Framework overlap

Does ISO 13485 cover ISO 55001?

You hold ISO 13485 and have been told to do ISO 55001. Here is how much overlaps, control by control.

5% of ISO 55001 you already have

ISO 13485 already covers about 5% of ISO 55001, leaving 38 of 40 controls as genuinely new work.

Already covered 0 Likely covered 2 New work 38

No control in ISO 13485 maps directly to one in ISO 55001. 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.

ISO55001-01
Cl. 6.2 Asset management objectives - policy, objectives, and planning for asset management system operation
ISO55001-02
Leadership commitment to quality
ISO55001-03
Risk-based thinking and planning
ISO55001-04
Resource management for quality
ISO55001-05
Organizational roles and responsibilities
ISO55001-06
Operational planning and control
ISO55001-07
Requirements for products and services
ISO55001-08
Design and development controls
ISO55001-09
Control of externally provided processes
ISO55001-10
Production and service provision controls
ISO55001-10.1
Nonconformity and corrective action
ISO55001-10.2
Preventive action
ISO55001-10.3
Continual improvement
ISO55001-11
Monitoring, measurement, and analysis
ISO55001-12
Internal audit program
ISO55001-13
Management review process
ISO55001-14
Customer satisfaction measurement
ISO55001-16
Continual improvement methodology
ISO55001-17
Corrective and preventive actions
ISO55001-4.1
Understanding the organization and its context
ISO55001-4.2
Understanding the needs and expectations of stakeholders
ISO55001-4.3
Determining scope of asset management system
ISO55001-4.4
Asset management system
ISO55001-5.1
Leadership and commitment
ISO55001-5.2
Policy
ISO55001-6.1
Actions to address risks and opportunities
ISO55001-6.2.1
Asset management objectives
ISO55001-6.2.2
Planning to achieve asset management objectives
ISO55001-7.1
Resources
ISO55001-7.2
Competence
ISO55001-7.5
Information requirements
ISO55001-7.6
Documented information
ISO55001-8.1
Operational planning and control
ISO55001-8.2
Management of change
ISO55001-8.3
Outsourcing
ISO55001-9.1
Monitoring, measurement, analysis and evaluation
ISO55001-9.2
Internal audit
ISO55001-9.3
Management review
Show the 2 you already have
ISO55001-15
Nonconformity and corrective action
ISO55001-18
Innovation and change management

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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