ISO 14004:2016vsISO 13485:2016
See exactly how ISO 14004:2016 controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 14004:2016 maps to ISO 13485:2016 with 27% coverage across 13 directly mapped controls. Analysis of 48 ISO 14004:2016 controls identifies 35 compliance gaps — primarily concentrated in Support – ISO 14004:2016.
Source: TheArtOfService Knowledge Graph | 48 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 19 of 19 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Improvement – ISO 14004:2016(1 mappings)
Context of the organization – ISO 14004:2016(2 mappings)
Planning – ISO 14004:2016(3 mappings)
Support – ISO 14004:2016(3 mappings)
Operation – ISO 14004:2016(7 mappings)
Performance evaluation – ISO 14004:2016(3 mappings)
Related Comparisons
Other ISO 14004:2016 comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ISO 14004:2016 and ISO 13485:2016?
ISO 14004:2016 has 48 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 13 overlapping controls (27% coverage). The frameworks diverge most significantly in Support – ISO 14004:2016, where 8 ISO 14004:2016 controls have no direct ISO 13485:2016 equivalent.
How many controls map between ISO 14004:2016 and ISO 13485:2016?
Of 48 total ISO 14004:2016 controls, 13 map directly to ISO 13485:2016 controls — representing 27% coverage. The remaining 35 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 14004:2016 to ISO 13485:2016?
35 ISO 14004:2016 controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in Support – ISO 14004:2016 with 8 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 14004:2016 and ISO 13485:2016?
The domain with the highest gap count is Support – ISO 14004:2016 (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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