Cross-Framework Mapping

ICH Q10 — Pharmaceutical Quality SystemvsISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories

See exactly how ICH Q10 — Pharmaceutical Quality System controls map to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. Pre-computed mappings, identified gaps, and coverage analysis.

19
Controls Mapped
0
Gaps Found
47%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH Q10 — Pharmaceutical Quality System maps to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories with 47% coverage across 7 directly mapped controls. Analysis of 15 ICH Q10 — Pharmaceutical Quality System controls identifies 8 compliance gaps — primarily concentrated in Section 2 - Management Responsibility.

Source: TheArtOfService Knowledge Graph | 15 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 19 of 19 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Section 1 - Pharmaceutical Quality System(2 mappings)

Q10-1.1Scope2 targets
ISO-15189-7.4Post-examination processes
ISO-15189-8.4Control of records

Section 2 - Management Responsibility(9 mappings)

Q10-2.1Management Commitment2 targets
ISO-15189-7.4Post-examination processes
ISO-15189-8.4Control of records
Q10-2.2Quality Policy3 targets
ISO-15189-6.7Service agreements
ISO-17025-5.1Legal entity
ISO-17025-5.4Personnel for the management system
Q10-2.3Quality Planning3 targets
ISO-15189-6.7Service agreements
ISO-17025-5.1Legal entity
ISO-17025-5.4Personnel for the management system
Q10-2.7Management of Outsourced Activities and Purchased Materials
ISO-15189-6.8Externally provided products and services

Section 3 - Continual Improvement of Process Performance and Product Quality(8 mappings)

Q10-3.1Lifecycle Stage Goals5 targets
ISO-15189-6.7Service agreements
ISO-15189-7.4Post-examination processes
ISO-15189-8.4Control of records
ISO-17025-5.1Legal entity
ISO-17025-5.4Personnel for the management system
Q10-3.2Corrective Action and Preventive Action (CAPA)3 targets
ISO-15189-8.1General requirements
ISO-17025-8.1Options
ISO-17025-8.7Corrective actions

Related Comparisons

Other ICH Q10 — Pharmaceutical Quality System comparisons

Other ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories comparisons

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What are the key differences between ICH Q10 — Pharmaceutical Quality System and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?

ICH Q10 — Pharmaceutical Quality System has 15 controls across its framework, while ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories covers 65 controls. Direct mapping analysis identifies 7 overlapping controls (47% coverage). The frameworks diverge most significantly in Section 2 - Management Responsibility, where 3 ICH Q10 — Pharmaceutical Quality System controls have no direct ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories equivalent.

How many controls map between ICH Q10 — Pharmaceutical Quality System and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?

Of 15 total ICH Q10 — Pharmaceutical Quality System controls, 7 map directly to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls — representing 47% coverage. The remaining 8 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ICH Q10 — Pharmaceutical Quality System to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?

8 ICH Q10 — Pharmaceutical Quality System controls have no direct equivalent in ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. The highest concentration of gaps is in Section 2 - Management Responsibility with 3 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 ICH Q10 — Pharmaceutical Quality System and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?

The domain with the highest gap count is Section 2 - Management Responsibility (3 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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