FDA Quality Management System Regulation (QMSR)vsISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
See exactly how FDA Quality Management System Regulation (QMSR) controls map to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories with 26% coverage across 9 directly mapped controls. Analysis of 34 FDA Quality Management System Regulation (QMSR) controls identifies 25 compliance gaps — primarily concentrated in Design and Development.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 22 mapped controls across 7 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Quality Management System Requirements(3 mappings)
Management Responsibility(3 mappings)
Resource Management(3 mappings)
Design and Development(2 mappings)
Production and Process Controls(4 mappings)
Measurement, Analysis, and Improvement(3 mappings)
Regulatory Compliance and Traceability(2 mappings)
+2 more mappings
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Related Comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Other ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories comparisons
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What are the key differences between FDA Quality Management System Regulation (QMSR) and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
FDA Quality Management System Regulation (QMSR) has 34 controls across its framework, while ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories covers 65 controls. Direct mapping analysis identifies 9 overlapping controls (26% coverage). The frameworks diverge most significantly in Design and Development, where 7 FDA Quality Management System Regulation (QMSR) controls have no direct ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
Of 34 total FDA Quality Management System Regulation (QMSR) controls, 9 map directly to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls — representing 26% coverage. The remaining 25 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
25 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories. The highest concentration of gaps is in Design and Development with 7 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 FDA Quality Management System Regulation (QMSR) and ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories?
The domain with the highest gap count is Design and Development (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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