3.2 Does the quality management system include quality policy, measurable quality objectives , quality manual, product safety, procedure and work instructions and reviewed at least annually?
质量管理体系是否包括质量方针，可测量的质量目标，质量手册，产品安全性，程序文件，作业指导书及年度评审？

3.3 Is there an adequate system for controlling customer requirement?
是否有足够的系统来控制顾客的要求？

3.4 Does the factory establish specifications for raw materials, components, and bought-in parts including packaging, intermediatemiprocessed and any product or service which could impact the integrity of the finish product?
对于所有影响最终产品的原材料，零部件，包材，半成品等，是否建立相关的规格要求？

3.5 Does the factory have clearly product specifications？
是否有成品规范？

3.6Are specifications accurate and complying to relevant safety, legislative and customer requirements?
规范是否正确并符合相关安全标准、法规及顾客要求？

3.7 Is there an up-to-date suppliers & sub-contractors list and suppliers / subcontractor control procedure available?
是否有最新的合格供方（供应商，分包商）清单，及供应商/分包商的控制程序？

3.8 Are there internal audit procedure and records available?
是否有内审程序和记录？

3.9 Does the factory have document control procedure?
是否有文件控制程序？

3.10 Does the factory have record control procedure?
是否有记录控制程序？

3.11 Does the factory document all process and product changes?
过程和产品的变更，是否都保留记录？

3.12 Does the factory have CAPA procedure?
是否有纠正预防措施程序？

3.13Are the management review conducted at least annually, documented and include the evaluation of below?
? Internal, customer and external audits
? Previous management review documents, corrective action plans and time frames
? Customer performance indicators, complaints and feedback
? Incidents, non conforming materials and corrective actions
? An assessment of process performance
? Review of the product risk assessment system
? Review of the results of monitoring and testing
? Developments in legal requirements or scientific information associated with the products in scope
? Resource requirements
?Improvement for the validity of quality management system
是否进行年度管理评审，记录包括：
内部的，第2或第3方的审核报告
以往的管理评审记录，纠正措施计划和时间表
客户业绩指标，投诉和反馈
事故，不合格品及纠正措施
过程业绩的评估
产品风险评估系统的评审
监控和测试结果的评审
与产品相关的法规要求或科技信息的开发和改进
资源需求
质量管理体系及其过程有效性的改进
 
3.14 Do finished products (including re-work) have a full traceability to raw material source and vice versa?
是否能从成品追溯到原材料，或反之亦然?