[Certification of pathology institutions --a new direction? The view of a certification institute]

A variety of standards for quality-management systems is presently applied in German healthcare institutions, ranging from the international standard ISO 9001:2000 to specific national models like KTQ for hospitals. Pathology institutes currently apply the ISO 9001 in the context of a certification, or alternatively the ISO 17020 as a basis for accreditation. The present article illustrates the different quality-management systems in view of their application in pathology. The focus is placed on the ISO 9001, since this broader system serves the needs of smaller private institutions as well as those of university institutes. For the latter, in addition, ISO 9001 provides the opportunity to include research and teaching activities. Examples of how to conform with the ISO 9001 standard are discussed.