BS EN ISO IEC 17043-2010 Conformity assessment - General requirements for proficiency testing《合格评定 能力验证的一般要求》.pdf

1、BS EN ISO/IEC 17043:2010ICS 03.120.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDConformity assessment General requirements for proficiency testing (ISO/CASCO 17043:2010) This British Standard was published under the authority of the Standards Policy and Str

2、ategy Committee on 31 May2010 BSI 2010ISBN 978 0 580 56522 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO/IEC 17043:2010National forewordThis British Standard is the UK implementation of EN ISO/IEC 17043:2010. It supersedes PD 6644-1:1999 and PD 6644-2:1999 which are withdrawn

3、.The UK participation in its preparation was entrusted to Technical Committee CAS/1/-/28, Proficiency testing by interlaboratory comparisons.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessar

4、y provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17043 February 2010 ICS 03.120.20 English version Conformity assessment - Genera

5、l requirements for proficiency testing (ISO/CASCO 17043:2010) valuation de la conformit - Exigences gnrales concernant les essais daptitude (ISO/CASCO 17043:2010)Konformittsbewertung - Allgemeine Anforderungen an Eignungsprfungen (ISO/CASCO 17043:2010) This European Standard was approved by CEN on 3

6、0 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 st

7、andards 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

8、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, G

9、ermany, 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 Marni

10、x 17, B-1000 Brussels 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17043:2010 EBS EN ISO/IEC 17043:2010EN ISO/IEC 17043:2010 (E) 3 Foreword This document (EN ISO/IEC 17043:2010) has b

11、een 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, eit

12、her 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/o

13、r 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

14、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:

15、2010 has been approved by CEN as a EN ISO/IEC 17043:2010 without any modification. BS EN ISO/IEC 17043:2010ISO/IEC 17043:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Technical Requirements.4 4.1 General

16、 .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 schemes11 4.7 Data analysis and evaluation of proficiency testing scheme results 12 4.8 Reports .13 4.9 Communicat

17、ion with participants14 4.10 Confidentiality15 5 Management requirements.15 5.1 Organization.15 5.2 Management system .16 5.3 Document control17 5.4 Review of requests, tenders and contracts18 5.5 Subcontracting services.19 5.6 Purchasing services and supplies 19 5.7 Service to the customer20 5.8 Co

18、mplaints 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)

19、 Statistical methods for proficiency testing28 Annex C (informative) Selection and use of proficiency testing35 Bibliography39 BS EN ISO/IEC 17043:2010ISO/IEC 17043:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) and IEC (the International Ele

20、ctrotechnical 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 tech

21、nical 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

22、(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

23、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

24、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 be

25、en technically revised. BS EN ISO/IEC 17043:2010ISO/IEC 17043:2010(E) ISO 2010 All rights reserved vIntroduction Interlaboratory comparisons are widely used for a number of purposes and their use is increasing internationally. Typical purposes for interlaboratory comparisons include: a) evaluation o

26、f 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, effectiven

27、ess 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 l

28、aboratories 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 tes

29、t 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 o

30、rganizations. 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 applica

31、tions 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 essen

32、tial 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 perfo

33、rmance 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

34、 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

35、 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 S

36、tandard 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 testin

37、g schemes by laboratories, accreditation bodies, regulatory bodies, and other interested parties. BS EN ISO/IEC 17043:2010BS EN ISO/IEC 17043:2010INTERNATIONAL STANDARD ISO/IEC 17043:2010(E) ISO 2010 All rights reserved 1Conformity assessment General requirements for proficiency testing 1 Scope This

38、 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

39、 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

40、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

41、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 a

42、ctivities 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 sam

43、e or similar items by two or more laboratories in accordance with predetermined conditions BS EN ISO/IEC 17043:2010ISO/IEC 17043:2010(E) 2 ISO 2010 All rights reserved3.5 outlier observation in a set of data that appears to be inconsistent with the remainder of that set NOTE An outlier can originate

44、 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 i

45、nspection 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

46、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 it

47、ems 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 profici

48、ency 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

49、 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 s