本文件为生物银行如何实施质量管理提供了指导， ISO 20387的管理和技术要求。它扩展了ISO 20387和 提供示例以供说明。本文件的目的是帮助生物银行解决 人员能力以及生物材料和数据收集的适当质量。这 该文件同样适用于新建立的和现有的生物库。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks.All current amendments available at time of purchase are included with the purchase of this document.