Framework overlap

Does ISO 9001:2015 cover ISO 13485:2016?

You hold ISO 9001:2015 and have been told to do ISO 13485:2016. Here is how much overlaps, control by control.

61% of ISO 13485:2016 you already have

ISO 9001:2015 already covers about 61% of ISO 13485:2016, leaving 28 of 72 controls as genuinely new work.

Already covered 15 Likely covered 29 New work 28

What is genuinely new work

Nothing in ISO 9001:2015 reaches these. This is the list to scope.

4.2
Documentation requirements
4.2.2
Quality manual
4.2.3
Medical device file
4.2.4
Control of documents
5.1
Management commitment
5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
5.5.2
Management representative
5.5.3
Internal communication
5.6.3
Review output
6.2
Human resources
6.4.2
Contamination control
7.2.1
Determination of requirements related to product
7.2.2
Review of requirements related to product
7.4.1
Purchasing process
7.4.3
Verification of purchased product
7.5.2
Cleanliness of product
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
8.2.1
Feedback
8.2.2
Complaint handling
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
8.5
Improvement
8.5.2
Corrective action
Show the 44 you already have
4.1
General requirements
5.2
Customer focus
5.4
Planning
5.4.1
Quality objectives
5.6
Management review
7.3
Design and development
7.3.2
Design and development planning
7.3.3
Design and development inputs
7.3.4
Design and development outputs
7.3.9
Control of design and development changes
7.5
Production and service provision
7.5.1
Control of production and service provision
7.5.11
Preservation of product
7.5.8
Identification
8.2.4
Internal audit
4.2.5
Control of records
5.3
Quality policy
5.4.2
Quality management system planning
5.6.2
Review input
6.1
Provision of resources
6.3
Infrastructure
6.4
Work environment and contamination control
6.4.1
Work environment
7.1
Planning of product realization
7.2
Customer-related processes
7.2.3
Communication
7.3.10
Design and development files
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
7.4
Purchasing
7.4.2
Purchasing information
7.5.10
Customer property
7.5.3
Installation activities
7.5.4
Servicing activities
7.5.9
Traceability
7.6
Control of monitoring and measuring equipment
8.2
Monitoring and measurement
8.2.3
Reporting to regulatory authorities
8.2.5
Monitoring and measurement of processes
8.2.6
Monitoring and measurement of product
8.4
Analysis of data
8.5.3
Preventive action

How this is calculated

Already covered means a mapping runs from a control in ISO 9001:2015 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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