1. Q U A L I T Y M A N A G E M E N T
S Y S T E M I N B R I E F
By Dr Mayuri Rani
2. VA R I A B L E S
A F F E C T I N G
Q U A L I T Y
• Material (reagents and consumables)
• Instruments
• Procedure
• Personnel
• Environment
• Patient Samples
• Contamination
• Kit Instructions from manufacturer
3. M O S T C O M M O N F A C T O R S A F F E C T I N G
Q U A L I T Y
Temperature variation Expired reagent
Non calibration of
equipment
Contamination of
reagents
Untrained operating
personnel
Incorrect type of
sample and wrong
patient sample
Delayed
transportation and
transportation in
wrong Temperature of
samples and reagents
Typographical error in
reports
4. R E S P O N S I B I L I T Y
Management
Doctors
Quality manager
Manufacturers
Vendors
Support staff
5. T Y P E S O F
Q U A L I T Y
C O N T R O L
• Internal quality control
• External quality control
6. I Q C
Preanalytical procedure
Analytical procedure
Post analytical procedure
Use of split testing/inter personnel comparison
7. E X T E R N A L
Q U A L I T Y
C O N T R O L
• Inter laboratory quality control
• External quality assurance scheme
8. M E A S U R E M E N T
O F Q U A L I T Y
• CV percentage
• Measurement uncertainty
• LJ charts
• SD
9. T O O L S F O R
A C H I E V I N G
Q U A L I T Y
• Policies(what to do?)
• Processes(way of doing it)
• Procedure/SOP(how to do it)
• Records (written evidence like
temperature log sheet/ daily qc
running records etc)
10. R E F E R R A L
D O C U M E N T S T O
B E U S E D
• ISO 15189 2022
• NABL 112
• Standard textbooks
• Kit inserts
