Framework overlap

Does ISO 13485:2016 cover ISO 30401?

You hold ISO 13485:2016 and have been told to do ISO 30401. Here is how much overlaps, control by control.

14% of ISO 30401 you already have

ISO 13485:2016 already covers about 14% of ISO 30401, leaving 36 of 42 controls as genuinely new work.

Already covered 4 Likely covered 2 New work 36

What is genuinely new work

Nothing in ISO 13485:2016 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
ISO30401-09
Control of externally provided processes
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
ISO30401-18
Innovation and change management
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
ISO30401-7.5
Documented information
ISO30401-8.1
Operational planning and control
ISO30401-9.1
Monitoring, measurement, analysis, evaluation
Show the 6 you already have
ISO30401-08
Design and development controls
ISO30401-10
Production and service provision controls
ISO30401-9.2
Internal audit
ISO30401-9.3
Management review
ISO30401-15
Nonconformity and corrective action
ISO30401-7.4
Communication

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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