Framework overlap

Does ISO 19011:2018 cover ISO 13485:2016?

You hold ISO 19011:2018 and have been told to do ISO 13485:2016. Here is how much overlaps, control by control.

43% of ISO 13485:2016 you already have

ISO 19011:2018 already covers about 43% of ISO 13485:2016, leaving 41 of 72 controls as genuinely new work.

Already covered 20 Likely covered 11 New work 41

What is genuinely new work

Nothing in ISO 19011:2018 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
5.2
Customer focus
5.4.2
Quality management system planning
5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
5.5.2
Management representative
5.6.3
Review output
6.2
Human resources
6.3
Infrastructure
6.4
Work environment and contamination control
6.4.1
Work environment
6.4.2
Contamination control
7.2
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
7.4.3
Verification of purchased product
7.5.1
Control of production and service provision
7.5.10
Customer property
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
7.5.8
Identification
7.5.9
Traceability
7.6
Control of monitoring and measuring equipment
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
8.4
Analysis of data
8.5
Improvement
8.5.2
Corrective action
8.5.3
Preventive action
Show the 31 you already have
4.1
General requirements
4.2.5
Control of records
5.3
Quality policy
5.4
Planning
5.4.1
Quality objectives
5.6
Management review
5.6.2
Review input
6.1
Provision of resources
7.1
Planning of product realization
7.3.10
Design and development files
7.3.2
Design and development planning
7.3.3
Design and development inputs
7.4.2
Purchasing information
7.5
Production and service provision
7.5.3
Installation activities
7.5.4
Servicing activities
8.2
Monitoring and measurement
8.2.3
Reporting to regulatory authorities
8.2.4
Internal audit
8.3.4
Rework
5.5.3
Internal communication
7.2.3
Communication
7.3
Design and development
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
7.5.11
Preservation of product
8.2.5
Monitoring and measurement of processes
8.2.6
Monitoring and measurement of product

How this is calculated

Already covered means a mapping runs from a control in ISO 19011:2018 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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