BS PD ISO TS 9002-2016 Quality management systems Guidelines for the application of ISO 9001 2015《质量管理体系 ISO 9001-2015应用指南》.pdf

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1、BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 Quality management systems Guidelines for the application of ISO 9001:2015 PD ISO/TS 9002:2016 Incorporating corrigendum November 2016National foreword This Published Document is the UK implementation of ISO/TS 9002:2

2、016. The UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and quality assurance procedures. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessa

3、ry provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016 Published by BSI Standards Limited 2016 ISBN 978 0 580 96410 7 ICS 03.120.10 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Documen

4、t was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016. Amendments/corrigenda issued since publication Date Text affected 30 November 2016 References to bibliography corrected PUBLISHED DOCUMENT PD ISO/TS 9002:2016 ISO 2016 Quality management systems G

5、uidelines for the application of ISO 9001:2015 Systmes de management de la qualit Lignes directrices pour lapplication de lISO 9001:2015 TECHNICAL SPECIFICATION ISO/TS 9002 Reference number ISO/TS 9002:2016(E) First edition 2016-11-01 PD ISO/TS 9002:2016 ISO/TS 9002:2016(E)ii ISO 2016 All rights res

6、erved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. 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 i

7、ntranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightis

8、o.org www.iso.org PD ISO/TS 9002:2016 ISO/TS 9002:2016(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Context of the organization . 1 4.1 Understanding the organization and its context . 1 4.2 Understanding the needs and expectations of interested pa

9、rties 2 4.3 Determining the scope of the quality management system . 4 4.4 Quality management system and its processes 5 5 Leadership 7 5.1 Leadership and commitment . 7 5.1.1 General 7 5.1.2 Customer focus 8 5.2 Policy . 8 5.2.1 Establishing the quality policy . 8 5.2.2 Communicating the quality po

10、licy 9 5.3 Organizational roles, responsibilities and authorities 9 6 Planning 10 6.1 Actions to address risks and opportunities 10 6.2 Quality objectives and planning to achieve them .12 6.3 Planning of changes .13 7 Support 14 7.1 Resources 14 7.1.1 General.14 7.1.2 People .14 7.1.3 Infrastructure

11、 14 7.1.4 Environment for the operation of processes 15 7.1.5 Monitoring and measuring resources 16 7.1.6 Organizational knowledge 17 7.2 Competence 18 7.3 Awareness 18 7.4 Communication .19 7.5 Documented information 20 7.5.1 General.20 7.5.2 Creating and updating 20 7.5.3 Control of documented inf

12、ormation 20 8 Operation 21 8.1 Operational planning and control .21 8.2 Requirements for products and services 22 8.2.1 Customer communication .22 8.2.2 Determining the requirements for products and services .23 8.2.3 Review of the requirements for products and services 23 8.2.4 Changes to requireme

13、nts for products and services .24 8.3 Design and development of products and services 24 8.3.1 General.24 8.3.2 Design and development planning 25 8.3.3 Design and development inputs 26 8.3.4 Design and development controls .26 8.3.5 Design and development outputs 27 8.3.6 Design and development cha

14、nges 28 ISO 2016 All rights reserved iii Contents Page PD ISO/TS 9002:2016 ISO/TS 9002:2016(E)8.4 Control of externally provided processes, products and services .28 8.4.1 General.28 8.4.2 Type and extent of control 29 8.4.3 Information for external providers .30 8.5 Production and service provision

15、 31 8.5.1 Control of production and service provision 31 8.5.2 Identification and traceability .32 8.5.3 Property belonging to customers or external providers 32 8.5.4 Preservation 33 8.5.5 Post-delivery activities 34 8.5.6 Control of changes .34 8.6 Release of products and services .35 8.7 Control

16、of nonconforming outputs .35 9 Performance evaluation 37 9.1 Monitoring, measurement, analysis and evaluation 37 9.1.1 General.37 9.1.2 Customer satisfaction .37 9.1.3 Analysis and evaluation 38 9.2 Internal audit .39 9.3 Management review 40 9.3.1 General.40 9.3.2 Management review inputs .41 9.3.3

17、 Management review outputs .41 10 Improvement .42 10.1 General 42 10.2 Nonconformity and corrective action 42 10.3 Continual improvement .44 Bibliography .45 iv ISO 2016 All rights reserved PD ISO/TS 9002:2016 ISO/TS 9002:2016(E) Foreword ISO (the International Organization for Standardization) is a

18、 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 represente

19、d 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. The procedures used to develop t

20、his 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 different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC

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

22、evelopment 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 is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of

23、 ISO specific terms and expressions 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 docume

24、nt is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. ISO 2016 All rights reserved v PD ISO/TS 9002:2016 ISO/TS 9002:2016(E) Introduction This document has been developed to assist users to apply the quality management system requirements

25、 of ISO 9001:2015 Quality management systems Requirements. This document provides guidance, with a clause by clause correlation to Clauses 4 to 10 of ISO 9001:2015, however it does not provide guidance on ISO 9001:2015, Annexes A and B . Where there is direct correlation between list items (i.e. bul

26、let points) in a clause in ISO 9001:2015 and the guidance, this is indicated within the clause of this document. This document gives examples of what an organization can do, but it does not add new requirements to ISO 9001. The examples in this document are not definitive and only represent possibil

27、ities, not all of which are necessarily suitable for every organization. ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its

28、relation to the overall management system of an organization. While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes. As the r

29、equirements of ISO 9001 are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization applies the guidance can vary based on factors such as the size or the complexity of the organization,

30、 the management model it adopts, the range of the organizations activities and the nature of the risks and opportunities it encounters. Risk is the level of uncertainty inherent in a quality management system. There are risks in all systems, processes and functions. Risk-based thinking ensures these

31、 risks are determined, considered and controlled throughout the design and use of the quality management system. Risk-based thinking has been implicit in previous editions of ISO 9001 in such requirements as determining the type and extent of control for external providers based on the effect of the

32、 product that is going to be provided, or taking corrective action based on the potential effect of an identified nonconformity. In addition, in previous editions of ISO 9001, a clause on preventive action was included. By using risk-based thinking the consideration of risk is integral. It becomes p

33、roactive rather than reactive in preventing or reducing undesired effects through early identification and action. Preventive action is built-in when a management system is risk-based. Not all the processes of a quality management system represent the same level of risk in terms of the organizations

34、 ability to meet its quality objectives. Some need more careful and formal planning and control than others. There is no requirement in ISO 9001 to use formal risk management in determining and addressing risks and opportunities. An organization can choose the methods that suit its needs. IEC 31010

35、23provides a list of risk assessment tools and techniques that can be considered, depending on the organizations context. In some cases, an organization might have a formal risk management process in place that is required by customers or statutory and regulatory requirements. In such circumstances,

36、 the organization can adapt its formal risk management process to meet the intent of the requirements in ISO 9001 concerning risks and opportunities. In addition to ISO 9001:2015, Annex A, ISO has published a number of other quality management standards and informative resources which can assist the

37、 user and provide information on additional implementation methods, including:vi ISO 2016 All rights reserved PD ISO/TS 9002:2016 ISO/TS 9002:2016(E) the ISO handbook: ISO 9001:2015 for Small Enterprises What to do ? Advice from ISO/TC 176 28 the ISO 9001 Auditing Practices Group (APG) papers: www.i

38、so.org/tc176/ ISO9001AuditingPracticesGroup 31 public information on the ISO/TC 176/SC2 website: https:/ /committee.iso.org/tc176sc2 30 the ISO handbook: The Integrated Use of Management System Standards 29 . Additional standards and documents are listed in the Bibliography. ISO 2016 All rights rese

39、rved vii PD ISO/TS 9002:2016This page deliberately left blank Quality management systems Guidelines for the application of ISO 9001:2015 1 Scope This document provides guidance on the intent of the requirements in ISO 9001:2015, with examples of possible steps an organization can take to meet the re

40、quirements. It does not add to, subtract from, or in any way modify those requirements. This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation. 2 Normative references The following documents are referred to in the text in such a way

41、 that some or all of their content constitutes requirements 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 9000:2015, Quality management systems Fundamentals and voc

42、abulary ISO 9001:2015, Quality management systems Requirements 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsin

43、g platform: available at http:/ /www.iso.org/obp IEC Electropedia: available at http:/ /www.electropedia.org/ 4 Context of the organization 4.1 Understanding the organization and its context The intent of this subclause is to understand the external and internal issues that are relevant to the organ

44、izations purpose and strategic direction and that can affect, either positively or negatively, the organizations ability to achieve the intended results of its quality management system. The organization should be aware that external and internal issues can change, and therefore, should be monitored

45、 and reviewed. An organization might conduct reviews of its context at planned intervals and through activities such as management review. Information about external and internal issues can be found from many sources, such as through internal documented information and meetings, in the national and

46、international press, websites, publications from national statistics offices and other government departments, professional and technical publications, conferences and meetings with relevant agencies, meetings with customers and relevant interested parties, and professional associations. TECHNICAL S

47、PECIFICATION ISO/TS 9002:2016(E) ISO 2016 All rights reserved 1 PD ISO/TS 9002:2016 ISO/TS 9002:2016(E) Examples of external and internal issues relevant to the organizations context can include, but are not limited to: a) external issues related to: 1) economic factors such as money exchange rates,

48、 economic situation, inflation forecast, credit availability; 2) social factors such as local unemployment rates, safety perception, education levels, public holidays and working days; 3) political factors such as political stability, public investments, local infrastructure, international trade agr

49、eements; 4) technological factors such as new sector technology, materials and equipment, patent expirations, professional code of ethics; 5) market factors such as competition, including the organizations market share, similar products or services, market leader trends, customer growth trends, market stability, supply chain relationships; 6) statutory and regulatory factors which affect the work environment (see ISO 9001:2015, 7.1.4) such as trade union regulations and regulations related to an industry; b) i