Framework overlap

Does ISO 13485:2016 cover ISO 45001:2018?

You hold ISO 13485:2016 and have been told to do ISO 45001:2018. Here is how much overlaps, control by control.

45% of ISO 45001:2018 you already have

ISO 13485:2016 already covers about 45% of ISO 45001:2018, leaving 24 of 44 controls as genuinely new work.

Already covered 5 Likely covered 15 New work 24

What is genuinely new work

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

6.1.2.1
Hazard identification
6.1.2.2
Assessment of OH&S risks and other risks to the OH&S MS
6.1.2.3
Assessment of OH&S opportunities and other opportunities for the OH&S MS
7.5
Threat assessment
8.1.1
Operational planning and control, general
8.1.2
Eliminating hazards and reducing OH&S risks
8.1.3
Management of change
8.1.4.1
Procurement, general
8.1.4.2
Contractors
8.1.4.3
Outsourcing
10.3
Continual improvement
4.1
Understanding the organization and its context
4.2
Understanding the needs and expectations of workers and other interested parties
4.3
Determining the scope of the OH&S management system
5.2
OH&S policy
5.3
Organizational roles, responsibilities and authorities
5.4
Consultation and participation of workers
6.2.1
OH&S objectives ISO 45001:2018
7.3
Awareness
7.5
Documented information
8.1.2
Eliminating hazards and reducing OH&S risks
8.1.3
Management of change
8.1.4
Procurement
9.1
Monitoring, measurement, analysis and performance evaluation
Show the 20 you already have
6.2.2
Planning to achieve OH&S
7.4.2
Internal communication
9.2
Internal audit
9.2.2
Internal audit programme
9.3
Management review
5.4
Establishing Audit Programme
10.2
Incident, nonconformity and corrective action
4.4
OH&S management system
5.1
Leadership and commitment
6.1
Actions to address risks and opportunities
6.2
OH&S objectives and planning to achieve them
7.1
Resources
7.2
Competence
7.4
Communication
7.4.3
External communication
7.5.2
Creating and updating
7.5.3
Control of documented information
8.1
Operational planning and control
8.2
Emergency preparedness and response
9.1.2
Evaluation of compliance

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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