Cross-Framework Mapping

FDA Quality Management System Regulation (QMSR)vsBS 65000:2014 — Guidance on Organizational Resilience

See exactly how FDA Quality Management System Regulation (QMSR) controls map to BS 65000:2014 — Guidance on Organizational Resilience. Pre-computed mappings, identified gaps, and coverage analysis.

14
Controls Mapped
20
Gaps Found
24%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA Quality Management System Regulation (QMSR) maps to BS 65000:2014 — Guidance on Organizational Resilience with 24% coverage across 8 directly mapped controls. Analysis of 34 FDA Quality Management System Regulation (QMSR) controls identifies 26 compliance gaps — primarily concentrated in Design and Development.

Source: TheArtOfService Knowledge Graph | 34 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 6 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Design and Development(4 mappings)

AQAP-5.7Dependability Requirements3 targets
BS65000-IM-01Resilience Assessment
BS65000-IM-03Continuous Improvement
BS65000-RM-03Leadership and Culture
ISO 13485 Cl. 7.3.1Design and Development Planning
ISO-8000-IMP-03Sector Applications

Quality Management System Requirements(3 mappings)

ISO 13485 Cl. 4.1General QMS Requirements3 targets
BS65000-IM-03Continuous Improvement
ISO-8000-IMP-02Quality Improvement
PBD-IMP-03Organisational Integration

Management Responsibility(1 mappings)

ISO 13485 Cl. 5.5Responsibility and Authority
FATF-TR-IMP-03VASP AML/CFT

Production and Process Controls(1 mappings)

ISO 13485 Cl. 7.4Purchasing Controls
ISO-8000-IMP-03Sector Applications

Measurement, Analysis, and Improvement(3 mappings)

ISO 13485 Cl. 8.5.2Corrective Action (CAPA)3 targets
BS65000-IM-03Continuous Improvement
ISO-8000-IMP-02Quality Improvement
PBD-IMP-03Organisational Integration

Regulatory Compliance and Traceability(2 mappings)

§ 820.10(b)Device Tracking
ISO-8000-IMP-03Sector Applications
§ 820.10(c)Medical Device Reporting
ISO-8000-IMP-03Sector Applications

Related Comparisons

Other FDA Quality Management System Regulation (QMSR) comparisons

Other BS 65000:2014 — Guidance on Organizational Resilience comparisons

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What are the key differences between FDA Quality Management System Regulation (QMSR) and BS 65000:2014 — Guidance on Organizational Resilience?

FDA Quality Management System Regulation (QMSR) has 34 controls across its framework, while BS 65000:2014 — Guidance on Organizational Resilience covers 19 controls. Direct mapping analysis identifies 8 overlapping controls (24% coverage). The frameworks diverge most significantly in Design and Development, where 6 FDA Quality Management System Regulation (QMSR) controls have no direct BS 65000:2014 — Guidance on Organizational Resilience equivalent.

How many controls map between FDA Quality Management System Regulation (QMSR) and BS 65000:2014 — Guidance on Organizational Resilience?

Of 34 total FDA Quality Management System Regulation (QMSR) controls, 8 map directly to BS 65000:2014 — Guidance on Organizational Resilience controls — representing 24% coverage. The remaining 26 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 BS 65000:2014 — Guidance on Organizational Resilience?

26 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in BS 65000:2014 — Guidance on Organizational Resilience. The highest concentration of gaps is in Design and Development with 6 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 BS 65000:2014 — Guidance on Organizational Resilience?

The domain with the highest gap count is Design and Development (6 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.