The purpose of this workshop was to provide the user with the means to create a quality assurance manual that met the requirements of ISO 15189 (International Organization for Standardization standard 15189, Medical laboratories – Particular requirements for quality and competence).
An overview of the manual’s content and structure was presented, which focused on its table of contents, headers and footers, and introduction, as well as the mission, vision, and objectives of the laboratory. Sample quality manuals were reviewed along with quality policy statements. Each quality system essential was presented, with emphasis on policies and processes.
Exercises focused on the development of policies, processes, and procedures. Sample exercises were performed to develop logs and forms, which are essential components of a quality manual. The Key to Quality was provided to each participant as a reference tool for developing his or her own laboratory’s quality manual. The workshop achieved its goal of providing a step-by-step explanation of the creation of an accurate and effective quality manual.