Costco QMS及GMP验厂审核所需文件证件清单.docx

Request Document List (Costco QMS GMP Audit)Costco QMS及GMP验厂审核所需文件证件清单2018-07-18SectionNo.Items 项目与内容Available 提供YES NO N/AGeneral Requirements 一般要求Factory profile工厂概况1.1Brief introduction of factory 工厂简介□ □ □1.2Business license 营业执照□ □ □1.3Organization chart 公司组织架构图□ □ □1.4Factory’s plane figure-factory floor plans (公司)厂区/厂房平面图□ □ □1.5Production process chart 生产工序流程图□ □ □1.6ISO 9000 certificate or other Quality Assurance systems. ISO9000证书或其他质量保证系统□ □ □1.7产品测试报告Relevant product lab test reports□ □ □A. Management Commitment and ContinualImprovement管理承诺和持续改善2.1Quality manual 质量手册□ □ □2.2Quality policy 质量方针□ □ □2.3Procedures 程序文件 （文件，记录，不合格，内审，纠正措施和预防措施控制程序）□ □ □2.4Quality objectives and monitoring records 质量目标和监控记录□ □ □2.5Management review records 管理评审记录□ □ □2.6Documents control records 文件更改收发记录□ □ □B. RiskManagement风险管理3.1External documents list and control records 外来文件清单和管控记录□ □ □3.2Products risk assessment procedure and records 产品风险评估程序和记录□ □ □3.3Products risk assessment action and validation 产品风险评估措施和验证□ □ □C. Quality ManagementSystems质量管理体系4.1Design control procedure 开发设计控制程序□ □ □4.2Design input and review record 设计输入和评审记录□ □ □4.3Verification and validation records 验证和确认记录□ □ □4.4Design testing and record 设计产品检测及报告□ □ □4.5Design output (technical file, BOM, Packing and using description) 设计输出（技术文件，物料单， 包装、使用说明）□ □ □4.6Engineering Change Notice 设计变更记录（ECN）□ □ □4.7Monitoring procedure and records of suppliers/subcontractor 供应商/分包商评审程序及记录□ □ □4.8Qualified supplier list 合格供应商清单□ □ □4.9Order review and customer focus procedure and records 订单评审和客户关注程序及记录□ □ □4.10Complaint handling procedure 客户投诉处理程序□ □ □4.11Complaint handling records (if applicable) 客户投诉处理记录 (如果有)□ □ □4.12Customer satisfication investigation and action records 客户满意度调查和改善措施记录□ □ □4.13Recall procedure and records召回程序和记录□ □ □4.14Internal audit plan and records 内部审核计划、记录□ □ □4.15Records of corrective actions and preventative actions for internalaudit 内审纠正与预防措施记录□ □ □4.16Business emergency contingency pla