ISO 13485vsISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
See exactly how ISO 13485 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:
ISO 13485 maps to ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories with 14% coverage across 2 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 42 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Improvement(3 mappings)
ISO 13485: Patient Data Protection(1 mappings)
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What are the key differences between ISO 13485 and ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories?
ISO 13485 has 44 controls across its framework, while ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories covers 90 controls. Direct mapping analysis identifies 2 overlapping controls (14% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories equivalent.
How many controls map between ISO 13485 and ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories?
Of 44 total ISO 13485 controls, 2 map directly to ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls — representing 14% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories?
42 ISO 13485 controls have no direct equivalent in ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories. The highest concentration of gaps is in Product Realisation 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 ISO 13485 and ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories?
The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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