EN ISO 9000-2015 en Quality management systems - Fundamentals and vocabulary《质量管理体系 基础和术语(ISO 9000 2015)》.pdf

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1、BSI Standards PublicationQuality management systems Fundamentals and vocabulary.making excellence a habit.TMBS EN ISO 9000:2015BS EN ISO 9000:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9000:2015.It supersedes BS EN ISO 9000:2005 which is withdrawn.

2、The UK participation in its preparation was entrusted to TechnicalCommittee QS/1, Quality management and quality assuranceprocedures.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisio

3、ns of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 78878 9ICS 01.040.03; 03.120.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was p

4、ublished under the authority of theStandards Policy and Strategy Committee on 30 September 2015.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9000 September 2015 ICS 01.040.03; 03.120.10 Supersedes EN ISO 9000:2005English Vers

5、ion Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) Systmes de management de la qualit - Principes essentiels et vocabulaire (ISO 9000:2015) Qualittsmanagementsysteme - Grundlagen und Begriffe (ISO 9000:2015) This European Standard was approved by CEN on 14 September 2015. C

6、EN 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 ap

7、plication to the CEN-CENELEC 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-CENELEC

8、Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

9、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue M

10、arnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9000:2015 EBS EN ISO 9000:2015EN ISO 9000:2015 (E) 3 European foreword This document (EN ISO 9000:2015) has been prepared by Technical Committee ISO

11、/TC 176 “Qualitymanagement and quality assurance“. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national standards shallbe withdrawn at the latest by March 2016. Atte

12、ntion is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 9000:2005. This document has been prepared under a mandate g

13、iven to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Aust

14、ria, Belgium, 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, Slovakia, Slovenia, Spain, Sweden,

15、Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 9000:2015 has been approved by CEN as EN ISO 9000:2015 without any modification. BS EN ISO 9000:2015ISO 9000:2015(E)Foreword ivIntroduction v1 Scope . 12 Fundamental concepts and quality management principles . 12.1 Genera

16、l . 12.2 Fundamental concepts . 22.2.1 Quality . 22.2.2 Quality management system . 22.2.3 Context of an organization 22.2.4 Interested parties 22.2.5 Support . 22.3 Quality management principles . 32.3.1 Customer focus 32.3.2 Leadership . 42.3.3 Engagement of people . 52.3.4 Process approach 62.3.5

17、 Improvement. 62.3.6 Evidence-based decision making 72.3.7 Relationship management . 82.4 Developing the QMS using fundamental concepts and principles . 92.4.1 QMS model 92.4.2 Development of a QMS 92.4.3 QMS standards, other management systems and excellence models .103 Terms and definitions 103.1

18、Terms related to person or people . 103.2 Terms related to organization. 113.3 Terms related to activity 133.4 Terms related to process . 153.5 Terms related to system . 163.6 Terms related to requirement . 183.7 Terms related to result 203.8 Terms related to data, information and document .233.9 Te

19、rms related to customer . 253.10 Terms related to characteristic 263.11 Terms related to determination 273.12 Terms related to action . 293.13 Terms related to audit 30Annex A (informative) Concept relationships and their graphical representation 33Bibliography .47Alphabetical index of terms .49 ISO

20、 2015 All rights reserved iiiContents PageBS EN ISO 9000:2015ISO 9000:2015(E)ForewordISO (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

21、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 clo

22、sely with the International 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

23、needed for the different 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 pate

24、nt rights. ISO shall 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

25、in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to World Trade Organization (WTO) principles

26、 in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 1, Concepts and terminology.This fourth edition cancels and replaces

27、 the third edition (ISO 9000:2005), which has been technically revised.iv ISO 2015 All rights reservedBS EN ISO 9000:2015ISO 9000:2015(E)IntroductionThis International Standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) and provides the foundati

28、on for other QMS standards. This International Standard is intended to help the user to understand the fundamental concepts, principles and vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards.This Internation

29、al Standard proposes a well-defined QMS, based on a framework that integrates established fundamental concepts, principles, processes and resources related to quality, in order to help organizations realize their objectives. It is applicable to all organizations, regardless of size, complexity or bu

30、siness model. Its aim is to increase an organizations awareness of its duties and commitment in fulfilling the needs and expectations of its customers and interested parties, and in achieving satisfaction with its products and services.This International Standard contains seven quality management pr

31、inciples supporting the fundamental concepts described in 2.2. In 2.3, for each quality management principle, there is a “statement” describing each principle, a “rationale” explaining why the organization would address the principle, “key benefits” that are attributed to the principles, and “possib

32、le actions” that an organization can take in applying the principle.This International Standard contains the terms and definitions that apply to all quality management and QMS standards developed by ISO/TC 176, and other sector-specific QMS standards based on those standards, at the time of publicat

33、ion. The terms and definitions are arranged in conceptual order, with an alphabetical index provided at the end of the document. Annex A includes a set of diagrams of the concept systems that form the concept ordering.NOTE Guidance on some additional frequently-used words in the QMS standards develo

34、ped by ISO/TC 176, and which have an identified dictionary meaning, is provided in a glossary available at: http:/www.iso.org/iso/03_terminology_used_in_iso_9000_family.pdf ISO 2015 All rights reserved vBS EN ISO 9000:2015BS EN ISO 9000:2015Quality management systems Fundamentals and vocabulary1 Sco

35、peThis International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: organizations seeking sustained success through the implementation of a quality management system; customers seeking confidence in an organizations

36、 ability to consistently provide products and services conforming to their requirements; organizations seeking confidence in their supply chain that product and service requirements will be met; organizations and interested parties seeking to improve communication through a common understanding of t

37、he vocabulary used in quality management; organizations performing conformity assessments against the requirements of ISO 9001; providers of training, assessment or advice in quality management; developers of related standards.This International Standard specifies the terms and definitions that appl

38、y to all quality management and quality management system standards developed by ISO/TC 176.2 Fundamental concepts and quality management principles2.1 GeneralThe quality management concepts and principles described in this International Standard give the organization the capacity to meet challenges

39、 presented by an environment that is profoundly different from recent decades. The context in which an organization works today is characterized by accelerated change, globalization of markets and the emergence of knowledge as a principal resource. The impact of quality extends beyond customer satis

40、faction: it can also have a direct impact on the organizations reputation.Society has become better educated and more demanding, making interested parties increasingly more influential. By providing fundamental concepts and principles to be used in the development of a quality management system (QMS

41、), this International Standard provides a way of thinking about the organization more broadly.All concepts, principles and their interrelationships should be seen as a whole and not in isolation of each other. No individual concept or principle is more important than another. At any one time, findin

42、g the right balance in application is critical.INTERNATIONAL STANDARD ISO 9000:2015(E) ISO 2015 All rights reserved 1BS EN ISO 9000:2015ISO 9000:2015(E)2.2 Fundamental concepts2.2.1 QualityAn organization focused on quality promotes a culture that results in the behaviour, attitudes, activities and

43、processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties.The quality of an organizations products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties.

44、The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.2.2.2 Quality management systemA QMS comprises activities by which the organization identifies its objectives and determines the processes and re

45、sources required to achieve desired results.The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties.The QMS enables top management to optimize the use of resources considering the long and short term consequences of their

46、decision.A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services.2.2.3 Context of an organizationUnderstanding the context of the organization is a process. This process determines factors which influence the organizations purpo

47、se, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments.Examples of the ways in which an o

48、rganizations purpose can be expressed include its vision, mission, policies and objectives.2.2.4 Interested partiesThe concept of interested parties extends beyond a focus solely on the customer. It is important to consider all relevant interested parties.Part of the process for understanding the co

49、ntext of the organization is to identify its interested parties. The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk.Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their success.2.2.5 Support2.2.5.1 GeneralTop management support of the QMS and engagement of people enables: prov