An audit is a systematic, independent and documented processfor obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
These can be audit criteria: standards, legislation, contracts, objectives/targets or any other specifications.
An ISO 13485 audit uses as audit criteria:
The ISO 13485 standard
Legislation applicable to medical devices
Thus, the auditor should understand very well the regulations (EU) 2017/745 or 2017/746, as well as know other documents such as MEDDEV and NBMEd.
Ensure that the selected audit team has a deep knowledge of the ISO 13485 standard as well as all applicable legislation and documents.
Our proposal includes the following steps of an audit: