QA/RA Consulting, Auditing & Training
Do any of These Quality System Challenges Sound Familiar? “Me too” nonconformances or 483 observations occurring in different areas of the business. “We do it this way” responses that differ by area when you ask employees how they execute quality system requirements. “I didn’t know that” responses when asked about an organizational quality goal. “How […]
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In part two of our conversation with Ed Kimmelman a member of the ISO working group responsible for developing ISO 13485:2016 and an Oriel STAT A MATRIX Executive Management Consultant we discuss applying the ISO 13485:2016 changes in your organization. Read Part I: Issues Driving the ISO 13485:2016 Revision. Which of the major changes in […]
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ISO 13485:2016 and ISO 9001:2015: Are They Aligned? Short answer: No. Longer answer: From a high-level perspective, the standards now differ in intent, content, and structure. A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 Intent: Not fully aligned The standards share one ultimate goal: Both ISO 9001:2015 and ISO 13485:2016 specify […]
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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, […]
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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 effortΓÇöwhich is necessary to retain certificationΓÇöas a series of changes and opportunities. For example, here are three major changes in ISO 13485:2016 and the opportunities […]
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