1、 AMERICAN NATIONAL STANDARD Managing for the sustained success of an organizationA quality management approach AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE, WI 53201-3005 ANSI/ISO/ASQ Q9004-2009(E)(This page intentionally left blank) AMERICAN NATIONAL STANDARD Managing for the sustained succ
2、ess of an organizationA quality management approach Approved as an American National Standard by: American Society for Quality February 25, 2010 American National Standards: An American National Standard implies a consensus of those substantially concerned with is scope and provisions. An American N
3、ational 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, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, proces
4、ses, 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 Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standar
5、ds 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 receive current information on all standards by calling of writing the American National Standards Institute.
6、ANSI/ISO/ASQ Q9004-2009(E)iii 2010 by ASQCopyright Protection Notice for the ANSI/ISO/ASQ Q9004-2009 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 retrieval system, with
7、out the prior written permission of ASQ. All requests pertaining to the ANSI/ISO/ASQ Q9004-2009 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 Standards.ASQ will c
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12、009(E)ivAlso available from ASQ Quality Press: ISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, John E. (Jack) West, and Joseph J. Tsiakals ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition J.P. Russell and Dennis R. Arter ISO 9001:2008 Internal Audits Made Easy: Tools,
13、 Techniques and Step-By-Step Guidelines for Successful Internal Audits, Second Edition Ann W. Phillips A Practical Field Guide for ISO 9001:2008 Erik Valdemar Myhrberg Cracking the Case of ISO 9001:2008 for Manufacturing, Second Edition: A Simple Guide to Implementing Quality Management in Manufactu
14、ring Charles A. Cianfrani and John E. (Jack) West Cracking the Case of ISO 9001:2008 for Service, Second Edition: A Simple Guide to Implementing Quality Management in Service Organizations Charles A. Cianfrani and John E. (Jack) West Process Driven Comprehensive Auditing: A New Way to Conduct ISO 90
15、01:2008 Internal Audits, Second Edition Paul C. Palmes ISO 9001:2008 Interpretive Guide for the Design and Construction Project Team (e-Book) Prepared by members of the ASQ Design and Construction Division and edited by John R. Broomfield How to Audit the Process-Based QMS Dennis R. Arter, John E. (
16、Jack) West, and Charles A. Cianfrani The ASQ Auditing Handbook, Third Edition J.P. Russell, editing director Quality Audits for Improved Performance, Third Edition Dennis R. Arter The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T. Westcott, editor To reques
17、t a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http:/www.asq.org/quality-press. ANSI/ISO/ASQ Q9004-2009(E)v(This page intentionally left blank) Contents PageForeword ivIntroduction.v1 Scope12 Normative references13 Terms and definitions .14 M
18、anaging for the sustained success of an organization 14.1 General .14.2 Sustained success 24.3 The organizations environment 24.4 Interested parties, needs and expectations .35 Strategy and policy .35.1 General .35.2 Strategy and policy formulation 35.3 Strategy and policy deployment 45.4 Strategy a
19、nd policy communication56 Resource management.56.1 General .56.2 Financial resources.66.3 People in the organization66.4 Suppliers and partners .76.5 Infrastructure .86.6 Work environment.96.7 Knowledge, information and technology96.8 Natural resources107 Process management .117.1 General .117.2 Pro
20、cess planning and control117.3 Process responsibility and authority 128 Monitoring, measurement, analysis and review 128.1 General .128.2 Monitoring 128.3 Measurement .138.4 Analysis168.5 Review of information from monitoring, measurement and analysis169 Improvement, innovation and learning .179.1 G
21、eneral .179.2 Improvement 179.3 Innovation 189.4 Learning .19Annex A (informative) Self-assessment tool20Annex B (informative) Quality management principles 38Annex C (informative) Correspondence between ISO 9004:2009 and ISO 9001:2008 .43Bibliography45ANSI/ISO/ASQ Q9004-2009(E)viiForeword ISO (the
22、International 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
23、 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnic
24、al standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bo
25、dies 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying an
26、y or all such patent rights. ISO 9004 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,Subcommittee SC 2, Quality systems.This third edition cancels and replaces the second edition (ISO 9004:2000), which has been technically revised. Managing for the sustained
27、 success of an organization is a major change in focus for ISO 9004, leading to substantial changes to its structure and contents. ANSI/ISO/ASQ Q9004-2009(E)viiiIntroduction This International Standard provides guidance to support the achievement of sustained success for any organization in a comple
28、x, demanding, and ever-changing environment, by a quality management approach. The sustained success of an organization is achieved by its ability to meet the needs and expectations of its customers and other interested parties, over the long term and in a balanced way. Sustained success can be achi
29、eved by the effective management of the organization, through awareness of the organizations environment, by learning, and by the appropriate application of either improvements, or innovations, or both. This International Standard promotes self-assessment as an important tool for the review of the m
30、aturity level of the organization, covering its leadership, strategy, management system, resources and processes, to identify areas of strength and weakness and opportunities for either improvements, or innovations, or both. This International Standard provides a wider focus on quality management th
31、an ISO 9001; it addresses the needs and expectations of all relevant interested parties and provides guidance for the systematic and continual improvement of the organizations overall performance. An extended model of a process-based quality management system incorporating the elements of ISO 9001 a
32、nd ISO 9004 is given in Figure 1. Key Information flow Value-adding activities Figure 1 Extended model of a process-based quality management system ANSI/ISO/ASQ Q9004-2009(E)ixThis International Standard has been developed to maintain consistency with ISO 9001 and be compatible with other management
33、 system standards. Such standards complement each other, but can also be used independently. Annex A provides a tool for organizations to self-assess their own strengths and weaknesses, to determine their level of maturity, and to identify opportunities for improvement and innovation. Annex B provid
34、es a description of the quality management principles that are the basis of the quality management standards prepared by ISO/TC 176. Annex C gives a clause by clause correspondence between ISO 9001:2008 and this International Standard. ANSI/ISO/ASQ Q9004-2009(E)xINTERNATIONAL STANDARD ANSI/ISO/ASQ Q
35、9004-2009(E)Managing for the sustained success of an organization A quality management approach 1 Scope This International Standard provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of
36、 size, type and activity. This International Standard is not intended for certification, regulatory or contractual use. 2 Normative references The following referenced documents relate to the application of this document. For dated references, only the edition cited applies. For undated references,
37、the latest edition of the referenced document (including any amendments) applies. ISO 9000, Quality management systems Fundamentals and vocabulary3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. 3.1sustained successorgani
38、zation result of the ability of an organization to achieve and maintain its objectives in the long term 3.2organizations environment combination of internal and external factors and conditions that can affect the achievement of an organizations objectives and its behaviour towards its interested par
39、ties 4 Managing for the sustained success of an organization 4.1 General To achieve sustained success, top management should adopt a quality management approach. The organizations quality management system should be based on the principles described in Annex B. These principles describe concepts tha
40、t are the foundation of an effective quality management system. To achieve sustained success, top management should apply these principles to the organizations quality management system. The organization should develop the organizations quality management system to ensure the efficient use of resour
41、ces, 1 decision making based on factual evidence, and focus on customer satisfaction, as well as on the needs and expectations of other relevant interested parties. NOTE In this International Standard, the term “top management” refers to the highest level of decision making authority in an organizat
42、ion and the term “the organization” covers all people in an organization. This is consistent with the definitions of these terms given in ISO 9000. 4.2 Sustained success The organization can achieve sustained success by consistently meeting the needs and expectations of its interested parties, in a
43、balanced way, over the long term. An organizations environment is ever-changing and uncertain, and to achieve sustained success its top management should have a long-term planning perspective, constantly monitor and regularly analyse the organizations environment, identify all its relevant intereste
44、d parties, assess their individual potential impacts on the organizations performance, as well as determining how to meet their needs and expectations in a balanced way, continually engage interested parties and keep them informed of the organizations activities and plans, establish mutually benefic
45、ial relationships with suppliers, partners and other interested parties, make use of a wide variety of approaches, including negotiation and mediation, to balance the often competing needs and expectations of interested parties, identify associated short and long-term risks and deploy an overall str
46、ategy for the organization to mitigate them, anticipate future resource needs (including the competences required of its people), establish processes appropriate to achieving the organizations strategy, ensuring that they are capable of responding quickly to changing circumstances, regularly assess
47、compliance with current plans and procedures, and take appropriate corrective and preventive actions, ensure that people in the organization have opportunities for learning for their own benefit, as well as for maintaining the vitality of the organization, and establish and maintain processes for in
48、novation and continual improvement. 4.3 The organizations environment An organizations environment will be undergoing change continually, regardless of its size (large or small), its activities and products, or its type (for profit or not-for-profit); consequently this should be monitored constantly
49、 by the organization. Such monitoring should enable the organization to identify, assess and manage the risks related to interested parties, and their changing needs and expectations. Top management should make decisions for organizational change and innovation in a timely manner in order to maintain and improve the organizations performance. NOTE For more information on risk management, see ISO 31000. ANSI/ISO/ASQ Q9004-2009(E)24.4 Interested parties, needs and expectations Interested parties are individ
