EN ISO IEC 17025-2005 en General requirements for the competence of testing and calibration laboratories《检测和校准实验室能力的通用要求 ISO IEC 17025-2005》.pdf

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1、BRITISH STANDARD BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories The European Standard EN ISO/IEC 17025:2005 has the status of a British Standard ICS 03.120.20 BS EN ISO/IEC 17025:2005 This British Standard was published under the authority of

2、 the Standards Policy and Strategy Committee on 29 June 2005 BSI 29 June 2005 ISBN 0 580 46330 3 National foreword This British Standard is the official English language version of EN ISO/IEC 17025:2005. It is identical with EN ISO/IEC 17025:2005. It supersedes BS EN ISO/IEC 17025:2000 which is with

3、drawn. The UK participation in its preparation was entrusted to Technical Committee QS/3, Conformity assessment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement

4、international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to

5、include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any e

6、nquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO/IEC title page, the EN ISO/IEC for

7、eword page, the ISO title page, pages ii to vi, page 1 to page 28, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD NORME EUROPENNE EUROP

8、ISCHE NORMEN ISO/IEC 17025 May 2005 ICS 03.120.20 Supersedes EN ISO/IEC 17025:2000 English version General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005) Exigences gnrales concernant la comptence des laboratoires dtalonnages et dessais (ISO/IEC 17025:200

9、5)Allgemeine Anforderungen an die Kompetenz von Prf- und Kalibrierlaboratorien (ISO/IEC 17025:2005) This European Standard was approved by CEN and CENELEC on 15 March 2005. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

10、 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 or CENELEC member. This European Standard exists in three off

11、icial versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN or 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 sta

12、ndards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Sp

13、ain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels rue de Stassart, 35 B-1050 Brussels 2005 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELE

14、C Members. Ref. No. EN ISO/IEC 17025:2005 EEN ISO/IEC 17025:2005 Foreword This document (EN ISO/IEC 17025:2005) 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”,

15、the secretariat of which is held by SN. 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 November 2005, and conflicting national standards shall be withdrawn at the latest by November 2005. This do

16、cument supersedes EN ISO/IEC 17025:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hun

17、gary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO/IEC 17025:2005 has been approved by CEN and CENELEC as EN ISO/IEC 17025:2005 without any m

18、odifications. Reference number ISO/IEC 17025:2005(E) INTERNATIONAL STANDARD ISO/IEC 17025 Second edition 2005-05-15 General requirements for the competence of testing and calibration laboratories Exigences gnrales concernant la comptence des laboratoires dtalonnages et dessais EN ISO/IEC 17025:2005

19、iiEN ISO/IEC 17025:2005 iii Contents Page Foreword . v Introduction . vi 1 Scope 1 2 Normative references . 2 3 Terms and definitions. 2 4 Management requirements 2 4.1 Organization 2 4.2 Management system. 3 4.3 Document control . 4 4.3.1 General . 4 4.3.2 Document approval and issue. 4 4.3.3 Docum

20、ent changes . 5 4.4 Review of requests, tenders and contracts . 5 4.5 Subcontracting of tests and calibrations . 6 4.6 Purchasing services and supplies 6 4.7 Service to the customer . 6 4.8 Complaints. 7 4.9 Control of nonconforming testing and/or calibration work 7 4.10 Improvement 7 4.11 Correctiv

21、e action. 8 4.11.1 General . 8 4.11.2 Cause analysis 8 4.11.3 Selection and implementation of corrective actions. 8 4.11.4 Monitoring of corrective actions . 8 4.11.5 Additional audits . 8 4.12 Preventive action 8 4.13 Control of records. 9 4.13.1 General . 9 4.13.2 Technical records . 9 4.14 Intern

22、al audits 9 4.15 Management reviews 10 5 Technical requirements 10 5.1 General . 10 5.2 Personnel . 11 5.3 Accommodation and environmental conditions . 12 5.4 Test and calibration methods and method validation. 12 5.4.1 General . 12 5.4.2 Selection of methods 13 5.4.3 Laboratory-developed methods 13

23、 5.4.4 Non-standard methods. 13 5.4.5 Validation of methods. 14 5.4.6 Estimation of uncertainty of measurement 14 5.4.7 Control of data. 15 5.5 Equipment 15 5.6 Measurement traceability. 17 5.6.1 General . 17 5.6.2 Specific requirements. 17 5.6.3 Reference standards and reference materials . 18 5.7

24、Sampling 19iv 5.8 Handling of test and calibration items 19 5.9 Assuring the quality of test and calibration results 20 5.10 Reporting the results 20 5.10.1 General.20 5.10.2 Test reports and calibration certificates.20 5.10.3 Test reports21 5.10.4 Calibration certificates22 5.10.5 Opinions and inte

25、rpretations .22 5.10.6 Testing and calibration results obtained from subcontractors23 5.10.7 Electronic transmission of results 23 5.10.8 Format of reports and certificates.23 5.10.9 Amendments to test reports and calibration certificates .23 Annex A (informative) Nominal cross-references to ISO 900

26、1:2000 .24 Annex B (informative) Guidelines for establishing applications for specific fields 26 Bibliography27 EN ISO/IEC 17025:2005v Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide s

27、tandardization. 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 field

28、s 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

29、 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 ca

30、sting 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 17025 was prepared by the ISO Committee on conformity assessment (CASCO). It wa

31、s circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This second edition cancels and replaces the first edition (ISO/IEC 17025:1999), which has been technically revised. EN ISO/IEC 17025:2005vi Introduction The first edition (1999) of this Inter

32、national Standard was produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced. It contained all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a manageme

33、nt system, are technically competent, and are able to generate technically valid results. The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have bee

34、n amended or added only when considered necessary in the light of ISO 9001:2000. Accreditation bodies that recognize the competence of testing and calibration laboratories should use this International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound manag

35、ement. Clause 5 specifies the requirements for technical competence for the type of tests and/or calibrations the laboratory undertakes. Growth in the use of management systems generally has increased the need to ensure that laboratories which form part of larger organizations or offer other service

36、s can operate to a quality management system that is seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by t

37、he laboratorys management system. Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001. Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of it

38、self demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to this International Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. The acceptance

39、of testing and calibration results between countries should be facilitated if laboratories comply with this International Standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this International Sta

40、ndard. The use of this International Standard will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures. EN ISO/IEC 17025:20051 General requirements for the competence of testing a

41、nd calibration laboratories 1 Scope 1.1 This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed met

42、hods. 1.2 This International Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. This Internat

43、ional Standard is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by this International Standard, such as sampling and the design/devel

44、opment of new methods, the requirements of those clauses do not apply. 1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard. 1.4 This International Standard is for use by laborat

45、ories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This International Standard is not intended to be used

46、as the basis for certification of laboratories. NOTE 1 The term management system in this International Standard means the quality, administrative and technical systems that govern the operations of a laboratory. NOTE 2 Certification of a management system is sometimes also called registration. 1.5

47、Compliance with regulatory and safety requirements on the operation of laboratories is not covered by this International Standard. 1.6 If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing

48、and calibration activities that also meets the principles of ISO 9001. Annex A provides nominal cross-references between this International Standard and ISO 9001. This International Standard covers technical competence requirements that are not covered by ISO 9001. NOTE 1 It might be necessary to ex

49、plain or interpret certain requirements in this International Standard to ensure that the requirements are applied in a consistent manner. Guidance for establishing applications for specific fields, especially for accreditation bodies (see ISO/IEC 17011) is given in Annex B. NOTE 2 If a laboratory wishes accreditation for part or all of its testing and calibration activities, it should select an accreditation body that operates in accordance with ISO/IEC 17011. EN ISO/IEC 17025:20052 2 Normative r