基于ISO9001的生物样本库质量管理体系构建

Construction of biobank quality management system based on ISO9001

介绍了国家心血管病中心生物样本库质量管理体系构建的思路和步骤，阐述了应用“过程方法”搭建组织结构、识别和分析工作过程、建立管理机制、规范文件记录，并以“PDCA，即Plan（策划）、Do（实施）、Check（检查）、Act（处置）”为核心思想，构建的一套完整的质量管理体系。该体系不仅有助于实现对生物样本库的规范化管理，还将为我国生物样本库行业标准的制定提供实践依据。

The paper presented the thoughts and steps taken by the National Center for Cardiovascular Diseaes in biobank quality management system. By means of ＂ process approach＂, the organizational structure,identification and analysis process were established, along with the management mechanism and normalized documentation. Centering on ＂Plan, Do, Check and Act（PDCA）＂, a complete set of quality management system was established. This system enables normalized management of biobanks in China,and provides practice guidelines for development industry standards of the country as well.