Framework overlap

Does ISO 13485:2016 cover ISO 19011:2018?

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

83% of ISO 19011:2018 you already have

ISO 13485:2016 already covers about 83% of ISO 19011:2018, leaving 8 of 48 controls as genuinely new work.

Already covered 26 Likely covered 14 New work 8

What is genuinely new work

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

5.3
Determining and evaluating audit programme risks and opportunities
6.3.1
Performing review of documented information
6.4.2
Assigning roles and responsibilities of guides and observers
6.4.4
Communicating during audit
7.2
Determining auditor competence
7.2.5
Achieving audit team leader competence
7.3
Establishing auditor evaluation criteria
7.6
Maintaining and improving auditor competence
Show the 40 you already have
5.2
Establishing audit programme objectives
5.4
Establishing the audit programme
5.4.4
Determining audit programme resources
5.5.3
Selecting and determining audit methods
5.5.4
Selecting audit team members
5.5.5
Assigning responsibility for an individual audit to the audit team leader
5.5.6
Managing audit programme results
5.5.7
Managing and maintaining audit programme records
5.6
Monitoring audit programme
5.7
Reviewing and improving audit programme
6.2
Initiating audit
6.3
Preparing audit activities
6.3.2
Audit planning
6.4
Conducting audit activities
6.4.3
Conducting opening meeting
6.4.5
Audit information availability and access
6.4.6
Reviewing documented information while conducting audit
6.4.7
Collecting and verifying information
6.5
Preparing and distributing audit report
6.5.2
Distributing audit report
6.6
Completing audit
6.7
Conducting audit follow-up
7.2.3
Knowledge and skills
7.2.4
Achieving auditor competence
7.4
Selecting appropriate auditor evaluation method
7.5
Conducting auditor evaluation
5.4.1
Roles and responsibilities of the individual(s) managing the audit programme
5.4.2
Competence of individual(s) managing audit programme
5.4.3
Establishing extent of audit programme
5.5
Implementing audit programme
5.5.2
Defining the objectives, scope and criteria for an individual audit
6.2.2
Establishing contact with auditee
6.2.3
Determining feasibility of audit
6.3.3
Assigning work to audit team
6.3.4
Preparing documented information for audit
6.4.10
Conducting closing meeting
6.4.8
Generating audit findings
6.4.9
Determining audit conclusions
6.5.1
Preparing audit report
7.2.2
Personal behaviour

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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