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.

Szymon Kurdyn
Head of Notified Body

Product Manager ISO 13485