QSR → QMSR Transition & ISO 13485 Alignment
Effective date
The QMSR final rule became effective February 2, 2026. Manufacturers were expected to be in full compliance with the updated 21 CFR Part 820 by this date.
What changed
The QMSR incorporates the text of ISO 13485:2016 by reference, meaning the QMSR standard is effectively ISO 13485 plus the following US-specific additions:
| US-specific QMSR addition | Description |
|---|---|
| § 820.30 — Design controls | Maintained separately (not fully merged into ISO 13485 design clauses) |
| § 820.198 — Complaint files | Explicit complaint handling tied to MDR trigger assessment |
| § 820.100 — CAPA | CAPA must be based on analysis of quality data sources including MDRs |
| § 820.160 — Distribution records | Must include initial consignee information |
| MDR integration | QMS procedures must include MDR trigger evaluation |
What did NOT change
- Design History File (DHF) — the DHF concept is maintained; ISO 13485 uses "design and development files" — FDA retains the DHF terminology and records requirements
- Device History Record (DHR) — maintained as the record of each production unit
- Device Master Record (DMR) — maintained as the reference specification document
- FDA inspection authority — unchanged; FDA inspects against QMSR
Transition approach
For manufacturers with an existing ISO 13485:2016-certified QMS:
- Review the QMSR-specific additions not fully covered by ISO 13485
- Update SOPs for MDR-QMS integration, complaint files, CAPA data sources
- Update design controls documentation to align with QMSR § 820.30
- Verify that distribution records capture initial consignee
For manufacturers without ISO 13485 certification:
- Consider ISO 13485 certification as the path to QMSR compliance
- Implement all clauses of ISO 13485:2016 plus US-specific QMSR additions