Framework overlap

Does ISO 10005:2005 cover ISO 13485:2016?

You hold ISO 10005:2005 and have been told to do ISO 13485:2016. Here is how much overlaps, control by control.

46% of ISO 13485:2016 you already have

ISO 10005:2005 already covers about 46% of ISO 13485:2016, leaving 39 of 72 controls as genuinely new work.

Already covered 25 Likely covered 8 New work 39

What is genuinely new work

Nothing in ISO 10005:2005 reaches these. This is the list to scope.

4.2
Documentation requirements
4.2.2
Quality manual
4.2.3
Medical device file
5.1
Management commitment
5.4
Planning
5.4.2
Quality management system planning
5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
5.5.2
Management representative
5.5.3
Internal communication
5.6
Management review
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
7.2.1
Determination of requirements related to product
7.2.2
Review of requirements related to product
7.2.3
Communication
7.4.3
Verification of purchased 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
7.6
Control of monitoring and measuring equipment
8.2.2
Complaint handling
8.2.3
Reporting to regulatory authorities
8.2.4
Internal audit
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 33 you already have
4.1
General requirements
4.2.4
Control of documents
4.2.5
Control of records
5.4.1
Quality objectives
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
7.4.1
Purchasing process
7.4.2
Purchasing information
7.5
Production and service provision
7.5.1
Control of production and service provision
7.5.10
Customer property
7.5.11
Preservation of product
7.5.8
Identification
8.2
Monitoring and measurement
8.2.1
Feedback
8.2.5
Monitoring and measurement of processes
8.2.6
Monitoring and measurement of product
8.3
Control of nonconforming product
5.2
Customer focus
5.3
Quality policy
5.6.2
Review input
7.2
Customer-related processes
7.3.9
Control of design and development changes
7.4
Purchasing
7.5.9
Traceability
8.3.4
Rework

How this is calculated

Already covered means a mapping runs from a control in ISO 10005:2005 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