EN ISO IEC 17025-2017 en General requirements for the competence of testing and calibration laboratories.pdf

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1、General requirements for the competence of testing and calibration laboratoriesBS EN ISO/IEC 17025:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO/IEC 17025:2017. It supersedes BS EN ISO/IE

2、C 17025:2005, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.A list of organizations represented on this committee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 necessary

3、provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 88466 5ICS 19.020; 03.120.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard

4、 was published under the authority of the Standards Policy and Strategy Committee on 31 December 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO/IEC 17025:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO/IEC 17025December 2017ICS 03.120.20 Supe

5、rsedes EN ISO/IEC 17025:2005EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO/IEC 17025:2017: EAll rights of exploitation in any form and by any means reserved wo

6、rldwide for CEN national MembersGeneral requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017)Exigences gnrales concernant la comptence des laboratoires dtalonnages et dessais (ISO/IEC 17025:2017)Allgemeine Anforderungen an die Kompetenz von Prf- und Kalibrierla

7、boratorien (ISO/IEC 17025:2017)This European Standard was approved by CEN on 10 November 2017.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 alteratio

8、n. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 langua

9、ge made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austr

10、ia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain

11、, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO/IEC 17025:2017 (E)European forewordThis document (EN ISO/IEC 17025:2017) has been prepared by Technical Committee ISO/CASCO “Committee on conformity assessment“ in collaboration with Technical Committee CEN/CLC/JTC 1 “Criteria fo

12、r 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 June 2018 and conflicting national standards shall be withdrawn at the lates

13、t by June 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO/IEC 17025:2005.According to the CEN-CENELEC Internal Re

14、gulations, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

15、 Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO/IEC 17025:2017 has been approved by CEN as EN ISO/IEC 17025:2017 without any modificat

16、ion.2BS EN ISO/IEC 17025:2017ISO 17025:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 34.1 Impartiality 34.2 Confidentiality . 35 Structural requirements 46 Resource requirements . 56.1 General . 56.2 Personnel . 56.3 Facilities

17、 and environmental conditions 56.4 Equipment . 66.5 Metrological traceability . 86.6 Externally provided products and services 87 Process requirements . 97.1 Review of requests, tenders and contracts . 97.2 Selection, verification and validation of methods107.2.1 Selection and verification of method

18、s 107.2.2 Validation of methods .117.3 Sampling 127.4 Handling of test or calibration items 127.5 Technical records . 137.6 Evaluation of measurement uncertainty . 137.7 Ensuring the validity of results 137.8 Reporting of results . 147.8.1 General. 147.8.2 Common requirements for reports (test, cali

19、bration or sampling) 147.8.3 Specific requirements for test reports .157.8.4 Specific requirements for calibration certificates 167.8.5 Reporting sampling specific requirements .167.8.6 Reporting statements of conformity 167.8.7 Reporting opinions and interpretations .177.8.8 Amendments to reports 1

20、77.9 Complaints . 177.10 Nonconforming work . 187.11 Control of data and information management . 188 Management system requirements .198.1 Options 198.1.1 General. 198.1.2 Option A 198.1.3 Option B 208.2 Management system documentation (Option A) .208.3 Control of management system documents (Optio

21、n A) .208.4 Control of records (Option A) 218.5 Actions to address risks and opportunities (Option A) 218.6 Improvement (Option A) . 218.7 Corrective actions (Option A) 228.8 Internal audits (Option A) 228.9 Management reviews (Option A) . 23 ISO 2017 All rights reserved iiiContents PageBS EN ISO/IE

22、C 17025:2017ISO 17025:2017(E)Annex A (informative) Metrological traceability 24Annex B (informative) Management system options .26Bibliography .28iv ISO 2017 All rights reservedBS EN ISO/IEC 17025:2017ISO 17025:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide fe

23、deration 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 com

24、mittee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. In the field of conformity assessment, ISO and the International Electrotechnical Commission (IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Con

25、formity assessment (ISO/CASCO).The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was

26、 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such paten

27、t rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not co

28、nstitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) s

29、ee the following URL: www.iso.org/iso/foreword.html.This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations.This third edition cancels and replaces the second edition

30、 (ISO/IEC 17025:2005), which has been technically revised.The main changes compared to the previous edition are as follows: the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements; there is greate

31、r flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities; a definition of “laboratory” has been added (see 3.6). ISO 2017 All rights reserved vBS EN ISO/IEC 17025:2017ISO 17025:2017(E)IntroductionThis documen

32、t has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also

33、operate generally in accordance with the principles of ISO 9001.This document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving imp

34、roved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.The use of this document will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in th

35、e harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to this document.In this document, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission;

36、“can” indicates a possibility or a capability.Further details can be found in the ISO/IEC Directives, Part 2.For the purposes of research, users are encouraged to share their views on this document and their priorities for changes to future editions. Click on the link below to take part in the onlin

37、e survey:17025_ed3_usersurvey vi ISO 2017 All rights reservedBS EN ISO/IEC 17025:2017General requirements for the competence of testing and calibration laboratories1 ScopeThis document specifies the general requirements for the competence, impartiality and consistent operation of laboratories.This d

38、ocument is applicable to all organizations performing laboratory activities, regardless of the number of personnel.Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the compet

39、ence of laboratories.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced

40、 document (including any amendments) applies.ISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)1)ISO/IEC 17000, Conformity assessment Vocabulary and general principles3 Terms and definitionsFor the purposes of this document, the terms and de

41、finitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.o

42、rg/ 3.1impartialitypresence of objectivityNote 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).Note 2 to entry: Other terms that are useful in conveying the element of impartiality i

43、nclude “freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.SOURCE: ISO/IEC 17021-1:2015, 3.2, modified The words “the certification body” have been replaced by “the laboratory” in Note

44、 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry.1) Also known as JCGM 200.INTERNATIONAL STANDARD ISO 17025:2017(E) ISO/IEC 2017 All rights reserved 1BS EN ISO/IEC 17025:2017ISO 17025:2017(E)3.2complaintexpression of dissatisfaction by any person or organiza

45、tion to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expectedSOURCE: ISO/IEC 17000:2004, 6.5, modified The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities o

46、f that body” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.3.3interlaboratory comparisonorganization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditi

47、onsSOURCE: ISO/IEC 17043:2010, 3.43.4intralaboratory comparisonorganization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory (3.6) in accordance with predetermined conditions3.5proficiency testingevaluation of participant performance agains

48、t pre-established criteria by means of interlaboratory comparisons (3.3) SOURCE: ISO/IEC 17043:2010, 3.7, modified Notes to entry have been deleted.3.6laboratorybody that performs one or more of the following activities: testing; calibration; sampling, associated with subsequent testing or calibrati

49、onNote 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.3.7decision rulerule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement3.8verificationprovision of objective evidence that a given item fulfils specified requirementsEXAMPLE 1 Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a