Quality Management in the Medical L

Quality Management in the Medical Laboratory
G E R M A N Y
Special regulation:
1) Accreditation of medical laboratories, based on ISO 15189
is voluntary.
2) Based on ISO 15189 all medical laboratories have to
establish a quality management system, appropriate to the
function of the laboratories. Additionally
- they have to run an internal quality control system.
- they have to participate in 4 external quality assessment
schemes (according to the Guideline of the Federal
Medical Association)
Nevertheless many medical laboratories follow both 1) and 2).