某药品企业质量手册

TOC \o "1-5" \h \z INTRODUCT 介绍 3Objective手册编制目的 3HYPERLINK \l "bookmark43" \o "Current Document"1 .

1 介绍 ........................................................................ INTRODUCT3 1.1 Objective 手册编制目的 .................................................................. 3 .2CompanyIntroduction 公司简介 ....................................................... 13 2 QualityManagementSystem 质量管理体系 ................................................ 3 2.1 Range 覆盖范围 ........................................................................ 3 Requirements 文件要求 ..................................................... 2.2DOCUMENT3 2.2.1 QualityManual 质量手册 ............................................................... 4 2.2.2DocumentControl 文件控制 ......................................................... 4 2.2.3RecordsControl 记录控制 ........................................................... 5 ManagementResponsibility 3.WSIIRW ................................................................................................................. 6 3.1 QualityPolic 丫质量方针 ................................................................ 6 策划 ....................................................................... 3.2PLANNING7 3.2.1 QualityObjective 质量目标 ............................................................ 7 3.2.2 QualityManagementSystemPlanning 质量管理体系策划 .................................. 8 职责和权艮 ............................................. 3.3RESPONSIBILITYANDAUTHORITY8 3.3.1 PrescriptionofResponsibilityandAuthority 职责和权，艮规定 .............................. I8 3.3.2 ResponsibilityofQualityManagement 质量管理职责 ....................................... 9 3.3.3QualifiedPerson 质量受权人 ........................................................ 12 3.4ReviewofQualitySystem 质量体系评审 ............................................... 13 4ResourcesManagement 资源管理 ...................................................... 14 4.1 HumanResources 人力资源 ............................................................. 14 4.1.1 ResponsibilitiesandAuthorities 人员职责及分工 .......................................... 14 1.2QualificationandTraining 资质及培训 ................................................ 4.14 4.2Facilities,EquipmentandMeasuringDevices 设施、设备及测量装置 ...................... 15 4.2.1 Facilities,Equipment 设施、设备 ........................................................ 15 4.2.2MeasuringDevices 测量装置 ....................................................... 16 4.3WorkingEnvironment 工作环境 ....................................................... 17 物料 ..................................................................... 4.4MATERIALS18 4.4.1 Purchase 采购 ....................................................................... 18