QMSR / ISO 13485 vs 21 CFR Part 820 (legacy)
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/qmsr-vs-part-820
COMPARE
vs
39QMSR REQUIREMENTS
37SHARED IN BOTH
2NEW IN QMSR
0RETIRED FROM PART 820
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONQMSR / ISO 1348521 CFR PART 820 (LEGACY)
OVERVIEW
StatusCurrent (effective Feb 2, 2026)Retired (replaced by QMSR)
Effective periodFeb 2026 – present1996 – 2026
Total requirements3930+ (no requirement mapping)
SCOPE
Risk integrationRequired (links to ISO 14971 throughout design)Not required
Plan maintenanceRequired throughout developmentInitial plans only
Document approvalExplicit approval signatures requiredGeneral document control
OPERATIONAL
Most common gapPlan-update records and design-review evidencen/a (legacy reference)
Audit focusPlan integrity, risk linkage, approval signaturesDesign control completeness
COVERAGE BREAKDOWN
What's shared, what's distinct
37SHARED IN BOTH
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 31 more
2NEW IN QMSR
- • Records Control
- • Labeling Controls
0RETIRED FROM PART 820
- No items.
OTHER COMPARISONS