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ISO 15189 CERTIFICATION
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 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.

This International Standard ISO 15189 is the gold standard for certifying medical laboratories as it covers both management and technical requirements needed for assessing the competence of the personnel.

Hence the ISO 15189 certification is an assurance that the laboratory has been assessed against internationally recognized standard which aims to improve the existence of a quality system, technical competence, and that the personnel is actually capable to generate technically valid results and suitable information for the intended use of each test.