Framework overlap

Does ISO 13485 cover Annex 11 to EU GMP?

You hold ISO 13485 and have been told to do Annex 11 to EU GMP. Here is how much overlaps, control by control.

47% of Annex 11 to EU GMP you already have

ISO 13485 already covers about 47% of Annex 11 to EU GMP, leaving 9 of 17 controls as genuinely new work.

Already covered 3 Likely covered 5 New work 9

What is genuinely new work

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

Clause 11
Periodic evaluation
Clause 14
Electronic signatures
Clause 15
Batch release
Clause 17
Archiving
Clause 4
Validation
Clause 5
Data
Clause 6
Accuracy checks
Clause 7
Data storage
Clause 8
Printouts
Show the 8 you already have
Clause 1
Risk management
Clause 12
Security
Clause 9
Audit trails
Clause 10
Change and configuration management
Clause 13
Incident management
Clause 16
Business continuity
Clause 2
Personnel
Clause 3
Suppliers and service providers

How this is calculated

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