Document Control
ISO 13485 §4.2
Enforced revision history, approval workflows and effective dates. Only the current approved version circulates; every superseded one stays retrievable.
ISO 13485 §6.2 · EU GMP Ch. 2
Training Management
Training is tied to the documents and roles that require it, so the matrix stays true as documents change rather than being rebuilt by hand before an audit.
What it does
- Training matrixRoles mapped to required documents
- AssignmentTriggered by document effectivity or assigned directly
- QuizzesPass thresholds with recorded attempts
- RequalificationRecurring cycles per role or document
- Trainee seatsRead-and-train access without a full QA seat
Records it produces
- Completion signed by the trainee, with date
- Competency evidence retained against the person
- Outstanding training by role or document
- Requalification due dates
Where it sits
What it triggers, and what triggers it
Training is downstream of Document Control and upstream of any audit that asks who was trained on what.
Document Control
The trigger. Effectivity, not a reminder email, is what assigns the read-and-understand.
Internal Audits
The outstanding-training report is the one an auditor asks for on day one.
Trainee seats
Fifteen trainee seats in the Compliance plan, so operators train without a QA licence each.
The other modules
Everything else in the Compliance plan
Deviation Management
EU GMP Ch. 1
Logged, risk-assessed, investigated and dispositioned, with a controlled path into CAPA when the investigation warrants one.
CAPA
ISO 13485 §8.5
Owned action items, due dates, and an effectiveness review that must complete before closure.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.