SANS 17043-2010 Conformity assessment - General requirements for proficiency testing《合格评定 对能力测试的一般要求》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23658-8 SANS 17043:2010Edition 1ISO/IEC 17043:2010Edition 1SOUTH AFRICAN NATIONAL STANDARD Conformity assessment General requirements for

4、proficiency testing This national standard is the identical implementation of ISO/IEC 17043:2010 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7

5、911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 17043:2010 Edition 1 ISO/IEC 17043:2010 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 180, Conformity assessment, in accordance with procedures of the SABS St

6、andards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in March 2010. Reference numberISO/IEC 17043:2010(E)ISO 2010INTERNATIONAL STANDARD ISO/IEC17043First edition2010-02-01Conformity assessment General requirements for proficiency testing valuation d

7、e la conformit Exigences gnrales concernant les essais daptitude SANS 17043:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17043:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licen

8、sing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO

9、 Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has bee

10、n taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 All rights reserved. Unless otherwise specified, no part of

11、this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-

12、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 2010 All rights reservedSANS 17043:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17043:2010(E) I

13、SO 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 .4 4.2 Personnel .4 4.3 Equipment, accommodation and environment 5 4.4 Design of proficiency testing schemes.6 4.5 Choice of meth

14、od 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 Communication with participants14 4.10 Confidentiality15 5 Management requirements.15 5.1 Organization.15 5.2 Management system .16 5.3 Docu

15、ment 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 Complaints and appeals .20 5.9 Control of nonconforming work 20 5.10 Improvement 20 5.11 Corrective actions .21 5.12 Preventive acti

16、ons.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) Statistical methods for proficiency testing28 Annex C (informative) Selection and use of proficiency testing35 Bibliography39 SAN

17、S 17043:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17043:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form th

18、e 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 techn

19、ical 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 de

20、velopment 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

21、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

22、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. SANS 1704

23、3:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/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 p

24、urposes for interlaboratory comparisons include: a) evaluation of 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

25、related to inadequate test or measurement procedures, effectiveness 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

26、 of interlaboratory differences; f) education of participating laboratories 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 mater

27、ials and assessment of their suitability for use in specific test 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 We

28、ights 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 laborator

29、y 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 fo

30、r 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 accreditatio

31、n 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 tho

32、se 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 organization

33、s 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 descriptio

34、ns 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 appropri

35、ate statistical methods, selection and use of proficiency testing schemes by laboratories, accreditation bodies, regulatory bodies, and other interested parties. SANS 17043:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 17043:2010Th

36、is s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO/IEC 17043:2010(E) ISO 2010 All rights reserved 1Conformity assessment General requirements for proficiency testing 1 Scope This International Standard specifies general

37、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 require

38、ments 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 ame

39、ndments) 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

40、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 activities involved in the operation of a p

41、roficiency 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 same or similar items by two or more laborato

42、ries in accordance with predetermined conditions SANS 17043:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17043:2010(E) 2 ISO 2010 All rights reserved3.5 outlier observation in a set of data that appears to be inconsistent with

43、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. 3.6 participant laboratory, organization or individual that receives proficiency test items and submits results for review by the proficiency testing p

44、rovider NOTE In some cases, the participant can be an inspection 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 take

45、n in its widest sense and includes, but is not limited 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)

46、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; d) simultaneous scheme where proficiency test items are distributed for concurrent testing or measurement within a defined

47、 time period; e) single occasion exercise where proficiency 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 wh

48、ere 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

49、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 set or other information used for proficiency testing 3.9 proficiency testing provider organization which takes responsibility for all tasks in the development and operation of a proficiency testing scheme 3.10 proficiency testing roun