Sr no Description Type(Major/Minor) Comments
1. Deputy Staff list available
2. Updated Organogram available
3. Quality policy available
4. Personal file maintained for all
staff
5. Vaccination (Anti-HbsAg) titre
log updated
6. Authorization log for Equipment
available
7. Safety Audit done
8. Fire and safety training done
9. Fire Extinguisher log updated
10. Hyploochlorite preparation log
updated
11. First aid and spill kit available
12. Accident and incident records
available
13. Biochemistry Analyzer
Calibration and Pm details
available
14. Urine analyzer IQ,OQ,PQ, Cal
and PM record available
15. Hematology Analyzer IQ, OQ,
PQ, breakdown log, service
reports records available
16. HBA1C Analyzer IQ, OQ, PQ,
installation, breakdown, service
reports and Validation records
not available
17. Glucose weighing machine
calibration certificates available
18. Lot to Lot verification records
available
19. Reagent consumption records
maintained
20. Agreement with outsource lab
available
21. Outsource lab evaluation done
22. Vendor list and evaluation
available
23. Patients’ instruction for Sample
collection made available in
sample collection area
24. Sample rejection log maintained
25. Emergency sample logs
maintained
26. Equipment instruction for use is
controlled
27. Equipment breakdown and
service reports maintained
28. IQC planner available
29. QC reconstitution log available
30. Analyte calibration logs
maintained
31. Monthly LJ chart available for
all instruments
32. IQC troubleshooting and CAPA
log implemented
33. EQAS, ILC and Split testing
Planner available
34. ILC performed
35. Split testing done
36. EQAS evaluation form
implemented
37. Retained sample testing done
38. Sample discarding log available
39. Daily NC (with RCA & CAPA)
available)
41. RCA for complaint and its
analysis available
42. Risk assessment done
43. Clinician feedback available
44. Staff suggestion available
45. Previous internal audit file
available
46 Quality indicators available up to
date
