1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23649-6 SANS 9004:2010Edition 3ISO 9004:2009Edition 3SOUTH AFRICAN NATIONAL STANDARD Managing for the sustained success of an organization
4、 A quality management approach This national standard is the identical implementation of ISO 9004:2009 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12
5、 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 9004:2010 Edition 3 ISO 9004:2009 Edition 3 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 176, Quality assurance and quality management matters, in accordance wit
6、h procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in February 2010. This SANS document supersedes SANS 9004:2000 (edition 2 as modified by nat. amdt 1:2005). Reference numberISO 9004:2009(E)ISO 2009INTERNATIONAL STANDAR
7、D ISO9004Third edition2009-11-01Managing for the sustained success of an organization A quality management approach Gestion des performances durables dun organisme Approche de management par la qualit SANS 9004:2010This s tandard may only be used and printed by approved subscription and freemailing
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13、This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 9004:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Managing for the sustained success of an o
14、rganization 1 4.1 General .1 4.2 Sustained success 2 4.3 The organizations environment 2 4.4 Interested parties, needs and expectations .3 5 Strategy and policy .3 5.1 General .3 5.2 Strategy and policy formulation 3 5.3 Strategy and policy deployment 4 5.4 Strategy and policy communication5 6 Resou
15、rce management.5 6.1 General .5 6.2 Financial resources.6 6.3 People in the organization6 6.4 Suppliers and partners .7 6.5 Infrastructure .8 6.6 Work environment.9 6.7 Knowledge, information and technology9 6.8 Natural resources10 7 Process management .11 7.1 General .11 7.2 Process planning and co
16、ntrol11 7.3 Process responsibility and authority 12 8 Monitoring, measurement, analysis and review 12 8.1 General .12 8.2 Monitoring 12 8.3 Measurement .13 8.4 Analysis16 8.5 Review of information from monitoring, measurement and analysis16 9 Improvement, innovation and learning .17 9.1 General .17
17、9.2 Improvement 17 9.3 Innovation 18 9.4 Learning .19 Annex A (informative) Self-assessment tool20 Annex B (informative) Quality management principles 38 Annex C (informative) Correspondence between ISO 9004:2009 and ISO 9001:2008 .43 Bibliography45 SANS 9004:2010This s tandard may only be used and
18、printed by approved subscription and freemailing clients of the SABS .ISO 9004:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan
19、dards is normally carried out through ISO technical committees. 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 t
20、ake part in the work. ISO collaborates closely with the International 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 2. The main task of technical committees
21、is to prepare International Standards. 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 75 % of the member bodies casting a vote. Attention is drawn to the possibil
22、ity that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any 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.
23、This third edition cancels and replaces the second edition (ISO 9004:2000), which has been technically revised. Managing for the sustained success of an organization is a major change in focus for ISO 9004, leading to substantial changes to its structure and contents. SANS 9004:2010This s tandard ma
24、y only be used and printed by approved subscription and freemailing clients of the SABS .ISO 9004:2009(E) ISO 2009 All rights reserved vIntroduction This International Standard provides guidance to support the achievement of sustained success for any organization in a complex, demanding, and ever-ch
25、anging 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 achieved by the effective man
26、agement 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 maturity level of the orga
27、nization, 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 than ISO 9001; it addresses
28、 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 and ISO 9004 is given in F
29、igure 1. Key Information flow Value-adding activities Figure 1 Extended model of a process-based quality management system SANS 9004:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 9004:2009(E) vi ISO 2009 All rights reservedThis Inte
30、rnational Standard has been developed to maintain consistency with ISO 9001 and be compatible with other management 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,
31、 to determine their level of maturity, and to identify opportunities for improvement and innovation. Annex B provides 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 betw
32、een ISO 9001:2008 and this International Standard. SANS 9004:2010This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 9004:2009(E) ISO 2009 All rights reserved 1Managing for the sustained success of an organization A qua
33、lity 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 size, type and activity. This International Standard is not intended f
34、or 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, the latest edition of the referenced document (including any amendments
35、) applies. ISO 9000, Quality management systems Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. 3.1 sustained success organization result of the ability of an organization to achieve and maint
36、ain its objectives in the long term 3.2 organizations environment combination of internal and external factors and conditions that can affect the achievement of an organizations objectives and its behaviour towards its interested parties 4 Managing for the sustained success of an organization 4.1 Ge
37、neral 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 that are the foundation of an effective quality management system. To
38、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 resources, SANS 9004:2010This s tandard may only be used and printed by a
39、pproved subscription and freemailing clients of the SABS .ISO 9004:2009(E) 2 ISO 2009 All rights reserved 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,
40、 the term “top management” refers to the highest level of decision making authority in an organization 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 su
41、stained success by consistently meeting the needs and expectations of its interested parties, in a 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, constant
42、ly monitor and regularly analyse the organizations environment, identify all its relevant interested 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 p
43、arties and keep them informed of the organizations activities and plans, establish mutually beneficial 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 expectat
44、ions of interested parties, identify associated short and long-term risks and deploy an overall strategy 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
45、, ensuring that they are capable of responding quickly to changing circumstances, regularly assess 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 we
46、ll as for maintaining the vitality of the organization, and establish and maintain processes for innovation 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 pro
47、ducts, or its type (for profit or not-for-profit); consequently this should be monitored constantly 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 sh
48、ould 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. SANS 9004:2010This s tandard may only be used and printed by approved subscription and freemail
49、ing clients of the SABS .ISO 9004:2009(E) ISO 2009 All rights reserved 34.4 Interested parties, needs and expectations Interested parties are individuals and other entities that add value to the organization, or are otherwise interested in, or affected by, the activities of the organization. Meeting the needs and expectations of interested parties contributes to the achievement of sustained success by the organization. In addition, the needs and expectations of individual interested parties
