IEC 81001-5-1 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/iec-81001-vs-iso-14971
COMPARE
vs
46IEC 81001 REQUIREMENTS
6SHARED IN BOTH
40NEW IN IEC 81001
9RETIRED FROM ISO 14971
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 81001-5-1ISO 14971
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2021 – present2019 – present
Total requirements469
SCOPE
Risk integrationCybersecurity risks integrated via ISO 14971 + threat modelingSafety risk management lifecycle, AFAP principle, benefit-risk analysis
Plan maintenanceSecurity lifecycle plan updated each release and tailored per productRisk management plan maintained throughout device lifecycle
Document approvalPre-release security verification checklist; conformance documentation requiredFormal risk management review approval required before commercial release
OPERATIONAL
Most common gapSecurity risk management siloed from safety risk managementRisk management treated as post-design checkbox exercise
Audit focusThreat model completeness, security-safety integration, release gate evidenceRisk file lifecycle integrity, AFAP rationale, post-market feedback loop
COVERAGE BREAKDOWN
What's shared, what's distinct
6SHARED IN BOTH
- • Security Risk Management
- • Risk Management Context and Product Security Context
- • Security Risk Estimation and Evaluation
- • Controlling Security Risks
- • Monitoring Risk Control Effectiveness
- • Addressing Security-Related Issues
40ONLY 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
- + 34 more
9ONLY IN ISO 14971
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Hazard Identification and Risk Estimation
- • Risk Evaluation Against Acceptability Criteria
- • Risk Control Option Analysis
- + 3 more
OTHER COMPARISONS