Accreditation in pathology and neuropathology in Germany : General regulations and requirements

Abstract

Accreditation in pathology and neuropathology in Germany is based on the requirements of the DIN EN ISO/IEC 17020 standard, which defines general requirements for the bodies performing inspections. In Germany, the national accreditation body of the Federal Republic of Germany (DAkkS) assumes the official task of accreditation. Evaluation in this area is based on acomprehensive assessment by board-certified pathologists (inspection) and is focused on correct diagnosis. The requirement of the DIN EN ISO 15189 standard on quality and competence in medical laboratories is taken into account. In Germany, more than 100 institutes of pathology and neuropathology have successfully performed the accreditation process. Interest in accreditation has been significantly growing in recent months, especially due to changes in the European law with the "Verordnung EO 2017/746 des Europäischen Parlaments und des Rates vom 05.April 2017 über Invitro-Diagnostica".However, accreditation is ademanding process that requires very good preparation. Necessary resources for accreditation should be secured before starting the process. Important framework conditions and requirements, but also some challenges that can arise during the accreditation process, are summarized in this article.