Audit programme

In a medical device company the internal audit programme usually covers every QMS process within a set cycle, with frequency based on risk and past results. ISO 13485 clause 8.2.4 requires one.

arrangements for a set of one or more audits (3.1) planned for a specific time frame and directed towards a specific purpose [SOURCE: ISO 9000:2015, 3.13.4, modified — wording has been added to the definition]

ISO 19011:2018, clause 3.4