Framework overlap

Does ISO 13485:2016 cover ISO 14001:2015?

You hold ISO 13485:2016 and have been told to do ISO 14001:2015. Here is how much overlaps, control by control.

64% of ISO 14001:2015 you already have

ISO 13485:2016 already covers about 64% of ISO 14001:2015, leaving 13 of 36 controls as genuinely new work.

Already covered 5 Likely covered 18 New work 13

What is genuinely new work

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

10.3
Continual improvement
3.3
Terms related to support and operation
3.4
Terms related to performance evaluation and improvement
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 environmental management system
5.2
Environmental policy
5.3
Organizational roles, responsibilities and authorities
6.1.2
Environmental aspects
6.1.3
Compliance obligations
7.3
Awareness
7.5
Documented information
9.1
Monitoring, measurement, analysis and evaluation
Show the 23 you already have
6.1.4
Planning action
7.4.2
Internal communication
9.2
Internal audit
9.2.2
Internal audit programme
9.3
Management review
10.2
Nonconformity and corrective action
3.1
Terms related to organization and leadership
3.2
Terms related to planning
4.4
Environmental management system
5.1
Leadership and commitment
6.1
Actions to address risks and opportunities
6.2
Environmental objectives and planning to achieve them
6.2.1
Environmental objectives
6.2.2
Planning actions to achieve environmental objectives
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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