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Cross-Framework Mapping

ISO 13485:2016vsISO 19011:2018

See exactly how ISO 13485:2016 controls map to ISO 19011:2018. Pre-computed mappings, identified gaps, and coverage analysis.

38
Controls Mapped
45
Gaps Found
24%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO 19011:2018 with 24% coverage across 20 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 63 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.

Source: TheArtOfService Knowledge Graph | 83 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 38 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Quality management system – ISO 13485:2016(8 mappings)

iso-13485-2016::4.1General requirements7 targets
→iso-19011-2018::5.1General
→iso-19011-2018::5.5.1General
→iso-19011-2018::6.1General
→iso-19011-2018::6.2.1General
→iso-19011-2018::6.4.1General
→iso-19011-2018::7.1General
→iso-19011-2018::7.2.1General
iso-13485-2016::4.2.5Control of records
→iso-19011-2018::5.5.7Managing and maintaining audit programme records

Management responsibility – ISO 13485:2016(7 mappings)

iso-13485-2016::5.3Quality policy
→iso-19011-2018::6.3.2Audit planning
iso-13485-2016::5.4Planning
→iso-19011-2018::5.4Establishing the audit programme
iso-13485-2016::5.4.1Quality objectives2 targets
→iso-19011-2018::5.2Establishing audit programme objectives
→iso-19011-2018::6.4.5Audit information availability and access
iso-13485-2016::5.6Management review
→iso-19011-2018::5.5.6Managing audit programme results
iso-13485-2016::5.6.2Review input2 targets
→iso-19011-2018::5.7Reviewing and improving audit programme
→iso-19011-2018::6.4.6Reviewing documented information while conducting audit

Resource management – ISO 13485:2016(1 mappings)

iso-13485-2016::6.1Provision of resources
→iso-19011-2018::5.4.4Determining audit programme resources

Product realization – ISO 13485:2016(4 mappings)

iso-13485-2016::7.1Planning of product realization
→iso-19011-2018::7.5Conducting auditor evaluation
iso-13485-2016::7.3.10Design and development files
→iso-19011-2018::5.5.5Assigning responsibility for an individual audit to the audit team leader
iso-13485-2016::7.3.2Design and development planning
→iso-19011-2018::6.3.2Audit planning
iso-13485-2016::7.3.3Design and development inputs
→iso-19011-2018::5.5.3Selecting and determining audit methods

+18 more mappings

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Related Comparisons

Other ISO 13485:2016 comparisons

ISO 13485:2016 vs ISO 10005:200525 mappingsISO 13485:2016 vs ISO 9001:201516 mappingsISO 13485:2016 vs ISO 900115 mappingsISO 13485:2016 vs ISO 50001:2018 - Energy Management Systems14 mappingsISO 13485:2016 vs ISO 39001:2012 - Road Traffic Safety Management13 mappingsISO 13485:2016 vs ISO/IEC 38500:202413 mappingsISO 13485:2016 vs ISO 41001:2018 - Facility Management Systems12 mappingsISO 13485:2016 vs ISO 22313:2020 - Guidance on Business Continuity Management Systems12 mappings

Other ISO 19011:2018 comparisons

ISO 14001:2015 vs ISO 19011:201846 mappingsISO 14004:2016 vs ISO 19011:201843 mappingsISO 31000:2018 vs ISO 19011:201842 mappingsISO 45001:2018 vs ISO 19011:201839 mappingsISO 27701:2019 vs ISO 19011:201833 mappingsISO 37301:2021 vs ISO 19011:201833 mappingsISO 22000:2018 vs ISO 19011:201831 mappingsISO 37001:2016 vs ISO 19011:201829 mappings

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What are the key differences between ISO 13485:2016 and ISO 19011:2018?

ISO 13485:2016 has 83 controls across its framework, while ISO 19011:2018 covers 55 controls. Direct mapping analysis identifies 20 overlapping controls (24% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 25 ISO 13485:2016 controls have no direct ISO 19011:2018 equivalent.

How many controls map between ISO 13485:2016 and ISO 19011:2018?

Of 83 total ISO 13485:2016 controls, 20 map directly to ISO 19011:2018 controls — representing 24% coverage. The remaining 63 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 19011:2018?

63 ISO 13485:2016 controls have no direct equivalent in ISO 19011:2018. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 25 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 19011:2018?

The domain with the highest gap count is Product realization – ISO 13485:2016 (25 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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