Framework overlap

Does ISO 30401 cover ISO 13485:2016?

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

22% of ISO 13485:2016 you already have

ISO 30401 already covers about 22% of ISO 13485:2016, leaving 56 of 72 controls as genuinely new work.

Already covered 4 Likely covered 12 New work 56

What is genuinely new work

Nothing in ISO 30401 reaches these. This is the list to scope.

4.1
General requirements
4.2
Documentation requirements
4.2.2
Quality manual
4.2.3
Medical device file
4.2.4
Control of documents
4.2.5
Control of records
5.1
Management commitment
5.2
Customer focus
5.3
Quality policy
5.4
Planning
5.4.1
Quality objectives
5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
5.5.2
Management representative
5.5.3
Internal communication
5.6.2
Review input
5.6.3
Review output
6.1
Provision of resources
6.2
Human resources
6.3
Infrastructure
6.4
Work environment and contamination control
6.4.1
Work environment
6.4.2
Contamination control
7.1
Planning of product realization
7.2
Customer-related processes
7.2.1
Determination of requirements related to product
7.2.2
Review of requirements related to product
7.3.9
Control of design and development changes
7.4
Purchasing
7.4.1
Purchasing process
7.4.2
Purchasing information
7.4.3
Verification of purchased product
7.5.10
Customer property
7.5.11
Preservation of product
7.5.2
Cleanliness of product
7.5.3
Installation activities
7.5.4
Servicing activities
7.5.5
Particular requirements for sterile medical devices
7.5.6
Validation of processes for production and service provision
7.5.7
Particular requirements for validation of processes for sterilization and
7.5.8
Identification
7.5.9
Traceability
7.6
Control of monitoring and measuring equipment
8.2
Monitoring and measurement
8.2.1
Feedback
8.2.2
Complaint handling
8.2.3
Reporting to regulatory authorities
8.2.5
Monitoring and measurement of processes
8.2.6
Monitoring and measurement of product
8.3
Control of nonconforming product
8.3.2
Actions in response to nonconforming product detected before delivery
8.3.3
Actions in response to nonconforming product detected after delivery
8.3.4
Rework
8.4
Analysis of data
8.5
Improvement
8.5.3
Preventive action
Show the 16 you already have
5.6
Management review
7.3
Design and development
7.5
Production and service provision
8.2.4
Internal audit
5.4.2
Quality management system planning
7.2.3
Communication
7.3.10
Design and development files
7.3.2
Design and development planning
7.3.3
Design and development inputs
7.3.4
Design and development outputs
7.3.5
Design and development review
7.3.6
Design and development verification
7.3.7
Design and development validation
7.3.8
Design and development transfer
7.5.1
Control of production and service provision
8.5.2
Corrective action

How this is calculated

Already covered means a mapping runs from a control in ISO 30401 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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