Capacity Building of Laboratory for In Vitro Diagnostic of Blood Transmitted Diseases to Comply with Requirements of ISO/IEC 17025:2005

Abstract

       Development of quality management system of in vitro diagnostics (IVD) for blood transmitted diseases laboratory, Institute of Biological Products, Department of Medical Sciences, has been conducted under the capacity building plan of the Institute in order to assure the quality of IVD for blood transmitted diseases and reducing the risk of fault in screening of blood donors which will affect the quality and safety of blood products. The laboratory system has been developed through Public Sector Management Quality Award (PMQA) processes, including executive’s policy; planning; customer and stakeholder focus; information and analysis; human resource focus; and operations focus in conjunction with ISO/IEC 17025:2005 requirements. As a result of this development, the laboratory has been certified for ISO/IEC 17025:2005 with the key success factors including executive’s policy; human competency development and appropriate operations in accordance with the quality system’s requirements.