All terms
Quality & RiskQuality System
Management Representative
Member of management appointed to ensure QMS processes are established and report on QMS performance.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Required by ISO 13485 §5.5.2 and 21 CFR 820.20(b)(3), the management representative has explicit authority to ensure QMS effectiveness and to escalate issues to top management.What this means in practice
Often confused with the Quality VP - the role is about authority and reporting line, not title.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
ISO·1MDIC·1FDA·1
- 1
ISO 13485:2016VerifiedISOiso.org
- 2
MDIC Case for QualityVerifiedMDICmdic.org
- 3
FDA - Quality SystemsVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.