Framework overlap

Does ISO 13485:2016 cover ISO 10005:2005?

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

68% of ISO 10005:2005 you already have

ISO 13485:2016 already covers about 68% of ISO 10005:2005, leaving 8 of 25 controls as genuinely new work.

Already covered 12 Likely covered 5 New work 8

What is genuinely new work

Nothing in ISO 13485:2016 reaches these. This is the list to scope.

4.2
Inputs to the quality plan
4.3
Scope of the quality plan
4.4
Preparation of the quality plan
5.5
Management responsibilities
5.8
Resources
5.9
Requirements
6.2
Implementation of the quality plan
6.3
Revision of the quality plan
Show the 17 you already have
5.11
Design and development
5.12
Purchasing
5.13
Production and service provision
5.14
Identification and traceability
5.15
Customer property
5.16
Preservation of product
5.17
Control of nonconforming product
5.18
Monitoring and measurement
5.4
Quality objectives
5.6
Control of documents and data
5.7
Control of records
6.4
Feedback and improvement
4.1
Identifying the need for the quality plan
5.10
Customer communication
5.19
Audits
5.3
Quality plan inputs
6.1
Review and acceptance of the quality plan

How this is calculated

Already covered means a mapping runs from a control in ISO 13485:2016 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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