A Review ISO 9001:2015 Draft What’s Important to Know Now. Prepared by Rand E Winters, Jr. Senior ASR Lead Auditor March 2014. ISO 9001 – Under Revision. Review based on ISO Working Draft 9001 – 6/13. Further revisions likely to occur.
Rand E Winters, Jr.
Senior ASR Lead Auditor
4. Context of Organization – addresses needs and expectations of interested parties, scope of QMS
5. Leadership – addresses management commitment, policy, roles, responsibility & authority
6. Planning – includes risks, opportunities, objectives and plans to achieve them, the planning of changes
7. Support – includesresources, competence, awareness, communication, documented information
8. Operation – includes planning & control, determine market needs, interaction w/customers, planning process, control of external provisions of goods/services, production of goods, provision of services, release of goods/services, non-conforming goods/services
9. Performance Evaluation – includes monitoring, measurement, analysis & evaluation, internal audit, management review
10. Improvement – addresses non-conformity & corrective action, improvement
June 2013 CD(Committee Draft)
April 2014 DIS(Draft International Standard)
July 2015 FDIS(Final Draft International Standard)
(Published International Standard)
Published International Standard
September 2015 start of 3 years transition period to September 2018
Nothing at this time ( well almost nothing).
Still too early in the 2015 revision process of ISO 9001 to make any significant changes to an existing QMS.
Some issues drafted may change or disappear in upcoming drafts or with final version.
Looking ahead…existing registered system documentation should conform with some small adjustments. In most cases, existing registered organizations should have enough documentation and records.
Since risk is documented in most sections of proposed revision to ISO 9001, consider starting your risk management plan, if you don’t have one. Begin thinking how to address risk in your business.
Four Phases of Risk
Risk Analysis Risk Evaluation