ISO 15189

BDS EN ISO 15189 Medical laboratories. Specific requirements on quality and competence

ISO 15189

BDS EN ISO 15189 is based on BDS EN ISO/IEC 17025 and ISO 9001 and although it is not intended to be used for the purposes of certification in fulfilling its requirements, it means that the medical laboratory meets both the requirements for technical competence and the requirements of the management system, which are necessary for the issuance of technically valid results.

The services provided by the medical laboratory are essential for the care of the patient and the medical staff responsible for this care. The results of the services provided by medical laboratories are actively involved in both the diagnosis and treatment of the patient, and in the prevention (prevention) of the disease. They are an important part of patient care, as they "measure health". 

Medical services may include:

• arrangements for requests for testing;

• Patient preparation and patient identification;

• Sampling;

• transport, storage, processing and verification of clinical samples;

• reporting and interpretation of the results;

• Consultations to ensure the safety of staff and compliance with medical ethics and morality in laboratory work.

The introduction and maintenance of a management system according to BDS EN ISO 15189 by medical laboratories and its subsequent assessment of compliance with the requirements of the standard provides confidence in the services offered to patients and the medical personnel responsible for these cares.