Quality Management System Regulation (QMSR)

The FDA Quality Management System Regulation (QMSR), codified at 21 CFR Part 820, is the FDA's updated quality management system (QMS) framework governing the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices intended for commercial distribution in the United States. The QMSR replaced the former Quality System Regulation (QSR) and took effect on February 2, 2026.

QMSR harmonized FDA’s QMS requirements with ISO 13485:2016, the internationally recognized standard for medical device quality management systems, and ISO 9000:2015 Clause 3. However, ISO certification itself does not fulfill compliance obligations. Manufacturers are responsible for meeting all applicable 21 CFR Part 820 requirements. The QMSR applies to manufacturers of finished devices and device accessories, including contract manufacturers, though certain types of devices are exempt from QMSR compliance.

When does FDA QMSR come into effect?

FDA QMSR is in effect as of February 2, 2026.

What is ISO 9000:2015 Clause 3?

Clause 3 of ISO 9001:2015 is titled "Terms and Definitions" and provides the foundational understanding needed to correctly interpret and apply ISO 9001's requirements. It covers concepts like quality control vs. quality assurance, the definition of a process, and customer satisfaction. Rather than listing definitions within the document itself, it directs readers to the companion standard, ISO 9000:2015 (Quality Management Systems — Fundamentals and Vocabulary), as the primary source for all relevant terminology.

What does “Incorporation by Reference” (IBR) mean?

"Incorporation by reference" means that ISO 13485:2016 is legally adopted as part of the FDA regulations (21 CFR Part 820) without being rewritten verbatim. ISO 13485:2016 and Clause 3 of ISO 9000:2015 are now the foundational standards for QMS compliance for medical devices in the US, though US-specific requirements also apply.  

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