TheArtOfService
Cross-Framework Mapping

ISO 31000:2018vsISO 13485:2016

See exactly how ISO 31000:2018 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
42
Gaps Found
12%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 31000:2018 maps to ISO 13485:2016 with 12% coverage across 7 directly mapped controls. Analysis of 57 ISO 31000:2018 controls identifies 50 compliance gaps — primarily concentrated in Process – ISO 31000:2018.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Framework – ISO 31000:2018(10 mappings)

iso-31000-2018::5.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::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

Process – ISO 31000:2018(5 mappings)

iso-31000-2018::6.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.2Communication and consultation
→iso-13485-2016::7.2.3Communication
iso-31000-2018::6.3.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.4.1General
→iso-13485-2016::4.1General requirements
iso-31000-2018::6.5.1General
→iso-13485-2016::4.1General requirements

Related Comparisons

Other ISO 31000:2018 comparisons

ISO 31000:2018 vs ISO/IEC 23894:202335 mappingsISO 31000:2018 vs ISO 19011:201830 mappingsISO 31000:2018 vs ISO 3100014 mappingsISO 31000:2018 vs ISO 14004:201612 mappingsISO 31000:2018 vs ISO/IEC 42001:20238 mappingsISO 31000:2018 vs ISO 22301:20198 mappingsISO 31000:2018 vs ISO/IEC 27557:2022 - Organisational Privacy Risk Management8 mappingsISO 31000:2018 vs ISO/IEC TR 24028:20207 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

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 723 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 723 framework browser
  • ✓ Cross-framework mappings (332K+)
  • ✓ 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 31000:2018 and ISO 13485:2016?

ISO 31000:2018 has 57 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 7 overlapping controls (12% coverage). The frameworks diverge most significantly in Process – ISO 31000:2018, where 13 ISO 31000:2018 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO 31000:2018 and ISO 13485:2016?

Of 57 total ISO 31000:2018 controls, 7 map directly to ISO 13485:2016 controls — representing 12% coverage. The remaining 50 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 31000:2018 to ISO 13485:2016?

50 ISO 31000:2018 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Process – ISO 31000:2018 with 13 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 31000:2018 and ISO 13485:2016?

The domain with the highest gap count is Process – ISO 31000:2018 (13 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.