Framework overlap

Does ISO 13485:2016 cover ISO 37301:2021?

You hold ISO 13485:2016 and have been told to do ISO 37301:2021. Here is how much overlaps, control by control.

57% of ISO 37301:2021 you already have

ISO 13485:2016 already covers about 57% of ISO 37301:2021, leaving 18 of 42 controls as genuinely new work.

Already covered 6 Likely covered 18 New work 18

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 interested parties
4.3
Determining the scope of the compliance management system
4.5
Compliance obligations
4.6
Compliance risk assessment
5.1.3
Compliance governance
5.2
Compliance policy
5.3
Roles, responsibilities and authorities
5.3.2
Compliance function
7.2
Competence
7.3
Awareness
7.5
Documented information
8.4
Investigation processes
9.1
Monitoring, measurement, analysis and evaluation
9.1.2
Sources of feedback on compliance performance
9.1.3
Development of indicators
9.1.4
Compliance reporting
9.1.5
Record-keeping
Show the 24 you already have
6.3
Planning of changes
9.2
Internal audit
9.2.2
Internal audit programme
9.3
Management review
9.3.2
Management review inputs
9.3.3
Management review results
10.1
Continual improvement
10.2
Nonconformity and corrective action
4.4
Compliance management system
5.1
Leadership and commitment
5.1.1
Governing body and top management
5.1.2
Compliance culture
5.3.4
Personnel
6.1
Actions to address risks and opportunities
6.2
Compliance objectives and planning to achieve them
7.1
Resources
7.2.2
Employment process
7.2.3
Training
7.4
Communication
7.5.2
Creating and updating documented information
7.5.3
Control of documented information
8.1
Operational planning and control
8.2
Establishing controls and procedures
8.3
Raising concerns

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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