ISO 15189 Medical laboratories – Requirements for quality and competence is an international standard that establishes specific quality management system requirements for laboratories. A revised version was published in 2012 which cancels and replaces the older version released in 2007. This standard was developed by the technical committee ISO – ISO / TC 212. They commissioned the ISO 15189 working group to prepare the standard based on the details of ISO / IEC 17025:1999 (General requirements for competence of testing and calibration laboratories). This standard establishes a stringent set of quality management requirements specific to laboratories at every level of the health care system. Some of the standard objectives for laboratory operations include ensuring the quality and traceability of patient information, maintaining the safety and integrity of laboratory materials, monitoring facility environmental conditions, and supporting public health decision making.
To see this working, head to your live site.