《质量管理体系文件》ISO 9001：2015正式英文版.pdf

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1、 ISO 2015Quality management systems RequirementsSystmes de management de la qualit ExigencesINTERNATIONAL STANDARDISO9001Fifth edition2015-09-15Reference numberISO 9001:2015(E) ISO 9001:2015(E) ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights r

2、eserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either

3、 ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.org ISO 9001:2015(E) Foreword .vIntroduction .vi1 Scope .12 Normative refer

4、ences .13Termsanddefinitions .14 Context of the organization .14.1 Understanding the organization and its context .14.2 Understanding the 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 Le

5、adership .35.1 Leadership and commitment .35.1.1 General.35.1.2 Customer focus .35.2 Policy .45.2.1 Establishing the quality policy .45.2.2 Communicating the quality policy .45.3 Organizational roles, responsibilities and authorities.46 Planning .46.1 Actions to address risks and opportunities .46.2

6、 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 .67.1.3 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

7、.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 documented information .98 Operation .98.1 Operational planning and control .98.2 Requirements for products and services .108.2.1 Customer communication .108.2.2 Determini

8、ng the requirements for products and services .108.2.3 Review of the requirements for products and services .108.2.4 Changes to requirements 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 d

9、evelopment inputs .118.3.4 Design and development controls .128.3.5 Design and development outputs .128.3.6 Design and development changes .12 ISO 2015 All rights reserved iiiContents Page ISO 9001:2015(E) 8.4 Control of externally provided processes, products and services .138.4.1 General.138.4.2 T

10、ype and extent of control .138.4.3 Information for external providers .138.5 Production and service provision .148.5.1 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 Po

11、st-delivery activities .158.5.6 Control of changes .158.6 Release of products and services .158.7 Control of nonconforming 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.

12、2 Internal audit .179.3 Management review .189.3.1 General.189.3.2 Management review inputs .189.3.3 Management review outputs .1810 Improvement .1910.1 General .1910.2 Nonconformity and corrective action .1910.3 Continual improvement .19Annex A (informative)Clarificationofnewstructure,terminologyan

13、dconcepts .21Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 .25Bibliography .28iv ISO 2015 All rights reserved ISO 9001:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation

14、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. I

15、nternational 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.The procedures used to develop this document and those

16、intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular 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

17、 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 shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the docume

18、nt 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 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 ex

19、pressions related to conformity assessment, as well as information about ISOs adherence to the 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 IS

20、O/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.This fifth 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 managemen

21、t principles and of new concepts. It also cancels and replaces the Technical Corrigendum ISO 9001:2008/Cor.1:2009. ISO 2015 All rights reserved v ISO 9001:2015(E)Introduction0.1 GeneralThe adoption of a quality management system is a strategic decision for an organization that can help to improve it

22、s overall performance and provide a sound basis for sustainable development initiatives.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 a

23、pplicable statutory and regulatory requirements;b) facilitating opportunities 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 Internatio

24、nal Standard can be used by internal and external parties.It is not the intent 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

25、specific terminology of this International Standard within the organization.The 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

26、 Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.The process approach 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 deter

27、mined and acted on.Risk-based thinking enables an organization to determine the 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 t

28、hey arise (see Clause A.4).Consistently meeting requirements and addressing future 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

29、in addition to correction and continual improvement, such as breakthrough change, 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

30、possibility or a capability.Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. vi ISO 2015 All rights reserved ISO 9001:2015(E)0.2 Quality management principlesThis International Standard is based on the quality management principles described in

31、ISO 9000. The descriptions include a statement of each principle, 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 quali

32、ty management principles are: customer focus; leadership; engagement 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, implementin

33、g and improving the effectiveness of a quality management system, 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 cont

34、ributes to the organizations effectiveness and efficiency in 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 proce

35、ss approach involves the systematic definition and management 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

36、 PDCA cycle (see 0.3.2) with an overall focus on risk-based 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) th

37、e consideration of processes in terms of added value;c) the 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 meas

38、uring 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 vii ISO 9001:2015(E)Figure 1 Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be app

39、lied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International Standard.Figure 2 Representation of the structure of this International Sta

40、ndard in the PDCA cycle viii ISO 2015 All rights reserved ISO 9001:2015(E)The PDCA cycle can be briefly described as follows: Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers requirements and the organizations po

41、licies, and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; Act: take actions to im

42、prove performance, as necessary.0.3.3 Risk-based thinkingRisk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying o

43、ut preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.To conform to the requirements of this International Standard, an organization needs to plan and

44、implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.Opportunities can arise as a result of a situation favourabl

45、e to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of

46、 uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.0.4 Relationship with other management system standardsThis International Standard applies th

47、e framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1).This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality manageme

48、nt system with the requirements of other management system standards.This International Standard relates to ISO 9000 and ISO 9004 as follows: ISO 9000 Quality management systems Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this Internat

49、ional Standard; ISO 9004 Managing for the sustained success of an organization A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.Annex B provides details of other International Standards on quality managem

50、ent and quality management systems that have been developed by ISO/TC 176.This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.Sector-specific qua