ISO 13485vsIATA Operational Safety Audit (IOSA) Standards Manual
See exactly how ISO 13485 controls map to IATA Operational Safety Audit (IOSA) Standards Manual. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to IATA Operational Safety Audit (IOSA) Standards Manual with 14% coverage across 4 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 25 compliance gaps — primarily concentrated in ISO 13485: Technical Safeguards.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
ISO 13485: Patient Data Protection(1 mappings)
ISO 13485: Administrative Safeguards(2 mappings)
ISO 13485: Physical Safeguards(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other IATA Operational Safety Audit (IOSA) Standards Manual comparisons
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What are the key differences between ISO 13485 and IATA Operational Safety Audit (IOSA) Standards Manual?
ISO 13485 has 29 controls across its framework, while IATA Operational Safety Audit (IOSA) Standards Manual covers 9 controls. Direct mapping analysis identifies 4 overlapping controls (14% coverage). The frameworks diverge most significantly in ISO 13485: Technical Safeguards, where 5 ISO 13485 controls have no direct IATA Operational Safety Audit (IOSA) Standards Manual equivalent.
How many controls map between ISO 13485 and IATA Operational Safety Audit (IOSA) Standards Manual?
Of 29 total ISO 13485 controls, 4 map directly to IATA Operational Safety Audit (IOSA) Standards Manual controls — representing 14% coverage. The remaining 25 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to IATA Operational Safety Audit (IOSA) Standards Manual?
25 ISO 13485 controls have no direct equivalent in IATA Operational Safety Audit (IOSA) Standards Manual. The highest concentration of gaps is in ISO 13485: Technical Safeguards with 5 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 and IATA Operational Safety Audit (IOSA) Standards Manual?
The domain with the highest gap count is ISO 13485: Technical Safeguards (5 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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