Implementation of ISO 9001:2015 quality management system in a clinicl [sic] clinical laboratory in the Southern suburb of Beirut

Abstract

Clinical laboratories are known for carrying out medical tests and analyzing body fluids in search for diseases and abnormalities. Over the time, advancements in technology and science resulted in increased tests requests and analysis techniques in addition to increased cost and responsibility. The increased use of technology including machines and laboratory systems created new challenges by creating quality and customer requirements that should be met. Facing these new concerns and challenges is based on achieving the highest level of accuracy and reliability in laboratory tests. For this goal to be achieved, the International Organization for Standardization ISO 9001:2015 Quality Management System (QMS) provided a framework for documenting the essential QMS requirements for organizations, including clinical laboratories, to ensure that quality practices are appropriately implemented, customer requirements are met and customer satisfaction is enhanced with continuous improvement. The aim of this study was to create a QMS based on ISO 9001:2015 requirements in X Medical Laboratory, a small laboratory with basic equipment and tests in the southern suburb of Beirut. In order for this aim to be achieved, objectives were set: conduct a Gap Analysis at X Medical Laboratory and develop procedures consistent with clauses 4,7,8,9,10 of ISO 9001:2015. This standardization system will help X Medical Laboratory in meeting ISO 9001:2015 requirements. To achieve this aim, an internship in X Medical Laboratory was performed and data was collected after continuous observations and interviews. Based on these observations and interviews, a Gap Analysis was conducted in all X Medical Laboratory departments in order to identify key areas (major gaps) that need improvement. Key areas identified, which are key processes, are improved by developing the adequate SOPs, followed by performance measurement using Key Performance Indicators (KPIs) and Risk Assessment. In conclusion, SOPs, Risk Assessment and KPIs were developed for the key areas of improvements which are the Quality Process and the Human Resources Process. This project helped X Laboratory in fulfilling ISO 9001:2015 standard requirements and ensuring continuous improvement.