62% of ISO 55001:2014 you already have
ISO 13485:2016 already covers about 62% of ISO 55001:2014, leaving
8 of 21 controls as genuinely new work.
Already covered 3
Likely covered 10
New work 8
What is genuinely new work
Nothing in ISO 13485:2016 reaches these. This is the list to scope.
10.3Continual improvement
4.1Understanding the organization and its context
4.2Understanding the needs and expectations of stakeholders
4.3Determining the scope of the asset management system
5.3Organizational roles, responsibilities and authorities
7.6Documented information
9.1Monitoring, measurement, analysis and evaluation
Show the 13 you already have
10.1Nonconformity and corrective action
4.4Asset management system
5.1Leadership and commitment
6.1Actions to address risks and opportunities for the asset management system
6.2Asset management objectives and planning to achieve them
8.1Operational planning and control
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.
Try another pair ยท
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