EN ISO 9001-2015 en Quality management systems - Requirements《质量管理体系 要求(ISO 9001 2015)》.pdf

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1、BSI Standards PublicationQuality management systems Requirements.making excellence a habit.TMBS EN ISO 9001:2015BS EN ISO 9001:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9001:2015.It supersedes BS EN ISO 9001:2008 which is withdrawn.The UK particip

2、ation 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 necessaryprovisions of a contrac

3、t. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 91816 2ICS 03.120.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authori

4、ty 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 9001 September 2015 ICS 03.120.10 Supersedes EN ISO 9001:2008English Version Quality management systems - Requ

5、irements (ISO 9001:2015) Systmes de management de la qualit - Exigences (ISO 9001:2015) Qualittsmanagementsysteme - Anforderungen (ISO 9001:2015) This European Standard was approved by CEN on 14 September 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate

6、 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-CENELEC Management Centre or to any CEN member. This European Stand

7、ard 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 Management Centre has the same status as the official versions. CEN members are the nati

8、onal 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slov

9、akia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means

10、 reserved worldwide for CEN national Members. Ref. No. EN ISO 9001:2015 EBS EN ISO 9001:2015EN ISO 9001:2015 (E) 3 European foreword This document (EN ISO 9001:2015) has been prepared by Technical Committee ISO/TC 176 “Qualitymanagement and quality assurance“. This European Standard shall be given t

11、he 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. Attention is drawn to the possibility that some of the elements of this document may be the su

12、bject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 9001:2008. This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and support

13、s 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: Austria, Belgium, Bulgaria,Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

14、Yugoslav Republic of Macedonia,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 9001:2015 ha

15、s been approved by CEN as EN ISO 9001:2015 without any modification. BS EN ISO 9001:2015ISO 9001:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Context of the organization . 14.1 Understanding the organization and its context . 14.2 Understanding the

16、needs and expectations of interested parties 24.3 Determining the scope of the quality management system . 24.4 Quality management system and its processes 25 Leadership 35.1 Leadership and commitment . 35.1.1 General 35.1.2 Customer focus 35.2 Policy . 45.2.1 Establishing the quality policy . 45.2.

17、2 Communicating the quality policy 45.3 Organizational roles, responsibilities and authorities 46 Planning . 46.1 Actions to address risks and opportunities . 46.2 Quality objectives and planning to achieve them 56.3 Planning of changes 57 Support . 67.1 Resources . 67.1.1 General 67.1.2 People 67.1

18、.3 Infrastructure . 67.1.4 Environment for the operation of processes . 67.1.5 Monitoring and measuring resources . 77.1.6 Organizational knowledge . 77.2 Competence . 87.3 Awareness . 87.4 Communication 87.5 Documented information . 87.5.1 General 87.5.2 Creating and updating . 97.5.3 Control of do

19、cumented information . 98 Operation . 98.1 Operational planning and control 98.2 Requirements for products and services 108.2.1 Customer communication . 108.2.2 Determining the requirements for products and services .108.2.3 Review of the requirements for products and services 108.2.4 Changes to req

20、uirements for products and services .118.3 Design and development of products and services 118.3.1 General. 118.3.2 Design and development planning 118.3.3 Design and development inputs 118.3.4 Design and development controls .128.3.5 Design and development outputs 128.3.6 Design and development cha

21、nges 12 ISO 2015 All rights reserved iiiContents PageBS EN ISO 9001:2015ISO 9001:2015(E)8.4 Control of externally provided processes, products and services .138.4.1 General. 138.4.2 Type and extent of control 138.4.3 Information for external providers . 138.5 Production and service provision 148.5.1

22、 Control of production and service provision 148.5.2 Identification and traceability . 148.5.3 Property belonging to customers or external providers 158.5.4 Preservation 158.5.5 Post-delivery activities 158.5.6 Control of changes .158.6 Release of products and services . 158.7 Control of nonconformi

23、ng outputs . 169 Performance evaluation 169.1 Monitoring, measurement, analysis and evaluation 169.1.1 General. 169.1.2 Customer satisfaction .179.1.3 Analysis and evaluation 179.2 Internal audit . 179.3 Management review 189.3.1 General. 189.3.2 Management review inputs . 189.3.3 Management review

24、outputs . 1810 Improvement .1910.1 General 1910.2 Nonconformity and corrective action 1910.3 Continual improvement . 19Annex A (informative) Clarification of new structure, terminology and concepts 21Annex B (informative) Other International Standards on quality management and quality management sys

25、tems developed by ISO/TC 176 .25Bibliography .28iv ISO 2015 All rights reservedBS EN ISO 9001:2015ISO 9001:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards

26、 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 p

27、art in the work. ISO collaborates closely 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 partic

28、ular the different approval criteria 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 thi

29、s document may be the subject of patent 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.

30、iso.org/patents).Any trade name used 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 the

31、World Trade Organization (WTO) principles 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 2, Quality systems.This fif

32、th edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically revised, through the adoption of a revised clause sequence and the adaptation of the revised quality management principles and of new concepts. It also cancels and replaces the Technical Corrigendum ISO 90

33、01:2008/Cor.1:2009. ISO 2015 All rights reserved vBS EN ISO 9001:2015ISO 9001:2015(E)Introduction0.1 GeneralThe adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development i

34、nitiatives.The potential benefits to an organization of implementing a quality management system based on this International Standard are:a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;b) facilitating opportunities

35、 to enhance customer satisfaction;c) addressing risks and opportunities associated with its context and objectives;d) the ability to demonstrate conformity to specified quality management system requirements.This International Standard can be used by internal and external parties.It is not the inten

36、t of this International Standard to imply the need for: uniformity in the structure of different quality management systems; alignment of documentation to the clause structure of this International Standard; the use of the specific terminology of this International Standard within the organization.T

37、he quality management system requirements specified in this International Standard are complementary to requirements for products and services.This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.The process approach

38、enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine t

39、he factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).Consistently meeting requirements and addressing f

40、uture needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough cha

41、nge, innovation and re-organization.In this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability.Information marked as “NOTE” is for guidance in u

42、nderstanding or clarifying the associated requirement.vi ISO 2015 All rights reservedBS EN ISO 9001:2015ISO 9001:2015(E)0.2 Quality management principlesThis International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each princ

43、iple, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organizations performance when applying the principle.The quality management principles are: customer focus; leadership; en

44、gagement of people; process approach; improvement; evidence-based decision making; relationship management.0.3 Process approach0.3.1 GeneralThis International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management sy

45、stem, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.Understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in

46、 achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.The process approach involves the systematic definition and managemen

47、t of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based

48、thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements;b) the consideration of processes in terms of added value;c) the

49、achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks. ISO 2015 All rights reserved viiBS EN ISO 9001:2015ISO 9001:2015(E)Figure 1 Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cyc