FDA Quality Management System Regulation (QMSR) vs ISO 9001:2015
What is the difference between FDA Quality Management System Regulation (QMSR) and ISO 9001:2015?
FDA Quality Management System Regulation (QMSR) is a quality management framework applying in the United States, with 13 controls across 7 domains. ISO 9001:2015 is a quality management framework applying in International, with 56 controls across 7 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.
FDA Quality Management System Regulation (QMSR)13 controls
ISO 9001:201556 controls
Questions people ask about FDA Quality Management System Regulation (QMSR) and ISO 9001:2015
What is the difference between FDA Quality Management System Regulation (QMSR) and ISO 9001:2015?
FDA Quality Management System Regulation (QMSR) has 13 controls while ISO 9001:2015 has 56 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both FDA Quality Management System Regulation (QMSR) and ISO 9001:2015?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between FDA Quality Management System Regulation (QMSR) and ISO 9001:2015 so you can identify shared requirements and avoid duplicate effort.
How do FDA Quality Management System Regulation (QMSR) and ISO 9001:2015 controls map to each other?
Our platform maps controls between FDA Quality Management System Regulation (QMSR) and ISO 9001:2015 at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, FDA Quality Management System Regulation (QMSR) or ISO 9001:2015?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
FDA Quality Management System Regulation (QMSR) vs SWIFT CSCF5 shared controlsFDA Quality Management System Regulation (QMSR) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements5 shared controlsFDA Quality Management System Regulation (QMSR) vs BRCGS Global Standard for Food Safety Issue 95 shared controlsISO 9001:2015 vs ISO 13485:201614 shared controlsISO 9001:2015 vs ISO 19011:201813 shared controlsISO 9001:2015 vs AS9100D - Aerospace Quality Management System12 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA Quality Management System Regulation (QMSR) and ISO 9001:2015 on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.