A document or system that links requirements to inspection steps, records, and approvals for full lineage tracking.
Traceability matrices ensure every regulatory or customer requirement is covered by a test, inspection, or document.
Combined with an audit trail , they provide an end-to-end view of compliance.
Constructing the matrix
Teams map each requirement to the responsible process, inspection checkpoint, and evidence collected.
Colour coding and status flags highlight gaps that still need documentation.
Maintaining accuracy
Product changes, regulatory updates, and corrective actions require the matrix to stay current.
Embedding the matrix within the QMS keeps updates in sync across teams.
Key takeaways
- Traceability matrices link requirements to verification evidence.
- They must be updated whenever requirements or processes change.