Implementation of Compliance Based Quality Management Systems in Medical Diagnostic Laboratories Benchmarked for Accreditation

Abstract

The present study was undertaken to follow up of implementation of current regulatory compliance related to quality systems in medical testing laboratories. Accreditation is the process which ensures that certification practices are implemented in laboratories to enhance their quality and efficiency. It in turn helps laboratories to improve technical processes, achieve competitive advantage and increase market share. To achieve accreditation, successful implementation of the laboratory quality management system (LQMS) is a requisite. In this study, evaluation of quality system implementation in small, medium and large sized laboratories, covering management and technical requirements were carried out. The objective of the present study was to identify, improve and maintain the implementation of quality system standard in the laboratory process and discuss the measures to achieve the current requirements of quality systems in the testing laboratories The study analysis was carried out by scoring the implementation of quality system in various operational activities of laboratory system. Data was gathered by auditing the laboratories using check list for the purpose of international organization for standardization (ISO) quality management system implementation. This study, emphasize that training is an essential element, and can play a major role in creating awareness and understanding to implement quality system in medical testing laboratory. There should be real time training on various aspects of laboratory activities. The training needs should be evidence based and assess the competency of laboratory staff, and evaluate staff performance in order to maintain world class service of the laboratory. The quality indicators can be used for benchmarking and improving services. The study concludes that LQMS in medical testing laboratories explicate the need for understanding current standard requirements of quality system implementation and maintenance to improve the quality of service of the laboratories and facilitate accreditation. A break down in implementation of quality systems can cause a decline in quality services and hence accreditation.