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1、J IS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association (IS0 / IEC GUIDE 65 : 1996) General requirements for bodies operating product certification systems ICs 03.120.20 Descriptors : quality assurance, quality assurance systems, non-profit-marking bodies, certif
2、ication (approval), certification bodies, general conditions Reference number : JIS Q 0065 : 1997 (E) PROTECTED BY COPYRIGHT 9s Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 20:29:05 MDTN
3、o reproduction or networking permitted without license from IHS -,-,- Q 0065 : 1997 (ISO/IEC GUIDE 65 : 1996) Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of International Trade and Industry through deliberations at the Japane
4、se Industrial Standards Committee in accordance with the Industrial Standardization Law. Date of Establishment: 1997-11-20 Date of Public Notice in Official Gazette: 1997-11-20 Investigated by: Japanese Industrial Standards Committee Divisional Council on Accreditation and Certification JIS Q 0065:
5、1997, 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 All rights reserved. Unless
6、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 Japanese Standards Associati
7、on Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 20:29:05 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS Q 0065 : 1997 (ISO/IEC GUIDE 65 : 1996) General requirements fo
8、r bodies operating product certification systems O Introduction 0.2 Certification of a product (a term used to include a process or service) is a means of providing assurance that it complies with specified standards and other normative documents. Some product certification systems may include initi
9、al testing of a product and assessment of its suppliers quality systems, followed by surveillance that takes into account the factory quality system and the testing of samples from the factory and the open market. Other systems rely on initial testing and surveillance testing, while still others com
10、prise type testing only. This Standard specifies requirements, the observance of which is intended to ensure that certification bodies operate third-party certification systems in a consistent and reliable manner, thereby facilitating their acceptance on a national and international basis and so fur
11、thering international trade. The requirements contained in this Standard are written, above all, to be considered as general criteria for organizations operating product certification systems; they may have to be amplified when specific industrial or other sectors make use of them, or when particula
12、r requirements such as health and safety have to be taken into account. Assertion of conformity to the appropriate standards or other normative documents will be in the form of certificates or marks of conformity. Systems for certifying particular products or product groups to specified standards or
13、 other normative documents will, in many cases, require their own explanatory documentation. While this Standard is concerned with third-parties providing product certification, many of its provisions may also be useful in first- and second-party product conformity assessment procedures. The diversi
14、ty in certification systems may at first seem unnecessary and even confuse newcomers in the field, clients and operators alike. The ISO/IEC publication Certification und related activities is available for background reading and will help to answer questions regarding the practices of the worldwide
15、conformity assessment community . NOTE: Subclause 0.2 corresponds to Introduction of the original Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16、 . 1 Scope 1.1 This Standard specifies general requirements that a third-party operating a product certification system shall meet if it is to be recognized as competent and reliable. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS E
17、mployees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 20:29:05 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 Q 0065 : 1997 (ISOIIEC GUIDE 65 : 1996) In this Standard the term “certification body“ is used to cover any body operating a product certification sy
18、stem. The word product is used in its widest sense and includes processes and services; the word “standard“ is used to include other normative documents such as specifications or technical regulations. 1.2 The certification system used by the certification body may include one or more of the followi
19、ng, which could be coupled with production surveillance or assessment and surveillance of the suppliers quality system or both, as described in ISO/IEC Guide 53: type testing or examination; testing or inspection of samples taken from the market or from suppliers stock or from a combination of both;
20、 testing or inspection of every product or of a particular product, whether new or already in use; batch testing or inspection; design appraisal. NOTE 1 ISO/IEC Guide 28 may be consulted for a model of one form of a third- party product certification system. 2 Normative references IS0 8402: 1994 JIS
21、 Z 9911-1-1996 Quality management and quality assurance - Vocabulary Guidelines for auditing quality systems -Part 1: Auditing ISOIIEC Guide 2:1996 Standardization and related activities - General Vocabulary Guidelines for drafting of standards suitable for use for conformity assessment Methods of i
22、ndicating conformity with standards for third-party certification systems JIS Z 9325-1996 General requirements for the competence of calibration and testing laboratories NOTE: ISOIEC Guide 25:1990 General requirements for the competence of ISOIIEC Guide 27: 1983 Guidelines for corrective action to b
23、e taken by a certification body in the event of misuse of its mark of conformity General rules for a model third-party certification system for products ISOIIEC Guide 39: 1988 General requirements for the acceptance of inspection bodies ISOIIEC Guide 53:1988 An approach to the utilization of a suppl
24、iers quality system in third-party product certification ISOIIEC Guide 7:1994 ISOIIEC Guide 23: 1982 _-_._-.-.-.- ._._-_ _ _ _ _ _ _ _ _ _ _ _ _ _ - - _ -_-_._ c_al.bca?i?! _and_ t_esttn9_ _laboratories- is _i_b_enti?!- -with the -said- st anbarb, ISOIIEC Guide 28: I982 PROTECTED BY COPYRIGHT Copyri
25、ght Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 20:29:05 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 Q 0065 : 1997 (ISOAEC GUIDE 65 : 1996) ISO/IEC Guide 62: 1996
26、General requirements for bodies operating assessment and certification / registration of quality systems 3 in ISO/IEC Guide 2 and IS0 8402 apply, together with the following definition. Definitions For the purposes of this Standard, the relevant definitions given 3 . 1 supplier The party that is res
27、ponsible for ensuring that products meet and, if applicable, continue to meet, the requirements on which the certification is based. 4 Certification body 4.1 General provisions 4 . 1 . 1 The policies and procedures under which the certification body operates and their administration shall be non-dis
28、criminatory and shall be administered in a non- discriminatory manner. Procedures shall not be used to impede or inhibit access by applicants, other than as provided for in this Standard. 4 . 1 . 2 The certification body shall make its services accessible to all applicants whose activities fall with
29、in its declared field of operation, There shall not be undue financial or other conditions. Access shall not be conditional upon the size of the supplier or membership of any association or group, nor shall certification be conditional upon the number of certificates already issued. 4 . 1 . 3 The cr
30、iteria against which the products of a supplier are evaluated shall be those outlined in specified standards. Requirements for standards suitable for this purpose are contained in ISO/IEC Guide 7. If explanation is required as to the application of these documents for a specific certification system
31、, it shall be formulated by relevant and impartial committees or persons possessing the necessary technical competence, and published by the certification body. 4 . 1 . 4 The certification body shall confine its requirements, evaluation and decision on certification to those matters specifically rel
32、ated to the scope of the certification being considered. 4.2 Organization The structure of the certification body shall be such as to foster confidence in its certifications. In particular, the certification body shall a) be impartial; b) c) be responsible for decisions relating to its granting, mai
33、ntaining, extending, suspending and withdrawing of certification; identify the management (committee, group or person) which shall have overall responsibility for all of the following: 1) performance of testing, inspection, evaluation and certification as defined in this Standard, 2) formulation of
34、policy matters relating to the operation of the certification body. 3) decisions on certification, 4) supervision of the implementation of its policies, PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing,
35、 Bernie Not for Resale, 03/14/2007 20:29:05 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Q 0065 : 1997 (ISO/IEC GUIDE 65 : 1996) 5j 6) 7) have documents which demonstrate it is a legal entity; have a documented structure which safeguards impartiality including provisio
36、ns to ensure the impartiality of the operations of the certification body; this structure shall enable the participation of all parties significantly concerned in the development of policies and principles regarding the content and functioning of the certification system; ensure that each decision o
37、n certification is taken by a person(s) different from those who carried out the evaluation; have rights and responsibilities relevant to its certification activities; have adequate arrangements to cover liabilities arising from its operations a n d or activities; have the financial stability and re
38、sources required for the operation of a certification system; employ a sufficient number of personnel having the necessary education, training, technical knowledge and experience for performing certification functions relating to the type, range and volume of work performed, under a responsible seni
39、or executive; have a quality system giving confidence in its ability to operate a certification system for products; have policies and procedures that distinguish between product certification and any other activities in which the certification body is engaged; together with its senior executive and
40、 staff, be free from any commercial, financial and other pressures which might influence the results of the certification process; have formal rules and structures for the appointment and operation of any committees which are involved in the certification process; such committees shall be free from
41、any commercial, financial and other pressures that might influence decisions; a structure where members are chosen to provide a balance of interests where no single interest predominates will be deemed to satisfy this provision; ensure that activities of related bodies do not affect the confidential
42、ity, objectivity and impartiality of its certifications, and it shall not 1) supply or design products of the type it certifies, 2) give advice or provide consultancy services to the applicant as to methods of dealing with matters which are barriers to the certification requested, provide any other
43、products or services which could compromise the confidentiality, objectivity or impartiality of its certification process and decisions; have policies and procedures for the resolution of complaints, appeals and disputes received from suppliers or other parties about the handling of certification or
44、 any other related matters. supervision of the finances of the body, delegation of authority to committees or individuals as required to undertake defined activities on its behalf, technical basis for granting Certification; 3) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided
45、 by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 20:29:05 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 Q 0065 : 1997 (ISOAEC GUIDE 65 : 1996) 4.3 The certification body shall take all steps necessary to evalu
46、ate conformance with the relevant product standards according to the requirements of specific product certification system (see clause 3). The certification body shall specify the relevant standards or parts thereof and any other requirements such as sampling, testing and inspection requirements whi
47、ch form the basis for the applicable certification system. In conducting its certification operations, the certification body shall observe, as appropriate, the requirements for the suitability and competence of body(ies) or person(s) carrying out testing, inspection and certificatiodregistration as
48、 specified in JIS Z 9325, ISO/IEC Guides 39 and 62. Operations 4.4 Subcontracting When a certification body decides to subcontract work related to certification (e.g. testing or inspection) to an external body or person, a properly documented agreement covering the arrangements including confidentiality and conflict of interest shall be drawn up. The certification body shall a) b) take full responsibility for such subcontracted work and maintain its responsibility for granting, maintaining, extending, suspending or withdrawing Certification; ensure that the subco