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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