QMSR / ISO 13485 vs ISO 14971
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-iso-14971
COMPARE
vs
39QMSR REQUIREMENTS
10SHARED IN BOTH
29NEW IN QMSR
0RETIRED FROM ISO 14971
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONQMSR / ISO 13485ISO 14971
OVERVIEW
StatusCurrent (effective Feb 2, 2026)Current — ISO 14971:2019
Effective periodFeb 2026 – present2019 – present
Total requirements399
SCOPE
Risk integrationRequired (links to ISO 14971 throughout design)Defines the risk management process referenced by QMSR
Plan maintenanceRequired throughout developmentRisk management plan and file maintained across full device lifecycle
Document approvalExplicit approval signatures requiredRisk Management Report requires management review before release
OPERATIONAL
Most common gapRisk management file weak or unlinked to designResidual risk benefit-risk justification absent or unsupported
Audit focusRisk file integrity, inspector entry point for entire QMSRisk acceptance matrix, post-control residual risk documentation
COVERAGE BREAKDOWN
What's shared, what's distinct
10SHARED IN BOTH
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Design Outputs
- + 4 more
29ONLY IN QMSR
- • Management Review
- • Corrective and Preventive Action (CAPA)
- • Complaint Handling
- • Document Control
- • Medical Device File
- • Supplier Management
- + 23 more
0ONLY IN ISO 14971
- No items.
OTHER COMPARISONS