» 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 are a 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.

Further information: 

• Deadline Extension for Transition to BS EN ISO 15189:2012
• Apply for accreditation
• The route to accreditation
• What are the costs of accreditation?
• Government policy on accreditation
• The benefits of accreditation
• CPA (transition)
• Medical Laboratory Accreditation (ISO 15189) - ILAC
• Peer Assessor information and application form
• Accreditation - Delivering patient safety

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.