QUALITY AND COMPETENCE OF CLINICAL ANALYSIS LABORATORIES REFERRING TO ISO 9001 AND ISO 15189

Abstract

The Quality Management System (QMS), which is normally regulated by ISO 9001 and ISO 15189, can manage and guarantee the quality of an organization provided by the resources necessary for operational procedures and processes. Continuous improvement and accuracy of results prior to the diagnostic decision depend on internal quality management in the healthcare sector, especially in clinical analysis laboratories. To implement an important system that allows rapid laboratory tests to be carried out and results to be delivered quickly. Due to financial difficulties and increasing technological complexity, clinical laboratories have experienced a series of changes in recent years. This is done through the daily use of clinical analysis laboratories, which provide quick and synthesized access to scientific results on the scientific area. Many benefits can be obtained from having a quality management system aware of the importance of agility in carrying out exams and delivering results to the patient for diagnostic purposes. Companies become more internally organized by standardizing administrative and technical processes and defining responsibilities. This results in less waste and less rework, which results in better quality of products and services, as well as greater production efficiency. When a company adopts a Quality Management System, it can carry out its activities in an organized and standardized way, meeting the needs of its customers and continually improving its processes.