兽医实验室质量管理体系与生物安全管理体系的融合探索

Exploration on the Integration of Quality Management System and Biosafety Management System in Veterinary Laboratories

建立融合型质量与生物安全管理体系是实现实验室质量与生物安全目标的重要举措。当前,部分第三方兽医实验室、养殖企业实验室建立的生物安全管理体系,编制的生物安全管理体系文件并不完善。部分兽医实验室以质量管理体系为主框架,补充生物安全相关内容编制而成的质量与生物安全管理体系文件系统性较差,不能满足生物安全的全部要求。本文从质量管理体系与生物安全管理体系运行对象、要素重叠情况出发,深入分析两者的关系,以内部审核要素为实例,探讨质量管理体系与生物安全管理体系融合的方法,以期为兽医实验室建立适宜且符合标准要求的融合型质量与生物安全管理体系提供参考。

For the purpose of achieving the goal of laboratory quality and biosafety,it is an important measure to establish an integrated system of quality and biosafety management.At present,some biosafety management systems established by third-party veterinary laboratories or laboratories affiliated to breeding enterprises as well as their documents concerning biosafety management systems are still incomplete.The documents compiled by some veterinary laboratories through taking their quality management systems as a main framework and supplementing relevant information about biosafety are poorly systematic,and fail to meet all the requirements for biosafety.To this end,the relationship between the quality management system and biosafety management system and overlapping of their elements were further analyzed in the paper.The method to integrate the two systems were discussed by taking the internal audit elements as an example,with a view to providing a reference for veterinary laboratories to establish an appropriate integrated system of quality and biosafety.