生物安全实验室质量安全管理体系的构建与应用

Study and Application on the Quality&Safety Management System of Bio-safe Laboratories

本文研究整理了生物安全相关法律法规,探讨了生物安全实验室安全要素及其控制策略。以某海关卫生检疫实验室为例,着重介绍了体系质量安全手册一级文件,尝试建立和运行了低级别(P2及以下)生物安全实验室质量安全管理体系,使其既能满足实验室资质评审要求,又能解决安全管理方面整体性较差、易用性不好、效率不高的问题。

By collecting and sorting safety-relative laws,regulations and other mandatory official documents,this article introduces the safety control scope and requirements,then explores the“basic safety elements”and controlling tragedy.A certain health quarantine laboratory belongs to China Customs applying the management system was investigated,the paper focus on discussing the first level documents of the management system,then establishes and runs the quality&safety management system of P1&P2 level bio-safe laboratory,other than a resolution to improve unity,efficiency,availability of management system,the new system is in accordance with laboratory CMA&Accreditation.