What is ISO 15189 standard?

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to laboratories. The revised version was published in the year 2012 which cancels and replaces the older version which was released on 2007. The standard was developed by ISO’s technical committee- ISO/TC 212. They assigned working group ISO 15189 to prepare the standard based on the details of ISO/IEC 17025:1999 (General requirements for the competence of testing and Calibration laboratories). The standard establishes a stringent set of quality management requirements specifically for laboratories at every level of the health care system. Some of the standard’s objectives for lab operations include ensuring the quality and traceability of patients’ information, maintaining the safety and integrity of lab materials, monitoring the facility’s environmental conditions, and supporting public health decision-making. Visit:iso 15189 malaysia