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Quick summary
  • Internal audit, management review and complaints each get one procedure task per framework and a single record task.
  • External auditors usually ask to see the internal audit record first.
Audit, management review, and feedback and complaints sit in the same Organisation group:
  • External auditors usually ask to see the internal audit record first.
  • ISO 9001 adds QMS audit schedule documented for the audit calendar, which you maintain manually. Setup → Workspace → Meetings only covers clinical safety schedules, not audit dates.
  • The management review record task also covers quality objectives, data analysis and improvement. Attach the minutes to the task.

CAPA and non-conformances

Where audit findings and complaints usually end up.

Procedures and records

What the auditor will be reading.