European Journal of Biomedical and Pharmaceutical Sciences

QUALITY MANAGEMENT SYSTEM IN TESTING LABORATORIES

Megha S. Jadhav, Dr. Prashant S. Malpure*, Yuvraj D. Nagare and Vaishanvi S. Nikam

ABSTRACT

A quality management system (QMS) organizes, regulates, and enhances the factors that affect the laboratory's ability to produce the intended results and the users' level of satisfaction. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Furthermore, laboratories can benefit from external quality assurance or assessment (EQA) programs in a number of ways, including method validation, results comparison with other laboratories, problem discovery during testing, compliance with accreditation requirements, and credibility. These programs are a tool to maintain strict control over the laboratory operations and all associated variables (people, equipment, and method) in order to control the quality of the procedures. The benefits of external quality assurance programs are examined and various accessible designs are assessed within the framework of a quality management system. However, past benefits won't materialize until each program's reported results are thoroughly examined. A process is proposed because integrating the EQA results into the laboratory's quality management system yields extra benefits. Furthermore, the laboratory's quality management system's internal controls have been proven effective by the outcomes of external quality assurance procedures.

Keywords: External quality management systems, external quality assurance ,quality control , laboratories , harmonization, quality indicators.