TheArtOfService
Cross-Framework Mapping

ISO 13485:2016vsISO/IEC 27003:2017

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

11
Controls Mapped
49
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO/IEC 27003:2017 with 7% coverage across 7 directly mapped controls. Analysis of 60 ISO 13485:2016 controls identifies 76 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.

Source: TheArtOfService Knowledge Graph | 60 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 3 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Management responsibility – ISO 13485:2016(5 mappings)

iso-13485-2016::5.3Quality policy
→AS9100D-5.2Quality Policy
iso-13485-2016::5.4.1Quality objectives
→AS9100D-6.2Quality Objectives and Planning to Achieve Them
iso-13485-2016::5.6Management review3 targets
→27003-9.3Management Review
→AS9100D-9.3Management Review
→ISO27003-9.3Management Review

Product realization – ISO 13485:2016(3 mappings)

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

Measurement, analysis and improvement – ISO 13485:2016(3 mappings)

iso-13485-2016::8.2.4Internal audit3 targets
→27003-9.2Internal Audit
→AS9100D-9.2Internal Audit
→ISO27003-9.2Internal Audit

Related Comparisons

Other ISO 13485:2016 comparisons

ISO 13485:2016 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products4 mappingsISO 13485:2016 vs ICH E6(R3) - Good Clinical Practice4 mappingsISO 13485:2016 vs FDA Quality Management System Regulation (QMSR)4 mappingsISO 13485:2016 vs ISO 45001:20184 mappingsISO 13485:2016 vs ISO 20000-14 mappingsISO 13485:2016 vs ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence4 mappingsISO 13485:2016 vs ISO 140014 mappingsISO 13485:2016 vs ASIS SPC.1-2009 - Organizational Resilience Standard4 mappings

Other ISO/IEC 27003:2017 comparisons

ISO 9001:2015 vs ISO/IEC 27003:201741 mappingsISO 14001:2015 vs ISO/IEC 27003:201734 mappingsISO 14004:2016 vs ISO/IEC 27003:201728 mappingsPIC/S Guide to Good Manufacturing Practice for Medicinal Products vs ISO/IEC 27003:201714 mappingsAS9100D - Aerospace Quality Management System vs ISO/IEC 27003:201713 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO/IEC 27003:201712 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO/IEC 27003:201711 mappingsICH Q10 - Pharmaceutical Quality System vs ISO/IEC 27003:201710 mappings

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 718 framework browser
  • ✓ Cross-framework mappings (330K+)
  • ✓ 824 compliance assessments
  • ✓ 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • ✓ Unlimited AI Compliance Advisory
  • ✓ Unlimited full-text search
  • ✓ Framework self-assessment
  • ✓ PDF, Excel & CSV exports
Start 7-Day Free Trial →

Popular framework comparisons

NIST CSF vs NIST 800-53ISO 27001 vs NIST CSFCMMC vs NIST 800-53FedRAMP vs NIST 800-53NIST CSF vs SOC 2HIPAA vs NIST 800-53ISO 27001 vs SOC 2ISO 27001 vs ISO 27701

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

ISO 13485:2016 has 60 controls across its framework, while ISO/IEC 27003:2017 covers 72 controls. Direct mapping analysis identifies 7 overlapping controls (7% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 30 ISO 13485:2016 controls have no direct ISO/IEC 27003:2017 equivalent.

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

Of 60 total ISO 13485:2016 controls, 7 map directly to ISO/IEC 27003:2017 controls — representing 7% 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 13485:2016 to ISO/IEC 27003:2017?

76 ISO 13485:2016 controls have no direct equivalent in ISO/IEC 27003:2017. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 30 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 13485:2016 and ISO/IEC 27003:2017?

The domain with the highest gap count is Product realization – ISO 13485:2016 (30 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.