The High Level Structure, well known from the revised ISO 9001:2015, was not adopted in ISO 13485:2016. Medical device manufacturers who wish to use both ISO 13485 and ISO 9001:2015 as a basis for certification must be aware of the differences in structure . On the other hand, this also has the positive aspect that the new ISO 13485 remains familiar in its structure.
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Author
Szymon Kurdyn
Szymon Kurdyn is Head of the Notified Body (non-active medical devices) and Product Manager for ISO 13485 (DAkkS accreditation). In this position, he keeps an eye on the regulatory and normative framework of certification activities, is in close contact with authorities, our experts and our customers and informs about changes and other relevant topics.
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