TheArtOfService
Cross-Framework Mapping

ISO 13485vsISO/IEC 27006:2024

See exactly how ISO 13485 controls map to ISO/IEC 27006:2024. Pre-computed mappings, identified gaps, and coverage analysis.

16
Controls Mapped
28
Gaps Found
14%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to ISO/IEC 27006:2024 with 14% coverage across 6 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 38 compliance gaps — primarily concentrated in Product Realisation.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 726 frameworks | 455K+ cross-framework mappings

Control Mappings

Showing 16 of 16 mapped controls across 5 domains. Sign up to explore all 455K+ mappings across 726 frameworks.

QMS(6 mappings)

4.1Password Policy3 targets
→ISO-15189-6.3Facilities and environmental conditions
→ISO-15189-6.5Equipment calibration and metrological traceability
→ISO-17025-6.5Metrological traceability
4.2Multi-Factor Authentication3 targets
→ISO-15189-6.3Facilities and environmental conditions
→ISO-15189-6.5Equipment calibration and metrological traceability
→ISO-17025-6.5Metrological traceability

Resource Management(3 mappings)

6.3Information security awareness, education and training3 targets
→ISO-15189-6.7Service agreements
→ISO-17025-5.1Legal entity
→ISO-17025-5.4Personnel for the management system

Product Realisation(3 mappings)

7.1Cyber Incident Response Planning3 targets
→ISO-15189-6.3Facilities and environmental conditions
→ISO-15189-6.5Equipment calibration and metrological traceability
→ISO-17025-6.5Metrological traceability

Improvement(3 mappings)

8.5Control effectiveness review3 targets
→ISO-15189-6.3Facilities and environmental conditions
→ISO-15189-6.5Equipment calibration and metrological traceability
→ISO-17025-6.5Metrological traceability

ISO 13485: Patient Data Protection(1 mappings)

ISO13485-01ePHI access controls and authorization
→ISO-15189-6.2Personnel

Related Comparisons

Other ISO 13485 comparisons

ISO 13485 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements16 mappingsISO 13485 vs FAA Cybersecurity Framework for Aviation14 mappingsISO 13485 vs GLI-33 - Gaming Laboratories International Event Wagering Systems13 mappingsISO 13485 vs FTC GLBA Safeguards Rule (16 CFR Part 314)13 mappingsISO 13485 vs MDS2 (Medical Device)13 mappingsISO 13485 vs FDA 21 CFR Part 1113 mappingsISO 13485 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)13 mappingsISO 13485 vs MARS-E13 mappings

Other ISO/IEC 27006:2024 comparisons

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO/IEC 27006:20249 mappingsPIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO/IEC 27006:20247 mappingsSQF Code Edition 9 - Safe Quality Food vs ISO/IEC 27006:20247 mappingsBRCGS Global Standard for Food Safety Issue 9 vs ISO/IEC 27006:20247 mappings21 CFR Part 211 - Current Good Manufacturing Practice vs ISO/IEC 27006:20247 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO/IEC 27006:20247 mappingsAS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence vs ISO/IEC 27006:20247 mappingsFDA Quality Management System Regulation (QMSR) vs ISO/IEC 27006:20247 mappings

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What are the key differences between ISO 13485 and ISO/IEC 27006:2024?

ISO 13485 has 44 controls across its framework, while ISO/IEC 27006:2024 covers 52 controls. Direct mapping analysis identifies 6 overlapping controls (14% coverage). The frameworks diverge most significantly in Product Realisation, where 6 ISO 13485 controls have no direct ISO/IEC 27006:2024 equivalent.

How many controls map between ISO 13485 and ISO/IEC 27006:2024?

Of 44 total ISO 13485 controls, 6 map directly to ISO/IEC 27006:2024 controls — representing 14% coverage. The remaining 38 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 ISO/IEC 27006:2024?

38 ISO 13485 controls have no direct equivalent in ISO/IEC 27006:2024. The highest concentration of gaps is in Product Realisation with 6 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 ISO/IEC 27006:2024?

The domain with the highest gap count is Product Realisation (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.