CLS 5200 Quality Systems
This course will discuss the concepts of total quality management and the implementation of an effective quality management system (QMS) model based on Clinical and Laboratory Standards Institute (CLSI) QMS01-A4 and ISO15189. Lectures and discussion will focus on the total quality management concepts, quality management system, and quality system essentials. Tools and techniques used in achieving quality objectives and risk assessment will be presented and applied. Case studies will be used to apply lessons learned. The course will also revisit topics as related to method validation and performance specification development for laboratory developed tests as needed - 3 lecture hours.