病毒学实验室质量管理体系的建立

Establishment of a Quality Management System for Virological Laboratories

建立既符合我国检验检测机构资质认定和评审通用要求,又适合病毒学实验室质量控制实际情况,能与最新的国际质量管理规范要求相适应,用于指导、规范病毒学实验室质量管理体系建设。结合我国病毒学检测机构的质量管理现状,以新版《检验检测机构资质认定能力评价检验检测机构通用要求》（RB/T214-2017）为基础,参考新版《检测和校准实验室能力通用要求》ISO/IEC17025：2017,增加和扩展了部分关联性强的条款,合并部分关联性弱的条款。建立了病毒学实验室质量管理规范的基本框架,共有22个基本要素、3个特殊条款,共同构成病毒学实验室质量控制和质量管理体系。

The purpose is to establish assessment criteria that satisfy the qualification accreditation criteria for China’s inspection and testing institutions.The system should be suitable for the quality control of virological laboratories,and meet the requirements of international quality management regulations,so as to guide and standardize the quality management system for virological laboratories.The method is to increase and expand some highly associated terms and merge some weakly associated terms,given the current status of quality management in China’s viral disease agencies,based on the ＂ Qualification accreditation criteria for inspection and testing institutions＂（Guorenshi[2016]No.33）and New edition of the international standard ISO/IEC17025：2017 ＂ General requirements for the competence of testing and calibration laboratories＂.Results and Conclusions：The basic framework of quality management regulations for quality control in virological laboratories should be divided into three aspects：quality management,technical management,and environmental protection ＆ safety.There are 22 basic elements,and 3 special terms,which constitute the quality management system for quality control in virological laboratories.