Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare

This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the ‘quality management project’ are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members’ skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities. 本文参考了帕多瓦大学临床生物伦理实验室（意大 利）的质量管理过程，该过程已通过ISO 9001：2008 质量认证，作为临床道德支持服务。其活动主要包括 临床伦理咨询和培训服务，针对那些被要求在临床环 境中具有伦理意义的决策者，提出一种结构化方法来 识别和分析可能在健康专业人员和患者之间关系中出 现的伦理问题并参与他们的解决方案。 应用ISO 9001的预期好处主要有以下几点：正式确定 临床道德咨询和培训所采用的程序，获得对文件，信 息和数据的受控管理，以确保和展示所提供活动的质 量，并使方法和组织公开可用。 “质量管理项目”取得的主要成果概括如下：阐述LCB 使命和质量方针;起草提供临床道德咨询的程序;成员技 能的正规化以及相关过程和结果指标的采用。 我们的经验可能有助于促进对道德咨询服务质量的责 任。我们认为认证过程是对当前医疗保健环境中最关 键任务之一进行透明和可靠管理的一种工具，它激励 类似的设施使用类似的工作方式，目的是对其活动提 供质量控制 本文參考了帕多瓦大學臨床生物倫理實驗室（意大 利）的品質管理過程，該過程已通過ISO 9001：2008 品質認證，作為臨床道德支持服務。其活動主要包括 臨床倫理諮詢和培訓服務，針對那些被要求在臨床環 境中具有倫理意義的決策者，提出一種結構化方法來 識別和分析可能在健康專業人員和患者之間關係中出 現的倫理問題並參與他們的解決方案。 應用ISO 9001的預期好處主要有以下幾點：正式確定 臨床道德諮詢和培訓所採用的程序，獲得對文件，信 息和數據的受控管理，以確保和展示所提供活動的品 質，並使方法和組織公開可用。 “品質管理項目”取得的主要成果概括如下：闡述LCB 使命和質量方針;起草提供臨床道德諮詢的程序;成員技 能的正規化以及相關過程和結果指標的採用。 我們的經驗可能有助於促進對道德諮詢服務品質的責 任。我們認為認證過程是對當前醫療保健環境中最關