New Aspects of ISO 9001:2015 Reviewed at SQA Client Day

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August 23, 2016

John Sedlak, founder of J&S Sedlak, LLC, shared nuances and updates incorporated in ISO 9001:2015 at the Smithers Quality Assessment (SQA) 4th Annual Client Event.


Sedlak explained that many of the changes in the new 2015 version are re-wordings and re-positioning of existing requirements from the 2008 version. He elaborated that risk-based thinking has replaced preventive action, there is increased responsibility for top management and that suppliers are now referred to as external providers in the 2015 version.


ISO 9001:2015 recognizes the shift that many businesses are now service-based and are pursuing certification. The definition of Products in the 2008 version has been replaced with Products and Services in the 2015 version.


“ISO 9001:2015 looks different and has a different feel than 2008 but in reality the updates are not drastic,” added Sedlak. “The goal with the 2015 version is for companies to recognize the business climate, including risks and opportunities, and to detail processes and evaluations."


Sedlak reviewed the major changes in Clauses 4, 5, 6, 7, 8, 9 and 10 during his presentation. Addressing risk and understanding the updated definitions used throughout the 2015 version are especially important. Risk and risk-based thinking take both positive and negative aspects into consideration.


He recommends that companies considering ISO 9001:2015 certification should:

  • Form a transition team. Don’t expect the quality manager to do all the work. And, don’t wait.
  • Get a copy of the standard, available at
  • Execute an internal audit of the entire quality management system that is in place
  • Review findings and next steps with management.

Current certifications to ISO 9001:2008 are in effect until September 15, 2018 and new certifications to the 2008 version will stop at the end of 2017. SQA would like current clients to be ISO 9001:2015 certified by December 31, 2017, at least a year before the deadline.