| 1. | It is difficult to configure and there are no documented procedures
它配置困难，而且过程没有文档说明。 |
| 2. | Are the audits to the suppliers performed with documented procedure
对供应商的稽核是否按照文件规定执行？ |
| 3. | Do you have a documented procedure for control of electrostatic discharge
你是否有记录的程序，为控制静电放电？ |
| 4. | Does audited facllity have documented procedures for control of critical drawings / formulations
受核查工厂是否有成文程序控制关键图纸/工艺？ |
| 5. | Provide the chart of organization structure the list of the quality manual the list of the documented procedures
提供组织机构图质量手册目录程序文件目录。 |
| 6. | Re - inspect repaired or reworked product in accordance with the control plan and / or other documented procedures
重新检验已修理的或已返工的产品,与控制计划和/或其他记录程序一致 |
| 7. | Does a documented procedure exist for developing and maintaining specific customer required statistical analyses / data
现存发展，维护特定客户的文件步骤是否需要统计分析/数据？ |
| 8. | Does a documented procedure exist for developing and maintaining specific customer required statistical analyses / data
一个文件程序是否为了发展和保持详细的顾客必需的统计分析/数据？ |
| 9. | The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure
不合格品的管制及处理的责任与授权，应被定义于文件化程序中。 |
| 10. | The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive action
对于纠正与预防措施所引起对程序文件的任何更改，组织均应遵照实施并予以记录。 |
