ISO 13485:2016 and ISO 9001:2015: Are They Aligned?

Decades ago, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors or related standards. What do we mean by alignment? A traditional dictionary definition of alignment is “the proper positioning or state of adjustment […]

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Issues Driving the ISO 13485:2016 Revision

Standards are not revised in a vacuum. Industry changes, regulatory challenges, and feedback from medical device manufacturers, regulators, and auditors are all considered. In this two-part series, we discuss key changes to ISO 13485:2016 with Ed Kimmelman, an Oriel STAT A MATRIX Executive Management Consultant who recently retired as the Convenor of the ISO/TC 210, Working Group 1 on quality systems – the ISO working group responsible for developing ISO 13485:2016. For ISO 13485:2016, there were several issues that led […]

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Three Major Opportunities Within ISO 13485:2016

The revised ISO 13485:2016 standard brings changes. Your organization will have to invest time and resources responding to the changes and complying with the new requirements. We recommend reframing this effort—which is necessary to retain certification—as a series of changes and opportunities. For example, here are three major changes in ISO 13485:2016 and the opportunities arising from these changes: The ISO 13485:2016 standard’s clause structure is not aligned with the clause structure of ISO 9001:2015. Impact and Opportunity: If your […]

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