TOTAL QUALITY MANAGEMENT FOR CLINICAL LABORATORIES - A NEED OR A NEW FASHION

In most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general s tandards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implem entation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical compete nce must be examined, but also if there is a real contact between path ologists and clinicians and if laboratory results are clinically valid ated (clinical audit). This new vision on quality in medical laborator ies will ask a reconsideration of the tasks, duties and knowledge of c linical pathologists.