Cross-Framework Mapping

ISO 39001:2012 - Road Traffic Safety ManagementvsICH Q10 - Pharmaceutical Quality System

See exactly how ISO 39001:2012 - Road Traffic Safety Management controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
158
Gaps Found
5%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 39001:2012 - Road Traffic Safety Management maps to ICH Q10 - Pharmaceutical Quality System with 5% coverage across 8 directly mapped controls. Analysis of 169 ISO 39001:2012 - Road Traffic Safety Management controls identifies 161 compliance gaps — primarily concentrated in Clause 7: Support.

Source: TheArtOfService Knowledge Graph | 169 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 10: Improvement(3 mappings)

ISO-39001-10.1Nonconformity and corrective action
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO-41001-10.1Nonconformity and corrective action
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO-56002-10.2Deviation, nonconformity and corrective action
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review

Clause 4: Context of the Organization(6 mappings)

ISO-41001-4.1Understanding the organization and its context2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO-41001-4.3Determining the scope of the FM management system2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO-56002-4.3Determining the scope of the innovation management system2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review

Clause 8: Operation(2 mappings)

ISO-41001-8.4Control of outsourced processes and services
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ISO-50001-8.3Procurement
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management

Related Comparisons

Other ISO 39001:2012 - Road Traffic Safety Management comparisons

Other ICH Q10 - Pharmaceutical Quality System comparisons

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What are the key differences between ISO 39001:2012 - Road Traffic Safety Management and ICH Q10 - Pharmaceutical Quality System?

ISO 39001:2012 - Road Traffic Safety Management has 169 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 8 overlapping controls (5% coverage). The frameworks diverge most significantly in Clause 7: Support, where 34 ISO 39001:2012 - Road Traffic Safety Management controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO 39001:2012 - Road Traffic Safety Management and ICH Q10 - Pharmaceutical Quality System?

Of 169 total ISO 39001:2012 - Road Traffic Safety Management controls, 8 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 5% coverage. The remaining 161 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 39001:2012 - Road Traffic Safety Management to ICH Q10 - Pharmaceutical Quality System?

161 ISO 39001:2012 - Road Traffic Safety Management controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Clause 7: Support with 34 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 39001:2012 - Road Traffic Safety Management and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Clause 7: Support (34 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.