实验室认可条件下动物生物安全实验室档案的规范化管理  

Standardized Management of Animal Biosafety Laboratory Files under Laboratory Accreditation Conditions

作　　者：任小侠[1] 王楠[1] 马苏[1] 辛凌翔[1] 王团结[1] 兰莹 郭辉[1] Ren Xiaoxia;Wang Nan;Ma Su;Xin Lingxiang;Wang Tuanjie;Lan Ying(China Institute of Veterinary Drug Control,Beijing 100081)

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国动物保健》2020年第12期73-75,共3页China Animal Health

基　　金：中国兽医药品监察所所级课题:CNAS认可条件下动物生物安全实验室档案管理模式研究。

摘　　要：动物生物安全实验室是开展兽用生物制品检验的重要场所,在设施运行过程中涉及大量相关文件、记录。本文根据《检测和校准实验室能力认可准则》(CNAS-CL 01:2018)和《实验室生物安全认可准则》(CNAS-CL 05:2015)的相关要求,围绕动物生物安全实验室产生的档案进行细化分类,从档案的建档、管理制度等方面探讨其规范化管理。做好档案的规范化管理工作不仅有利于兽用生物制品检验工作的可追溯性和持续性,也对整个认可体系的质量管理和现场评审认证有着重要作用。Animal biosafety laboratory is an important place to inspect animal biological products,which involves a large number of relevant documents and records during its operation.According to the CNAS-CL 01 and CNAS-CL 05 regulations,this paper classifies the files produced during the operation of animal biosafety laboratory,and discusses the normalization of archives management in the aspects of filing and management regulations.The standardized management of archives is not only conducive to the traceability and continuity of veterinary biological products inspection,but also plays an important role in the quality control and assessment and authentication of the whole accreditation system.

关 键 词：动物生物安全实验室 CNAS 档案管理 

分 类 号：S851.7[农业科学—预防兽医学]