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 Notified Body (non-active medical devices) and Product Manager for ISO 13485 (under DAkkS accreditation). In this position he keeps an eye on the legal and normative framework, is in close exchange with authorities, our assessors and our customers and thereby informs about developments and relevant changes.
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