1. Quality Manual (including quality
policy, objectives, organization chart, job description, reference to /
procedures for the Quality Management System)
品質手冊（包括質量方針，質量目標，組織架構圖，工作職責描述，及與品質管理體系相關的程序）
2. Management Review (procedure,
agenda, report) 管理評審（程序，議題，報告）
3. Internal audit documents
(procedure, plan, audit report) 內審文件（程序文件，計劃，評審報告）
4. Supplier Control documents (supplier
approval control procedure / criteria, list of approval supplier list, supplier
evaluation records) 供應商管控文件（供應商評估控制程序/標準，合格供應商明細，供應商評估報告）
5. Document Control procedure
(including that for record keeping) 文件控制程序（包括記錄文件）
6. Inspection Specification /
Instruction (including IQC, In-process, Final) 檢驗標準/指導（包括來料檢驗，制成檢驗及終檢）
7. Work Instruction for each
manufacturing process 作業指導：所有生產工序的指導
8. Procedure for definition and
reporting of “incident” 事故定義及報告程序
9. Product recall procedure 產品招回程序
10. Customer complaints procedure and
complaint records 客戶投訴程序及記錄
11. Corrective Action reports (related
to incident, internal audit, complaint, etc) 改善措施報告（與事故，內審及投訴等相關的）
12. Test records on Traceability
system 追溯體系的測試記錄
13. Equipment maintenance documents
(plan, procedure, record) 設備保養文件（保養計劃，保養程序及保養記錄）
14. Calibration of monitoring &
measuring devices (plan, procedures, records) 監控及測量儀器的校驗（計劃，程序文件，記錄）
15. Written procedure for handling
glass and hard clear plastic breakages Cleaning
schedule and procedure 書面玻璃及利器管控程序和清理安排
16. Waste handling / storage procedure
or record 廢品控制/存儲程序及記錄
17. Pest control documents (list of
trained pest control staff, contract with external pest control agency, pest
control inspection record, bait documentation)
