Medical Device Quality Audit Form
Device Name
Device Model/Type
Serial Number
Department
Audit Date
Auditor Name
Checklist
Audit Area
Compliant
Non-compliant
N/A
Comments
Documentation (User Manual, Certificates, etc.)
Device Labelling & Identification
Calibration & Maintenance Records
Functional Testing
Cleaning & Disinfection Procedures
Non-conformities / Corrective Actions Required
Additional Notes
Auditor Signature
Date