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10 February 2015 Yours Sincerely Document: ISO/TC 176/SC 2/N 1238 Secretariat of ISO/TC 176/SC 2 Date: 8 December 2014 To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/ Quality Systems Working Draft of ISO/TS 9002 Quality management systems - Guidelines for the application of ISO 9001 Please find a copy of the working draft attached. Please note that SC2 is being asked by ISO C/S to decide whether to continue with this project, or to run it in parallel with the development of a revision to the ISO Handbook "ISO 9001 for Small Businesses – What to do ? Advice from ISO/TC 176". A survey of SC2's members has been launched to consult over this matter (see document SC2/N1237). It should be noted that: a) this text was prepared against ISO/DIS 9001, so has not yet taken account of the recent changes to that text in the preparation of ISO/FDIS 9001. b) the included guidance text is currently considered to be suitable for use in either the TS or in the Handbook We would now be grateful to receive comments against the working draft. When making comments, please: - do not provide comments against the ISO/DIS 9001 text given in the text boxes, or Annexes A, B and C - ensure that you have given the correct line number reference - use the 2012 version of the ISO commenting template for the submission of comments (this can be downloaded from: http://isotc.iso.org/livelink/livelink?func=ll&objId=5156909&objAction=browse&sort=name ) - submit any comments in MicroSoft Word format Please submit your comments to the SC2 Secretariat before: 10 February 2015 Yours sincerely Charles Corrie For the BSI Secretariat of ISO/TC 176/SC 2 [email protected] © ISO 2014 – All rights reserved ISO/TC 176/SC 2/ N 1238 Date: 2014-05-18 ISO/PDTS 9002 ISO/TC 176/SC 2/WG 24 Secretariat: BSI Quality management systems — Guidelines for the application of ISO 9001 Systèmes de management de la qualité — Lignes directrices pour l'application de l'ISO 9001 Warning This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Document type: Technical Specification Document subtype: Document stage: (20) Preparatory Document language: E ISO/PDTS 9002 1 Copyright notice 2 This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the 3 reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards 4 development process is permitted without prior permission from ISO, neither this document nor any extract 5 from it may be reproduced, stored or transmitted in any form for any other purpose without prior written 6 permission from ISO. 7 Requests for permission to reproduce this document for the purpose of selling it should be addressed as 8 shown below or to ISO's member body in the country of the requester: 9 ISO copyright office 10 Case postale 56 CH-1211 Geneva 20 11 Tel. + 41 22 749 01 11 12 Fax + 41 22 749 09 47 13 E-mail [email protected] 14 Web www.iso.org 15 Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. 16 Violators may be prosecuted. © ISO 2014 – All rights reserved iii ISO/PDTS 9002 17 Contents Page 18 Foreword ..............................................................................................................................................................v 19 Introduction ....................................................................................................................................................... vi 20 1 Scope ......................................................................................................................................................1 21 1.1 Scope of this Technical Specification .................................................................................................1 22 1.2 Guidance on the scope of ISO/DIS 9001:2014, Quality management systems - 23 Requirements .........................................................................................................................................1 24 2 Normative references ............................................................................................................................2 25 3 Terms and Definitions ...........................................................................................................................2 26 4 Context of the organization ............................................................................................................... 15 27 4.1 Understanding the organization and its context ............................................................................. 15 28 4.2 Understanding the needs and expectations of interested parties ................................................ 16 29 4.3 Determining the scope of the quality management system ........................................................... 16 30 4.4 Quality management system and its processes ............................................................................. 18 31 5 Leadership ........................................................................................................................................... 20 32 5.1 Leadership and commitment ............................................................................................................. 20 33 5.2 Quality policy ...................................................................................................................................... 23 34 5.3 Organizational roles, responsibilities and authorities .................................................................... 26 35 6 Planning for the quality management system ................................................................................. 27 36 6.1 Actions to address risks and opportunities .................................................................................... 27 37 6.2 Quality objectives and planning to achieve them ........................................................................... 30 38 6.3 Planning of changes ........................................................................................................................... 31 39 7 Support ................................................................................................................................................ 32 40 7.1 Resources ............................................................................................................................................ 32 41 7.2 Competence ........................................................................................................................................ 39 42 7.3 Awareness ........................................................................................................................................... 40 43 7.4 Communication ................................................................................................................................... 40 44 7.5 Documented information ................................................................................................................... 41 45 8 Operation ............................................................................................................................................. 48 46 8.1 Operational planning and control ..................................................................................................... 48 47 8.2 Determination of requirements for products and services ............................................................ 51 48 8.3 Design and development of products and services ....................................................................... 57 49 8.4 Control of externally provided products and services ................................................................... 66 50 8.5 Production and service provision ..................................................................................................... 71 51 8.6 Release of products and services..................................................................................................... 77 52 8.7 Control of nonconforming process outputs, products and services ............................................ 78 53 9 Performance evaluation ..................................................................................................................... 80 54 9.1 Monitoring, measurement, analysis and evaluation ....................................................................... 80 55 9.2 Internal audit ....................................................................................................................................... 86 56 9.3 Management review ............................................................................................................................ 88 57 10 Improvement ....................................................................................................................................... 91 58 10.1 General ................................................................................................................................................. 91 59 10.2 Nonconformity and corrective action ............................................................................................... 92 60 10.3 Continual improvement .....................................................................................................................
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