ISO GUIDE 34-2009 General requirements for the competence of reference material producers《参考材料生产商权限的一般要求》.pdf

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1、 Third edition 2009 ISO 2009 GUIDE 34 General requirements for the competence of reference material producers Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO GUIDE 3

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6、ss below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedCopyright International Organization for S

7、tandardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Organiz

8、ation and management requirements4 4.1 Management system requirements .4 4.2 Organization and management6 4.3 Document and information control .7 4.4 Request, tender and contract reviews 8 4.5 Use of subcontractors 8 4.6 Procurement of services and supplies .9 4.7 Customer service 9 4.8 Complaints .

9、9 4.9 Control of non-conforming work and/or reference materials.9 4.10 Corrective actions .10 4.11 Preventive actions.11 4.12 Improvement 11 4.13 Records 11 4.14 Internal audits 12 4.15 Management reviews 13 5 Technical and production requirements.13 5.1 General .13 5.2 Personnel .14 5.3 Subcontract

10、ors 14 5.4 Production planning15 5.5 Production control 16 5.6 Accommodation and environmental conditions16 5.7 Material handling and storage .17 5.8 Material processing.18 5.9 Measurement methods .18 5.10 Measuring equipment .18 5.11 Data evaluation 19 5.12 Metrological traceability .19 5.13 Assess

11、ment of homogeneity .21 5.14 Assessment of stability 21 5.15 Characterization 22 5.16 Assignment of property values and their uncertainties23 5.17 Certificates or documentation for users.23 5.18 Distribution service .24 Annex A (informative) Metrological traceability of certified property values of

12、reference materials 25 Annex B (informative) Commutability of reference materials 27 Annex C (informative) ISO/IEC 17025/ISO Guide 34 cross-reference table 29 Bibliography34 Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction

13、or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norm

14、ally 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 t

15、he work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft Guides adopted by the responsible Committee o

16、r Group are circulated to the member bodies for voting. Publication as a Guide 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 responsib

17、le for identifying any or all such patent rights. ISO Guide 34 was prepared by the ISO Reference Materials Committee (REMCO). This third edition cancels and replaces the second edition (ISO Guide 34:2000), which has been technically revised. It also incorporates the Technical Corrigendum ISO Guide 3

18、4:2000/Cor.1:2003. Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) ISO 2009 All rights reserved vIntroduction The use of reference materials enables

19、 the transfer of the values of measured or assigned properties between testing and measurement laboratories. Such materials are widely used, e.g. for the calibration of measuring equipment and for the evaluation or validation of measurement procedures. In certain cases, they enable properties to be

20、expressed conveniently in arbitrary units. NOTE The concept “reference material” is included in the concept “measurement standard”, both of which also include physical reference materials used for calibrating instruments in mechanical, non-destructive and construction type-testing facilities. There

21、are an increasing number of reference material producers, and a demonstration of their scientific and technical competence is nowadays a basic requirement for ensuring the quality of reference materials. The demand for new reference materials of higher quality is increasing as a consequence of both

22、the increased precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. Some previously acceptable reference materials may not meet these more stringent requirements anymore. It is, therefore, not only necessary for refe

23、rence material producers to provide information about their materials in the form of reports, certificates and statements, but also to demonstrate their competence in producing reference materials of appropriate quality. The first edition of ISO Guide 34 set out specific guidelines on the interpreta

24、tion of ISO/IEC Guide 25 and the International Standards prepared by ISO/TC 1761)in the context of reference material production. The more general requirements of these International Standards were omitted. Since the first edition of ISO Guide 34 was published in 1996, the assessment of the competen

25、ce of reference material producers has gained considerable impetus. The second edition of ISO Guide 34 set out all the general requirements in accordance with which a reference material producer has to demonstrate that it operates. The present edition makes these requirements mandatory and in line w

26、ith ISO/IEC 17025:2005/Cor.1:2006 in view of its use for the assessment of the competence of reference material producers applying for accreditation. For tests performed in the medical field, ISO 15189 may be used as the reference instead of ISO/IEC 17025. 1) Including ISO 9000, ISO 9001 and ISO 900

27、4. Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo repro

28、duction or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) ISO 2009 All rights reserved 1General requirements for the competence of reference material producers 1 Scope 1.1 This Guide specifies general requirements in accordance with which a reference material producer has to

29、demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials. 1.2 This Guide is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical o

30、perations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers. NOTE This Guide is not intended to be used as the basis for conformity assessment by certification bodies. 1.3 This G

31、uide sets out the management system requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producers general quality assurance (QA) procedures. 1.4 This Guide covers the production of certified and non-certified referenc

32、e materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide. 2 Normative references The following referen

33、ced 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 Guide 30, Terms and definitions used in connection with reference

34、materials ISO Guide 31, Reference materials Contents of certificates and labels ISO Guide 35, Reference materials General and statistical principles for certification ISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM) ISO/IEC Guide 99,

35、International vocabulary of metrology Basic and general concepts and associated terms (VIM) ISO 9000, Quality management systems Fundamentals and vocabulary ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment ISO 15189, Medical laboratories Partic

36、ular requirements for quality and competence Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) 2 ISO 2009 All rights reservedISO/IEC 17000, Conformity

37、 assessment Vocabulary and general principles ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC 17025, ISO Guides 30 and 35, ISO 9000, ISO

38、/IEC Guide 99 and the following apply. NOTE The definition of (certified) reference materials in this Guide is referenced to ISO Guide 30 (not ISO/IEC Guide 99). Unless explicitly stated otherwise, the term “certification” is used for the certification of reference materials and shall not be confuse

39、d with product certification or certification of management systems. 3.1 reference material producer body (organization or company, public or private) that is fully responsible for project planning and management, assignment of and decision on property values and relevant uncertainties, authorizatio

40、n of property values and issue of the certificate or other statements for the reference materials it produces 3.2 subcontractor body (organization or company, public or private) that undertakes aspects of the processing, handling, homogeneity and stability assessment, characterization, storage or di

41、stribution of the reference material on behalf of the reference material producer, on a contractual basis, either paid or non-paid (see 5.3.1) NOTE 1 Key tasks/aspects of the reference material production process which cannot be performed by external parties are project planning, assignment and deci

42、sion on property values and relevant uncertainties, authorization of property values and issuing of certificates or other statements for the reference materials. NOTE 2 The concept “subcontractor” is equivalent to the concept “collaborator”. NOTE 3 Advisors, who could be asked for recommendations, b

43、ut who are not involved in decision making or the execution of any aspects mentioned in the definition above, are not considered as subcontractors. 3.3 production of a reference material all necessary activities and tasks leading to a reference material (certified or non-certified) supplied to custo

44、mers NOTE Production of a reference material includes production planning, production control, material handling and storage, material processing (also referred to as “manufacturing” or “preparation”), assessment of homogeneity and stability, issue of statements and post-distribution service of the

45、reference materials. It can include characterization, assignment of property values and their uncertainties, authorization and issue of certificates for certified reference materials. 3.4 reference material RM material, sufficiently homogeneous and stable with respect to one or more specified proper

46、ties, which has been established to be fit for its intended use in a measurement process NOTE 1 RM is a generic term. NOTE 2 Properties can be quantitative or qualitative (e.g. identity of substances or species). NOTE 3 Uses may include the calibration of a measurement system, assessment of a measur

47、ement procedure, assigning values to other materials, and quality control. Copyright International Organization for Standardization Provided by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO GUIDE 34:2009(E) ISO 2009 All rights reser

48、ved 3NOTE 4 A single RM cannot be used for both calibration and validation of results in the same measurement procedure. NOTE 5 VIM has an analogous definition (ISO/IEC Guide 99:2007, 5.13), but restricts the term “measurement” to apply to quantitative values and not to qualitative properties. Howev

49、er, Note 3 of ISO/IEC Guide 99:2007, 5.13, specifically includes the concept of qualitative attributes, called “nominal properties”. ISO Guide 30:1992/Amd.1:2008, definition 2.1 3.5 certified reference material CRM reference material characterized by a metrologically valid procedure for one or more specified p