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[Accreditation in pathology and neuropathology : Paths and pitfalls].

作者信息

Holl-Ulrich K, Hagel C, Köhler G, Flechtenmacher C

机构信息

Pathologie - Hamburg, Labor Lademannbogen MVZ GmbH, 22339, Hamburg, Deutschland.

Institut für Neuropathologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Deutschland.

出版信息

Pathologie (Heidelb). 2022 Sep;43(5):338-345. doi: 10.1007/s00292-022-01098-w. Epub 2022 Aug 3.

DOI:10.1007/s00292-022-01098-w
PMID:35925317
Abstract

There are many good reasons for accreditation in pathology or neuropathology as per DIN EN ISO/IEC 17020, regardless of the size and range of services of the facility. Only accreditation - in contrast to certification - also confirms professional competence. This article describes how to establish a quality management system that conforms to standards as effectively as possible and how to maintain it, involve staff, and avoid common pitfalls. Adequate resources and active management support are essential. In this way, not only can accreditation succeed, but the facility itself and its employees can benefit from quality management in their daily work.

摘要

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Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology.法规(EU)2017/746(IVDR):病理学中附件 I 的实际实施。
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[Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology].

本文引用的文献

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[Structure and content of the EU-IVDR : Current status and implications for pathology].[欧盟体外诊断医疗器械法规的结构与内容:现状及对病理学的影响]
Pathologie (Heidelb). 2022 Sep;43(5):351-364. doi: 10.1007/s00292-022-01077-1. Epub 2022 May 19.
[欧盟第2017/746号法规(体外诊断医疗器械法规):附件I在病理学中的实际应用]
Pathologie (Heidelb). 2023 Nov;44(6):381-391. doi: 10.1007/s00292-023-01231-3. Epub 2023 Oct 4.