Maps to
FDA QMSR (Part 820): §820.25
ISO 13485: ISO 13485 §6.2
Requirement text
Personnel performing work affecting product quality shall be competent on the basis of education, training, skills, and experience.
Atomic constraints
- •Competency requirements must be defined for each role
- •Training records must be maintained
- •Training effectiveness must be evaluated
- •Training matrix must exist
Evidence signals
- •
FILE_EXISTS
(Training.*Matrix|Competency|Training.*Record|Training.*SOP|Qualification)
- •
CONTENT_MATCH
Does this document describe training requirements, competency assessment, or training records for quality-affecting personnel?
Audit defense
Personnel competency for [your product] manufacturing and quality activities is managed through [your document ID]. Competency requirements are defined for each quality-affecting role, with training records and effectiveness evaluations maintained per QMSR 820.25.