医学检验专业人员为成功获得ISO 15189认可需要哪些技能以及应如何获得这些技能。

Department of Medical Biochemistry, Medical Faculty, Pamukkale University, Denizli, Turkey.

EJIFCC. 2018 Dec 5;29(4):264-273. eCollection 2018 Dec.

Clinical laboratories worldwide are accredited according to the "ISO standard, 15189:2012: Medical Laboratories-Requirements for Quality and Competence." Seeking accreditation has many challenges. Success requires the right competencies and knowledge and the right technical expert and trainer to lead the laboratory through the process. The right competencies and knowledge typcially are beyond the core knowledge, skills and attitudes gained during education of laboratory professionals. The main objective of this paper is to discuss what competencies, knowledge and expertise are essential for laboratories to meet accreditation challenges and gain ISO 15189:2012 accreditation.

全球范围内的临床实验室均依据“ISO标准15189:2012：医学实验室——质量和能力要求”进行认可。寻求认可面临诸多挑战。成功需要具备恰当的能力和知识，以及合适的技术专家和培训师来引领实验室完成这一过程。恰当的能力和知识通常超出了实验室专业人员在教育过程中所获得的核心知识、技能和态度。本文的主要目的是探讨实验室为应对认可挑战并获得ISO 15189:2012认可所需的能力、知识和专业技能。