Framework overlap

Does ISO 13485:2016 cover ISO 14004:2016?

You hold ISO 13485:2016 and have been told to do ISO 14004:2016. Here is how much overlaps, control by control.

43% of ISO 14004:2016 you already have

ISO 13485:2016 already covers about 43% of ISO 14004:2016, leaving 23 of 40 controls as genuinely new work.

Already covered 5 Likely covered 12 New work 23

What is genuinely new work

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

10.3
Continual improvement
10.3.1
Opportunities for improvement
10.3.2
Implementation of 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
4.2.3
Determining relevant needs and expectations of relevant interested parties
4.2.5
Use and application of the needs and expectations of interested parties
5.1
Leadership and commitment
5.3
Organizational roles, responsibilities and authorities
6.1
Actions to address risks and opportunities
6.1.2
Environmental aspects
6.1.3
Compliance obligations
6.2
Environmental objectives and planning to achieve them
6.2.4
Performance indicators
7.1
Resources
7.2
Competence
7.3
Awareness
7.4.3
External communication
7.5
Documented information
8.1
Operational planning and control
9.1
M o nito ring, meas urement, analys is and evaluatio n
Show the 17 you already have
6.1.4
Planning action
7.4.2
Internal communication
8.1.1
General guidance: Operational control
9.2
Internal audit
9.3
Management review
3.1
Terms related to organization and leadership
3.2
Terms related to planning
4.2.2
Determining relevant interested parties
4.2.4
Determining compliance obligations
6.2.2
Establishing environmental objectives
6.2.3
Planning actions to achieve environmental objectives
7.4
Communication
7.5.2
Creating and updating
7.5.3
Control of documented information
8.1.3
Establishing operational controls
8.2
E mergency p rep arednes s and res p o ns e
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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