A review on quality management system in laboratory testing

Abstract

A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Continuous improvement of laboratory quality service is vital to ensure accuracy, reliability, and timeliness of laboratory results. Implementation of the quality management system is an effective way of monitoring and assuring laboratory quality service. Various standards and regulations outline specific requirements for implementing a Quality Management System (QMS) in a laboratory environment, such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493. These standards provide guidelines and criteria for laboratory processes, including testing, calibration, documentation, personnel competency, and overall quality control. This article will discuss the applicable standards and legislation, the 12 essential elements of laboratory QMS, and the role of QMS software in a laboratory environment. The objective of this study is to assess the impact of laboratory quality management system implementation on improving quality laboratory service.