Cross-Framework Mapping

ISO 26262:2018 - Functional Safety for Road VehiclesvsAnnex 11 to EU GMP - Computerised Systems

See exactly how ISO 26262:2018 - Functional Safety for Road Vehicles controls map to Annex 11 to EU GMP - Computerised Systems. Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
63
Gaps Found
6%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 26262:2018 - Functional Safety for Road Vehicles maps to Annex 11 to EU GMP - Computerised Systems 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 6 of 6 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Part 3: Concept Phase(4 mappings)

ISO-26262-3-5Item definition3 targets
Clause 10Change and configuration management
Clause 2Personnel
Clause 3Suppliers and service providers
ISO-26262-3-7Hazard analysis and risk assessment (HARA)
Clause 1Risk management

Part 8: Supporting Processes(2 mappings)

ISO-26262-8-7Configuration management
Clause 10Change and configuration management
ISO-26262-8-8Change management
Clause 10Change and configuration management

Related Comparisons

Other ISO 26262:2018 - Functional Safety for Road Vehicles comparisons

Other Annex 11 to EU GMP - Computerised Systems comparisons

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What are the key differences between ISO 26262:2018 - Functional Safety for Road Vehicles and Annex 11 to EU GMP - Computerised Systems?

ISO 26262:2018 - Functional Safety for Road Vehicles has 69 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 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 Annex 11 to EU GMP - Computerised Systems equivalent.

How many controls map between ISO 26262:2018 - Functional Safety for Road Vehicles and Annex 11 to EU GMP - Computerised Systems?

Of 69 total ISO 26262:2018 - Functional Safety for Road Vehicles controls, 4 map directly to Annex 11 to EU GMP - Computerised Systems 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 Annex 11 to EU GMP - Computerised Systems?

65 ISO 26262:2018 - Functional Safety for Road Vehicles controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. 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 Annex 11 to EU GMP - Computerised Systems?

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.

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