ISO/IEC 17025:2017 - General Requirements for Testing and CalibrationvsISO 13485:2016
See exactly how ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration maps to ISO 13485:2016 with 12% coverage across 5 directly mapped controls. Analysis of 41 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls identifies 36 compliance gaps — primarily concentrated in Process requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration.
Source: TheArtOfService Knowledge Graph | 41 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Resource requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration(1 mappings)
Process requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration(1 mappings)
Management system requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration(3 mappings)
Related Comparisons
Other ISO/IEC 17025:2017 - General Requirements for Testing and Calibration comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration and ISO 13485:2016?
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration has 41 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 5 overlapping controls (12% coverage). The frameworks diverge most significantly in Process requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration, where 20 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration and ISO 13485:2016?
Of 41 total ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls, 5 map directly to ISO 13485:2016 controls — representing 12% coverage. The remaining 36 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 to ISO 13485:2016?
36 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Process requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration with 20 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 and ISO 13485:2016?
The domain with the highest gap count is Process requirements – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration (20 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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