Framework overlap

Does ISO 13485 cover OSFI B-13?

You hold ISO 13485 and have been told to do OSFI B-13. Here is how much overlaps, control by control.

63% of OSFI B-13 you already have

ISO 13485 already covers about 63% of OSFI B-13, leaving 3 of 8 controls as genuinely new work.

Already covered 1 Likely covered 4 New work 3

What is genuinely new work

Nothing in ISO 13485 reaches these. This is the list to scope.

OSFIB13-2
Technology Operations, Architecture, and Resilience
OSFIB13-5
Cyber Hygiene and Security Awareness
OSFIB13-6
Independent Assurance, Internal Audit, External Examination
Show the 5 you already have
OSFIB13-3
Cyber Security: Identification, Protection, Detection, Response, Recovery
OSFIB13-1
Governance, Risk Management, and Three Lines of Defense
OSFIB13-4
Third-Party Risk Management and Cloud
OSFIB13-7
Incident Reporting to OSFI and Regulatory Coordination
OSFIB13-8
Metrics, Monitoring, Continuous Improvement, Maturity

How this is calculated

Already covered means a mapping runs from a control in ISO 13485 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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