Cross-Framework Mapping

ISO 13485vsGS1 Global Standards - Supply Chain Traceability and Data Security

See exactly how ISO 13485 controls map to GS1 Global Standards - Supply Chain Traceability and Data Security. Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
42
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to GS1 Global Standards - Supply Chain Traceability and Data Security with 9% coverage across 1 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 43 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 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Improvement(2 mappings)

8.5Control effectiveness review2 targets
GS1-DataSecurity-Integrity-AccessControlGS1 Data Security and Integrity in Exchange, Access Control and Tamper Evidence
GS1-Traceability-Healthcare-FMD-MDR-DSCSA-UDIGS1 Supply Chain Traceability, Healthcare + Pharma + Food Sectors, EU FMD + MDR + IVDR + TPD, FDA DSCSA + UDI

Related Comparisons

Other ISO 13485 comparisons

Other GS1 Global Standards - Supply Chain Traceability and Data Security comparisons

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • 718 framework browser
  • Cross-framework mappings (330K+)
  • 824 compliance assessments
  • 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • Unlimited AI Compliance Advisory
  • Unlimited full-text search
  • Framework self-assessment
  • PDF, Excel & CSV exports
Start 7-Day Free Trial →

What are the key differences between ISO 13485 and GS1 Global Standards - Supply Chain Traceability and Data Security?

ISO 13485 has 44 controls across its framework, while GS1 Global Standards - Supply Chain Traceability and Data Security covers 13 controls. Direct mapping analysis identifies 1 overlapping controls (9% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct GS1 Global Standards - Supply Chain Traceability and Data Security equivalent.

How many controls map between ISO 13485 and GS1 Global Standards - Supply Chain Traceability and Data Security?

Of 44 total ISO 13485 controls, 1 map directly to GS1 Global Standards - Supply Chain Traceability and Data Security controls — representing 9% coverage. The remaining 43 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 GS1 Global Standards - Supply Chain Traceability and Data Security?

43 ISO 13485 controls have no direct equivalent in GS1 Global Standards - Supply Chain Traceability and Data Security. 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 GS1 Global Standards - Supply Chain Traceability and Data Security?

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.