TheArtOfService
Cross-Framework Mapping

ISO/IEC 27003:2017vsISO 13485:2016

See exactly how ISO/IEC 27003:2017 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
61
Gaps Found
14%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27003:2017 maps to ISO 13485:2016 with 14% coverage across 10 directly mapped controls. Analysis of 72 ISO/IEC 27003:2017 controls identifies 62 compliance gaps — primarily concentrated in Support (Clause 7).

Source: TheArtOfService Knowledge Graph | 72 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 5 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Performance(2 mappings)

27003-9.2Internal Audit
→iso-13485-2016::8.2.4Internal audit
27003-9.3Management Review
→iso-13485-2016::5.6Management review

Leadership (Clause 5)(1 mappings)

AS9100D-5.2Quality Policy
→iso-13485-2016::5.3Quality policy

Planning (Clause 6)(1 mappings)

AS9100D-6.2Quality Objectives and Planning to Achieve Them
→iso-13485-2016::5.4.1Quality objectives

Operation (Clause 8)(3 mappings)

AS9100D-8.3Design and Development of Products
→iso-13485-2016::7.3Design and development
AS9100D-8.5Production and Service Provision2 targets
→iso-13485-2016::7.5Production and service provision
→iso-13485-2016::7.5.1Control of production and service provision

Performance Evaluation (Clause 9)(4 mappings)

AS9100D-9.2Internal Audit
→iso-13485-2016::8.2.4Internal audit
AS9100D-9.3Management Review
→iso-13485-2016::5.6Management review
ISO27003-9.2Internal Audit
→iso-13485-2016::8.2.4Internal audit
ISO27003-9.3Management Review
→iso-13485-2016::5.6Management review

Related Comparisons

Other ISO/IEC 27003:2017 comparisons

ISO/IEC 27003:2017 vs ISO 9001:201541 mappingsISO/IEC 27003:2017 vs ISO 14001:201534 mappingsISO/IEC 27003:2017 vs ISO 14004:201628 mappingsISO/IEC 27003:2017 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products14 mappingsISO/IEC 27003:2017 vs AS9100D - Aerospace Quality Management System13 mappingsISO/IEC 27003:2017 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements12 mappingsISO/IEC 27003:2017 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence11 mappingsISO/IEC 27003:2017 vs ICH Q10 - Pharmaceutical Quality System10 mappings

Other ISO 13485:2016 comparisons

PIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO 13485:20164 mappingsICH E6(R3) - Good Clinical Practice vs ISO 13485:20164 mappingsFDA Quality Management System Regulation (QMSR) vs ISO 13485:20164 mappingsISO 45001:2018 vs ISO 13485:20164 mappingsISO 20000-1 vs ISO 13485:20164 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO 13485:20164 mappingsISO 14001 vs ISO 13485:20164 mappingsASIS SPC.1-2009 - Organizational Resilience Standard vs ISO 13485:20164 mappings

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What are the key differences between ISO/IEC 27003:2017 and ISO 13485:2016?

ISO/IEC 27003:2017 has 72 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 10 overlapping controls (14% coverage). The frameworks diverge most significantly in Support (Clause 7), where 9 ISO/IEC 27003:2017 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO/IEC 27003:2017 and ISO 13485:2016?

Of 72 total ISO/IEC 27003:2017 controls, 10 map directly to ISO 13485:2016 controls — representing 14% coverage. The remaining 62 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27003:2017 to ISO 13485:2016?

62 ISO/IEC 27003:2017 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Support (Clause 7) with 9 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 27003:2017 and ISO 13485:2016?

The domain with the highest gap count is Support (Clause 7) (9 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.