1. Quality Manual (including quality
policy, objectives, organization chart, job description, reference to /
procedures for the Quality Management System)
品质手册(包括质量方针,质量目标,组织架构图,工作职责描述,及与品质管理体系相关的程序)
2. Management Review (procedure,
agenda, report) 管理评审(程序,议题,报告)
3. Internal audit documents
(procedure, plan, audit report) 内审文件(程序文件,计划,评审报告)
4. Supplier Control documents (supplier
approval control procedure / criteria, list of approval supplier list, supplier
evaluation records) 供应商管控文件(供应商评估控制程序/标准,合格供应商明细,供应商评估报告)
5. Document Control procedure
(including that for record keeping) 文件控制程序(包括记录文件)
6. Inspection Specification /
Instruction (including IQC, In-process, Final) 检验标准/指导(包括来料检验,制成检验及终检)
7. Work Instruction for each
manufacturing process 作业指导:所有生产工序的指导
8. Procedure for definition and
reporting of “incident” 事故定义及报告程序
9. Product recall procedure 产品招回程序
10. Customer complaints procedure and
complaint records 客户投诉程序及记录
11. Corrective Action reports (related
to incident, internal audit, complaint, etc) 改善措施报告(与事故,内审及投诉等相关的)
12. Test records on Traceability
system 追溯体系的测试记录
13. Equipment maintenance documents
(plan, procedure, record) 设备保养文件(保养计划,保养程序及保养记录)
14. Calibration of monitoring &
measuring devices (plan, procedures, records) 监控及测量仪器的校验(计划,程序文件,记录)
15. Written procedure for handling
glass and hard clear plastic breakages Cleaning
schedule and procedure 书面玻璃及利器管控程序和清理安排
16. Waste handling / storage procedure
or record 废品控制/存储程序及记录
17. Pest control documents (list of
trained pest control staff, contract with external pest control agency, pest
control inspection record, bait documentation) 虫害控制文件(专业虫害控制人员名单,与外部虫害控制公司的合同书,虫害控制记录等)