Framework overlap

Does ISO 13485 cover ISO 30401?

You hold ISO 13485 and have been told to do ISO 30401. Here is how much overlaps, control by control.

5% of ISO 30401 you already have

ISO 13485 already covers about 5% of ISO 30401, leaving 40 of 42 controls as genuinely new work.

Already covered 0 Likely covered 2 New work 40

No control in ISO 13485 maps directly to one in ISO 30401. 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.

ISO30401-01
Knowledge management systems - policy and objectives for organizational knowledge management
ISO30401-02
Leadership commitment to quality
ISO30401-03
Risk-based thinking and planning
ISO30401-04
Resource management for quality
ISO30401-05
Organizational roles and responsibilities
ISO30401-06
Operational planning and control
ISO30401-07
Requirements for products and services
ISO30401-08
Design and development controls
ISO30401-09
Control of externally provided processes
ISO30401-10
Production and service provision controls
ISO30401-10.1
Nonconformity and corrective action
ISO30401-10.2
Continual improvement
ISO30401-11
Monitoring, measurement, and analysis
ISO30401-12
Internal audit program
ISO30401-13
Management review process
ISO30401-14
Customer satisfaction measurement
ISO30401-16
Continual improvement methodology
ISO30401-17
Corrective and preventive actions
ISO30401-4.1
Understanding organisation and context
ISO30401-4.2
Needs and expectations of stakeholders
ISO30401-4.3
Scope of KMS
ISO30401-4.4
Knowledge management system
ISO30401-4.5
Knowledge development
ISO30401-4.6
Knowledge conveyance and transformation
ISO30401-4.7
Knowledge enablers
ISO30401-4.8
Knowledge management culture
ISO30401-5.1
Leadership and commitment
ISO30401-5.2
Knowledge management policy
ISO30401-5.3
Roles, responsibilities, authorities
ISO30401-6.1
Actions to address risks and opportunities
ISO30401-6.2
Knowledge management objectives
ISO30401-7.1
Resources
ISO30401-7.2
Competence
ISO30401-7.3
Awareness
ISO30401-7.4
Communication
ISO30401-7.5
Documented information
ISO30401-8.1
Operational planning and control
ISO30401-9.1
Monitoring, measurement, analysis, evaluation
ISO30401-9.2
Internal audit
ISO30401-9.3
Management review
Show the 2 you already have
ISO30401-15
Nonconformity and corrective action
ISO30401-18
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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