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Cross-Framework Mapping

ISO 19011:2018vsISO 13485:2016

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

38
Controls Mapped
17
Gaps Found
60%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 19011:2018 maps to ISO 13485:2016 with 60% coverage across 33 directly mapped controls. Analysis of 55 ISO 19011:2018 controls identifies 22 compliance gaps — primarily concentrated in Conducting an audit – ISO 19011:2018.

Source: TheArtOfService Knowledge Graph | 55 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 38 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Managing an audit programme – ISO 19011:2018(13 mappings)

iso-19011-2018::5.1General
→iso-13485-2016::4.1General requirements
iso-19011-2018::5.2Establishing audit programme objectives
→iso-13485-2016::5.4.1Quality objectives
iso-19011-2018::5.4Establishing the audit programme
→iso-13485-2016::5.4Planning
iso-19011-2018::5.4.4Determining audit programme resources
→iso-13485-2016::6.1Provision of resources
iso-19011-2018::5.5.1General
→iso-13485-2016::4.1General requirements
iso-19011-2018::5.5.3Selecting and determining audit methods
→iso-13485-2016::7.3.3Design and development inputs
iso-19011-2018::5.5.4Selecting audit team members2 targets
→iso-13485-2016::7.5.4Servicing activities
→iso-13485-2016::8.3.4Rework
iso-19011-2018::5.5.5Assigning responsibility for an individual audit to the audit team leader
→iso-13485-2016::7.3.10Design and development files
iso-19011-2018::5.5.6Managing audit programme results
→iso-13485-2016::5.6Management review
iso-19011-2018::5.5.7Managing and maintaining audit programme records
→iso-13485-2016::4.2.5Control of records
iso-19011-2018::5.6Monitoring audit programme
→iso-13485-2016::8.2Monitoring and measurement
iso-19011-2018::5.7Reviewing and improving audit programme
→iso-13485-2016::5.6.2Review input

Conducting an audit – ISO 19011:2018(7 mappings)

iso-19011-2018::6.1General
→iso-13485-2016::4.1General requirements
iso-19011-2018::6.2Initiating audit
→iso-13485-2016::8.2.4Internal audit
iso-19011-2018::6.2.1General
→iso-13485-2016::4.1General requirements
iso-19011-2018::6.3Preparing audit activities2 targets
→iso-13485-2016::7.5.3Installation activities
→iso-13485-2016::7.5.4Servicing activities
iso-19011-2018::6.3.2Audit planning2 targets
→iso-13485-2016::5.3Quality policy
→iso-13485-2016::7.3.2Design and development planning

+18 more mappings

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Related Comparisons

Other ISO 19011:2018 comparisons

ISO 19011:2018 vs ISO 14001:201546 mappingsISO 19011:2018 vs ISO 14004:201643 mappingsISO 19011:2018 vs ISO 31000:201842 mappingsISO 19011:2018 vs ISO 45001:201839 mappingsISO 19011:2018 vs ISO 27701:201933 mappingsISO 19011:2018 vs ISO 37301:202133 mappingsISO 19011:2018 vs ISO 22000:201831 mappingsISO 19011:2018 vs ISO 37001:201629 mappings

Other ISO 13485:2016 comparisons

ISO 10005:2005 vs ISO 13485:201625 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 mappingsISO 22313:2020 - Guidance on Business Continuity Management Systems vs ISO 13485:201612 mappings

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

ISO 19011:2018 has 55 controls across its framework, while ISO 13485:2016 covers 83 controls. Direct mapping analysis identifies 33 overlapping controls (60% coverage). The frameworks diverge most significantly in Conducting an audit – ISO 19011:2018, where 11 ISO 19011:2018 controls have no direct ISO 13485:2016 equivalent.

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

Of 55 total ISO 19011:2018 controls, 33 map directly to ISO 13485:2016 controls — representing 60% coverage. The remaining 22 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 19011:2018 to ISO 13485:2016?

22 ISO 19011:2018 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Conducting an audit – ISO 19011:2018 with 11 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 19011:2018 and ISO 13485:2016?

The domain with the highest gap count is Conducting an audit – ISO 19011:2018 (11 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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