» Medical Laboratory accreditation (ISO 15189)
Medical Laboratory accreditation (ISO 15189)
UKAS provides accreditation to the internationally recognised standard ISO 15189:2012 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
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 17043:2010, Conformity Assessment – General requirements for proficiency testing.
UKAS 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.
- 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
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.