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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association (IS0 Guide 34) : 2000 General requirements for the competence of reference material producer ICs 03.120.1071.040.30 Desvriptors : control samples, work study, product tests, inspection specification, Referenc
2、e number : JIS Q 0034 : 2001 (E) quality auditing, chemical reagents PROTECTED BY COPYRIGHT 18 s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDTNo reproduction or networking pe
3、rmitted without license from IHS -,-,- Q 0034 : ZOOl(IS0 Guide 34 : 2000) Foreword This translation has been made based on the original Japanese Indus- trial Standard established by the Minister of Economy, Trade and Industry, through deliberations at the Japanese Industrial Standards Committee in a
4、ccordance with the Industrial Standardization Law. Consequentry, JIS Q 0034 : 1997 is replaced with JIS Q 0034 : 2001 In the revision of this Standard, IS0 Guide 34, General requirements for the competence of reference material producer has been used as a base. Date of Establishment: 1997-03-20 Date
5、 of Public Notice in Official Gazette: 2003-03-20 Investigated by: Japanese Industrial Standards Committee Accreditation and certification JIS Q 0034 : 2001, First English edition published in 2003-12 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-
6、8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. Q JSA 2003 All rights 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 phot
7、ocopying and microfilm, without permission in writing from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDTNo reproduction
8、 or networking permitted without license from IHS -,-,- Q 0034 : ZOOl(IS0 Guide 34 : 2000) Contents Page . Introduction 1 1 2 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 5 5.1 5.2 5.3 5.4 5.5 0.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 Scope 2 Normative references 2 Terms and
9、definitions 3 Organization and management requirements 3 Quality system requirements 3 Organization and management 4 Document and information control 5 Request, tender and contract reviews 7 Use ofcolJaborators 7 Procurement of services and supplies 8 Client feedback 8 Control of non-conforming (poo
10、r quality) reference materials - - - - - - - - - - - - - - - 8 Corrective action 9 Preventative action 10 Records 10 Internal audits 11 Management reviews 12 Technical and production requirements 12 Management, stafhg and training 12 . . . . . . . . Collaborators 13 Production planning 14 Production
11、 control 14 Environment 15 Material handling and storage 15 Post- - 1989 - - Cerx$G-al:On drefe-renc-e- ma?eriaLs:-Gene-ral and-sxatsticrrln-cle5 NOTE : IS0 Guide 35 :1989 tisticalprinciples is identical with the said standard. CertiJcation o f reference materials - General and sta- 515-Q . 1 7 o s
12、S r . z o o o G e n e a . e i r e m e n ? - h e - c o e e n c e _t!:ng-and-cabrat!:on-Eabo. raxor!:es NOTE : ISOEC-17025-:19-99-Ge-niraeire-en?soqr-the-cometence.o.testn.anb caltbPi?tm LaoOraQres I.s.ibentcaiwlththesbstan*rb, IS0 8402 1 1994 IS0 10012-1 : 1992 Quality management and qualis assurance
13、 - Vocabulary Quality assurance requirements for measuring equipment - Part I : Metrological confirmation system for measuring equipment ISODEC Guide 2 : 1996 Standardization and related activities - General vocabulary VIM : 1993 International vocabulary of basic and general terms in metrology (issu
14、ed by ISO, IEC, BIPM, IFCC, IUPAC, IUPU and OIML) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDTNo reproduction or networking permitted without license
15、from IHS -,-,- 3 Q 0034 : 2001(ISO Guide 34 : 2000) 3 For the purposes of this Standard, the terms and defini- tions given in ISOIEC Guide 2, JIS Q 17025, JIS Q 0030, IS0 8402, VIM and the following apply. 3 . 1 reference material producer technically competent body (organization or firm, public or
16、private) that is fully responsible for assigning the certifed or other property values of the reference materials it produces and supplies which have been produced in accordance with JIS Q 0031 and J I S Q 0035 3 . 2 collaborator technically competent body (organization or firm, public or private) t
17、hat undertakes aspects of the manufacture or characterization of the (certified) refer- ence material on behalf of the reference material producer, either on a contractual (as a subcontractor) or voluntary basis Terms and definitions 4 Organization and management requirements 4 . 1 Quality system re
18、quirements 4 . 1 . 1 General The reference material producer shall establish, implement and main- tain a quality system appropriate to the scope of its activities, including the type, range and magnitude of the reference material production it undertakes. It should be recognized that a reference mat
19、erial needs to be characterized mainly to the level of accuracy required for its intended purpose (i.e. appropriate measurement uncertainty). The reference material producer shall describe the procedure for estab- lishing the quality of materials as a component of the quality system. Reference mater
20、ial producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability and characterization studies, and any limitations due to the material matrix. 4 . 1 . 2 Quality policy The reference material producer shall define and document its policy,
21、objectives and commitment to ensuring and maintaining the quality of all as- pects of reference material production, including material quality (e.g. homogeneity and stability), characterization (e.g. equipment calibration and measurement method validation), assignment of property values (e.g. use o
22、f appropriate statistical proce- dures) and material handling, storage and transport procedures. The quality policy shall, when appropriate, include use of interlaboratory charac- terization studies employing laboratories which are active and competent in the re- spective field of measurement. In th
23、is context, the policy shall include a commitment to interact with the appropriate sectors of the measurement community, in order to pre- vent working in isolation. The policy shall also include a commitment to produce ref- erence materials which conform to the definitions given in JIS Q 0030, chara
24、cterized according to the requirements of JTS Q 0035 and whose property values are assessed using accepted statistical techniques. The policy shall, where appropriate, include a commitment to comply with JIS Q 0031 for the contents of reference material certifi- cates and supply of associated inform
25、ation for users. It is important that the policy also spec preparation procedures; achievement of the required degree of homogeneity of the reference material; assessment of the stability of the reference material; including on-going assess- ment of stability where necessary; procedures for undertak
26、ing characterization; practical realization of traceability to national or international standards of meas- urement; assignment of property values, including preparation of certificates or statements in accordance with JIS Q 0031 when appropriate; arrangements for ensuring adequate storage facilitie
27、s; arrangements for suitable identification, labelling and packaging facilities, packing and delivery procedures and customer service; compliance with JIS Q 0030, JIS Q 0031, JIS Q 0034 and JIS Q 0035. The documented quality system should spec* which activities are undertaken by the reference materi
28、al producer and, where relevant, which activities are undertaken by collaborators. It shall include policies and procedures used by the producer to en- sure that all activities conducted by collaborators comply with the relevant clauses of this Standard. The documented quality system shall define th
29、e roles and responsibilities of the technical manager (however named) and quality manager, including their responsibili- ties for ensuring compliance with this Standard. 4.2 Organization and management 4 . 2 . 1 legally identifiable. 4 . 2 . 2 The reference material producer shall be organized and s
30、hall operate in such a The reference material producer, or the organization of which it is part, shall be PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDT
31、No reproduction or networking permitted without license from IHS -,-,- 5 Q 0034 : ZOOl(IS0 Guide 34 2000) way that it meets all the applicable requirements of this Standard, whether carrying out work in its permanent facilities or at sites (including associated temporary or mo- bile facilities) away
32、 rom its permanent facilities (including work undertaken by collaborators). 4.2.3 The reference material producer shall: have managerial personnel supported by technical personnel with the authority and resources needed to discharge their duties and to ident have arrangements to ensure that its mana
33、gement and personnel are free from any commercial, financial and other internal and external pressures that may ad- versely affect the quality of their work; have policies and procedures to ensure the protection of its clients confidential in- formation and proprietary rights; have policies and proc
34、edures to avoid involvement in any activities that might di- minish confidence in its competence, impartiality, judgement or operational integ- rity; define, with the aid of organizational charts, the organization and management structure of the reference material producer, its place in any parent o
35、rganization, and the relations between management, technical operations, support services, collaborators and the quality management system; spec have technical management, which has overall responsibility for the technical op- erations and the provision of the resources needed to ensure the required
36、 quality of each operation which forms part of the reference material production; appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the requirements of this Standard a
37、re implemented and followed at all times. The quality manager shall have direct access to the highest level of management at which decisions are taken on production policy or resources; where appropriate, appoint deputies for key managerial personnel such as the technical and quality managers. 4.3 D
38、ocument and information control 4.3.1 General The reference material producer shall establish and maintain proce- dures to control all documents (both internally generated and rom external sources) and other information that form part of its quality documentation. These may include documents of exte
39、rnal origin, such as standards, guides, test and/or calibration meth- PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDTNo reproduction or networking permit
40、ted without license from IHS -,-,- 6 Q 0034 : ZOOl(IS0 Guide 34 : 2000) ods, as well as specifications, instructions and manuals related to the reference mate- rial under production. In this context “document” means any information or instruction includ- ing policy statements, text books, procedures
41、, specifications, calibration tables, charts, software, etc. These may be on various media, whether hard or electronic, and they may be digital, analog, photographic or written. 4 . 3 . 2 Document approval and issue 4 . 3 . 2 . 1 All documents (including documented procedures) issued to personnel as
42、 part of the quality system shall be suitably controlled. This shall include review and ap- proval for use by authorized personnel prior to issue. A master list or equivalent, iden- tifymg the current revision status of documents in the quality system, shall be estab- lished and be readily available
43、 to preclude the use of invalid and/or obsolete docu- ments. 4 . 3 . 2 . 2 The procedures adopted shall also ensure that: NOTE a) b) C ) d) authorized editions of appropriate documents are available at all locations where operations essential to the effective production of reference materials are pe
44、r- formed; documents are periodically reviewed and, where necessary, revised to ensure con- tinuing suitability and compliance with applicable requirements; invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; obsolete docum
45、ents retained for either legal or information preservation purposes are suitably marked. 4 . 3 . 3 Document changes 4 . 3 . 3 . 1 Changes to documents (including documented procedures) shall be reviewed and approved by designated personnel performing the same function as that conducted for the origi
46、nal review and approval unless specifically decided otherwise. The desig- nated personnel shall have access to pertinent background information upon which to base their review and approval. 4 . 3 . 3 . 2 Where practicable, the nature of the change shall be identified in the docu- ment with appropria
47、te attachments. 4 . 3 . 3 . 3 If the reference material producers documentation control system allows for the amendment of documents by hand, pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined and shall ensure that amendments are initialled and
48、 dated. Documents amended by hand shall be marked, signed and dated and shall be formally re-issued as soon as practicable. 4.3.3.4 Procedures shall be established to describe how changes in documents main- tained in computerized systems are made. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 19:38:16 MDTNo reproduction or networking permitted without license from IHS -,-,- 7 Q 0034 : ZOOi(IS0 Guide 34 : 2000) 4.4