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Cross-Framework Mapping

ISO/IEC 27003:2017vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO/IEC 27003:2017 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
61
Gaps Found
14%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27003:2017 maps to ICH Q10 - Pharmaceutical Quality System with 14% coverage across 10 directly mapped controls. Analysis of 72 ISO/IEC 27003:2017 controls identifies 62 compliance gaps — primarily concentrated in Support (Clause 7).

Source: TheArtOfService Knowledge Graph | 72 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Improvement (Clause 10)(3 mappings)

AS9100D-10.2Nonconformity 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
ISO27003-10.1Continual Improvement
→ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO27003-10.2Nonconformity 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

Operation (Clause 8)(4 mappings)

AS9100D-8.1Operational Planning and Control
→ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
AS9100D-8.4Control of Externally Provided Processes, Products, 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
ISO27003-8.1Operational Planning and Control
→ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ISO27003-8.3Information Security Risk Treatment
→ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)

Context of the Organization (Clause 4)(3 mappings)

ISO27003-4.2Understanding Needs and Expectations of Interested Parties
→ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ISO27003-4.3Determining the Scope of the ISMS2 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

Planning (Clause 6)(1 mappings)

ISO27003-6.1Actions to Address Risks and Opportunities
→ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)

Related Comparisons

Other ISO/IEC 27003:2017 comparisons

ISO/IEC 27003:2017 vs ISO 9001:201541 mappingsISO/IEC 27003:2017 vs ISO 14001:201534 mappingsISO/IEC 27003:2017 vs ISO 14004:201628 mappingsISO/IEC 27003:2017 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products14 mappingsISO/IEC 27003:2017 vs AS9100D - Aerospace Quality Management System13 mappingsISO/IEC 27003:2017 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements12 mappingsISO/IEC 27003:2017 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence11 mappingsISO/IEC 27003:2017 vs ISO 13485:201610 mappings

Other ICH Q10 - Pharmaceutical Quality System comparisons

PIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ICH Q10 - Pharmaceutical Quality System5 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ICH Q10 - Pharmaceutical Quality System5 mappingsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs ICH Q10 - Pharmaceutical Quality System4 mappingsNATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production vs ICH Q10 - Pharmaceutical Quality System4 mappingsISO/IEC 23894:2023 vs ICH Q10 - Pharmaceutical Quality System4 mappingsAged Care Quality Standards (Australia) vs ICH Q10 - Pharmaceutical Quality System4 mappingsIEC 60601-1 - Medical Electrical Equipment Safety vs ICH Q10 - Pharmaceutical Quality System4 mappingsNIST AI Risk Management Framework (AI RMF 1.0) vs ICH Q10 - Pharmaceutical Quality System4 mappings

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What are the key differences between ISO/IEC 27003:2017 and ICH Q10 - Pharmaceutical Quality System?

ISO/IEC 27003:2017 has 72 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 10 overlapping controls (14% coverage). The frameworks diverge most significantly in Support (Clause 7), where 9 ISO/IEC 27003:2017 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO/IEC 27003:2017 and ICH Q10 - Pharmaceutical Quality System?

Of 72 total ISO/IEC 27003:2017 controls, 10 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 14% coverage. The remaining 62 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27003:2017 to ICH Q10 - Pharmaceutical Quality System?

62 ISO/IEC 27003:2017 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Support (Clause 7) 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/IEC 27003:2017 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Support (Clause 7) (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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