移植用组织库与ISO质量标准

Allograft Tissue Bank and ISO Standard Series

移植用组织库是一个特殊的医学部门,在此人们依照相关原则和操作规程完成组织移取、组织处理、保存、管理和应用等。随着医学和生物技术的迅速发展,由于人体器官和其他生物组织需求量的增加,病毒感染危险性也在增加,这时对组织库在网络基础上的技术合作、标准化制定以及指导原则的国际协同化等问题提出了新要求。组织库主要操作环节包括供体筛查、组织获取、组织处理和组织保存等。要建立一个覆盖组织库特殊性在内的总体质量管理系统,需要采用国际标准(ISO9000)。本文结合对ISO9000质量管理系统(QMS)的各质量元素的认识和分析,对组织库各环节的技术操作和质量要求分别进行阐述,建立了移植用组织库的质量管理、质量计划、质量控制和质量检测等在内的完整质量控制管理系统。

Allograft tissue bank is a particular department in medicine which is established and operated for harvesting, processing, preserving, managing and being to applied the tissues according to the involving principles and procedures. The rapid developments of medicine and biology generated huge improvement to allograft tissue bank in the past decades. Meanwhile, some new requirements of the technology, quality standards in the establishment and application of tissue bank were needed due to the increasing needing of human organs and tissues, increasing risk of virus infection, and the appearance of international coordination of standards and guidelines of tissue bank. Allograft tissue bank procedures donor detection, tissue harvesting processing and preserving. It is possible to establish a general quality management system covering all aspects of allograft tissue bank based on the international standards of ISO 9000. In this paper, in order to establish a whole QMS for quality management, quality plan, quality control and test of allograft tissue bank, on the basis of our practical experience on tissue banking over twenty years, we discussed all the technological steps and requirements of allograft tissue bank with the learning and analysis of all elements in ISO 9000 quality management system （ QMS）.