ISO 15189 accreditation: Navigation between quality management and patient safety
In this 2017 paper by Plebani and Sciacovelli of the University Hospital of Padova, the duo offer their insights into the benefits and challenges of a clinical laboratory getting ISO 15189 accredited. Noting that in the European theater “major differences affect the approaches to accreditation promoted by the national bodies,” the authors discuss the quality management approach that ISO 15189 prescribes and why its worth following. The conclude that while laboratories can realize “world-class quality and the need for a rigorous process of quality assurance,” it still requires a high level of awareness among staff of the importance of ISO 15189 accreditation, an internal assessment plan, and well-defined, “suitable and user-friendly operating procedures.”
