Framework overlap

Does ISO 13485:2016 cover ISO 37001:2016?

You hold ISO 13485:2016 and have been told to do ISO 37001:2016. Here is how much overlaps, control by control.

59% of ISO 37001:2016 you already have

ISO 13485:2016 already covers about 59% of ISO 37001:2016, leaving 16 of 39 controls as genuinely new work.

Already covered 2 Likely covered 21 New work 16

What is genuinely new work

Nothing in ISO 13485:2016 reaches these. This is the list to scope.

4.1
Understanding the organization and its context
4.2
Understanding the needs and expectations of stakeholders
4.3
Determining the scope of the anti-bribery management system
4.5
Bribery risk assessment
5.2
Anti-bribery policy
5.3
Organizational roles, responsibilities and authorities
5.3.1
Roles and responsibilities
5.3.2
Anti-bribery compliance function
7.2
Competence
7.3
Awareness and training
7.5
Documented information
8.10
Investigating and dealing with bribery
8.4
Non-financial controls
8.6
Anti-bribery commitments
9.1
Monitoring, measurement, analysis and evaluation
9.4
Review by anti-bribery compliance function
Show the 23 you already have
9.2
Internal audit
9.3
Management review
10.1
Nonconformity and corrective action
10.2
Continual improvement
4.4
Anti-bribery management system
5.1
Leadership and commitment
5.1.1
Governing body
5.1.2
Top management
6.1
Actions to address risks and opportunities
6.2
Anti-bribery objectives andISO planning
7.2.2
Employment process
7.4
Communication
7.5.2
Creating and updating
7.5.3
Control of documented information
8.1
Operational planning and control
8.2
Due diligence
8.3
Financial controls
8.5
Implementation of anti-bribery controls by controlled organizations and by
8.7
Gifts, hospitality, donations and similar benefits
8.8
Managing inadequacy of anti-bribery controls
8.9
Raising concerns
9.3.1
Top management review
9.3.2
Governing body review

How this is calculated

Already covered means a mapping runs from a control in ISO 13485:2016 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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