2018年3月1日发布2018年3月1日实施CNAS-GL005实验室内部研制质量控制样品的指南Guidanceforthein-housepreparationofqualitycontrolmaterials(QCM)(IDTISOGuide80:2014)中国合格评定国家认可委员会CNAS-GL005:2018第1页共48页2018年3月1日发布2018年3月1日实施目录引言.................................................................31范围.................................................................42规范性引用文件.......................................................43术语和定义...........................................................44质量控制样品.........................................................55质量控制样品的用途...................................................56质量控制样品的内部研制步骤...........................................67样品的技术要求.......................................................67.1基体类型、匹配性及通用性...........................................77.2特性和特性值.......................................................77.3单元规格...........................................................77.4样品总量...........................................................78质量控制样品的制备...................................................88.1取样...............................................................88.2加工处理...........................................................88.3分装和包装........................................................109均匀性..............................................................119.1概述..............................................................119.2分析方法..........................................................129.3均匀性数据的统计处理..............................................1210定值和赋值.........................................................1411稳定性.............................................................1411.1概述.............................................................1411.2稳定性评价.......................................................1511.3质控样有效期评定..............................