质量记录一览表01Word文档下载推荐.docx

1、HBM/BD-4-007008外来文件一览表HBM/BD-4-008009查阅登记单HBM/BD-4-009010质量手册修改控制表HBM/BD-4-010011HBM/BD-4-011编号 002 表码：管理评审通知单HBM/BD-5-001纠正和预防措施处理单HBM/BD-5-002管理评审报告HBM/BD-5-003管理评审计划表HBM/BD-5-004编号 003 表码：培训申请报告HBM/BD-6-001培训登记表HBM/BD-6-002车间压差梯值监测记录HBM/BD-6-003品管部职工健康档案HBM/BD-6-004工位器具清洗记录HBM/BD-6-005生技部车间工作服、口罩

2、、鞋帽发放记录HBM/BD-6-006车间工作服、口罩、鞋帽清洗记录HBM/BD-6-007职工个人卫生检查记录HBM/BD-6-008车间尘埃监测记录-十万级HBM/BD-6-009尘埃粒子数监测-万级HBM/BD-6-009-01尘埃粒子数监测-百级操作台HBM/BD-6-009-02012温、湿度监测记录HBM/BD-6-010013菌落数监测记录-十万级HBM/BD-6-011014菌落数监测记录-生物测试室HBM/BD-6-011-01015菌落数监测记录-百级操作台HBM/BD-6-011-02016中央空调、送风系统开启、检修、保养记录HBM/BD-6-01212.05.0101

3、7设备、工装申请报告HBM/BD-6-013018设备开箱验收单HBM/BD-6-014019设备安装调试记录单HBM/BD-6-015编号 004 表码：020部门负责人考核评价记录表HBM/BD-6-016021设备完好核查表HBM/BD-6-017022设备运行记录HBM/BD-6-018023工装模具维修记录HBM/BD-6-019024设备、工装报废申请表HBM/BD-6-020025主要模具清单HBM/BD-6-021026主要设备清单HBM/BD-6-022027设备维修保养计划表HBM/BD-6-023028工艺纪律考核表HBM/BD-6-024029设备登记台帐HBM/BD-

4、6-025030设备改装调试记录单HBM/BD-6-026031设备改进记录HBM/BD-6-027032设备、工装维修申请报告HBM/BD-6-028033设备、工装检修记录表HBM/BD-6-029034设备、工装封存、启封申请单HBM/BD-6-030035工装模具验证报告HBM/BD-6-031036工装模具领用单HBM/BD-6-032037特殊过程设备验证报告HBM/BD-6-033038特殊过程工艺验证报告HBM/BD-6-034编号 005 表码：039年度培训计划HBM/BD-6-035040净化车间环境分析报告HBM/BD-6-036041卫生、环境监测检验报告单（尘埃粒子

5、数监测）HBM/BD-6-037（001）042卫生、环境监测检验报告单（菌落数监测）HBM/BD-6-037（002）043卫生、环境监测检验报告单（换气次数）HBM/BD-6-037（003）044仪器使用、保养记录HBM/BD-6-038045净化车间生产人员手、物体表面细菌检查记录HBM/BD-6-039046车间风速监测记录HBM/BD-6-040047换气次数监测记录-生物测试室HBM/BD-6-040-01048风速监测记录-百级操作台HBM/BD-6-040-02049工艺用水检测记录（微生物限度）HBM/BD-6-041（001）050工艺用水检测记录（热原/细菌内毒素）HB

6、M/BD-6-041（002）051工艺用水检测记录（化学性能）HBM/BD-6-041（003）052工艺用水全性能检测报告HBM/BD-6-042053设备改装审批表HBM/BD-6-043054化学试剂配制记录HBM/BD-6-044055标准液配制及标化记录HBM/BD-6-045056产品留样记录HBM/BD-6-046057留样观察登记台帐HBM/BD-6-047编号 006 表码：058取样记录单HBM/BD-6-048059洁净区域净化系统运行记录HBM/BD-6-049060纯化水用水点电导率监测记录HBM/BD-6-050061纯化水制取记录HBM/BD-6-051062蒸

7、馏水、注射用水制取原始记录HBM/BD-6-052063工艺用水贮器、管道清洗、消毒记录HBM/BD-6-053064设备履历卡HBM/BD-6-054065设备、工装申购报告HBM/BD-6-055066主要设备保养年度计划表HBM/BD-6-056067工位器具明细表HBM/BD-6-057068环氧乙烷灭菌设备每月检修、保养记录HBM/BD-6-058069环氧乙烷灭菌设备每日检修、保养记录HBM/BD-6-059070环氧乙烷灭菌设备每周检修、保养记录HBM/BD-6-060071环氧乙烷灭菌设备每年检修、保养记录HBM/BD-6-061072注塑成型机每日检修、保养记录HBM/BD-

8、6-062073员工花名册HBM/BD-6-063074工作服、口罩、鞋帽消毒（灭菌）记录HBM/BD-6-064075厂区工作环境检查记录HBM/BD-6-065076员工年度业绩考核评表HBM/BD-6-066编号 007 表码：特殊合同评审表HBM/BD-7-001供销部合同更改通知单HBM/BD-7-002销售合同台帐HBM/BD-7-003用户档案HBM/BD-7-004设计和开发转换记录HBM/BD-7-005设计更改通知单HBM/BD-7-006设计更改建议单HBM/BD-7-007设计更改记录单HBM/BD-7-008供方调查表HBM/BD-7-009外购（协）件检验报告单HB

9、M/BD-7-010供方质量及履约能力评定表HBM/BD-7-011质量体系调查表HBM/BD-7-012合格供方名录HBM/BD-7-013采购物质一览表HBM/BD-7-014采购计划HBM/BD-7-015供货合同HBM/BD-7-016外购协议及质保书HBM/BD-7-017请验单HBM/BD-7-018特殊物质采购申请单HBM/BD-7-019编号 008 表码：货位卡HBM/BD-7-020产品合格证HBM/BD-7-021上岗证HBM/BD-7-022入库单HBM/BD-7-023出库单HBM/BD-7-024发货通知单HBM/BD-7-025提货单HBM/BD-7-026计量设

10、备分类台帐HBM/BD-7-027在用计量设备周检历史记录卡HBM/BD-7-028计量设备申购单HBM/BD-7-029计量设备验收单HBM/BD-7-030计量设备周期鉴定计划表HBM/BD-7-031计量设备领用单HBM/BD-7-032计量设备借用单HBM/BD-7-033计量设备移交单HBM/BD-7-034计量设备报废单HBM/BD-7-035鉴定合格证书HBM/BD-7-036合格证HBM/BD-7-037停用证HBM/BD-7-038编号 009 表码：顾客意见反馈卡HBM/BD-7-039售后服务登记表HBM/BD-7-040顾客来电、来函、来访登记表HBM/BD-7-041质量信息反馈单HBM/BD-7-042授权委托书HBM/BD-7-043质量策划任务书HBM/BD-7-044订货记录单HBM/BD-7-045发货清单HBM/BD-7-046采购单HBM/BD-7-047外购（协）件检验原始记录HBM/BD-7-048外购（协）件质量检验台帐HBM/BD-7-049成品入库通知单HBM/BD-7-050退回产品控制表HBM/BD-7-051检验合格证-一次性使用灭菌橡胶外科手套HBM/BD-7-052（001）检验合格证-一次性使用医用橡胶检查手套HBM