This document discusses key aspects of quality management systems for clinical laboratories. It identifies variables that can affect quality like materials, instruments, procedures, personnel and environment. The most common factors affecting quality are listed as temperature variation, expired reagents, uncalibrated equipment, contamination, untrained personnel, incorrect samples, delayed transportation and typographical errors. Responsibility is shared between management, doctors, quality managers, manufacturers and support staff. The document also outlines types of quality control including internal and external quality control. Tools for achieving quality include policies, processes, procedures, records and referral documents.

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