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Cross-Framework Mapping

ISO 13485:2016vsISO 10005:2005

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

25
Controls Mapped
35
Gaps Found
0%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485:2016 maps to ISO 10005:2005 with 0% coverage across 25 directly mapped controls. Analysis of 60 ISO 13485:2016 controls identifies 58 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 20 of 25 mapped controls across 4 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Quality management system – ISO 13485:2016(3 mappings)

iso-13485-2016::4.1General requirements
→iso-10005-2005::5.1General
iso-13485-2016::4.2.4Control of documents
→iso-10005-2005::5.6Control of documents and data
iso-13485-2016::4.2.5Control of records
→iso-10005-2005::5.7Control of records

Management responsibility – ISO 13485:2016(1 mappings)

iso-13485-2016::5.4.1Quality objectives
→iso-10005-2005::5.4Quality objectives

Product realization – ISO 13485:2016(16 mappings)

iso-13485-2016::7.3Design and development
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.10Design and development files
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.2Design and development planning
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.3Design and development inputs
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.4Design and development outputs
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.5Design and development review
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.6Design and development verification
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.7Design and development validation
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.3.8Design and development transfer
→iso-10005-2005::5.11Design and development
iso-13485-2016::7.4.1Purchasing process
→iso-10005-2005::5.12Purchasing
iso-13485-2016::7.4.2Purchasing information
→iso-10005-2005::5.12Purchasing
iso-13485-2016::7.5Production and service provision
→iso-10005-2005::5.13Production and service provision
iso-13485-2016::7.5.1Control of production and service provision
→iso-10005-2005::5.13Production and service provision
iso-13485-2016::7.5.10Customer property
→iso-10005-2005::5.15Customer property
iso-13485-2016::7.5.11Preservation of product
→iso-10005-2005::5.16Preservation of product
iso-13485-2016::7.5.8Identification
→iso-10005-2005::5.14Identification and traceability

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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 10005:2005 comparisons

ISO 9001:2015 vs ISO 10005:20057 mappingsAS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence vs ISO 10005:20055 mappingsISO 31000:2018 vs ISO 10005:20054 mappingsISO 9001 vs ISO 10005:20054 mappingsISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories vs ISO 10005:20053 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs ISO 10005:20053 mappingsASIS SPC.1-2009 - Organizational Resilience Standard vs ISO 10005:20053 mappingsISO/IEC 23894:2023 vs ISO 10005:20053 mappings

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What are the key differences between ISO 13485:2016 and ISO 10005:2005?

ISO 13485:2016 has 60 controls across its framework, while ISO 10005:2005 covers 27 controls. Direct mapping analysis identifies 25 overlapping controls (0% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 17 ISO 13485:2016 controls have no direct ISO 10005:2005 equivalent.

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

Of 60 total ISO 13485:2016 controls, 25 map directly to ISO 10005:2005 controls — representing 0% coverage. The remaining 58 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 10005:2005?

58 ISO 13485:2016 controls have no direct equivalent in ISO 10005:2005. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 17 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 10005:2005?

The domain with the highest gap count is Product realization – ISO 13485:2016 (17 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.