JIS-Q-0043-1-1998-R2004-ENG.pdf

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1、JIS JAPANESE 1 N DUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS Q 0043-1 1998 (IS0 / IEC GUIDE 43- 1 : 1997) Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes ICs 03.120.20 Descriptors : certificate

2、s of conformity, approval laboratories, inspectors, approval testing, personnel management, laboratory accreditation, quality assurance systems Reference number : JIS Q 0043-1 : 1998 (E) 17 S PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicens

3、ee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of International Trade a

4、nd Industry through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law. JI$ Q 0043 consists of the following two parts with the title of Proficiency testing by interlaboratory comparisons. Part 1: Part 2: Development and operation of pr

5、oficiency testing schemes Selection and use of proficiency testing schemes by laboratory accreditation bodies Date of Establishment: 1998-11-20 Date of Public Notice in Official Gazette: 1998-11-20 Investigated by: Japanese Industrial Standards Committee Divisional Council on Accreditation and Certi

6、fication JIS Q 0043-1: 1998, First English edition published in 2002-09 Translated and published by: Japanese standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2002 Ail r

7、ights reserved. Unless otherwise specified, no part of 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 the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japan

8、ese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- JIS Q 0043-1 : 1998 (ISO/IEC GUIDE 43-1 : 1997) Contents Page 1 0 Introdu

9、cti on 1 Scope 2 2 References 3 . Annex A (informative) Examples of statistical methods for treatment of proficiencytestdata 18 Annex B (informative) Quality management of proficiency testing schemes - - - - - * * 24 Annex C (ififormative) Bibliography 26 . ( i PROTECTED BY COPYRIGHT Copyright Japan

10、ese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS Q 0043-1 1998 (ISOLIEC GUIDE 43-1 : 1997

11、) Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes O. Introduction 0.1 This Japanese Industrial Standard has been prepared based on the second edition of ISODEC GUIDE 43-1, Proficiency testing by interlaboratory comparisons-Part 1

12、: De- velopment and operation of proficiency testing schemes published in 1997 without modi- fying the technical contents. Portions underlined with dots are the matters not stated in the original Guide. 0.2 Interlaboratory comparisons are conducted for a number of purposes and may be used by partici

13、pating laboratories and other parties. Interlaboratory comparisons may be used, for example, to: a) determine the performance of individual laboratories for specific tests or measure- ments and to monitor laboratories continuing performance; . . . hfO-ZW- establish the effectiveness and comparabilit

14、y of new test or measurement methods and similarly to monitor established methods; d) provide additional confidence to laboratory clients; e) identify interlaboratory differences; f) c) determine the performance characteristics of a method- often known as collabora- tive trials; g) assign values to

15、reference materials (RMs) and assess their suitability for use in specific test or measurement procedures. Proficiency testing is the use of interlaboratory comparisons for purpose a ) ; i.e. the determination of laboratory testing or measurement performance. However, the operation of proficiency te

16、sting schemes may often also provide information for the other purposes listed above. Participation in proficiency testing schemes provides laboratories with an objective means of assessing and demonstrating the reliability of the data they are producing. Although there are several types of proficie

17、ncy testing schemes (see clause 4), most share the common feature of the comparison of test and measurement results obtained by two or more laboratories. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing

18、, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 Q 0043-1 : 1998 (ISO/IEC GUIDE 43-1 : 1997) One of the main uses of proficiency testing schemes is to assess laboratories ability to perform tests competently. This may include as

19、sessment by laboratories themselves, by their clients, or by other parties such as accreditation or regulatory bodies. It thus sup- plements laboratories own internal quality control procedures by providing an additional external measure of their testing capability. These activities also complement

20、the tech- nique of on-site laboratory assessment by technical specialists (usually used by laborato- ry accreditation bodies). Confidence that a testing or calibration laboratory consistently obtains reliable results is of major importance to users of laboratory services. Users seeking such an assur

21、ance may undertake their own evaluation of results or may use the evaluation of other bodies. IInformatI-n -: ?he- -us.ers- .mean. w h l e users- of .testing .and.ca!ibratian l c e - s . ie-. di eats. of testing. and .alibxattion,. usera af re0.1-t ancl .c-edific-ates. .ek While the emphasis of this

22、 part of JIS Q 0043 is on operation of interlaboratory com- parisons for proficiency testing, most of the principles and guidance given are applicable to operation of interlaboratory comparisons for other purposes. While many laboratory accreditation bodies operate their own proficiency testing sche

23、mes, significant number also use proficiency testing schemes or other forms of inter- laboratory comparisons operated by other bodies. The purpose of part 2 of JIS Q 0043 is to provide harmonized principles for the selection of suitable interlaboratory comparisons for use as proficiency testing sche

24、mes by laboratory accreditation bodies. Most bodies assessing the technical competence of laboratories require or expect satis- factory performance in proficiency testing schemes as significant evidence of a laborato- rys ability to produce reliable results (except where proficiency testing is inapp

25、ropriate). However, it is emphasized that a major distinction exists between: a) the evaluation of the competence of a laboratory by the assessment of its total op- eration against predetermined requirements; and b) the examination of the results of a laboratorys participation in proficiency testing

26、 which may only be considered as giving information about the technical competence of the testing laboratory at a single point of time under the specific conditions of the test (or tests) involved in a particular proficiency testing scheme. In preparing ISODEC Guide 43-1, reference was made to a num

27、ber of guidance docu- ments relevant to proficiency testing produced by ILAC; IS0 (TC 69); ISO/REMCO; IUPAC; AOAC; ASTM; and WECC and WELAC (now combined as EAL). 1 Scope While there are a number of uses of interlaboratory comparisons, and varia- tions in their design and implementation, it is still

28、 possible to specify the essential prin- ciples that need to be considered when organizing such comparisons. This part of ISO/IEC Guide 43. defines those principles and describes the factors which should be taken into account in the organization and conduct of proficiency testing schemes. Part 2 of

29、JIS Q 0043 describes how laboratory accreditation bodies, who assess techni- cal competence of laboratories, should select and use proficiency testing schemes. This part of ISO/IEC Guide 43 is intended for use by proficiency testing operators and PROTECTED BY COPYRIGHT Copyright Japanese Standards A

30、ssociation Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 Q 0043-1 : 1998 (ISO/IEC GUIDE 43-1 : 1997) users such as participant laboratories, ac

31、creditation bodies, regulatory authorities and clients of laboratory services who have a need to assess the technical competence of labo- ratories. It is particularly useful for laboratories in self-evaluation, but recognizes that proficiency testing is only one mechanism which can contribute to he

32、establishment of mutual confidence between users of different testing laboratories. It is currently a condition of some accreditation bodies that laboratories participate regularly in proficiency testing schemes that they have accepted as fit for purpose. There- fore, it is essential that operators

33、of such schemes comply with principles for conduct of professionally managed proficiency schemes, both in terms of technical requirements, statistical procedures (see examples in annex A), and in quality management (see guidance in annex B), The methods of operation within different proficiency test

34、ing organizations are not expected to be identical and this Standard does not give specific operational details for interlaboratory comparisons. The contents of this Standard are intended only as a framework to be modified appropriately for particular situations, including schemes with either small

35、or large numbers of participants. This Standard is not intended to cover a technique often used by organizations to evaluate a single laboratorys performance through submissions of certified reference materials or other well-characterized test items. A bibliography is given in annex C. 2 References

36、JIS Q 0043-2 : 1998 Proficiency testing by interlaboratory comparisons-Part 2 : Selection and use of proficiency testing schemes by laboratory accreditation bodies Remarks : ISO/IEC GUIDE 43-2 : 1997, Proficiency testing by interlaboratory comparisons -Part 2 : Selection and use of proficiency testi

37、ng schemes by laboratory accreditation bodies is identical with the said standard. JIS Z 9325 : 1996 General requirements for the competence of calibration and testing laboratories Remarks : ISO/IEC GUIDE 25 : 1990, General requirements for the competence of calibration and testing laboratories is i

38、dentical with the said stan- dard. IS0 3534-1 : 1993, Statistics-Vocabulary and symbols-Part 1 : Probability and general statistical terms Accuracy (trueness and precision) of measurement methods and results-Part 1 : General principles and definitions Accuracy (trueness and precision) of measurement

39、 methods and results-Part 2 : Basic method for the determination of re- peatability and reproducibility of a standard measurement method IS0 5725-1 : 1994, IS0 5725-2 : 1994, PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/

40、1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Q 0043-1 : 1998 (ISOIIEC GUIDE 43-1 : 1997) IS0 5725-4 : 1994, Accuracy (trueness and precision) ofmeasurement methods and results-Part 4 : Basic methods for

41、the determination of the trueness of a standard measurement method 1nfrmakitio.n. :_ J1S-Zm-8$Q2:1, ._Z-_rl-.sl.are-e-U-lid. .-.l:clentic.al-with. ISQ 572-5-4. - r2. -ad 4. LYSJX-CYX. IS0 9000 Quality Management Compendium, 1994 _._. Information : _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Generally 2 _.

42、_ JIS Z 9900 family _- _._ “ B. uality _._._ _._._ management _._ and system” _._ corresP-O-nda with. the. said .standard* ISO/IEC GUIDE 2 : 1996 lary Guide to the Expression of Uncertainty in Measurement : 1993, issued by BIPM ; IEC ; IFCC ; IS0 ; IUPAC ; IUPAP ; OIML International vocabulary of ba

43、sic and general terms in metrology : 1993, issued by BIPM ; IEC ; IFCC ; IS0 ; IUPAC ; IUPAP ; OIML W M : 19931 The International Harmonized Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories. Journal of AOAC International, 76, No.4, 1993, pp.926-940. Evaluation of Matrix Eff

44、ects : Proposed Guideline, NCCLS Document EP-14P. Na- tional Committee for Clinical Laboratory Standards, Villanova, PA, 1994 Standardization and related activities -General vocabu- 3 definitions are taken from other IS0 Guides and International Standards. as shown. Definitions For the purposes of t

45、his Standard, the following definitions apply. Some 3 . 1 teristics of a given product, process or service according to a specified procedure ISO/IEC Guide 21 test technical operation that consists of the determination of one or more charac- 3 . 2 testing laboratory laboratory that performs tests No

46、te The term “testing laboratory” can be used in the sense of a legal entity, a technical entity or both. ISO/IEC Guide 21 3.3 test item material or artefact presented to the participating laboratory for the purpose of proficiency testing 3.4 test method specified technical procedure for performing a

47、 test ISO/IEC Guide 2 1 3 . 5 specified measurement method test result the value of a characteristic obtained by completely carrying out a IS0 5725-11 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, B

48、ernie Not for Resale, 03/13/2007 23:08:21 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 1997) Q 0043-1 : 1998 (ISO/IEC GUIDE 43-1 3.6 (laboratory) proficiency testing determination of laboratory testing performance by means of interlaboratory comparisons ISODEC Guide 21 Note For the purposes of this Standard, the term laboratory proficiency testing is taken in its widest sense and includes, for example: Qualitative schemes- for example where