Medical laboratories Accreditation in accordance with DIN EN ISO 15189

The work of medical laboratories focuses on the analysis of biological materials. Medical laboratories often provide the basis for medical diagnoses. Medical laboratory services are therefore essential when it comes to assessing the health of patients and verifying the effectiveness of medical treatment.

The accreditation of medical laboratories is in accordance with the standard DIN EN ISO 15189.

Accreditation in accordance with DIN EN ISO 15189

In the area of conformity assessment, DIN EN ISO 15189 sets out the specific requirements for the quality and competence of medical laboratories. The main focus here is on requirements for quality management systems and general requirements for testing laboratory operations.

Accreditation in accordance with DIN EN ISO 15189 also establishes five further critical criteria for medical laboratories. These include advice on the nature of samples and any testing that may be required, interaction with clinical staff, collaboration with physicians or the evaluation of test results as regards diagnosis and patient care.

Sectors and departments

DAkkS provides accreditation in sectors including medicine, health and forensics in accordance with DIN EN ISO 15189.

Link to sector

The relevant departments are here:

More information

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