Accreditation according to EN DIN 45004 is a new way of documenting quality assurance and competence in pathology institutes and practices. In addition to a quality-assurance program according to ISO 9002, the accreditation requires the demonstration of diagnostic competence to a panel of experts. Accreditation results in a marked improvement of diagnostic quality and appears suitable to document special competence in pathology according to a flexible internationally-recognized norm. The evaluation of both process- and outcome quality makes it superior to a formal quality management.
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