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).
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