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克罗地亚萨格勒布医学研究所和职业健康研究所认证经验。

Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia.

机构信息

Institute for Medical Research and Occupational Health, Zagreb, Croatia.

出版信息

Arh Hig Rada Toksikol. 2020 Dec 31;71(4):312-319. doi: 10.2478/aiht-2020-71-3449.

Abstract

Accreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

摘要

根据国际通用要求对测试和校准实验室的能力进行认证(HRN EN ISO/IEC 17025 标准)已经成为质量管理的广泛接受的方法和测试和校准实验室技术能力、知识和技能的客观证据。2010 年,医学研究所和职业健康研究所(IMROH)的管理系统根据 HRN EN ISO/IEC 17025 标准进行了认证,认证范围包括:放射性测定、环境空气质量测试以及电离辐射防护范围内的测试。该认证涵盖了三个实验室:辐射防护单元、环境卫生单元以及辐射剂量学和放射生物学单元。根据克罗地亚认可机构的规定,第二次重新认证应在 2020 年进行。本文介绍并讨论了 IMROH 在实施该系统的十年中质量管理系统。我们分享了在常规工作、内部审核以及克罗地亚认可机构进行的外部审核中发现的不符合项的经验。经认证的管理系统显著提高了认证单位的绩效,研究所提高了其知名度和营销优势,从而改善了其市场地位。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a19e/7968506/8562ea8fe776/aiht-71-312-g001.jpg

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