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
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Explore individual standards
49
11
46
38
What's actually different
StatusCurrent (effective Feb 2, 2026)Current — IEC 81001-5-1:2021
Effective periodFeb 2026 – present2021 – present
Total requirements4946
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
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
What's shared, what's distinct
11
- • Design and Development Planning
- • Supplier Management
- • Human Resources / Training
- • QMS and Security Responsibilities
- • Security Expertise and Training
- • Third-Party Supplier Security
- + 5 more
46
- • Risk Control Option Analysis
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- • Corrective and Preventive Action (CAPA)
- + 40 more
38
- • Identification of Applicability
- • Security Risk Management
- • Development Environment Security
- • Secure Coding Standards Planning
- • Health Software Security Requirements
- • Security Requirements Review
- + 32 more