Management Review
The management review your auditor asks for — a signed record, not a slide deck.
Record top management's periodic review of the quality system: the standard inputs (quality metrics and trending, CAPA status, complaints and customer feedback, audit results, nonconformances, supplier performance, risk status, status of prior actions, and regulatory changes), management's conclusions on the system's suitability, adequacy, and effectiveness, and the action items that come out of it.
The review moves Draft → Approved with a two-component e-signature by management/QA — and approval is blocked until conclusions are recorded. Once approved, the record is locked and bound to the signature, so it can't be quietly edited after the fact. Action items carry owners and due dates. Everything is on the immutable, hash-chained audit trail.
- ✓ Structured inputs covering the full ISO 13485 §5.6.2 list
- ✓ E-signed approval, gated on recorded conclusions
- ✓ Action items with owners, due dates, and status
- ✓ Signed record bound to its content — tamper-evident