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EN ISO/IEC 17043:2010

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

прийнято як національний стандарт
методом підтвердження за позначенням

ДСТУ EN ISO/IEC 17043:2014

uk: Оцінка відповідності. Загальні вимоги до перевірки кваліфікації
лабораторій

(EN ISO/IEC 17043:2010, IDT)

З наданням чинності від 2016-01-01

EN ISO/IEC 17043

February 2010

Evaluation de la conformite - Exigences дёпёгаіеэ
concernant les essais d'aptitude (ISO/CASCO 17043:2010)

Konformitatsbewertung - Allgemeine Anforderungen an
Eignungsprufungen (ISO/CASCO 17043:2010)

EUROPEAN STANDARD NORME EUROPEENNE EUROPAlSCHE norm

ICS 03.120.20

English version

Conformity assessment - General requirements for proficiency
testing (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:

Avenue Marnix 17, B-1000 Brussels

CENELEC Central Secretariat: Avenue Marnix 17, B-1000 Brussel

sThis 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.

INTERNATIONAL

STANDARD

ISO/IEC

17043

First edition 2010-02-01

Conformity assessment — General requirements for proficiency testing

Evaluation de la conformite — Exigences generales concernant les essais d'aptitude

Reference number

I

I EC

W⁷

SO/IEC 17043:2010(E)

© ISO 2010

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.Introduction

Interlaboratory comparisons are widely used for a number of purposes and their use is increasing internationally. Typical purposes for interlaboratory comparisons include:

1. evaluation of the performance of laboratories for specific tests or measurements and monitoring laboratories’ continuing performance;

2. 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;

3. establishment of the effectiveness and comparability of test or measurement methods;

4. provision of additional confidence to laboratory customers;

5. identification of interlaboratory differences;

6. education of participating laboratories based on the outcomes of such comparisons;

7. validation of uncertainty claims;

8. evaluation of the performance characteristics of a method - often described as collaborative trials;

9. assignment of values to reference materials and assessment of their suitability for use in specific test or measurement procedures; and

10. 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.

I

ISO/IEC 17043:2010(E)

NTERNATIONAL STANDARD

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.

assigned value

value attributed to a particular property of a proficiency test item

coordinator

one or more individuals with responsibility for organizing and managing all of the activities involved in the operation of a proficiency testing scheme

customer

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

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

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.

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.

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:

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

2. qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item;

3. 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;

4. simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period;

5. single occasion exercise — where proficiency test items are provided on a single occasion;

6. continuous scheme — where proficiency test items are provided at regular intervals;

7. sampling — where samples are taken for subsequent analysis; and

8. 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.

proficiency test item

sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing

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

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 ILAC¹) 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).

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 В 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

   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.

NOTE Where technical experts are used on an ad-hoc basis or as part of an advisory or steering group (see 4.4.1.4), the existence of formal agreements through, for example, group terms of reference or other means, can be considered to satisfy this requirement.

1. select appropriate proficiency test items;

2. plan proficiency testing schemes;

3. perform particular types of sampling;

4. operate specific equipment;

5. conduct measurements to determine stability and homogeneity, as well as assigned values and associated uncertainties of the measurands of the proficiency test item;

6. prepare, handle and distribute proficiency test items;

7. operate the data processing system;

8. conduct statistical analysis;

9. evaluate the performance of proficiency testing participants;

10. give opinions and interpretations; and

11. authorize the issue of proficiency testing reports.