Quality Management System
The organizational structure, processes, and resources a manufacturer implements to consistently design, manufacture, and support devices meeting regulatory and quality requirements.
Definition
A quality management system is the set of interrelated processes, documented procedures, and management structures a manufacturer uses to ensure that devices are consistently designed, produced, and monitored to meet applicable regulatory requirements and their own quality objectives. ISO 13485:2016 is the internationally recognized QMS standard specific to medical devices, structured around a process approach covering management responsibility, resource management, product realization (including design controls), and measurement/analysis/improvement, including corrective and preventive action (CAPA). In the United States, FDA's Quality System Regulation, 21 CFR Part 820, historically ran in parallel to ISO 13485 with some differences; the Quality Management System Regulation (QMSR), effective February 2, 2026, replaces the Part 820 requirements by incorporating ISO 13485:2016 by reference, substantially harmonizing the US and international frameworks.What this means in practice
A certified or FDA-compliant QMS is a prerequisite for market access under both the EU MDR/IVDR (via notified body QMS certification, typically under Annex IX) and the US FDA framework (via QMSR conformance, subject to FDA inspection). Manufacturers commonly maintain a single integrated QMS referencing ISO 13485:2016 to satisfy both regimes, supplementing it with jurisdiction-specific procedures (e.g. MDR vigilance reporting timelines, US Medical Device Reporting).- •Assuming ISO 13485 certification alone satisfies all US FDA QMSR expectations without reviewing the specific FDA amendments and definitions layered onto the incorporated standard.
- •Treating the QMS as a documentation exercise for audits rather than an operating system that should demonstrably drive day-to-day design, production, and CAPA decisions.
- •Failing to update QMS procedures promptly when regulatory requirements change (e.g. new vigilance timelines, new UDI requirements), leaving the documented system out of sync with actual practice.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsStructured process governing the design of medical devices.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
The lifecycle process defined by ISO 14971 for identifying, analyzing, evaluating, controlling, and monitoring risks associated with a medical device throughout its life cycle.
International standard for medical device quality management systems.
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Verification step confirming a corrective or preventive action actually fixed the problem.
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Process for receiving, evaluating, and responding to device complaints.
Where this term appears across MedTech Terms.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1ISO 13485:2016Tier 1 VerifiedISOiso.org
- 221 CFR Part 820, Quality System Regulation / QMSRTier 1 VerifiedeCFRecfr.gov
- 3FDA, Quality Management System Regulation Final RuleTier 1 UncheckedFDAfederalregister.gov
Inline markers like [1] jump to the matching reference above.