The development of Medical laboratory Quality System of the hospital in Health Area 2 to Comply with ISO 15189
Keywords:
ISO 15189, The model for developing to ISO 15189Abstract
Department of Medical Sciences realizes on the quality of medical laboratory by focusing on the accuracy, precision and reliability for the benefit of the patients. The pilot project was initiated by the collaboration between the Department and the Crown Prince Hospital (CPH) Foundation for development of the quality of the CPH laboratories to comply with ISO 15189. The steps of these performances could be a role model for development of other community hospitals. From 2011 to 2015, there were 7 hospital laboratories in Health Area 2 were applied to the laboratory quality development project that was carried out by Regional Medical Sciences Center (RMSC) 2, Phitsanulok. The requirements of ISO 15189 were informed to the hospitals staffs. The stages of development were set. Some processes were supported by RMSC2. The results showed that all applied laboratories were certified for ISO 15189 by The Bureau of Laboratory Quality Standards. This accomplishment of the hospital laboratories in meeting the international standard led to the acceptance of these hospital services for the AEC in the near future.
References
ISO 15189:2007. Medical laboratories -- Particular requirements for quality and competence. Geneva, Switzerland: ISO; 2007.
ISO 15189:2012. Medical laboratories -- Requirements for quality and competence. Geneva, Switzerland: ISO; 2012.
ISO 19011:2011. Guidelines for auditing management systems. Geneva, Switzerland: ISO; 2011.
ISO 22870:2006. Point-of-care testing (POCT) -- Requirements for quality and competence. Geneva, Switzerland: ISO; 2006.
ISO 15190:2003. Medical laboratories -- Requirements for safety. Geneva, Switzerland: ISO; 2003.
กุลนารี สิริสาลี, ไพโรจน์ ลีฬหกุล, สุดารัตน์ มโนเชี่ยวพินิจ, โสภณ สิริสาลี. Clinical laboratory analytical quality. กรุงเทพฯ : เอส.ที.พี.เพรส.จำกัด; 2548.
