revised.
iv © ISO 2010 — All rights reserved
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)
Introduction

Interlaboratory comparisons are widely used for a number of purposes and their use is increasing

internationally. Typical purposes for interlaboratory comparisons include:

a) evaluation of the performance of laboratories for specific tests or measurements and monitoring

laboratories' continuing performance;

b) identification of problems in laboratories and initiation of actions for improvement which, for example, may

be related to inadequate test or measurement procedures, effectiveness of staff training and supervision,

or calibration of equipment;

c) establishment of the effectiveness and comparability of test or measurement methods;

d) provision of additional confidence to laboratory customers;
e) identification of interlaboratory differences;

f) education of participating laboratories based on the outcomes of such comparisons;

g) validation of uncertainty claims;

h) evaluation of the performance characteristics of a method – often described as collaborative trials;

i) assignment of values to reference materials and assessment of their suitability for use in specific test or

measurement procedures; and

j) support for statements of the equivalence of measurements of National Metrology Institutes through “key

comparisons” and supplementary comparisons conducted on behalf of the International Bureau of

Weights and Measurement (BIPM) and associated regional metrology organizations.

Proficiency testing involves the use of interlaboratory comparisons for the determination of laboratory

performance, as listed in a) to g) above. Proficiency testing does not usually address h), i) and j) because

laboratory competence is assumed in these applications, but these applications can be used to provide

independent demonstrations of laboratory competence. The requirements of this International Standard can

be applied to many of the technical planning and operational activities for h), i) and j).

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, laboratory accreditation bodies and other

organizations that specify requirements for laboratories. ISO/IEC 17011 requires accreditation bodies to take

account of laboratories' participation and performance in proficiency testing. There is a growing need for

proficiency testing for other conformity assessment activities, such as inspection or product certification. Most

of the requirements in this International Standard apply to those evolving areas, especially regarding

management, planning and design, personnel, assuring quality, confidentiality, and other aspects, as

appropriate.

This International Standard has been prepared to provide a consistent basis for all interested parties to

determine the competence of organizations that provide proficiency testing. In doing so it replaces both parts

of ISO/IEC Guide 43:1997. ISO/IEC Guide 43 included not only guidance on development and operation of

proficiency testing and selection and use of proficiency testing by laboratory accreditation bodies, but also

useful descriptions of typical types of proficiency testing. This International Standard has preserved and

updated the principles for the operation of proficiency testing described in ISO/IEC Guide 43 and has retained

in Annexes A to C information on typical types of proficiency testing schemes, guidance on appropriate

statistical methods, selection and use of proficiency testing schemes by laboratories, accreditation bodies,

regulatory bodies, and other interested parties.
© ISO 2010 — All rights reserved v
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SIST EN ISO/IEC 17043:2010
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SIST EN ISO/IEC 17043:2010
INTERNATIONAL STANDARD ISO/IEC 17043:2010(E)
Conformity assessment — General requirements for proficiency
testing
1 Scope

This International Standard specifies general requirements for the competence of providers of proficiency

testing schemes and for the development and operation of proficiency testing schemes. These requirements

are intended to be general for all types of proficiency testing schemes, and they can be used as a basis for

specific technical requirements for particular fields of application.
2 Normative references

The following referenced documents are indispensable for the application 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 17000:2004, Conformity assessment — Vocabulary and general principles

ISO/IEC Guide 99:2007, 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 17000:2004,

ISO/IEC Guide 99:2007 and the following apply.
3.1
assigned value
value attributed to a particular property of a proficiency test item
3.2
coordinator

one or more individuals with responsibility for organizing and managing all of the activities involved in the

operation of a proficiency testing scheme
3.3
customer

organization or individual for which a proficiency testing scheme is provided through a contractual

arrangement
3.4
interlaboratory comparison

organization, performance and evaluation of measurements or tests on the same or similar items by two or

more laboratories in accordance with predetermined conditions
© ISO 2010 — All rights reserved 1
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)
3.5
outlier

observation in a set of data that appears to be inconsistent with the remainder of that set

NOTE An outlier can originate from a different population or be the result of an incorrect recording or other gross

error.
3.6
participant

laboratory, organization or individual that receives proficiency test items and submits results for review by the

proficiency testing provider
NOTE In some cases, the participant can be an inspection body.
3.7
proficiency testing

evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons

NOTE 1 For the purposes of this International Standard, the term “proficiency testing” is taken in its widest sense and

includes, but is not limited to:

a) quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item;

b) qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test

item;

c) sequential scheme — where one or more proficiency test items are distributed sequentially for testing or

measurement and returned to the proficiency testing provider at intervals;

d) simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a

defined time period;

e) single occasion exercise — where proficiency test items are provided on a single occasion;

f) continuous scheme — where proficiency test items are provided at regular intervals;

g) sampling — where samples are taken for subsequent analysis; and

h) data transformation and interpretation — where sets of data or other information are furnished and the information is

processed to provide an interpretation (or other outcome).

NOTE 2 Some providers of proficiency testing in the medical area use the term “External Quality Assessment (EQA)”

for their proficiency testing schemes, or for their broader programmes, or both (see Annex A). The requirements of this

International Standard cover only those EQA activities that meet the definition of proficiency testing.

3.8
proficiency test item

sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other

information used for proficiency testing
3.9
proficiency testing provider

organization which takes responsibility for all tasks in the development and operation of a proficiency testing

scheme
3.10
proficiency testing round

single complete sequence of distribution of proficiency test items, and the evaluation and reporting of results

to the participants
2 © ISO 2010 — All rights reserved
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)
3.11
proficiency testing scheme

proficiency testing designed and operated in one or more rounds for a specified area of testing, measurement,

calibration or inspection

NOTE A proficiency testing scheme might cover a particular type of test, calibration, inspection or a number of tests,

calibrations or inspections on proficiency test items.
3.12
robust statistical method

statistical method insensitive to small departures from underlying assumptions surrounding an underlying

probabilistic model
3.13
standard deviation for proficiency assessment

measure of dispersion used in the evaluation of results of proficiency testing, based on the available

information

NOTE 1 The standard deviation applies only to ratio and differential scale results.

NOTE 2 Not all proficiency testing schemes evaluate proficiency based on the dispersion of results.

3.14
subcontractor

organization or individual engaged by the proficiency testing provider to perform activities specified in this

International Standard and that affect the quality of a proficiency testing scheme

NOTE The term “subcontractor” includes what many proficiency testing providers call collaborators.

3.15
metrological traceability

property of a measurement result whereby the result can be related to a reference through a documented

unbroken chain of calibrations, each contributing to the measurement uncertainty

NOTE 1 For this definition, a “reference” can be a definition of a measurement unit through its practical realization, or a

measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard.

NOTE 2 Metrological traceability requires an established calibration hierarchy.

NOTE 3 Specification of the reference must include the time at which this reference was used in establishing the

calibration hierarchy, along with any other relevant metrological information about the reference, such as when the first

calibration in the calibration hierarchy was performed.

NOTE 4 For measurements with more than one input quantity in the measurement model, each of the input quantity

values should itself be metrologically traceable and the calibration hierarchy involved may form a branched structure or a

network. The effort involved in establishing metrological traceability for each input quantity value should be commensurate

with its relative contribution to the measurement result.

NOTE 5 Metrological traceability of a measurement result does not ensure that the measurement uncertainty is

adequate for a given purpose or that there is an absence of mistakes.

NOTE 6 A comparison between two measurement standards may be viewed as a calibration if the comparison is used

to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the measurement

standards.

NOTE 7 The ILAC considers the elements for confirming metrological traceability to be an unbroken metrological

traceability chain to an international measurement standard or a national measurement standard, a documented

measurement uncertainty, a documented measurement procedure, accredited technical competence, metrological

traceability to the SI, and calibration intervals (see ILAC P-10:2002).
1) International Laboratory Accreditation Cooperation.
© ISO 2010 — All rights reserved 3
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)

NOTE 8 The abbreviated term “traceability” is sometimes used to mean “metrological traceability” as well as other

concepts, such as “sample traceability” or “document traceability” or “instrument traceability” or “material traceability”,

where the history (“trace”) of an item is meant. Therefore, the full term of “metrological traceability” is preferred if there is

any risk of confusion.
[ISO/IEC Guide 99:2007, definition 2.41]
3.16
measurement uncertainty
uncertainty of measurement
uncertainty

non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand,

based on the information used

NOTE 1 Measurement uncertainty includes components arising from systematic effects, such as components

associated with corrections and the assigned quantity values of measurement standards, as well as the definitional

uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement

uncertainty components are incorporated.

NOTE 2 The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a

specified multiple of it), or the half-width of an interval, having a stated coverage probability.

NOTE 3 Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by

Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of

measurements and can be characterized by standard deviations. The other components, which may be evaluated by

Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from

probability density functions based on experience or other information.

NOTE 4 In general, for a given set of information, it is understood that the measurement uncertainty is associated with

a stated quantity value attributed to the measurand. A modification of this value results in a modification of the associated

uncertainty.
[ISO/IEC Guide 99:2007, definition 2.26]
4 Technical Requirements
4.1 General

The development and operation of proficiency testing schemes shall be undertaken by proficiency testing

providers having competence to conduct interlaboratory comparisons and access to expertise with the

particular type of proficiency test items. Proficiency testing providers or their subcontractors shall also have

competence in the measurement of the properties being determined.

NOTE ISO/IEC 17025 or ISO 15189 can be used to demonstrate the competence of a proficiency testing provider's

laboratory, or the laboratory subcontracted to perform tests or measurements related to the proficiency testing schemes.

ISO Guide 34 can be used to demonstrate the competence of producers of reference materials that provide proficiency

test items.
4.2 Personnel

4.2.1 The proficiency testing provider shall have managerial and technical personnel with the necessary

authority, resources and technical competence required to perform their duties.

4.2.2 The proficiency testing provider's management shall define the minimum levels of qualification and

experience necessary for the key positions within its organization and ensure those qualifications are met.

4.2.3 The proficiency testing provider shall use personnel who are either employed by, or under contract to

it. Where contracted and additional technical and key support personnel are used, the proficiency testing

provider shall ensure that such personnel are supervised and competent and that they work in accordance

with the management system.
4 © ISO 2010 — All rights reserved
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SIST EN ISO/IEC 17043:2010
ISO/IEC 17043:2010(E)

NOTE Where technical experts are used on an ad-hoc basis or as part of an advisory or

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