TheArtOfService
Cross-Framework Mapping

ISO 10005:2005vsISO 13485:2016

See exactly how ISO 10005:2005 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.

25
Controls Mapped
2
Gaps Found
48%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 10005:2005 maps to ISO 13485:2016 with 48% coverage across 13 directly mapped controls. Analysis of 27 ISO 10005:2005 controls identifies 14 compliance gaps — primarily concentrated in Content of the quality plan – ISO 10005:2005.

Source: TheArtOfService Knowledge Graph | 27 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 25 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Content of the quality plan – ISO 10005:2005(20 mappings)

iso-10005-2005::5.1General
→iso-13485-2016::4.1General requirements
iso-10005-2005::5.11Design and development9 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
iso-10005-2005::5.12Purchasing2 targets
→iso-13485-2016::7.4.1Purchasing process
→iso-13485-2016::7.4.2Purchasing information
iso-10005-2005::5.13Production and service provision2 targets
→iso-13485-2016::7.5Production and service provision
→iso-13485-2016::7.5.1Control of production and service provision
iso-10005-2005::5.14Identification and traceability
→iso-13485-2016::7.5.8Identification
iso-10005-2005::5.15Customer property
→iso-13485-2016::7.5.10Customer property
iso-10005-2005::5.16Preservation of product
→iso-13485-2016::7.5.11Preservation of product
iso-10005-2005::5.17Control of nonconforming product
→iso-13485-2016::8.3Control of nonconforming product
iso-10005-2005::5.18Monitoring and measurement2 targets
→iso-13485-2016::8.2Monitoring and measurement
→iso-13485-2016::8.2.5Monitoring and measurement of processes

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Related Comparisons

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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 10005:2005 and ISO 13485:2016?

ISO 10005:2005 has 27 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 13 overlapping controls (48% coverage). The frameworks diverge most significantly in Content of the quality plan – ISO 10005:2005, where 7 ISO 10005:2005 controls have no direct ISO 13485:2016 equivalent.

How many controls map between ISO 10005:2005 and ISO 13485:2016?

Of 27 total ISO 10005:2005 controls, 13 map directly to ISO 13485:2016 controls — representing 48% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 10005:2005 to ISO 13485:2016?

14 ISO 10005:2005 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Content of the quality plan – ISO 10005:2005 with 7 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 10005:2005 and ISO 13485:2016?

The domain with the highest gap count is Content of the quality plan – ISO 10005:2005 (7 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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