Framework overlap

Does ISO 13485 cover ISO 22316?

You hold ISO 13485 and have been told to do ISO 22316. Here is how much overlaps, control by control.

15% of ISO 22316 you already have

ISO 13485 already covers about 15% of ISO 22316, leaving 28 of 33 controls as genuinely new work.

Already covered 0 Likely covered 5 New work 28

No control in ISO 13485 maps directly to one in ISO 22316. 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.

ISO22316-02
BCM program scope and objectives
ISO22316-03
Resource allocation for BCM
ISO22316-04
BCM roles and responsibilities
ISO22316-05
Management commitment to BCM
ISO22316-06
Business impact analysis methodology
ISO22316-07
Critical activity identification
ISO22316-09
Resource requirements assessment
ISO22316-10
Interdependency mapping
ISO22316-11
Continuity strategy development
ISO22316-13
Alternate site and resource planning
ISO22316-16
Exercise program development
ISO22316-17
Tabletop and simulation exercises
ISO22316-18
Full-scale testing procedures
ISO22316-19
Post-exercise review and improvement
ISO22316-20
Plan maintenance and update
ISO22316-4
Context and Scope of Organizational Resilience
ISO22316-5.1
Shared Vision and Clarity of Purpose
ISO22316-5.2
Understanding and Influencing Context
ISO22316-5.3
Effective and Empowered Leadership
ISO22316-5.4
Culture Supportive of Organizational Resilience
ISO22316-5.5
Shared Information and Knowledge
ISO22316-5.6
Availability of Resources
ISO22316-5.7
Coordinated Management Disciplines
ISO22316-5.8
Supporting Continual Improvement
ISO22316-5.9
Ability to Anticipate and Manage Change
ISO22316-6.1
Evaluation of Organizational Resilience
ISO22316-6.2
Integration with Strategic Planning
ISO22316-A.1
Stakeholder Engagement and Trust
Show the 5 you already have
ISO22316-01
Organizational resilience and security - business continuity policy for building security and resilience
ISO22316-08
Recovery time and point objectives
ISO22316-12
Recovery strategy for critical activities
ISO22316-14
Supply chain continuity
ISO22316-15
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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