BS EN ISO 9004-2009 一个组织持续成功的管理.质量管理方法.pdf

raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI British StandardsWB9423_BSI_StandardColCov_noK_AW:BSI FRONT COVERS 5/9/08 12:55 Page 1Managing for the sustainedsuccess of an organization A quality managementapproachBS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSINational forewordThis British Standard is the UK implementation of EN ISO 9004:2009. It is identical to ISO 9004:2009. It supersedes BS EN ISO 9004:2000 which is withdrawn.The UK participation in its preparation was entrusted to Technical CommitteeQS/1, Quality management and quality assurance procedures.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2009 ISBN 978 0 580 55523 7 ICS 03.120.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 November 2009Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o m EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9004 November 2009 ICS 03.120.10 Supersedes EN ISO 9004:2000English Version Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009) Gestion des performances durables dun organisme - Approche de management par la qualit (ISO 9004:2009) Leiten und Lenken fr den nachhaltigen Erfolg einer Organisation - Ein Qualittsmanagementansatz (ISO 9004:2009) This European Standard was approved by CEN on 1 October 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9004:2009: ELicensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o m3 Foreword This document (EN ISO 9004:2009) has been prepared by Technical Committee ISO/TC 176 Quality management and quality assurance. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9004:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9004:2009 has been approved by CEN as a EN ISO 9004:2009 without any modification. ISO 9004:2009(E) BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o mISO 9004:2009(E) ISO 2009 All rights reserved iii Contents Page Foreword .iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Managing for the sustained success of an organization.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 communication.5 6 Resource management.5 6.1 General .5 6.2 Financial resources.6 6.3 People in the organization.6 6.4 Suppliers and partners .7 6.5 Infrastructure .8 6.6 Work environment.9 6.7 Knowledge, information and technology.9 6.8 Natural resources.10 7 Process management .11 7.1 General .11 7.2 Process planning and control.11 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 Analysis.16 8.5 Review of information from monitoring, measurement and analysis.16 9 Improvement, innovation and learning.17 9.1 General .17 9.2 Improvement.17 9.3 Innovation .18 9.4 Learning .19 Annex A (informative) Self-assessment tool.20 Annex B (informative) Quality management principles .38 Annex C (informative) Correspondence between ISO 9004:2009 and ISO 9001:2008.43 Bibliography.45 BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o mISO 9004:2009(E) iv ISO 2009 All rights reserved Foreword ISO (the 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 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 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 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 possibility 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. 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. BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o m ISO 2009 All rights reserved v Introduction This International Standard provides guidance to support the achievement of sustained success for any organization in a complex, 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 achieved 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 maturity 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 than 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 and ISO 9004 is given in Figure 1. Key Information flow Value-adding activities Figure 1 Extended model of a process-based quality management system ISO 9004:2009(E) BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o mISO 9004:2009(E) vi ISO 2009 All rights reserved This International 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, 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 between ISO 9001:2008 and this International Standard. BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o mINTERNATIONAL STANDARD ISO 9004:2009(E) ISO 2009 All rights reserved 1 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 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, the latest edition of the referenced document (including any amendments) 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 maintain 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 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 that 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 resources, BS EN ISO 9004:2009Licensed Copy: Queens UniversityAthens, The Queens University of Belfast, 03/11/2009 15:55, Uncontrolled Copy,(c) BSIw w w . b z f x w . c o mISO 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, 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 sustained 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, constantly 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 parties 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 expectations 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, 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 well 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