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
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Explore individual standards
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What's actually different
StatusCurrent (effective Feb 2, 2026)Current — ISO 14971:2019
Effective periodFeb 2026 – present2019 – present
Total requirements499
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
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
What's shared, what's distinct
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- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Design Outputs
- + 4 more
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- • Management Review
- • Corrective and Preventive Action (CAPA)
- • Complaint Handling
- • Document Control
- • Medical Device File
- • Supplier Management
- + 33 more
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