Framework overlap

Does ISO 13485 cover ISO 37301?

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

5% of ISO 37301 you already have

ISO 13485 already covers about 5% of ISO 37301, leaving 41 of 43 controls as genuinely new work.

Already covered 0 Likely covered 2 New work 41

No control in ISO 13485 maps directly to one in ISO 37301. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

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

ISO37301-01
Cl. 4.1-4.6 Compliance management policy - compliance obligations, objectives, and applicable compliance requirements
ISO37301-02
Leadership commitment to quality
ISO37301-03
Risk-based thinking and planning
ISO37301-04
Resource management for quality
ISO37301-05
Organizational roles and responsibilities
ISO37301-06
Operational planning and control
ISO37301-07
Requirements for products and services
ISO37301-08
Design and development controls
ISO37301-09
Control of externally provided processes
ISO37301-10
Production and service provision controls
ISO37301-10.1
Nonconformity and Corrective Action
ISO37301-10.2
Continual Improvement
ISO37301-11
Monitoring, measurement, and analysis
ISO37301-12
Internal audit program
ISO37301-13
Management review process
ISO37301-14
Customer satisfaction measurement
ISO37301-16
Continual improvement methodology
ISO37301-17
Corrective and preventive actions
ISO37301-4.1
Understanding the Organization and Context
ISO37301-4.2
Needs and Expectations of Interested Parties
ISO37301-4.5
Compliance Obligations
ISO37301-4.6
Compliance Risk Assessment
ISO37301-5.1
Leadership and Commitment
ISO37301-5.2
Compliance Policy
ISO37301-5.3.2
Compliance Function
ISO37301-5.3.3
Governance Body and Top Management Responsibilities
ISO37301-6.1
Actions to Address Risks and Opportunities
ISO37301-6.2
Compliance Objectives and Planning
ISO37301-7.2
Competence
ISO37301-7.3
Awareness and Training
ISO37301-7.4
Communication
ISO37301-7.5
Documented Information
ISO37301-8.1
Operational Planning and Control
ISO37301-8.2
Establishing Controls and Procedures
ISO37301-8.3
Raising Concerns
ISO37301-8.4
Investigation Processes
ISO37301-9.1.1
Monitoring, Measurement, Analysis, and Evaluation
ISO37301-9.1.5
Reporting
ISO37301-9.2
Internal Audit
ISO37301-9.3
Management Review
ISO37301-CL4.4
Cl. 4.4 Compliance obligations - determining and maintaining specific compliance obligations applicable to the organization
Show the 2 you already have
ISO37301-15
Nonconformity and corrective action
ISO37301-18
Innovation and change management

How this is calculated

Already covered means a mapping runs from a control in ISO 13485 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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