Cross-Framework Mapping

ISO 31000vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO 31000 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

4
Controls Mapped
39
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 31000 maps to ICH Q10 - Pharmaceutical Quality System with 9% coverage across 4 directly mapped controls. Analysis of 43 ISO 31000 controls identifies 39 compliance gaps — primarily concentrated in Principles.

Source: TheArtOfService Knowledge Graph | 43 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

ISO 31000: Risk Framework & Governance(2 mappings)

ISO31000-01Risk management policy and scope
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ISO31000-05Risk management integration
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)

ISO 31000: Risk Monitoring & Review(2 mappings)

ISO31000-18Risk register maintenance
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ISO31000-19Continuous improvement of risk processes
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review

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What are the key differences between ISO 31000 and ICH Q10 - Pharmaceutical Quality System?

ISO 31000 has 43 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 4 overlapping controls (9% coverage). The frameworks diverge most significantly in Principles, where 9 ISO 31000 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO 31000 and ICH Q10 - Pharmaceutical Quality System?

Of 43 total ISO 31000 controls, 4 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 9% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 31000 to ICH Q10 - Pharmaceutical Quality System?

39 ISO 31000 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Principles with 9 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 31000 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Principles (9 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.