Presentation on theme: "ISO 9001:2015 Revision overview - General users"— Presentation transcript:
1 ISO 9001:2015 Revision overview - General users December 2013
2 Purpose of presentation To provide an overview of the revision of ISO 9001 which will be published in 2015
3 Background to this presentation developed by the ISO sub-committee responsible for communicating key information about the current revisions to ISO 9001this will be updated as the revision progressesthis presentation is available to anyoneEmphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organization’s quality management system since it could change.
4 DisclaimersVerbal statements made by the presenter may represent personal opinions and/or interpretationsthe presentation includes information related to the revision process up to and including December 2013further changes are likely to occur as the revision process progressesyou may wish to consider the changes as these occur and plan accordinglyEmphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organization’s quality management system since it could change.
5 ISO facts ISO is the International Organization for Standardization ISO is based in Switzerland, over 160 nations participate with approximately 20,000 standardsall ISO standards are based on consensusISO standards are usually developed by Technical Committees (TCs) or their sub-committees, or by Project CommitteesISO work involves experts nominated by their national standards bodies
6 ISO 9001:2015 development process an international ballot agreed the need for revisionthere are several distinct stages when developing an ISO standard; the key ones being:Working Drafts (WDs)Committee Draft (CD)Draft International Standard (DIS)Final Draft International Standard (FDIS)International Standard (IS)The standard is published after approval of the FDIS by participating national standards bodies and is reviewed at regular intervals after then.
7 Key perspectives ISO 9001 needs to: maintain relevance integrate with other management systemsprovide an integrated approach to organizational managementprovide a consistent foundation for the next 10 yearsreflect the increasingly complex environments in which organizations operateensure the new standard reflects the needs of all potential user groupsenhance an organization's ability to satisfy its customersThe slide indicates summarized results of the surveyIt tells you the five critical items that the users felt must be addressed
8 What was considered? the results of an extensive web-based user survey the increasing diversity of ISO 9001 usersdevelopments in knowledge and technologiesbroader user interestschanges in industry
9 customers remain the primary focus Main changesan emphasis on risk-based thinkingincreased emphasis on achieving value for the organization and its customersincrease flexibility on the use of documentationmore readily applicable by “service” type organizationscustomers remain the primary focus
10 High level structurea new common format has been developed for use in all management system standardsstandardized core text and structurestandardized core definitionsOrganizations implementing multiple management systems (e.g. quality, environmental, information security) can achieve better integration and easier implementationEmphasize that the structure has been mandated by the TMB and that the belief is that this will enhance consistency.This information is based on published information related to Annex SL and not directly the result of any particular published study or survey.The high level structure and common text is public information and can be found in Annex SL of the
11 Structure 1 Scope 2 Normative references 3 Terms and definitions 1/31 Scope2 Normative references3 Terms and definitions4 Context of the organizationcontextinterested partiesscope of QMSquality management system5 Leadershipgeneralmanagement commitmentpolicyroles, responsibility and authority6 Planningactions to address risks and opportunitiesobjectives and plans to achieve themplanning of changesFocus on that the high level structure and that the new structure should not cause an organization to renumber existing documents. However, it is realized that this might have a significant impact on software.Common stamp format and quantity to support businessesNew stamps across the enterprise (pilot one site in 2011, complete all sites/programs in 2012)Single source vendor contractApprovals from applicable functions/ business units of common solutionsIT system (eSMS) for single source ordering/delivery systemCommon process writings (3-BPIs, 1-PRO, sub-tier writings)Training developed for AS9100C AuditorsQMS Teams will work with programs and sites to help them prepareInternal Audit schedules developed11
12 Structure 7 Support 8 Operation 2/3 resources competence awareness communicationdocumented information8 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 servicesFocus on that the high level structure and that the new structure should not cause an organization to renumber existing documents. However, it is realized that this might have a significant impact on software.Common stamp format and quantity to support businessesNew stamps across the enterprise (pilot one site in 2011, complete all sites/programs in 2012)Single source vendor contractApprovals from applicable functions/ business units of common solutionsIT system (eSMS) for single source ordering/delivery systemCommon process writings (3-BPIs, 1-PRO, sub-tier writings)Training developed for AS9100C AuditorsQMS Teams will work with programs and sites to help them prepareInternal Audit schedules developed12
13 Structure 9 Performance evaluation 10 Improvement 3/3 monitoring, measurement, analysis and evaluationinternal auditmanagement review10 ImprovementNon-conformity and corrective actionimprovement
14 Supporting documents certification transition plan and timeframe guidance documents on specific topics, e.g. the process approachcomparison of ISO 9001:2008 and 9001:2015frequently asked questionsISO website updates
15 ISO 9001:2015 Timeline 2015 2014 2013 June 2013 CD April 2014 DIS (Committee Draft)April 2014 DIS(Draft International Standard)July 2015 FDIS(Final Draft International Standard)September 2015Published International Standard
16 ISO 9001:2015 Certification Transition Timeline 2018201720162015September 2015Published International StandardSeptember 2015 start of 3 years transition period to September 2018
17 Other important Information The revision of ISO 9001 will impact on other related standards and documents.Expect changes to:- industry-specific standards- supporting documents
18 I need to ensure my organization . . . knows about the key changesunderstands the key conceptsplans to implement the new requirementsstays informed as the revision proceedstakes full advantage of the revision of ISO 9001
19 Updates will be made available as the revision proceeds What is next?Updates will be made available as the revision proceeds