QMSR / ISO 13485 vs IEC 81001-5-1
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-iec-81001
COMPARE
vs
39QMSR REQUIREMENTS
0SHARED IN BOTH
39NEW IN QMSR
46RETIRED FROM IEC 81001
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONQMSR / ISO 13485IEC 81001-5-1
OVERVIEW
StatusCurrent (effective Feb 2, 2026)Current — IEC 81001-5-1:2021
Effective periodFeb 2026 – present2021 – present
Total requirements3946
SCOPE
Risk integrationRequired (links to ISO 14971 throughout design)Security risk management integrated with ISO 14971 safety risk file
Plan maintenanceRequired throughout developmentSecurity lifecycle plan maintained from conception through decommissioning
Document approvalExplicit approval signatures requiredPre-release security verification checklist required before each release
OPERATIONAL
Most common gapRisk management file weak or unlinked to designThreat model incomplete; SBOM not maintained per release
Audit focusRisk file integrity and design-control linkageThreat model coverage, security test evidence, SBOM currency
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
39ONLY IN QMSR
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 33 more
46ONLY IN IEC 81001
- • QMS and Security Responsibilities
- • Identification of Applicability
- • Security Expertise and Training
- • Third-Party Supplier Security
- • Continuous Improvement and Periodic Review
- • Disclosing Security-Related Issues
- + 40 more
OTHER COMPARISONS