对设备供应商的质量保证监查关注点探讨

Analysis on QA Audit Checklist for Equipment Suppliers

本文对设备供应商的质量方针和质量目标、管理部门审查、文件和记录控制、人员配备和培训、设计控制、采购控制、物项控制、工艺过程控制、检查和试验控制、不符合项控制以及内外部监查11个方面的工作进行了分析,阐述了质量保证监查关注点,并列举了质量保证监查中发现的实际问题。

Eleven aspects during the equipment manufacturing by the suppliers, including the guide- lines and objectives of quality assurance, management department review, document and record control, staffing and training, design control, procurement control, control of items, process control, inspection and testing control, non-conformance control, and internal and external QA audit, are analyzed in this article. The detailed QA audit checklist on these above mentioned aspects are described and the problems found in real QA audit are listed in this article.