Cross-Framework Mapping

ISO 13485vsISO/IEC 25012:2008 - Data Quality Model

See exactly how ISO 13485 controls map to ISO/IEC 25012:2008 - Data Quality Model. Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
42
Gaps Found
14%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to ISO/IEC 25012:2008 - Data Quality Model with 14% coverage across 2 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 42 compliance gaps — primarily concentrated in Product Realisation.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Improvement(1 mappings)

8.5Control effectiveness review
ISO-25012-4.11Traceability

ISO 13485: Patient Data Protection(1 mappings)

ISO13485-05Audit trail for ePHI access
ISO-25012-4.11Traceability

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What are the key differences between ISO 13485 and ISO/IEC 25012:2008 - Data Quality Model?

ISO 13485 has 44 controls across its framework, while ISO/IEC 25012:2008 - Data Quality Model covers 36 controls. Direct mapping analysis identifies 2 overlapping controls (14% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct ISO/IEC 25012:2008 - Data Quality Model equivalent.

How many controls map between ISO 13485 and ISO/IEC 25012:2008 - Data Quality Model?

Of 44 total ISO 13485 controls, 2 map directly to ISO/IEC 25012:2008 - Data Quality Model controls — representing 14% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 13485 to ISO/IEC 25012:2008 - Data Quality Model?

42 ISO 13485 controls have no direct equivalent in ISO/IEC 25012:2008 - Data Quality Model. The highest concentration of gaps is in Product Realisation 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 13485 and ISO/IEC 25012:2008 - Data Quality Model?

The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.