ISO INTERNATIONAL STANDARD 10005 Third edition 2018-06 Quality management - Guidelines for quality plans Management de laqualiteLignesdirectrices pourles plans qualite Referencenumber IS010005:2018(E) ISO2018 zation for S ed by IHS Markit under lic Not for Resale, 07/10/2018 05:48:06 MDT IS010005:2018(E) COPYRIGHTPROTECTEDDOCUMENT @IS02018 All rights reserved. Unless otherwise specified, 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 office CP 40i: Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland @IS02018-All rights reserved tinalganizationforandardizaion Provided by IHS Markit under licen No reproduction or networking permitod without icense from IHS Not for Resale, 07/10/2018 05:48:06 MDT IS010005:2018(E) Contents Page Foreword .V Introduction. .vii 1 Scope. .1 2 Normative references 3 Terms and definitions .1 4 Using a quality plan .2 4.1 Introduction 2 4.2 Requestingexternal providerqualityplans 2 4.3 Managing external providerqualityplans 3 5 Development of a qualityplan 4 5.1 Contextofthequalityplan .4 5.2 Inputstothequalityplan. 4 5.3 Definingthescopeofthequalityplan 5 5.4 Preparationofthequalityplan. 5 5.4.1 .5 Initiation. 5.4.2 Defining the quality plan. 5 5.4.3 Consistencyand compatibility 5 5.4.4 Presentation and structure. 6 6 Contentof thequalityplan 6 6.1 General 6 6.2 Scopeofthe qualityplan 6 6.3 Qualityplaninputs 6 .7 6.4 Quality objectives. 6.5 Qualityplanresponsibilities 7 .7 6.6 Controlofdocumentedinformation 6.7 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 Infrastructureandenvironmentfortheoperationofprocesses 8 6.7.5 Monitoring and measuring resources .8 6.8 Customersandotherinterestedpartiescommunication .9 6.9 Design and development .9 6.9.1 Designanddevelopmentprocess.. .9 6.9.2 Controlof design and development changes 9 6.10 Externallyprovidedprocesses,productsandservices 10 6.11 Production and serviceprovision. 10 6.12 Identification andtraceability. .11 6.13 Propertybelongingtocustomersorexternalproviders 11 6.14 Preservation ofoutputs .11 6.15 Controlofnonconformingoutputs 12 6.16 Monitoring and measurement .12 .12 6.17 Audits. 7 Operationand control ofthequalityplan 13 7.1 Reviewand acceptanceofthequalityplan .13 7.2 Implementationandmonitoringofthequalityplan 13 7.3 Revision of the qualityplan. 14 7.4 Feedbackandimprovement. 14 AnnexA(informative)Examplesofformatsforqualityplans .15 AnnexB (informative)Schematicrepresentationofaprocess approachappliedtoqualityplans.22 emationalorgS2hrightsreserved ili e with ANS Not for Resale, 07/10/2018 05:48:06 MDT