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1、ANSI/ISO/ASQ Q9004-2000 AMERICAN NATIONAL STANDARD Quality management systems- Guidelines for performance improvements Approved as a American National Standard by: American Society for Quality An American National Standard Approved on December 13,2000 American National Standards: An American Nationa
2、l Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, w
3、hether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice:This American
4、 National Standard may be revised or withdrawn at any time.The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may rece
5、ive current information on all standards by calling or writing the American National Standards Institute. Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or netwo
6、rking permitted without license from IHS -,-,- 02000 by ASQ Copyright Protection Notice for the ANSI/ISO/ASQ Q9004-2000 Standard. This standard is subject to copyright claims of ISO, ANSI, and ASQ. Not for resale. No part of this publication may be reproduced in any form, including an electronic ret
7、rieval system, without the prior written permission of ASQ. All requests pertaining to the ANSI/ISO/ASQ Q9004-2000 Standard should be submitted to ASQ. Note: As used in this document, the term “International Standard” refers to the American National Standard adoption of this and other International
8、Standards. ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards administrator at the address below. ASQ Mission: The American Society for Quality advances individual and or
9、ganizational performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange. PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be viewed but shall not be edited or printed. In
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11、ve to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by our customers. In the unlikely event that a problem relating to it is found, please inform ASQ at the address below. Published by: American Society for Qu
12、ality fiwrASQ L l . . . I I . I m a m w o Quality Press PO. Box 3005 Milwaukee, Wisconsin 53201 -3005 800-248-1946 Fax 414-272-1734 wwwasq.org hiip:/qualitypress.asq.org hiip:/standardsgroup.asq.org Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/
13、1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or networking permitted without license from IHS -,-,- November 8,2002 RE: IS0 9004:2000 PRODUCT SUPPORT INITIATIVE FOR TC176 Dear IS0 9000:2000 Professional, When ISO/Technical Committee (TC) 176 began the process
14、of drafting revised editions of the IS0 9000 series in 1996, a significant goal was to verify and validate the drafts to ensure that they fulfilled TC 176s objectives and provided added value for their users. Validation consisted of obtaining feedback from users on the ability of the draft standards
15、 to meet their needs. The US TAG wants to continue this process - which will result in useful inputs for future revisions to the IS0 9000 family. As a result the Product Support Initiative was created to help enhance the value of the IS0 9000:2000 family and help organizations make greater use of IS
16、0 9004:2000. Please lend your support by completing a short online survey at: htt p: i/ www. asq . arg/ rn ri psi is09004. ht rn I The intent is for the Survey to be easy to use, to not be timeconsuming to complete and to provide valuable data for two purposes: 1) Provide quantifiable measurements o
17、f the experiences of organizations using IS0 9004:2000, and 2) Publicize and promote the use of IS0 9004:2000 through reports of the Survey results and through case studies demonstrating real-world utilization of IS0 9004:2000. The US TAG and TCI 76 thank you in advance for your input. On behalf of
18、the US TAG and TC176, Karen J. Hitchcock PSI ISO-9004 Sub-team 6 Leader Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or networking permitted without license f
19、rom IHS -,-,- ANSIIISOIASQ Q9004-2000 Contents Page . 3 Terms and definitions . . 4 Quality management system 4.1 Managing systems and processes . . 4.2 Documentation 4.3 Use of quality management principles . 5 Management responsibility 5.1 General guidance 5.2 Needs and expectations of interested
20、parties . 5.3 Quality policy 5.4 Planning . 5.6 Management review 6 Resource management . 6.1 General guidance 6.2 People . . 6.3 Infrastructure 6.4 Work environment 6.5 Information . 6.7 Natural resources . . 6.8 Financial resources 7 Product realization . . 7.1 General guidance . . 7.2 Processes r
21、elated to interested parties . 7.3 Design and development . 7.4 Purchasing 7.5 Production and service operations . 8 Measurement, analysis and improvement 8.1 General guidance . . 8.3 Control of nonconformity . 8.5 Improvement . 1 1 1 2 2 3 4 5 5 7 9 10 11 12 14 14 15 17 18 18 19 19 19 20 20 23 24 2
22、9 31 33 34 34 35 40 41 42 . 111 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSIIISOIASQ Q9004-2000 Ann
23、exes A Guidelines for self-assessment B Process for continual improvement. Bibliography . 55 iv Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or networking perm
24、itted without license from IHS -,-,- ANSIIISOIASQ Q9004-2000 Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical commi
25、ttees. Each member body interested in a subject for which a technical committee has been established 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. IS0 collaborates closely with the I
26、nternational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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
27、bodies for voting. Publication as an International Standard requires approval by at least 75 % 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. IS0 shall not be held responsible fo
28、r identifying any or all such patent rights. International Standard IS0 9004 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This second edition of IS0 9004 cancels and replaces IS0 9004-1:1994, which has been technically
29、revised. The title has been modified to reflect the comprehensiveness of the quality management system. Many of the existing International Standards within the IS0 9000 family will be reviewed for withdrawal, or for re-issue as Technical Reports, as many of their provisions are incorporated into thi
30、s International Standard. In comparison to previous editions, IS0 9001 and IS0 9004 now form a consistent pair of standards on quality management. IS0 9001 aims to give quality assurance of product and to enhance customer satisfaction, while IS0 9004 uses a broader perspective of quality management
31、to give guidance for performance improvement. Annexes A and B of this International Standard are for information only. V Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reprod
32、uction or networking permitted without license from IHS -,-,- ANSIIISOIASQ Q9004-2000 I n t ro d u ct i o n 0.1 General 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 manag
33、ement system is influenced 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
34、to imply uniformity in 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 co
35、mpetitive advantage, and 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 managi
36、ng costs and risks. Benefit, 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 su
37、ch as revenue and market share, - 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, - u
38、nderstanding and motivation of people towards 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 organizat
39、ions performance, product life cycle, and reputation, - 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. 0.2 Process approach This International Standard promotes the ad
40、option of a process approach when developing, 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
41、and manage numerous linked activities. An activity 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 organiz
42、ation, together with the identification and interactions and managing of these processes can be referred to as the “process approach“. vi Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:2
43、3:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSIIISOIASQ Q9004-2000 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 well as their combination and inter
44、action. 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 effectiveness, and d) continual improvement
45、 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 requirements as inputs. Monitoring
46、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. I Key _ec Value-adding activities - F inf
47、ormation flow I nterected parties - Satisfaction Figure 1 - Model of a process-based quality management system Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 03:23:00 MDTNo reproduction or
48、networking permitted without license from IHS -,-,- ANSIIISOIASQ Q9004-2000 0.3 Relationship with IS0 9001 The present editions of IS0 9001 and IS0 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each 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. IS0 9001 specifies