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.

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