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1、INTERNATIONAL STANDARD ISO 9004 Second edition 2000-12-15 Reference number ISO 9004:2000(E) ISO 2000 Quality management systems Guidelines for performance improvements Systmes de management de la qualit Lignes directrices pour lamlioration des performances ISO 9004:2000(E) ii ISO 2000 All rights res
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5、ISO 2000 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec- tronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs mem- ber body
6、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.ch Web www.iso.ch Printed in Switzerland ISO 9004:2000(E) ISO 2000 All rights reserved iii ContentsPage 1Scope .1 2Normative reference .1 3Terms an
7、d definitions 1 4Quality management system 2 4.1Managing systems and processes 2 4.2Documentation 3 4.3Use of quality management principles 4 5Management responsibility .5 5.1General guidance 5 5.2Needs and expectations of interested parties .7 5.3Quality policy .9 5.4Planning .10 5.5Responsibility,
8、 authority and communication .11 5.6Management review 12 6Resource management 14 6.1General guidance 14 6.2People 15 6.3Infrastructure .17 6.4Work environment 18 6.5Information .18 6.6Suppliers and partnerships 19 6.7Natural resources 19 6.8Financial resources .19 7Product realization 20 7.1General
9、guidance 20 7.2Processes related to interested parties .23 7.3Design and development .24 7.4Purchasing .29 7.5Production and service operations 31 7.6Control of measuring and monitoring devices .33 8Measurement, analysis and improvement 34 8.1General guidance 34 8.2Measurement and monitoring 35 8.3C
10、ontrol of nonconformity .40 8.4Analysis of data .41 8.5Improvement 42 -,-,- ISO 9004:2000(E) iv ISO 2000 All rights reserved Annexes AGuidelines for self-assessment.46 BProcess for continual improvement.53 Bibliography.55 ISO 9004:2000(E) ISO 2000 All rights reserved v Foreword ISO (the Internationa
11、l Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been es
12、tablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardi
13、zation. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 7
14、5 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 9004 was prepared b
15、y Technical Committee ISO/TC 176,Quality management and quality assurance, Subcommittee SC 2,Quality systems. This second edition of ISO 9004 cancels and replaces ISO 9004-1:1994, which has been technically revised. The title has been modified to reflect the comprehensiveness of the quality manageme
16、nt system. Many of the existing International Standards within the ISO 9000 family will be reviewed for withdrawal, or for re-issue as Technical Reports, as many of their provisions are incorporated into this International Standard. In comparison to previous editions, ISO 9001 and ISO 9004 now form
17、a consistent pair of standards on quality management. ISO 9001 aims to give quality assurance of product and to enhance customer satisfaction, while ISO 9004 uses a broader perspective of quality management to give guidance for performance improvement. Annexes A and B of this International Standard
18、are for information only. ISO 9004:2000(E) vi ISO 2000 All rights reserved Introduction 0.1General The adoption of a quality management system should be a strategic decision by the top management of an organization. The design and implementation of an organizations quality management system is influ
19、enced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. This International Standard is based on eight quality management principles. However, it is not the intent of this International Standard to imply uniformity i
20、n the structure of quality management systems or uniformity of documentation. The purpose of an organization is to identify and meet the needs and expectations of its customers and other interested parties (people in the organization, suppliers, owners, society), to achieve competitive advantage, an
21、d to do this in an effective and efficient manner, and to achieve, maintain, and improve overall organizational performance and capabilities. The application of quality management principles not only provides direct benefits but also makes an important contribution to managing costs and risks. Benef
22、it, cost and risk management considerations are important for the organization, its customers and other interested parties. These considerations on overall performance of the organization may impact customer loyalty, repeat business and referral, operational results such as revenue and market share,
23、 flexible and fast responses to market opportunities, costs and cycle times through effective and efficient use of resources, alignment of processes which will best achieve desired results, competitive advantage through improved organizational capabilities, understanding and motivation of people tow
24、ards the organizations goals and objectives, as well as participation in continual improvement, confidence of interested parties in the effectiveness and efficiency of the organization, as demonstrated by the financial and social benefits from the organizations performance, product life cycle, and r
25、eputation, ability to create value for both the organization and its suppliers by optimization of costs and resources as well as flexibility and speed of joint responses to changing markets. 0.2Process approach This International Standard promotes the adoption of a process approach when developing,
26、implementing and improving the effectiveness and efficiency of a quality management system to enhance interested party satisfaction by meeting interested party requirements. For an organization to function effectively and efficiently, it has to identify and manage numerous linked activities. An acti
27、vity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and in
28、teractions and managing of these processes can be referred to as the “process approach”. ISO 9004:2000(E) ISO 2000 All rights reserved vii An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as
29、 well as their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of a)understanding and fulfilling the requirements, b)the need to consider processes in terms of added value, c)obtaining results of process performance and effectiven
30、ess, and d)continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that interested parties play a significant role in defining req
31、uirements as inputs. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to whether the organization has met their requirements. The model shown in Figure 1 does not show processes at a detailed level. Figure 1
32、Model of a process-based quality management system ISO 9004:2000(E) viii ISO 2000 All rights reserved 0.3Relationship with ISO 9001 The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement eac
33、h other but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. ISO 9001 specifies requirements for a quality management system that can be used for internal applicatio
34、n by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the con
35、tinual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is no
36、t intended for certification or for contractual purposes. For further benefit to the user, the basic content of the ISO 9001 requirements are included in boxed text following the comparable clause in this International Standard. Information marked “NOTE” is for guidance in understanding or clarifica
37、tion. 0.4Compatibility with other management systems This International Standard does not include guidance specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management. However, this In
38、ternational Standard enables an organization to align or integrate its own quality management system with related management systems. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that follows the guidelines of this In
39、ternational Standard. INTERNATIONAL STANDARDISO 9004:2000(E) ISO 2000 All rights reserved 1 Quality management systems Guidelines for performance improvements 1Scope This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness
40、and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performan
41、ce of the organization. This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improveme
42、nt, measured through the satisfaction of customers and other interested parties. This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001. 2Normative reference The follo
43、wing normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International
44、 Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International
45、Standards. ISO 9000:2000,Quality management systems Fundamentals and vocabulary. 3Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9004 to describe the supply-chain, have been ch
46、anged to reflect the vocabulary currently used: Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. supplierorganizationcustomer (interested parties) -,-,- ISO 9004:2000(E) 2 ISO 2000 All rights reserved 4Quality management system 4.1Ma
47、naging systems and processes Leading and operating an organization successfully requires managing it in a systematic and visible manner. Success should result from implementing and maintaining a management system that is designed to continually improve the effectiveness and efficiency of the organiz
48、ations performance by considering the needs of interested parties. Managing an organization includes quality management, among other management disciplines. Top management should establish a customer-oriented organization a)by defining systems and processes that can be clearly understood, managed an
49、d improved in effectiveness as well as efficiency, and b)by ensuring effective and efficient operation and control of processes and the measures and data used to determine satisfactory performance of the organization. Examples of activities to establish a customer-oriented organization include defining and promoting processes that lead to improved organizational performance, acquiring and using process data and informati