All terms
Quality & RiskQuality System
Training Records
Documented evidence personnel have the education, training, and experience for assigned tasks.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
21 CFR 820.25 and ISO 13485 clause 6.2 require establishing competency needs, providing training, and maintaining records that demonstrate personnel are qualified for their roles.What this means in practice
Common audit gaps include missing read-and-understood records for new SOP versions and lack of effectiveness evaluation for safety-critical training.Cross-references
Part of
A larger framework or document this term belongs to.
Primary references
3 sourcesLink health: 2 verified 1 needs review· last checked 2026-05-09
eCFR·1MDIC·1FDA·1
- 1
21 CFR 820.25Needs revieweCFRecfr.gov
- 2
MDIC Case for QualityVerifiedMDICmdic.org
- 3
FDA - Quality SystemsVerifiedFDAfda.gov
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