BCBS 239vsISO 13485:2016
See exactly how BCBS 239 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
BCBS 239 maps to ISO 13485:2016 with 7% coverage across 1 directly mapped controls. Analysis of 14 BCBS 239 controls identifies 13 compliance gaps — primarily concentrated in BCBS 239 Risk Reporting Practices.
Source: TheArtOfService Knowledge Graph | 14 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
BCBS 239 Supervisory Review, Tools and Cooperation(2 mappings)
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What are the key differences between BCBS 239 and ISO 13485:2016?
BCBS 239 has 14 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 1 overlapping controls (7% coverage). The frameworks diverge most significantly in BCBS 239 Risk Reporting Practices, where 5 BCBS 239 controls have no direct ISO 13485:2016 equivalent.
How many controls map between BCBS 239 and ISO 13485:2016?
Of 14 total BCBS 239 controls, 1 map directly to ISO 13485:2016 controls — representing 7% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping BCBS 239 to ISO 13485:2016?
13 BCBS 239 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in BCBS 239 Risk Reporting Practices 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 BCBS 239 and ISO 13485:2016?
The domain with the highest gap count is BCBS 239 Risk Reporting Practices (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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