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Provläsningsexemplar / Preview INTERNATIONAL ISO STANDARD 10005 Third edition 2018-06 Quality management — Guidelines for quality plans Management de la qualité — Lignes directrices pour les plans qualité Reference number
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  ©  ISO 2018 Quality management — Guidelines for quality plans Management de la qualité — Lignes directrices pour les plans qualité  INTERNATIONAL STANDARD ISO10005 Third edition2018-06Reference numberISO 10005:2018(E) Provläsningsexemplar / Preview    ISO 10005:2018(E)  ii   © ISO 2018 – All rights reserved COPYRIGHT PROTECTED DOCUMENT © ISO 2018 All rights reserved. Unless otherwise speciied, or required in the context of its implementation, 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 ISO at the address below or ISO’s member body in the country of the requester.ISO copyright oficeCP 401 ã Ch. de Blandonnet 8CH-1214 Vernier, GenevaPhone: +41 22 749 01 11Fax: +41 22 749 09 47Email: copyright@iso.org Website: www.iso.org Published in Switzerland Provläsningsexemplar / Preview    ISO 10005:2018(E)  Foreword  .......................................................................................................................................................................................................................................... vIntroduction  .............................................................................................................................................................................................................................. vii1 Scope  ................................................................................................................................................................................................................................. 12 Normative references  ...................................................................................................................................................................................... 1 3 Terms and definitions  ..................................................................................................................................................................................... 14 Using a quality plan  ........................................................................................................................................................................................... 2 4.1 Introduction  .............................................................................................................................................................................................. 2 4.2 Requesting external provider quality plans  .................................................................................................................. 2 4.3 Managing external provider quality plans  ...................................................................................................................... 3 5 Development of a quality plan  ............................................................................................................................................................... 4 5.1 Context of the quality plan  ............................................................................................................................................................ 45.2 Inputs to the quality plan  ............................................................................................................................................................... 45.3 Deining the scope of the quality plan  ................................................................................................................................ 5 5.4 Preparation of the quality plan  ................................................................................................................................................. 5 5.4.1 Initiation .................................................................................................................................................................................. 5 5.4.2 Deining the quality plan  ........................................................................................................................................... 5 5.4.3 Consistency and compatibility  ............................................................................................................................. 5 5.4.4 Presentation and structure  ..................................................................................................................................... 6 6 Content of the quality plan  ......................................................................................................................................................................... 6 6.1 General  ........................................................................................................................................................................................................... 6 6.2 Scope of the quality plan  ................................................................................................................................................................ 6 6.3 Quality plan inputs  .............................................................................................................................................................................. 6 6.4 Quality objectives .................................................................................................................................................................................. 76.5 Quality plan responsibilities  ....................................................................................................................................................... 76.6 Control of documented information  ..................................................................................................................................... 76.7 Resources  ..................................................................................................................................................................................................... 8 6.7.1 Provision of resources  ................................................................................................................................................. 8 6.7.2 Materials, products and services  ....................................................................................................................... 8 6.7.3 People  ........................................................................................................................................................................................ 8 6.7.4 Infrastructure and environment for the operation of processes  ........................................... 8 6.7.5 Monitoring and measuring resources  ........................................................................................................... 8 6.8 Customers and other interested parties communication  .................................................................................. 96.9 Design and development   ................................................................................................................................................................ 96.9.1 Design and development process  ...................................................................................................................... 96.9.2 Control of design and development changes  ........................................................................................... 96.10 Externally provided processes, products and services  ..................................................................................... 10 6.11 Production and service provision  ........................................................................................................................................ 10 6.12 Identiication and traceability  ................................................................................................................................................ 11 6.13 Property belonging to customers or external providers  ................................................................................. 11 6.14 Preservation of outputs  ................................................................................................................................................................ 116.15 Control of nonconforming outputs  ..................................................................................................................................... 12 6.16 Monitoring and measurement   ................................................................................................................................................ 12 6.17 Audits  ........................................................................................................................................................................................................... 12 7 Operation and control of the quality plan  ............................................................................................................................... 13 7.1 Review and acceptance of the quality plan  ................................................................................................................. 137.2 Implementation and monitoring of the quality plan ........................................................................................... 137.3 Revision of the quality plan ....................................................................................................................................................... 147.4 Feedback and improvement   ..................................................................................................................................................... 14  Annex A (informative)  Examples of formats for quality plans  ............................................................................................... 15 Annex B (informative)  Schematic representation of a process approach applied to quality plans  . 22 © ISO 2018 – All rights reserved iii Contents Page Provläsningsexemplar / Preview    ISO 10005:2018(E)   Annex C (informative)  Correlation matrix between the clauses in this document and those in ISO 9001:2015  ............................................................................................................................................................................................... 23 Annex D (informative)  Correlation matrix between the clauses of this document and the quality management principles from ISO 9000:2015  ................................................................................................ 24Bibliography  ............................................................................................................................................................................................................................. 27 iv   © ISO 2018 – All rights reserved 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