EN ISO 9004-2018 Quality management - Quality of an organization - Guidance to achieve sustained success.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)BS EN ISO 9004:2018National forewordThis British Standard is the UK implementation of EN ISO 9004:2018. It is identi

2、cal to ISO 9004:2018. It supersedes BS EN ISO 9004:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee QS/1/2, Quality Management System Standards.A list of organizations represented on this committee can be obtained on request to its secretary.This

3、publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 95692 8ICS 03.100.70; 03.120.10Compliance with a British Standard cannot

4、 confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 9004:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISC

5、HE NORMEN ISO 9004April 2018ICS 03.120.10; 03.100.70 Supersedes EN ISO 9004:2009EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 9004:2018: EAll rights of exploi

6、tation in any form and by any means reserved worldwide for CEN national MembersQuality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)Management de la qualit - Qualit dun organisme - Lignes directrices pour obtenir des performances durables (ISO 9004:2

7、018)Qualittsmanagement - Qualitt einer Organisation - Anleitung zum Erreichen nachhaltigen Erfolgs (ISO 9004:2018)This European Standard was approved by CEN on 22 March 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europ

8、ean 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-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions

9、(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-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgi

10、um, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,

11、 Switzerland, Turkey and United Kingdom.English VersionEN ISO 9004:2018 (E)European forewordThis document (EN ISO 9004:2018) 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

12、by publication of an identical text or by endorsement, at the latest by October 2018, and conflicting national standards shall be withdrawn at the latest by October 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall no

13、t be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 9004:2009.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,

14、Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

15、Turkey and the United Kingdom.Endorsement noticeThe text of ISO 9004:2018 has been approved by CEN as EN ISO 9004:2018 without any modification.2BS EN ISO 9004:2018ISO 9004:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Quality of an organization and sus

16、tained success . 14.1 Quality of an organization . 14.2 Managing for the sustained success of an organization 25 Context of an organization . 35.1 General . 35.2 Relevant interested parties 35.3 External and internal issues 36 Identity of an organization 46.1 General . 46.2 Mission, vision, values a

17、nd culture 57 Leadership 57.1 General . 57.2 Policy and strategy. 67.3 Objectives. 87.4 Communication 88 Process management . 88.1 General . 88.2 Determination of processes . 98.3 Responsibility and authority for processes 108.4 Managing processes. 109 Resource management 119.1 General 119.2 People.

18、 129.2.1 General. 129.2.2 Engagement of people 129.2.3 Empowerment and motivation of people 129.2.4 Competence of people 139.3 Organizational knowledge . 139.4 Technology . 149.5 Infrastructure and work environment 149.5.1 General. 149.5.2 Infrastructure 149.5.3 Work environment 149.6 Externally pro

19、vided resources . 159.7 Natural resources 1510 Analysis and evaluation of an organizations performance 1610.1 General 1610.2 Performance indicators 1610.3 Performance analysis . 1810.4 Performance evaluation . 1810.5 Internal audit . 1910.6 Self-assessment . 2010.7 Reviews . 2011 Improvement, learni

20、ng and innovation 2111.1 General 21 ISO 2018 All rights reserved iiiContents PageBS EN ISO 9004:2018ISO 9004:201811.2 Improvement . 2111.3 Learning . 2211.4 Innovation 2211.4.1 General. 2211.4.2 Application . 2311.4.3 Timing and risk 23Annex A (informative) Self-assessment tool 24Bibliography .58iv

21、ISO 2018 All rights reservedBS EN ISO 9004:2018ISO 9004:2018ForewordISO (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 committ

22、ees. 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 Int

23、ernational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the d

24、ifferent types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO s

25、hall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document

26、 is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organ

27、ization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee 2, Quality systems.This fourth edition cancels and replaces the

28、third edition (ISO 9004:2009), which has been technically revised. The main changes compared to the previous edition are as follows: alignment with the concepts and terminology of ISO 9000:2015 and ISO 9001:2015; focus on the concept of “quality of an organization”; focus of the concept of “identity

29、 of an organization”. ISO 2018 All rights reserved vBS EN ISO 9004:2018ISO 9004:2018IntroductionThis document provides guidance for organizations to achieve sustained success in a complex, demanding and ever-changing environment, with reference to the quality management principles described in ISO 9

30、000:2015. Where they are applied collectively, quality management principles can provide a unifying basis for an organizations values and strategies.While ISO 9001:2015 focuses on providing confidence in an organizations products and services, this document focuses on providing confidence in the org

31、anizations ability to achieve sustained success.Top managements focus on the organizations ability to meet the needs and expectations of customers and other relevant interested parties provides confidence in achieving sustained success. This document addresses the systematic improvement of the organ

32、izations overall performance. It includes the planning, implementation, analysis, evaluation and improvement of an effective and efficient management system.Factors affecting an organizations success continually emerge, evolve, increase or diminish over the years, and adapting to these changes is im

33、portant for sustained success. Examples include social responsibility, environmental and cultural factors, in addition to those that might have been previously considered, such as efficiency, quality and agility; taken together, these factors are part of the organizations context.The ability to achi

34、eve sustained success is enhanced by managers at all levels learning about and understanding the organizations evolving context. Improvement and innovation also support sustained success.This document promotes self-assessment and provides a self-assessment tool for reviewing the extent to which the

35、organization has adopted the concepts in this document (see Annex A).A representation of the structure of this document, incorporating the elements essential to achieve sustained success of an organization as covered in this document, is presented in Figure 1.vi ISO 2018 All rights reservedBS EN ISO

36、 9004:2018ISO 9004:2018Figure 1 Representation of the structure of this document ISO 2018 All rights reserved viiBS EN ISO 9004:2018This page deliberately left blankQuality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)1 ScopeThis document gives guide

37、lines for enhancing an organizations ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015.This document provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document.

38、This document is applicable to any organization, regardless of its size, type and activity.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited

39、 applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 9000:2015, Quality management systems Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.ISO

40、 and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/4 Quality of an organization and sustained success4.1 Quality of an organizati

41、onThe quality of an organization is the degree to which the inherent characteristics of the organization fulfil the needs and expectations of its customers and other interested parties, in order to achieve sustained success. It is up to the organization to determine what is relevant to achieve susta

42、ined success.NOTE 1 The term “quality of an organization” is derived from the definition of “quality” given in ISO 9000:2015, 3.6.2 (“the degree to which a set of inherent characteristics of an object fulfils requirements”), and from the definition of “requirement” given in ISO 9000:2015, 3.6.4, (“n

43、eeds or expectations that are stated, generally implied or obligatory”). It is distinct from the purpose of ISO 9001, which focuses on the quality of products and services in order to give confidence in the ability of an organization to provide conforming products and services and to enhance its cus

44、tomers satisfaction.NOTE 2 All references to “needs and expectations” mean “relevant needs and expectations”.NOTE 3 All references to “interested parties” mean “relevant interested parties”.NOTE 4 All references to “interested parties” include customers.The organization should go beyond the quality

45、of its products and services and the needs and expectations of its customers. To achieve sustained success, the organization should focus on INTERNATIONAL STANDARD ISO 9004:2018 ISO 2018 All rights reserved 1BS EN ISO 9004:2018ISO 9004:2018anticipating and meeting the needs and expectations of its i

46、nterested parties, with the intent of enhancing their satisfaction and overall experience.The organization should apply all of the quality management principles (see ISO 9000:2015) to achieve sustained success. Particular attention should be given to the principles of “customer focus” and “relations

47、hip management” to meet the different needs and expectations of interested parties.The needs and expectations of individual interested parties can be different, aligned to, or in conflict with those of other interested parties, or can change quickly. The means by which the needs and expectations of

48、interested parties are expressed and met can take a wide variety of forms, for example co-operation, negotiation, outsourcing, or by terminating an activity; consequently, the organization should give consideration to the interrelationships of its interested parties when addressing their needs and e

49、xpectations.The composition of interested parties can differ significantly over time and between organizations, industries, cultures and nations; Figure 2 provides examples of interested parties and their needs and expectations.Figure 2 Examples of interested parties and their needs and expectations4.2 Managing for the sustained success of an organization4.2.1 The quality of an organization is enhanced and sustained success can be achieved by consistently meeting the needs and expectations of its interested parties over the long term