QUALITY MANAGEMENT IN MEDICAL LABORATORIES: EN ISO 15189 REQUIREMENTS FOR IMPLEMENTATION Tıbbi Laboratuvarlarda Kalite Yönetimi: EN ISO 15189 Uygulama Şartları

With each passing day, it is required to use the Total Quality Management and quality standards in the diagnostic laboratories because of the increased number of clinical diagnostic laboratories and technological developments on this subject. In this context, medical laboratories are at the hub of the information flow. Laboratory analysis results affect the clinical decisions at a rate of 75%. Thus, it should be an indispensable policy to deliver the correct and reliable test results. There are some quality standards to be fulfilled in order to implement this policy and to deliver the test results that have the same validity everywhere. To this end, accreditation is an important tool. A medical laboratory should warrant a high quality service to the patients and clinicians during the process which include withdrawing blood from the patients and delivering their results. ISO 15189 is an international standard used by the medical laboratories to enhance their quality management systems and to evaluate their efficiency. This standard is used by the accreditation organizations to recognize and confirm the efficiency of the medical laboratories. In this review, this subject is taken into consideration by reviewing the literature and applying the secondary resources, and aims to provide a theoretical framework for the future studies.