Framework overlap

Does ISO 45001:2018 cover ISO 13485:2016?

You hold ISO 45001:2018 and have been told to do ISO 13485:2016. Here is how much overlaps, control by control.

39% of ISO 13485:2016 you already have

ISO 45001:2018 already covers about 39% of ISO 13485:2016, leaving 44 of 72 controls as genuinely new work.

Already covered 4 Likely covered 24 New work 44

What is genuinely new work

Nothing in ISO 45001:2018 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
5.3
Quality policy
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
7.2.1
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
Production and service provision
7.5.1
Control of production and service provision
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
8.2.1
Feedback
8.2.2
Complaint handling
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
8.4
Analysis of data
8.5
Improvement
8.5.2
Corrective action
Show the 28 you already have
5.4
Planning
5.5.3
Internal communication
5.6
Management review
8.2.4
Internal audit
4.1
General requirements
4.2.5
Control of records
5.2
Customer focus
5.4.1
Quality objectives
5.6.2
Review input
6.1
Provision of resources
7.1
Planning of product realization
7.2
Customer-related processes
7.2.3
Communication
7.3
Design and development
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
7.4.2
Purchasing information
7.5.10
Customer property
8.2
Monitoring and measurement
8.2.3
Reporting to regulatory authorities
8.3.4
Rework
8.5.3
Preventive action

How this is calculated

Already covered means a mapping runs from a control in ISO 45001:2018 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.

Try another pair ยท Today's edition