Framework overlap

Does ISO 13485 cover ISO 22318?

You hold ISO 13485 and have been told to do ISO 22318. Here is how much overlaps, control by control.

14% of ISO 22318 you already have

ISO 13485 already covers about 14% of ISO 22318, leaving 31 of 36 controls as genuinely new work.

Already covered 0 Likely covered 5 New work 31

No control in ISO 13485 maps directly to one in ISO 22318. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

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

ISO22318-01
Business continuity policy
ISO22318-02
BCM program scope and objectives
ISO22318-03
Resource allocation for BCM
ISO22318-04
BCM roles and responsibilities
ISO22318-05
Management commitment to BCM
ISO22318-06
Business impact analysis methodology
ISO22318-07
Critical activity identification
ISO22318-09
Resource requirements assessment
ISO22318-10
Interdependency mapping
ISO22318-11
Continuity strategy development
ISO22318-16
Exercise program development
ISO22318-17
Tabletop and simulation exercises
ISO22318-18
Full-scale testing procedures
ISO22318-19
Post-exercise review and improvement
ISO22318-20
Plan maintenance and update
ISO22318-4.1
Supply Chain Continuity Programme
ISO22318-4.2
Supply Chain Risk Appetite
ISO22318-5.1
Supplier Identification and Mapping
ISO22318-5.2
Supplier Criticality Assessment
ISO22318-5.3
Supplier Dependency Analysis
ISO22318-5.4
Supplier Continuity Requirements
ISO22318-5.5
Supplier Due Diligence
ISO22318-6.1
Supply Chain Continuity Strategies
ISO22318-6.2
Alternative Supplier Arrangements
ISO22318-6.3
Inventory and Buffer Stock Strategy
ISO22318-7.1
Supplier Continuity Plans
ISO22318-7.2
Communication and Coordination
ISO22318-8.1
Supplier Continuity Exercising
ISO22318-8.2
Supplier Performance Monitoring
ISO22318-9.1
Concentration and Systemic Risk Review
ISO22318-9.2
Continual Improvement of Supply Chain Continuity
Show the 5 you already have
ISO22318-08
Recovery time and point objectives
ISO22318-12
Recovery strategy for critical activities
ISO22318-13
Alternate site and resource planning
ISO22318-14
Supply chain continuity
ISO22318-15
Communication strategy during disruption

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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