These areas include product development, design verification and validation, component and/or supplier selection, documentation, development of labeling, design transfer, process development and validation, pilot production, routine manufacturing, test/inspection, device history record evaluation, distribution, service or repair, and complaints.
Management and employees should have the correct attitude if their quality system program is to be effective. 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.
The result is an organization 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.