ISO 13485:2016vsCritical Infrastructure Risk Management Program (CIRMP) Rules 2023
See exactly how ISO 13485:2016 controls map to Critical Infrastructure Risk Management Program (CIRMP) Rules 2023. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to Critical Infrastructure Risk Management Program (CIRMP) Rules 2023 with 0% coverage across 1 directly mapped controls. Analysis of 60 ISO 13485:2016 controls identifies 82 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 60 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Product realization – ISO 13485:2016(1 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Other Critical Infrastructure Risk Management Program (CIRMP) Rules 2023 comparisons
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What are the key differences between ISO 13485:2016 and Critical Infrastructure Risk Management Program (CIRMP) Rules 2023?
ISO 13485:2016 has 60 controls across its framework, while Critical Infrastructure Risk Management Program (CIRMP) Rules 2023 covers 11 controls. Direct mapping analysis identifies 1 overlapping controls (0% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 32 ISO 13485:2016 controls have no direct Critical Infrastructure Risk Management Program (CIRMP) Rules 2023 equivalent.
How many controls map between ISO 13485:2016 and Critical Infrastructure Risk Management Program (CIRMP) Rules 2023?
Of 60 total ISO 13485:2016 controls, 1 map directly to Critical Infrastructure Risk Management Program (CIRMP) Rules 2023 controls — representing 0% coverage. The remaining 82 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485:2016 to Critical Infrastructure Risk Management Program (CIRMP) Rules 2023?
82 ISO 13485:2016 controls have no direct equivalent in Critical Infrastructure Risk Management Program (CIRMP) Rules 2023. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 32 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between ISO 13485:2016 and Critical Infrastructure Risk Management Program (CIRMP) Rules 2023?
The domain with the highest gap count is Product realization – ISO 13485:2016 (32 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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