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Cross-Framework Mapping

FDA Quality Management System Regulation (QMSR)vsIMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)

See exactly how FDA Quality Management System Regulation (QMSR) controls map to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2). Pre-computed mappings, identified gaps, and coverage analysis.

3
Controls Mapped
10
Gaps Found
23%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA Quality Management System Regulation (QMSR) maps to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) with 23% coverage across 3 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 10 compliance gaps — primarily concentrated in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8).

Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 3 of 3 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(3 mappings)

QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→IMO-MSC-FAL-Recover-BackupRestore-ContinuityOfNavigation-LessonsLearned-DrillsIMO MSC-FAL Recover Function - Backup and Restore + Continuity of Navigation + Continuity of Cargo Operations + Continuity of Propulsion + Lessons Learned + Drills + Resilience
QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
QMSR-ISO13485-Sec8Measurement, analysis and improvement (ISO 13485:2016 Section 8)
→IMO-MSC-FAL-Recover-BackupRestore-ContinuityOfNavigation-LessonsLearned-DrillsIMO MSC-FAL Recover Function - Backup and Restore + Continuity of Navigation + Continuity of Cargo Operations + Continuity of Propulsion + Lessons Learned + Drills + Resilience

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Other IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) comparisons

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsIEC 62443 vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsAPI 1164 vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsIAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsOWASP ASVS vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsMITRE D3FEND vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsDAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsNIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappings

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What are the key differences between FDA Quality Management System Regulation (QMSR) and IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) covers 8 controls. Direct mapping analysis identifies 3 overlapping controls (23% coverage). The frameworks diverge most significantly in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8), where 3 FDA Quality Management System Regulation (QMSR) controls have no direct IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) equivalent.

How many controls map between FDA Quality Management System Regulation (QMSR) and IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

Of 13 total FDA Quality Management System Regulation (QMSR) controls, 3 map directly to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) controls — representing 23% coverage. The remaining 10 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

10 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2). The highest concentration of gaps is in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) with 3 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 FDA Quality Management System Regulation (QMSR) and IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

The domain with the highest gap count is QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) (3 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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