A. Quality Management System Alignment
✔ Confirm transition from QSR (1996) to QMSR (2026) across all internal documentation.
✔ Update your Quality Manual to reflect ISO 13485:2016 requirements.
✔ Verify the use of ISO 9000:2015 Clause 3 for terminology.
✔ Perform a QMS gap analysis comparing your current system to ISO 13485.
✔ Ensure all risk-based processes (design, manufacturing, supplier control, PMS) align with ISO 13485 and FDA expectations.
B. Documentation & Process Updates
✔ Map all QMS elements directly to ISO 13485 clauses (as recommended in FDA draft guidance).
✔ Update procedures for:
- Document control
- Design controls
- Risk management
- CAPA
- Complaint handling
- Supplier management
✔ Ensure your Device Master Records (DMR) and Design History Files (DHF) reflect ISO structure.
C. FDA Submission Requirements (PMA/HDE)
✔ Confirm DUNS numbers for all manufacturing, packaging, and sterilization sites.
✔ Prepare or update your UDI assignment & maintenance plan.
✔ Check labeling and regulatory submissions for consistency with ISO 13485 processes.
✔ Prepare a cross-table showing where FDA-required elements are addressed in ISO-aligned procedures.
D. Internal and Supplier Audits
✔ Schedule an ISO 13485–aligned internal audit before February 2026.
✔ Verify suppliers’ compliance with ISO 13485 or equivalent requirements.
✔ Document evidence of supplier risk assessments and ongoing monitoring.
E. Training & Change Management
✔ Train management and staff on the new QMSR terminology and expectations.
✔ Update competency matrices and training records.
✔ Communicate the QMSR effective date: 2 February 2026.
F. Post-Market Activities
✔ Align complaint handling, vigilance, and PMS with:
- ISO 13485
- FDA reporting requirements
✔ Ensure traceability aligns with UDI and ISO 13485 Clause 7.5.9.2.
✔ Confirm that PMS data feeds into management review and CAPA.
G. Management Review
✔ Add QMSR transition as a standing agenda item.
✔ Review:
- Gap analysis outcomes
- Audit results
- UDI readiness
- Supplier compliance
- PMS and CAPA trends
✔ Approve update actions and allocate resources.
H. Final Readiness Before 2 February 2026
✔ Validate that all updated procedures are approved, implemented, and communicated.
✔ Replace QSR terminology in documents with QMSR/ISO-based terms.
✔ Ensure that all submission-relevant information (UDI plan, DUNS numbers, mapping tables) is ready for FDA inspections.
✔ Maintain validation records for software, equipment, and critical processes according to ISO 13485.