This standard specifies the requirements for quality and qualification of medical testing laboratories (hereinafter referred to as testing laboratories). This standard is used by medical testing laboratories to develop and qualify a quality management system. Laboratory clients, regulatory authorities, and accreditation bodies may also use this standard to confirm or recognize the competence of medical testing laboratories. This standard is not intended to be used as a basis for certifying testing laboratories.
KS P ISO 15189:2013 history
2019KS P ISO 15189-2019 Medical laboratories ─ Requirements for quality and competence
2013KS P ISO 15189:2013 Medical laboratories ─ Requirements for quality and competence
2011KS P ISO 15189:2011 Medical laboratories-Particular requirements for quality and competence