» Medical Laboratory accreditation (ISO 15189)

Medical Laboratory accreditation (ISO 15189)

UKAS provides accreditation to the internationally recognised standard ISO 15189 Medical Laboratories – requirements for quality and competence. 

UKAS accreditation covers the following disciplines: 

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

All CPA (UK) Ltd. customers are currently in the process of transitioning from CPA accreditation to UKAS accreditation against ISO 15189. If you you are Technical/Peer Assessor or a CPA customer, you may find the CPA Transition page useful. 

Medical laboratories can also be accredited as an External Quality Assurance Provider (EQA) to ISO/IEC 17043, Conformity Assessment – General requirements for proficiency testing.

UKAS also accredits organisations which provide point of care testing against ISO 22870 (Point of Care Testing: particular requirements for quality and competence), applied in conjunction with ISO 15189 (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.

For commissioners

Further information: 

 

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.