QMSR / ISO 13485 vs IEC 62366
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-62366
COMPARE
vs
49QMSR REQUIREMENTS
0SHARED IN BOTH
49NEW IN QMSR
7RETIRED FROM IEC 62366
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONQMSR / ISO 13485IEC 62366
OVERVIEW
StatusCurrent (effective Feb 2, 2026)Current — IEC 62366-1:2015+AMD1:2020
Effective periodFeb 2026 – present2015 (amended 2020) – present
Total requirements4914
SCOPE
Risk integrationRequired (links to ISO 14971 throughout design)UI hazard analysis feeds directly into ISO 14971 risk file
Plan maintenanceRequired throughout developmentUsability Engineering File maintained through summative evaluation
Document approvalExplicit approval signatures requiredEvaluation plan and report require formal approval before release
OPERATIONAL
Most common gapRisk management file weak or unlinked to designHazard-related use scenarios missing or incomplete summative coverage
Audit focusRisk file integrity and design-control linkageTraceability from use scenarios through summative test results
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
49ONLY IN QMSR
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 43 more
7ONLY IN IEC 62366
- • RISK CONTROL as it relates to USER INTERFACE design
- • Information for SAFETY as it relates to USABILITY
- • Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- • Identify and describe HAZARD-RELATED USE SCENARIOS
- • Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
- • Establish USER INTERFACE SPECIFICATION
- + 1 more
OTHER COMPARISONS