SIST EN ISO/IEC 17043:2010
(Main)Conformity assessment - General requirements for proficiency testing (ISO/CASCO 17043:2010)
Conformity assessment - General requirements for proficiency testing (ISO/CASCO 17043:2010)
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.
Konformitätsbewertung - Allgemeine Anforderungen an Eignungsprüfungen (ISO/CASCO 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/CASCO 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
Relations
Standards Content (Sample)
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
2
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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.
3
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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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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.
1)
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
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17043:2009
01-februar-2009
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/IEC/DIS 17043:2008)
Conformity assessment - General requirements for proficiency testing (ISO/IEC/DIS
17043:2008)
Konformitätsbewertung - Allgemeine Anforderungen an Eignungsprüfungen (ISO/IEC
DIS 17043:2008)
Évaluation de la conformité - Exigences générales pour les essais d'aptitude
(ISO/IEC/DIS 17043:2008)
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 17043:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO/IEC 17043:2009
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oSIST prEN ISO/IEC 17043:2009
EUROPEAN STANDARD
DRAFT
prEN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2008
ICS 03.120.20
English version
Conformity assessment - General requirements for proficiency
testing (ISO/IEC/DIS 17043:2008)
Évaluation de la conformité - Exigences générales pour les
essais d'aptitude (ISO/IEC/DIS 17043:2008)
This draft European Standard is submitted to CEN/CENELEC members for parallel enquiry. It has been drawn up by the Technical
Committee CEN/CLC/TC 1.
If this draft becomes a European Standard, CEN/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.
This draft European Standard was established by CEN/CENELEC in three official versions (English, French, German). A version in any
other language made by translation under the responsibility of a CEN/CENELEC member into its own language and notified to the CEN
Management Centre has the same status as the official versions.
CEN/CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium,
Bulgaria, 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.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels
© 2008 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO/IEC 17043:2008 E
worldwide for CEN national Members and for CENELEC
Members.
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oSIST prEN ISO/IEC 17043:2009
prEN ISO/IEC 17043:2008 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO/IEC 17043:2009
prEN ISO/IEC 17043:2008 (E)
Foreword
This document (prEN ISO/IEC 17043:2008) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/IEC/DIS 17043:2008 has been approved by CEN as a prEN ISO/IEC 17043:2008 without any
modification.
3
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oSIST prEN ISO/IEC 17043:2009
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oSIST prEN ISO/IEC 17043:2009
DRAFT INTERNATIONAL STANDARD ISO/IEC 17043
CASCO Secretariat: ISO/CS
Voting begins on Voting terminates on
2008-11-13 2009-04-13
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION • МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ • COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
Conformity assessment — General requirements for proficiency
testing
Évaluation de la conformité — Exigences générales pour les essais d'aptitude
ICS 03.120.20
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a
subject of interest to European standardization. In accordance with the ISO-lead mode of
collaboration as defined in the Vienna Agreement, consultation on this ISO/DIS has the same
effect for CEN members as would a CEN enquiry on a draft European Standard. Should this draft
be accepted, a final draft, established on the basis of comments received, will be submitted to a
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© International Organization for Standardization, 2008
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Contents Page
Foreword .v
Introduction.vi
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
4.4.1 Planning .6
4.4.2 Preparation of proficiency test items.8
4.4.3 Homogeneity and stability.8
4.4.4 Statistical design.9
4.4.5 Assigned values .10
4.5 Choice of method or procedure.10
4.6 Operation of proficiency testing schemes.10
4.6.1 Instructions for participants.10
4.6.2 Proficiency test items handling and storage.11
4.6.3 Packaging, labelling and distribution of proficiency test items.11
4.7 Data analysis and evaluation of proficiency testing scheme results .12
4.7.1 Data analysis and records.12
4.7.2 Evaluation of performance .12
4.8 Reports .13
4.9 Communication with participants.14
4.10 Confidentiality.14
5 Management Requirements .15
5.1 Organization.15
5.2 Management system .16
5.3 Document control.17
5.3.1 General .17
5.3.2 Document approval and issue .17
5.3.3 Document changes .17
5.4 Review of requests, tenders and contracts.18
5.5 Subcontracting services.18
5.6 Purchasing services and supplies .19
5.7 Service to the customer.19
5.8 Complaints .19
5.9 Control of nonconforming activities .19
5.10 Improvement.20
5.11 Corrective action .20
5.11.1 General.20
5.11.2 Cause analysis.20
5.11.3 Selection and implementation of corrective actions.20
5.11.4 Monitoring of corrective actions.21
5.11.5 Additional audits .21
5.12 Preventive action.21
5.13 Control of records .21
5.13.1 General.21
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5.13.2 Technical records . 21
5.14 Internal audits . 22
5.15 Management reviews. 22
Annex A (informative) Types of proficiency testing schemes. 24
A.1 General. 24
A.2 Sequential participation schemes. 24
A.3 Simultaneous participation schemes . 25
A.3.1 General. 25
A.3.2 Split-level designs . 26
A.3.3 Split-sample testing schemes . 26
A.3.4 Partial-process schemes . 26
A.4. External Quality Assessment (EQA) programmes .26
Annex B (informative) Statistical Methods for Proficiency Testing. 28
B.1 General. 28
B.2 Determination of the assigned value and its uncertainty. 28
B.3 Calculation of performance statistics . 29
B.3.1 Performance on single test items for quantitative results . 29
B.3.2 Performance on single test items for qualitative and semi-quantitative results . 31
B.3.3 Combined performance scores. 32
B.4 Evaluation of performance . 32
B.4.1 Initial performance. 32
B.4.2 Monitoring performance over time . 33
B.5 Demonstration of proficiency test item homogeneity and stability . 33
Annex C (informative) Selection and Use of Proficiency Testing . 34
C.1 Introduction. 34
C.2 Selection of proficiency testing schemes. 34
C.3 Policies on participation in proficiency testing schemes . 35
C.4 Use of proficiency testing by laboratories. 35
C.5 Use of results by interested parties. 36
C.5.1 Accreditation bodies . 36
C.5.2 Other interested parties . 36
C.6 Use of proficiency testing by regulatory bodies .36
Bibliography. 38
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ISO/IEC DIS 17043
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member 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.
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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, individual staff performance 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-g. Proficiency testing does not usually address purposes, 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 purposes, 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 who specify requirements for laboratories. The International Standard 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 Parts 1 and
2 of the previous ISO/IEC Guide 43. 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. ISO/IEC 17043 has preserved and updated
the principles for the operation of proficiency testing described in ISO/IEC Guide 43 and has retained in
Annexes A-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.
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DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 17043
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, ISO/IEC Guide 99 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 comparisons
organization, performance and evaluation of measurements or tests on the same or similar items by two or
more laboratories in accordance with predetermined conditions
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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 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 may 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 schemes – where the objective is to quantify one or more measurands of the proficiency test item ;
b) qualitative schemes —where the objective is to identify or describe one or more characteristics of the proficiency test
item;
c) sequential scheme — where one or more items are distributed sequentially and returned to the organizer at intervals;
d) bulk interlabor
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