ISO 9001:2015 Revision Overview - ASQ0511

ISO 9001:2015Revision overviewDecember 2013ISO/TC 176/SC 2/WG23 N0631

Purpose of presentationISO/TC 176/SC 2/WG23 N063To provide an overview of the revision ofISO 9001 which will be published in 20152Date:

Background to this presentation developed by the ISO sub-committeeresponsible for communicating key informationabout the current revisions to ISO 9001ISO/TC 176/SC 2/WG23 N063 this information will be updated as the revisionprogresses3Date:

Disclaimers the presentation includes information related tothe revision process up to and includingDecember 2013ISO/TC 176/SC 2/WG23 N063 further changes are likely to occur as the revisionprocess progresses you will want to consider the changes as theseoccur and plan accordingly4Date:

Copyright for Draft StandardsPlease note:ISO/TC 176/SC 2/WG23 N064‘This ISO document is a Draft International Standard andis copyright-protected by ISO. Except as permitted underthe applicable laws of the user’s country, neither this ISOdraft nor any extract from it may be reproduced, stored ina retrieval system or transmitted in any form or by anymeans, electronic, photocopying, recording or otherwise,without prior written permission being secured’ (ISO/TC176/SC2/NXXXX 2013:XX).4Date:

ISO facts ISO is the International Organization forStandardizationISO is based in Switzerland, over 160 nations participatewith approximately 20,000 standardsall ISO standards are based on consensusISO/TC 176/SC 2/WG23 N063 ISO standards are usually developed by TechnicalCommittees (TCs) or their sub-committees, or byProject Committees ISO work involves experts nominated by theirnational standards bodies5Date:

ISO 9001:2015 development process an international ballot agreed the need for revision there are several distinct stages when developingan ISO standard; the key ones being:1. Working Drafts (WDs)ISO/TC 176/SC 2/WG23 N0632. Committee Draft (CD)3. Draft International Standard (DIS)4. Final Draft International Standard (FDIS)5. International Standard (IS)The standard is published after approval of the FDIS byparticipating national standards bodies and is reviewed at regularintervals after then.6Date:

Revision intentISO 9001 needs to: maintain relevance integrate with other management systems provide an integrated approach to organizationalmanagementISO/TC 176/SC 2/WG23 N064 provide a consistent foundation for the next 10 years reflect the increasingly complex environments in whichorganizations operate ensure the new standard reflects the needs of all potentialuser groups enhance an organization's ability to satisfy its customers5Date:

What was considered? the results of an extensive web-based user survey the increasing diversity of ISO 9001 users developments in knowledge and technologies broader user interestsISO/TC 176/SC 2/WG23 N063 changes in industry8Date:

High level structure a new common format has been developed foruse in all management system standardsstandardized core text and structureISO/TC 176/SC 2/WG23 N063standardized core definitionsOrganizations implementing multiplemanagement systems (e.g. quality,environmental, information security) can achievebetter integration and easier implementationThe high level structure and common text is public information and can be found in Annex SL of thewww.iso.org/directives10Date:

Main changes an emphasis on risk-based thinking increased emphasis on achieving value for theorganization and its customersISO/TC 176/SC 2/WG23 N063 increase flexibility on the use of documentation more readily applicable by “service” typeorganizationscustomers remain theprimary focus9Date:

Main changes use of the High Level Structure (HLS) improved applicability for services fewer prescribed requirements increased emphasis on organizational contextISO/TC 176/SC 2/WG23 N064 boundaries of the QMS must now be defined consideration of exclusions9Date:

Main changes risk-based thinking throughout the standardsupersedes a single clause on preventive action the term ‘documented information’ replaces‘documents and records’ISO/TC 176/SC 2/WG23 N064 the term ‘outsourcing’ is replaced by ‘externalprovision’ increased leadership requirements no requirement for a management representative10Date:

Changes to requirements objectives must include reference to who, what, when planning of changes explicit reference to knowledge management no need for a Quality ManualISO/TC 176/SC 2/WG23 N064 operational planning includes addressing risks greater emphasis on processes achieving requirementsfor goods or services and customer satisfaction11Date:

Changes to requirements control of changes monitoring and measurement internal audits now require the consideration of relatedrisksISO/TC 176/SC 2/WG23 N064 management review to take into considerationstrategic direction of the organization12Date:

Structure1/31234ScopeNormative referencesTerms and definitionsContext of the organizationISO/TC 176/SC 2/WG23 N063contextinterested partiesscope of QMSquality management system5Leadership6Planninggeneralmanagement commitmentpolicyroles, responsibility and authorityactions to address risks and opportunitiesobjectives and plans to achieve themplanning of changes11Date:

Structure2/37 cumented informationISO/TC 176/SC 2/WG23 N0638 Operationoperational planning and controldetermination of market needs and interaction with customersoperational planning processcontrol of external provisions of goods and servicesdevelopment of goods and servicesproduction of goods and provision of servicesrelease of goods and servicesnon conforming goods and services12Date:

Structure3/39 Performance evaluationmonitoring, measurement, analysis and evaluationinternal auditmanagement reviewISO/TC 176/SC 2/WG23 N06310 ImprovementNon-conformity and corrective actionimprovement13Date:

QMS StructurePLAN4 Context oftheorganization5 Leadership7 SupportLeadershipandcommitmentActions toaddress riskandopportunityExpectations ofinterestedpartiesScope ofmanagementsystemISO/TC 176/SC 2/WG23 N064Understandingof theorganizationand its context6 PlanningQMSDOCHECK8 Operation9 Performanceand evaluationACT10 ImprovementResourcesOperationsof planningand controlMonitoring,measurement,analysis andevaluationNonconformityand correctiveactionQuality policyQualityobjectivesCompetenceDeterminationof marketneeds andinteractionswith customersInternal authoritiesPlanning mentreviewCommunicationControl ofexternalprovision ofgoods andservicesDocumentedinformationDevelopmentof goods andservicesProduction ofgoods andprovision ofservicesRelease ofgoods andservicesNonconforming goods andservices6Date:

ISO 9001:2015 Timeline201320142015June 2013 CD(Committee Draft)ISO/TC 176/SC 2/WG23 N063April 2014 DIS(Draft InternationalStandard)July 2015 FDIS(Final Draft InternationalStandard)September 2015PublishedInternational Standard15Date:

ISO 9001:2015 CertificationTransition Timeline2015201620172018ISO/TC 176/SC 2/WG23 N063September 2015Published InternationalStandardSeptember 2015 start of 3 years transition periodto September 201816Date:

Supporting documents certification transition plan and timeframe guidance documents on specific topics, e.g. theprocess approach comparison of ISO 9001:2008 and 9001:2015ISO/TC 176/SC 2/WG23 N063 frequently asked questions ISO website updates14Date:

Other important InformationThe revision of ISO 9001 will impact onother related standards and documents.Expect changes to:ISO/TC 176/SC 2/WG23 N063- industry-specific standards- supporting documents17Date:

Ensure your organization. knows about the key changes understands the key concepts plans to implement the new requirementsISO/TC 176/SC 2/WG23 N063 stays informed as the revision proceeds takes full advantage of the revision of ISO 900118Date:

What is next?ISO/TC 176/SC 2/WG23 N063Updates will be made available asthe revision proceeds19Date:

ISO 9001:2015 Revision overview December 2013 ISO/TC 176/SC 2/WG23 N063 1. Purpose of presentation To provide an overview of the revision of ISO 9001 which will be published in 2015 2 ISO/TC Date: 176/ S C 2/ W G 23 N063. Background to this present