ISO 15189:2012 Medical Laboratory Accreditation

International Standards Observer provides accreditation to the internationally recognised standard ISO 15189:2012 Medical Laboratories requirements for quality and competence.

ISO 15189:2012 accreditation covers the following disciplines:

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

Internation Standards Observer also accredits organisations which provide point of care testing against ISO 22870:2006 (Point of Care Testing: particular requirements for quality and competence), applied in conjunction with ISO 15189:2012 (Medical Laboratories: particular requirements for quality and competence). This accreditation is an important element in establishing and maintaining confidence in a point of care testing service.

In order to address the confusion caused by the perception that accredited laboratories do not operate a recognised quality management system, a joint ISO-ILAC-IAF communique can be provided to laboratory clients to demonstrate that the management system requirements of ISO 15189 meet the principles and requirements of ISO 9001.

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