TheArtOfService
Cross-Framework Mapping

ISO 19011vsISO 13485

See exactly how ISO 19011 controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
35
Gaps Found
12%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 19011 maps to ISO 13485 with 12% coverage across 4 directly mapped controls. Analysis of 42 ISO 19011 controls identifies 30 compliance gaps — primarily concentrated in Audit Principles.

Source: TheArtOfService Knowledge Graph | 42 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Audit Process(7 mappings)

6.4Logging and Monitoring
→ISO13485-12Unique user identification and authentication
6.5Preparing and Distributing Audit Report2 targets
→6.4Logging and Monitoring
→ISO13485-12Unique user identification and authentication
6.6Confidentiality or non-disclosure agreements2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption
6.7Conducting Audit Follow-up2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption

Related Comparisons

Other ISO 19011 comparisons

ISO 19011 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements7 mappingsISO 19011 vs NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security6 mappingsISO 19011 vs NIST SP 800-1466 mappingsISO 19011 vs NIST SP 800-1456 mappingsISO 19011 vs NIST SP 800-1446 mappingsISO 19011 vs MTCS (Singapore)6 mappingsISO 19011 vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsISO 19011 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence6 mappings

Other ISO 13485 comparisons

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 1348516 mappingsNIST SP 800-66 vs ISO 1348513 mappingsMDS2 (Medical Device) vs ISO 1348513 mappingsMARS-E vs ISO 1348513 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs ISO 1348513 mappingsISO 27799 vs ISO 1348513 mappingsNIST Privacy Framework vs ISO 1348512 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs ISO 1348512 mappings

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What are the key differences between ISO 19011 and ISO 13485?

ISO 19011 has 42 controls across its framework, while ISO 13485 covers 44 controls. Direct mapping analysis identifies 4 overlapping controls (12% coverage). The frameworks diverge most significantly in Audit Principles, where 7 ISO 19011 controls have no direct ISO 13485 equivalent.

How many controls map between ISO 19011 and ISO 13485?

Of 42 total ISO 19011 controls, 4 map directly to ISO 13485 controls — representing 12% coverage. The remaining 30 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 19011 to ISO 13485?

30 ISO 19011 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Audit Principles with 7 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 19011 and ISO 13485?

The domain with the highest gap count is Audit Principles (7 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.