文档介绍：医疗器械质量体系手册第二章质量体系
的重要性。
After a quality system is in place and checked, it should not be allowed to stagnate -- it should continue to be dynamic. The system remains dynamic through continuous feedback, "big-picture" monitoring by system audits, management review, and corrective and preventive action. Sufficient personnel with necessary education, background, and experience should be in all departments to ensure that quality system activities are properly and adequately performed. 当质量体系一旦建立并运作,则不能停滞,它应该持续地保持动态。体系通过连续的反馈来保持动态,宏观地通过体系审核,管理评审以及改正及预防措施来监控。每个部门要有足够的,受过必要教育,有必要背景及经验的人员来确保质量体系活动正确和适当地执行。
The result is anization that is operating in a known state-of-control for the device design, process design, manufacturing processes, and records. A properly functioning quality system results in increased safety and effectiveness of the device, reduced liability exposure, reduced regulatory exposure, increased customer satisfaction, less scrap, lower costs, much less confusion, higher employee morale, and, as a result, higher profits.
其结果是一个组织能够以所谓“受控状态”运行其医疗器械设计, 工艺设计, 生产流程及记录。一个正常运行的质量体系可以使医疗器械的安全及有效性得以提高, 降低赔偿, 降低法规曝光,提高客户满意度,减少报废,降低成本,减少混淆,提升员工士气,并且,作为最终结果,提高利润。
There are several QA systems mon use, including quality control, good manufacturing practices, product design assurance, the ISO 9000 series of international QA standards, and total quality assurance. Quality control is a minimal system which emphasizes test and inspection. The QS regulation is a government mandated QA system for medical device manufacturers. It emphasizes device, labeling, packaging and process design and all aspects of production: facilities, equipment, design development, design and production documentation, correct design transfer, production control, production records and feedback. Total quality assurance is a system which emphasizes that: all employees and suppliers are responsible for their activities; design requirements are established and met; process requirements are establishe