Framework overlap

Does ISO 13485:2016 cover ISO 22000:2018?

You hold ISO 13485:2016 and have been told to do ISO 22000:2018. Here is how much overlaps, control by control.

62% of ISO 22000:2018 you already have

ISO 13485:2016 already covers about 62% of ISO 22000:2018, leaving 21 of 55 controls as genuinely new work.

Already covered 10 Likely covered 24 New work 21

What is genuinely new work

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

10.3
Update of the food safety management system
4.1
Understanding the organization and its context
4.2
Understanding the needs and expectations of interested parties
4.3
Determining the scope of the food safety management system
5.2.2
Communicating the food safety policy
5.3
Organizational roles, responsibilities and authorities
7.1.5
Externally developed elements of the food safety management system
7.1.6
Control of externally provided processes, products or services
7.2
Competence
7.3
Awareness
7.5
Documented information
7.5.2
Creating and updating
8.4
Emergency preparedness and response
8.5.3
Validation of control measure(s) and combinations of control measures
8.6
Updating the information specifying the PRPs and the hazard control plan
8.8
Verification related to PRPs and the hazard control plan
8.8.2
Analysis of results of verification activities
8.9
Control of product and process nonconformities
8.9.4
Handling of potentially unsafe products
8.9.5
Withdrawal/recall
9.1
Monitoring, measurement, analysis and evaluation
Show the 34 you already have
6.3
Planning of changes
7.1.4
Work environment
7.4.3
Internal communication
8.3
Traceability system
8.7
Control of monitoring and measuring
8.8.1
Verification
9.2
Internal audit
9.3
Management review
9.3.2
Management review input
9.3.3
Management review output
10.1
Nonconformity and corrective action
10.2
Continual improvement
4.4
Food safety management system
5.1
Leadership and commitment
5.2
Policy
5.2.1
Establishing the food safety policy
6.1
Actions to address risks and opportunities
6.2
Objectives of the food safety management system and planning to achieve them
7.1
Resources
7.1.2
People
7.1.3
Infrastructure
7.4
Communication
7.4.2
External communication
7.5.3
Control of documented information
8.1
Operational planning and control
8.2
Prerequisite programmes (PRPs)
8.4.2
Handling of emergencies and incidents
8.5
Hazard control
8.5.1
Preliminary steps to enable hazard analysis
8.5.2
Hazard analysis
8.5.4
Hazard control plan (HACCP/OPRP plan)
8.9.2
Corrections
8.9.3
Corrective actions
9.1.2
Analysis and evaluation

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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