INTRODUCTION
About IS0 15189 Standard and its importance ISO 15189 is an international standard, prepared the International Organization for Standardization (popularly referred to as ISO, which brings together a worldwide federation of national standardization bodies to formulate standards), that specifies requirements for competence and quality that are specific for medical laboratories to meet both the technical competence and management system requirements necessary for delivering consistent technically valid results. It is based upon ISO/IEC 17025 and ISO 9001 and deals with the important aspects and processes in a medical laboratory such as arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, interpretation and reporting of results, etc.
Background
Medical Laboratories play an important role in the Health Care System. The results obtained from Medical Laboratories are critical for detection of disease in individuals and populations as well as for the proper treatment provided to the patients. Quality management has been around for long time and the quality management system (QMS) model has been adapted to the medical laboratory environment through the use of international standards such as ISO 15189. Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. To be useful, laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely. Some significant consequences of poor quality in the laboratory can include unnecessary treatment or treatment complications, failure to provide correct treatment, delayed diagnosis, and
unnecessary follow-up diagnostic testing. These consequences result in increased cost in time and work, as well as poor patient outcomes.
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