Medical Diagnostics Technical unit 3.5 at a glance

Focus of the technical unit

This technical unit processes accreditations in the area of medical laboratory diagnostics and pathology. It also accredits proficiency testing providers.

Medical laboratories

Accreditations in this area include the following:

  • Clinical chemistry
  • Immunology
  • Transfusion medicine
  • Microbiology
  • Virology
  • Human genetics
  • Point-of-care testing (POCT)

The work of medical laboratories focuses on the analysis of human materials. Medical laboratories often provide the basis for diagnostic and therapeutic decisions. The accreditation of medical laboratories is in accordance with the standard DIN EN ISO 15189. Allowance is also made for “RiLi-BÄK”, the guidance published by the German Medical Association concerning quality assurance in medical laboratory examinations.


In this area, accreditations are granted in the fields of pathology, neuropathology and dermatohistology on the basis of the standard DIN EN ISO/IEC 17020. All pathology institutes are therefore accredited as inspection bodies. The accreditation focuses on the expert assessment of the physician – i.e on the diagnosis. The requirements of the standard ISO 15189 are also taken into account.

Proficiency testing providers

In the field of medical diagnostics, proficiency testing providers are a very important part of the quality assurance system. The accreditation of these organisations is in accordance with DIN EN ISO/IEC 17043 and is a prerequisite for designation as a reference institution by the German Medical Association.


Dr.-medic Simona Curelea

Head of Technical Unit Medical Diagnostics

Dr. Uwe Hildebrandt

Principal Expert Medical Laboratory Diagnostics

Nach oben