1.质量体系文件：质量手册、SOP/SIP、内部审核报告、管理评审记录
Quality System Docs: Quality Manual, SOP/SIP, Internal Audit Report, Management Review Records
2.资质合规文件：营业执照、生产许可证、ISO 9001 证书（有效期内）
Qualification Docs: Business License, Production License, Valid ISO 9001 Certificate
3.供应商管理：合格供方名录、年度评估报告、高风险物料第三方检测报告
Supplier Management: Approved Supplier List, Annual Evaluation Report, Third-party Test Reports for High-risk Materials
4.检验记录：来料（IQC）、过程（IPQC）、成品（OQC）检验记录（含 AQL 抽样标准）
Inspection Records: IQC/IPQC/OQC Records (Including AQL Sampling Standard)
5.设备管理：设备台账、维护计划、校准记录（内校 / 外校报告）
Equipment Management: Equipment List, Maintenance Plan, Calibration Records (Internal/External)
6.追溯与交易：批次台账、出入库单据、销售合同、发票、提单 / 送货单
Traceability & Transaction: Batch Records, Warehousing Docs, Sales Contract, Invoice, Bill of Lading/Delivery Order
7.产品合规：型式测试报告、安全 / 环保检测报告（如 CE、GB 标准，有效期内）
Product Compliance: Type Test Report, Safety/Environmental Test Reports (Valid, e.g., CE/GB Standards)
8.纠正预防：CAPA 报告、客户投诉处理记录、不合格品评审 / 处理记录
Corrective & Preventive: CAPA Reports, Customer Complaint Records, Non-conforming Product Review/Disposal Records
9.培训记录：关键岗位培训签到表、技能考核记录（如检验员、特种设备操作员）
Training Records: Training Attendance Sheets, Skill Assessment Records (Inspectors, Special Equipment Operators)
