TheArtOfService
Cross-Framework Mapping

ISMAP (Japan)vsFDA Quality Management System Regulation (QMSR)

See exactly how ISMAP (Japan) controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
6
Gaps Found
25%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISMAP (Japan) maps to FDA Quality Management System Regulation (QMSR) with 25% coverage across 2 directly mapped controls. Analysis of 8 ISMAP (Japan) controls identifies 6 compliance gaps — primarily concentrated in ISMAP Assessment + International Coordination.

Source: TheArtOfService Knowledge Graph | 8 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.

ISMAP Cloud Governance(1 mappings)

ISMAP-CloudGovernance-ISMS-RiskAssessment-SharedResponsibility-Policy-RegulatoryCompliance-RolesResponsibilitiesISMAP Cloud Governance - ISMS per ISO 27001/JIS Q 27001 + Risk Assessment + Shared Responsibility Model + Cloud Security Policy + Regulatory Compliance + Roles and Responsibilities
→QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

ISMAP Data Protection(1 mappings)

ISMAP-DataProtection-Classification-Encryption-DataResidencyJapan-Backup-SecureDeletion-Cryptography-FIPSISMAP Data Protection - Data Classification + AES-256 Encryption At Rest + TLS 1.3 In Transit + Data Residency Japan + Backup + Secure Deletion + Cryptography per FIPS 140-3 + CRYPTREC + KMS HSM
→QMSR-820.45Device labelling and packaging controls (§820.45)

Related Comparisons

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Other FDA Quality Management System Regulation (QMSR) comparisons

ICH E6(R3) - Good Clinical Practice vs FDA Quality Management System Regulation (QMSR)6 mappingsSWIFT CSCF vs FDA Quality Management System Regulation (QMSR)5 mappingsISO 45001:2018 vs FDA Quality Management System Regulation (QMSR)5 mappingsISO 20000-1 vs FDA Quality Management System Regulation (QMSR)5 mappingsISO 14001 vs FDA Quality Management System Regulation (QMSR)5 mappingsAS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence vs FDA Quality Management System Regulation (QMSR)5 mappingsBRCGS Global Standard for Food Safety Issue 9 vs FDA Quality Management System Regulation (QMSR)5 mappingsISO 9001:2015 vs FDA Quality Management System Regulation (QMSR)5 mappings

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What are the key differences between ISMAP (Japan) and FDA Quality Management System Regulation (QMSR)?

ISMAP (Japan) has 8 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 2 overlapping controls (25% coverage). The frameworks diverge most significantly in ISMAP Assessment + International Coordination, where 1 ISMAP (Japan) controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between ISMAP (Japan) and FDA Quality Management System Regulation (QMSR)?

Of 8 total ISMAP (Japan) controls, 2 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 25% coverage. The remaining 6 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISMAP (Japan) to FDA Quality Management System Regulation (QMSR)?

6 ISMAP (Japan) controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in ISMAP Assessment + International Coordination with 1 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 ISMAP (Japan) and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is ISMAP Assessment + International Coordination (1 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.