ISO 13485:2016vsISAE 3402 - Assurance Reports on Controls at a Service Organisation
See exactly how ISO 13485:2016 controls map to ISAE 3402 - Assurance Reports on Controls at a Service Organisation. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to ISAE 3402 - Assurance Reports on Controls at a Service Organisation with 2% coverage across 2 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 81 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 83 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Quality management system – ISO 13485:2016(1 mappings)
Product realization – ISO 13485:2016(1 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Other ISAE 3402 - Assurance Reports on Controls at a Service Organisation comparisons
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What are the key differences between ISO 13485:2016 and ISAE 3402 - Assurance Reports on Controls at a Service Organisation?
ISO 13485:2016 has 83 controls across its framework, while ISAE 3402 - Assurance Reports on Controls at a Service Organisation covers 34 controls. Direct mapping analysis identifies 2 overlapping controls (2% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 32 ISO 13485:2016 controls have no direct ISAE 3402 - Assurance Reports on Controls at a Service Organisation equivalent.
How many controls map between ISO 13485:2016 and ISAE 3402 - Assurance Reports on Controls at a Service Organisation?
Of 83 total ISO 13485:2016 controls, 2 map directly to ISAE 3402 - Assurance Reports on Controls at a Service Organisation controls — representing 2% coverage. The remaining 81 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 ISAE 3402 - Assurance Reports on Controls at a Service Organisation?
81 ISO 13485:2016 controls have no direct equivalent in ISAE 3402 - Assurance Reports on Controls at a Service Organisation. 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 ISAE 3402 - Assurance Reports on Controls at a Service Organisation?
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.
Related Resources
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