Cross-Framework Mapping

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration LaboratoriesvsPIC/S Guide to Good Manufacturing Practice for Medicinal Products

See exactly how ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Pre-computed mappings, identified gaps, and coverage analysis.

27
Controls Mapped
38
Gaps Found
18%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories maps to PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 18% coverage across 12 directly mapped controls. Analysis of 65 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls identifies 53 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 65 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 27 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Clause 6: Resource Requirements(13 mappings)

ISO-15189-6.3Facilities and environmental conditions3 targets
PICS-GMP-3.1Premises Design
PICS-GMP-3.2Equipment Qualification
PICS-GMP-4.2Record Keeping
ISO-15189-6.5Equipment calibration and metrological traceability3 targets
PICS-GMP-3.1Premises Design
PICS-GMP-3.2Equipment Qualification
PICS-GMP-4.2Record Keeping
ISO-15189-6.7Service agreements3 targets
PICS-GMP-2.2Key Personnel Responsibilities
PICS-GMP-5.1Production Operations
PICS-GMP-7.1Outsourced Activities
ISO-15189-6.8Externally provided products and services
PICS-GMP-7.1Outsourced Activities
ISO-17025-6.5Metrological traceability3 targets
PICS-GMP-3.1Premises Design
PICS-GMP-3.2Equipment Qualification
PICS-GMP-4.2Record Keeping

Clause 7: Process Requirements(1 mappings)

ISO-15189-7.4Post-examination processes
PICS-GMP-1.1Quality Management System

Clause 8: Management System Requirements(6 mappings)

ISO-15189-8.1General requirements2 targets
PICS-GMP-1.1Quality Management System
PICS-GMP-1.2Good Manufacturing Practice
ISO-15189-8.4Control of records
PICS-GMP-1.1Quality Management System
ISO-17025-8.1Options2 targets
PICS-GMP-1.1Quality Management System
PICS-GMP-1.2Good Manufacturing Practice
ISO-17025-8.7Corrective actions
PICS-GMP-1.1Quality Management System

+7 more mappings

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Related Comparisons

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

Other PIC/S Guide to Good Manufacturing Practice for Medicinal Products comparisons

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What are the key differences between ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories has 65 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 17 controls. Direct mapping analysis identifies 12 overlapping controls (18% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls have no direct PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.

How many controls map between ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

Of 65 total ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls, 12 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 18% coverage. The remaining 53 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories to PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

53 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The highest concentration of gaps is in Clause 7: Process Requirements with 18 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 17025:2017 — General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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