ISO/IEC 27014:2020vsFDA Quality Management System Regulation (QMSR)
See exactly how ISO/IEC 27014:2020 controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 27014:2020 maps to FDA Quality Management System Regulation (QMSR) with 10% coverage across 4 directly mapped controls. Analysis of 39 ISO/IEC 27014:2020 controls identifies 40 compliance gaps — primarily concentrated in Clause 7: Governance Objectives and Processes.
Source: TheArtOfService Knowledge Graph | 39 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Clause 1-4: Introduction and Context(3 mappings)
Clause 5: Guiding Principles(2 mappings)
Related Comparisons
Other ISO/IEC 27014:2020 comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 706 frameworks — at a fraction of consulting costs.
Free
- ✓ 706 framework browser
- ✓ Cross-framework mappings (324K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between ISO/IEC 27014:2020 and FDA Quality Management System Regulation (QMSR)?
ISO/IEC 27014:2020 has 39 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 4 overlapping controls (10% coverage). The frameworks diverge most significantly in Clause 7: Governance Objectives and Processes, where 6 ISO/IEC 27014:2020 controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between ISO/IEC 27014:2020 and FDA Quality Management System Regulation (QMSR)?
Of 39 total ISO/IEC 27014:2020 controls, 4 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 10% coverage. The remaining 40 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 27014:2020 to FDA Quality Management System Regulation (QMSR)?
40 ISO/IEC 27014:2020 controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in Clause 7: Governance Objectives and Processes 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 ISO/IEC 27014:2020 and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is Clause 7: Governance Objectives and Processes (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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.