ISO 15189:2012

ISO 15189:2012 Medical Laboratory Accreditation

International Standards Observer accredits medical laboratories to the internationally recognized standard ISO 15189:2012, which outlines requirements for quality and competence in medical laboratories.

Accreditation under ISO 15189:2012 encompasses a range of disciplines, including:

» Clinical Biochemistry
» Toxicology
» Endocrinology
» Haematology - Blood Transfusion
» Microbiology - Virology - Parasitology
» Serology - Mycology
» Histopathology
» Cytology - Mortuaries
» Immunology
» Genetics
» Andrology

International Standards Observer also accredits organizations that offer point-of-care testing, aligning with ISO 22870:2006 (Point of Care Testing: particular requirements for quality and competence), in conjunction with ISO 15189:2012 (Medical Laboratories: particular requirements for quality and competence). This accreditation plays a crucial role in instilling and maintaining confidence in point-of-care testing services.

To alleviate confusion arising from the perception that accredited laboratories may not operate a recognized quality management system, a joint ISO-ILAC-IAF communique can be provided to laboratory clients. This serves to demonstrate that the management system requirements of ISO 15189 align with the principles and requirements of ISO 9001.