Cross-Framework Mapping

ISO 26262:2018 - Functional Safety for Road VehiclesvsISO 13485:2016

See exactly how ISO 26262:2018 - Functional Safety for Road Vehicles controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

4
Controls Mapped
65
Gaps Found
6%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 26262:2018 - Functional Safety for Road Vehicles maps to ISO 13485:2016 with 6% coverage across 4 directly mapped controls. Analysis of 69 ISO 26262:2018 - Functional Safety for Road Vehicles controls identifies 65 compliance gaps — primarily concentrated in Part 8: Supporting Processes.

Source: TheArtOfService Knowledge Graph | 69 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 4 of 4 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Part 7: Production, Operation, Service and Decommissioning(1 mappings)

ISO-26262-7-5Production
iso-13485-2016::7.5Production and service provision

Part 8: Supporting Processes(2 mappings)

ISO-26262-8-10Documentation
iso-13485-2016::4.2Documentation requirements
ISO-26262-8-9Verification
iso-13485-2016::7.4.3Verification of purchased product

Production and Operation(1 mappings)

ISO26262-7.5Production
iso-13485-2016::7.5Production and service provision

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What are the key differences between ISO 26262:2018 - Functional Safety for Road Vehicles and ISO 13485:2016?

ISO 26262:2018 - Functional Safety for Road Vehicles has 69 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 4 overlapping controls (6% coverage). The frameworks diverge most significantly in Part 8: Supporting Processes, where 8 ISO 26262:2018 - Functional Safety for Road Vehicles controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO 26262:2018 - Functional Safety for Road Vehicles and ISO 13485:2016?

Of 69 total ISO 26262:2018 - Functional Safety for Road Vehicles controls, 4 map directly to ISO 13485:2016 controls — representing 6% coverage. The remaining 65 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 26262:2018 - Functional Safety for Road Vehicles to ISO 13485:2016?

65 ISO 26262:2018 - Functional Safety for Road Vehicles controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Part 8: Supporting Processes with 8 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between ISO 26262:2018 - Functional Safety for Road Vehicles and ISO 13485:2016?

The domain with the highest gap count is Part 8: Supporting Processes (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.