ISO 14001vsFDA Quality Management System Regulation (QMSR)
See exactly how ISO 14001 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 14001 maps to FDA Quality Management System Regulation (QMSR) with 11% coverage across 4 directly mapped controls. Analysis of 35 ISO 14001 controls identifies 31 compliance gaps — primarily concentrated in ISO 14001: Operational Controls.
Source: TheArtOfService Knowledge Graph | 35 controls analysed | 715 frameworks | 415K+ cross-framework mappings
Control Mappings
Showing 7 of 7 mapped controls across 3 domains. Sign up to explore all 415K+ mappings across 715 frameworks.
Improvement(2 mappings)
Context(4 mappings)
Performance(1 mappings)
Related Comparisons
Other ISO 14001 comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between ISO 14001 and FDA Quality Management System Regulation (QMSR)?
ISO 14001 has 35 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 4 overlapping controls (11% coverage). The frameworks diverge most significantly in ISO 14001: Operational Controls, where 5 ISO 14001 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between ISO 14001 and FDA Quality Management System Regulation (QMSR)?
Of 35 total ISO 14001 controls, 4 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 11% coverage. The remaining 31 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 14001 to FDA Quality Management System Regulation (QMSR)?
31 ISO 14001 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in ISO 14001: Operational Controls with 5 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 14001 and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is ISO 14001: Operational Controls (5 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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