ISO 56002vsICH Q10 - Pharmaceutical Quality System
See exactly how ISO 56002 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 56002 maps to ICH Q10 - Pharmaceutical Quality System with 4% coverage across 7 directly mapped controls. Analysis of 164 ISO 56002 controls identifies 157 compliance gaps — primarily concentrated in Clause 7: Support.
Source: TheArtOfService Knowledge Graph | 164 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 3 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Clause 10: Improvement(3 mappings)
Clause 4: Context of the Organization(6 mappings)
Clause 8: Operations - Innovation Process(2 mappings)
Related Comparisons
Other ISO 56002 comparisons
Other ICH Q10 - Pharmaceutical Quality System comparisons
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What are the key differences between ISO 56002 and ICH Q10 - Pharmaceutical Quality System?
ISO 56002 has 164 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 7 overlapping controls (4% coverage). The frameworks diverge most significantly in Clause 7: Support, where 34 ISO 56002 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.
How many controls map between ISO 56002 and ICH Q10 - Pharmaceutical Quality System?
Of 164 total ISO 56002 controls, 7 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 4% coverage. The remaining 157 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 56002 to ICH Q10 - Pharmaceutical Quality System?
157 ISO 56002 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 56002 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.
Related Resources
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