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BUSINESS ASSURANCEISO 9001:2015 Draft International StandardOverviewA Survey of Proposed Changes to ISO 9001:2008Burt HolmNorthern District Sales Manager1DNV GL 2013SAFER, SMARTER, GREENER
Who is DNV GL?Is now2DNV GL 2013
http://www.dnvgl.com/ DNV founded in Norway 140 years ago Merged with GL in 2013 Certified Body/Registrar since 1990 (US)– System Certification audits– Training– Sustainability Services Accredited through ANAB, RvA & UKAS Multiple North American locations– Multiple Global locations3DNV GL 2013
Change is on the way4DNV GL 2013
Agenda ISO Survey What is ISO Why ISO 9001 is being revised The ISO Framework What is changing The timeline for transition What to do now References and Resources5DNV GL 2013
ISO 9001 Certifications in the US6DNV GL 2013
ISO 9001 Certifications Globally7DNV GL 2013
Types of Businesses Earning CertificationDocument: ISO/TC 176/SC 2/N 10178DNV GL 2013
Factors which Influenced Organization to Become CertifiedDocument: ISO/TC 176/SC 2/N 10179DNV GL 2013
What is ISO? ISO is the International Organization for Standardization, headquartered inGeneva, Switzerland– www.iso.org ISO is a worldwide federation of the national standards organizations of 157countries– ANSI is the US member body More than 19,000 International Standards and growing10DNV GL 2013
ISO/TC 176Source: ISO 9001:2015 – From CD to DIS, Dr. Nigel H Croft 201311DNV GL 2013
The ISO 9000 Document Group ISO 9000:2005 Fundamentals and Vocabulary ISO 9001:2008 Quality Management Systems Requirements ISO 9004:2009 Managing for the Sustained Success of an OrganizationThe Certified Body or Registrar ISO 17021 IRCA and RAB QSA IAF and Mandatory Documents12DNV GL 2013
Why ISO 9001 is Being Revised Maintain Relevance Integration among all standards Consistent foundation for the long-term (next 10-25 years) Increase adoption of the standard Address increased variety of business users– Service industries– Office environments Address increasing complexity of business environment– Non-office/virtual office13DNV GL 2013
Caution and Disclaimer ISO 9001:2015 as a Draft International Standard is not available publicly No portion of the Draft International Standard may be– Reproduced– Transmitted– Stored– Copied, recorded, etc. Available information is from TC176 member organizations– Public webinars– Commentaries– Limited information releases14DNV GL 2013
ISO and Management System Standards 2012: all Management Systems standards will have common Framework– High level structure– Common text and terminology– New standards and revisions to existing standards The Common Framework: Appendix 3 of ISO/IEC Directives, Part 1 Annex SL– Annex SL is the generally used shorthand15DNV GL 2013
The Common Framework Standardize and effectively develop standards Enhance alignment and compatibility of standards Useful for organizations which pursue multiple standards Some standards already under Common Framework ISO 22000 ISO 20001 ISO 50001 Under revision to the Common Framework ISO 14001 ISO 27001 ISO 900116DNV GL 2013
What is Changing?ISO 9001:2008ISO 9001:20150. Introduction0. Introduction1. Scope1. Scope2. Normative References2. Normative References3. Terms and Definitions3. Terms and Definitions4. Quality Management System4. Context of the Organization5. Management Responsibility5. Leadership6. Resource Management6. Planning7. Product Realization7. Support8. Measurement, Analysis and Improvement 8. Operations9. Performance Evaluations10.Improvement17DNV GL 2013
Key Changes Emphasis on Risk-based management– Preventive action Increase emphasis on achieving value for organization and its customers Documented Information– Decreased emphasis on documentation– Expands concept of documentation– Replaces Documents and Records Organizational Context– Responsiveness to business environment Outsourcing is now External Provision Enhanced leadership requirements No requirement for Management Representative No requirement for Quality Manual18DNV GL 2013
High Level StructureNew Clause Numbers1.Scope2.Normative References1.Resources3.Terms and Definitions2.Competence4.Context of the d Information1.Needs and expectations3.Scope4.Management systemLeadership8.SupportOperations1.9.Operational planning and controlPerformance evaluation1.Monitoring, measurement, analysis andevaluation1.Management commitment2.Policy2.Internal audit3.Roles, Responsibility and Authority3.Management review6.Planning1.2.19Understanding the Organization and itscontext2.5.7.DNV GL 2013Actions to address risks andopportunitiesObjectives and plans to achieve them10. Improvement1.Nonconformity and corrective action2.Continual improvement
4. Context of the Organization20DNV GL 2013
4. Context of the Organization21DNV GL 2013
4. Context of the Organization22DNV GL 2013
5.1 Leadership23DNV GL 2013
6.1 Actions to address risks and opportunities24DNV GL 2013
7.1 Resources25DNV GL 2013
8.1 Operational Planning and Control26DNV GL 2013
8.4 Control of external provision of goods and services27DNV GL 2013
9. Performance Evaluation28DNV GL 2013
10. Improvement29DNV GL 2013
Terminology: Changes and Concepts1. Product is now Goods and Services2. Process Approach is now stated requirement (Clause 4.4.2)3. “Risk” is defined as effect of uncertainty1. ISO 310004. Design and Development is now Development5. Monitoring and Measurement are now separate1. Monitoring: status of a system, a process or an activity2. Measurement: a process to determine a value6. Context of Organization1. From stakeholders, industry groups, trading partners, others2. Laws, regulations, standards, codes of practice, Industry regulation, corporategovernance, others3. Economic, financial, environmental, socail4. Industry or government analysis7. Media information30DNV GL 2013
Other Considerations Change to the standard brings challenges– To the user community– To Certified Bodies/Registrars ISO 9001:2008 is central to other standards– AS9100Aerospace– TS16949Automotive– FSSC22001Food Safety Comments and Feedback can still be provided to TC17631DNV GL 2013
Tentative Transition TimelineFebruary 2014 DraftInnternationalStandard32DNV GL 2013July 2015 Final DraftInternationalStandardSeptember 2015Publish InternationalStandard
Tentative Implementation TimelineDecember 2015Publish InternationalStandard33DNV GL 2013January 2016 BeginImplementation2019 Complete 3year ImplementationPeriod
What should we be doing? Learn about the key changes Evaluate the impact on your organization Begin planning to revise your management system Keep informed of the Draft International Standard Begin a dialogue with your Registrar34DNV GL 2013
References and Resources Webinars– nars/webinars-ondemand/Pages/ISO-9001-2015.aspx– Brand X– Google will net many similar reviews– http://www.omnex.com/training/webinars/iso 9001 2015 next revision.aspx– Detailed review including supporting standards– www.iso.org– General information only– IAF– IRCA35DNV GL 2013
Questions36DNV GL 2013
Thank you37DNV GL 2013
Burt Holm, Northern District Sales 4465www.dnvgl.comSAFER, SMARTER, GREENER38DNV GL 2013Cell
The ISO 9000 Document Group ISO 9000:2005 Fundamentals and Vocabulary ISO 9001:2008 Quality Management Systems Requirements ISO 9004:2009 Managing for the Sustained Success of an Organization The Certified Body or Registrar 12 ISO
