Checklist of Mandatory Documentation Required by ISO 13485:2016

Download a complimentary checklist (PDF)

This checklist shows you exactly what documents and records are necessary for ISO 13485:2016, to help you cut down on unnecessary work. This straight-forward document outlines:

which ISO 13485:2016 clause each mandatory document refers to
which non-mandatory documents are commonly used
how to structure documents and records
where to find sample documents

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