Framework overlap

Does ISO 13485:2016 cover ISO 22301:2019?

You hold ISO 13485:2016 and have been told to do ISO 22301:2019. Here is how much overlaps, control by control.

59% of ISO 22301:2019 you already have

ISO 13485:2016 already covers about 59% of ISO 22301:2019, leaving 16 of 39 controls as genuinely new work.

Already covered 3 Likely covered 20 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 interested parties
5.3
Roles, responsibilities and authorities
6.1.2
Risk assessment
6.1.3
Risk treatment
7.2
Competence
7.3
Awareness
7.5
Documented information
7.5.2
Creating and updating
8.2.2
Business impact analysis
8.2.3
Risk assessment
8.4
Business continuity plans and procedures
8.4.4
Business continuity plans
8.4.5
Recovery
8.6
Evaluation of business continuity documentation and capabilities
9.1
Monitoring, measurement, analysis and evaluation
Show the 23 you already have
8.3.2
Identification of strategies and solutions
9.2
Internal audit
9.3
Management review
10.1
Continual improvement
10.2
Nonconformity and corrective action
4.3
Determining the scope of the management system
4.4
Management system
5.1
Leadership and commitment
5.2
Policy
6.1
Actions to address risks and opportunities
6.2
Objectives and planning to achieve them
7.1
Resources
7.4
Communication
7.5.3
Control of documented information
8.1
Operational planning and control
8.2
Business impact analysis and risk assessment
8.3
Business continuity strategies and solutions
8.3.3
Selection of strategies and solutions
8.3.4
Resource requirements
8.3.5
Implementation of solutions
8.4.2
Response structure
8.4.3
Warning and communication
8.5
Exercise programme

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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