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Cross-Framework Mapping

ISO/IEC 23894:2023vsISO 13485:2016

See exactly how ISO/IEC 23894:2023 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

17
Controls Mapped
68
Gaps Found
11%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 23894:2023 maps to ISO 13485:2016 with 11% coverage across 9 directly mapped controls. Analysis of 85 ISO/IEC 23894:2023 controls identifies 76 compliance gaps — primarily concentrated in Risk management process – ISO/IEC 23894:2023.

Source: TheArtOfService Knowledge Graph | 85 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 17 of 17 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Framework(1 mappings)

23894-5.5Communication and Consultation
→iso-13485-2016::7.2.3Communication

Process (Clause 6)(1 mappings)

ISO23894-6.1Communication and Consultation
→iso-13485-2016::7.2.3Communication

Framework – ISO/IEC 23894:2023(10 mappings)

iso-iec-23894-2023::5.1General
→iso-13485-2016::4.1General requirements
iso-iec-23894-2023::5.4Design9 targets
→iso-13485-2016::7.3Design and development
→iso-13485-2016::7.3.10Design and development files
→iso-13485-2016::7.3.2Design and development planning
→iso-13485-2016::7.3.3Design and development inputs
→iso-13485-2016::7.3.4Design and development outputs
→iso-13485-2016::7.3.5Design and development review
→iso-13485-2016::7.3.6Design and development verification
→iso-13485-2016::7.3.7Design and development validation
→iso-13485-2016::7.3.8Design and development transfer

Risk management process – ISO/IEC 23894:2023(5 mappings)

iso-iec-23894-2023::6.1General
→iso-13485-2016::4.1General requirements
iso-iec-23894-2023::6.2Communication and consultation
→iso-13485-2016::7.2.3Communication
iso-iec-23894-2023::6.3.1General
→iso-13485-2016::4.1General requirements
iso-iec-23894-2023::6.4.1General
→iso-13485-2016::4.1General requirements
iso-iec-23894-2023::6.5.1General
→iso-13485-2016::4.1General requirements

Related Comparisons

Other ISO/IEC 23894:2023 comparisons

ISO/IEC 23894:2023 vs ISO 31000:201848 mappingsISO/IEC 23894:2023 vs ISO 3100034 mappingsISO/IEC 23894:2023 vs ISO/IEC 27557:2022 - Organisational Privacy Risk Management24 mappingsISO/IEC 23894:2023 vs ISO/IEC 27003:201722 mappingsISO/IEC 23894:2023 vs AS9100D - Aerospace Quality Management System20 mappingsISO/IEC 23894:2023 vs ISO 39001:2012 - Road Traffic Safety Management18 mappingsISO/IEC 23894:2023 vs ISO 41001:2018 - Facility Management Systems18 mappingsISO/IEC 23894:2023 vs ISO 22313:2020 - Guidance on Business Continuity Management Systems18 mappings

Other ISO 13485:2016 comparisons

ISO 10005:2005 vs ISO 13485:201625 mappingsISO 19011:2018 vs ISO 13485:201620 mappingsISO 9001:2015 vs ISO 13485:201616 mappingsISO 9001 vs ISO 13485:201615 mappingsISO 50001:2018 - Energy Management Systems vs ISO 13485:201614 mappingsISO 39001:2012 - Road Traffic Safety Management vs ISO 13485:201613 mappingsISO/IEC 38500:2024 vs ISO 13485:201613 mappingsISO 41001:2018 - Facility Management Systems vs ISO 13485:201612 mappings

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What are the key differences between ISO/IEC 23894:2023 and ISO 13485:2016?

ISO/IEC 23894:2023 has 85 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 9 overlapping controls (11% coverage). The frameworks diverge most significantly in Risk management process – ISO/IEC 23894:2023, where 12 ISO/IEC 23894:2023 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO/IEC 23894:2023 and ISO 13485:2016?

Of 85 total ISO/IEC 23894:2023 controls, 9 map directly to ISO 13485:2016 controls — representing 11% coverage. The remaining 76 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 23894:2023 to ISO 13485:2016?

76 ISO/IEC 23894:2023 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Risk management process – ISO/IEC 23894:2023 with 12 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/IEC 23894:2023 and ISO 13485:2016?

The domain with the highest gap count is Risk management process – ISO/IEC 23894:2023 (12 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

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