FDA Quality Management System Regulation (QMSR)vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how FDA Quality Management System Regulation (QMSR) controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 31% coverage across 4 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 9 compliance gaps — primarily concentrated in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status.
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(8 mappings)
Related Comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (332K+)
- ✓ 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 FDA Quality Management System Regulation (QMSR) and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 4 overlapping controls (31% coverage). The frameworks diverge most significantly in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status, where 2 FDA Quality Management System Regulation (QMSR) controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 4 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 31% coverage. The remaining 9 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
9 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status with 2 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is QMSR: Transition Plan from Prior QSR, FDA Inspection Approach, Status (2 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.