Construction of biobank quality management system based on ISO9001 / 中华医院管理杂志

ABSTRACT

The paper presented the thoughts and steps taken by the National Center for Cardiovascular Diseaes in biobank quality management system.By means ofprocess approach,the organizational structure,identification and analysis process were established,along with the management mechanism and normalized documentation.Centering onPlan,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.