IJCA Vol 4 Issue 1 - Flipbook - Page 50
50 The International Journal of Conformity Assessment
The Evolution of Quality Management in Laboratory
Services: Ensuring Accuracy, Safety, and E昀케ciency
By Vikash Chandra Mishra, PhD, Quality Manager, Chimera Transplant Research Foundation, New Delhi, India; Dinesh
Chandra, MSc (Biotechnology), Assistant Quality Manager, Chimera Transplant Research Foundation, New Delhi, India; and
Vimarsh Raina, MD (Pathology), Medical Director, Chimera Transplant Research Foundation, New Delhi, India
DOI: 10.55459/IJCA/v4i1/VM.DC.VR
-ABSTRACTQuality management (QM) is a critical component of laboratory services and has evolved significantly to
improve the accuracy, reliability, and consistency of test results while meeting increasing demands for patient
safety and regulatory compliance. This article highlights the historical development of quality management
practices in laboratory settings, key milestones, and recent advancements, including the implementation of
quality management systems, adherence to global (like ISO) standards, and the integration of technology to
enhance both patient outcomes and operational efficiency.
Keywords: Quality Management, Quality Management System, ISO, Laboratory
Historical Development
Early History
In its early stages, laboratory testing lacked de昀椀ned
processes and procedures, focusing primarily on
scienti昀椀c innovation rather than standardized protocols.
Results often relied on individual expertise, and there
was little to no quality assurance. Without established
procedures, laboratory services operated informally.
The foundation of the International Organization
for Standardization (ISO) marked a turning point
toward standardized laboratory techniques. Early ISO
standards emphasized accuracy and reproducibility,
laying the groundwork for modern quality
management (QM) practices [1, 2].
Development of Standards and Guidelines
In 1968, the Clinical Laboratory Standards Institute
(CLSI), formerly known as the National Committee for
Clinical Laboratory Standards (NCCLS), introduced
guidelines for laboratory practice, which helped
promote quality control (QC) in clinical settings [3].
The Clinical Laboratory Improvement Amendments
(CLIA) of 1988 further advanced laboratory quality in
the United States by requiring laboratories to meet
stringent standards of practice and seek accreditation
from approved organizations [4].
Quality Control and Management Integration
These developments helped QC approaches gain
broader acceptance in the 1970s and 1980s. To
ensure consistency in 昀椀ndings, laboratories began
adopting control samples, calibration methods, and
pro昀椀ciency testing through internal quality control
(IQC) and external quality assessment (EQA) [5]. The
introduction of total quality management (TQM) to
laboratories in the 1990s further enhanced work昀氀ows,
operations, training, and equipment maintenance. In
addition, the implementation of the ISO 9000 series
and ISO 15189 standards helped establish norms for
competence and quality in laboratory services [6].
Technological Advancements and Modern QMS
In recent decades, technological innovations such as
digital tools, automation, and laboratory information
management systems (LIMS) have simpli昀椀ed
laboratory procedures, reduced human error, and
increased testing capacity—ultimately enhancing
e昀케ciency [7].
Today, modern laboratories implement quality
management systems (QMS) that integrate leadership,
strategy, process control, and continuous improvement
to ensure compliance and reliable results.
Current Scenario
From its informal and unstructured beginnings,
the 昀椀eld has evolved into a highly structured and
regulated discipline, ensuring robust test accuracy
and reliability through the adoption of standards
such as ISO 9001 (quality management systems),
ISO 17025 (competence of testing and calibration
laboratories), ISO 15189 (quality and competence in
medical laboratories), and ISO 17043 (competence of
pro昀椀ciency testing providers).
