Quality Improvement Is Essential for Maintaining Competitiveness

In: Business and Management

Submitted By miriam777
Words 1554
Pages 7
INTRODUCTION
Quality improvement is essential
Why Quality is so important? The Quality System (QS) regulation requires that each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured (820.5 and 820.20). The GMP requirements are harmonized with the International
Organization for Standards (ISO) 9001:1994 and ISO DIS 13485. The quality system should be an integrated effort a total systems approach, to satisfy the particular safety and performance needs of a specific manufacturer, product, and user-market. The quality assurance (QA) activities do not simply consist of inspection and testing spot solutions or "fire-fighting," no matter what the product is or how small the manufacturer. In all cases, quality should be considered at the earliest stages in every significant area that has an effect on the quality, safety, and effectiveness of the device. 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. Complaints and, of course, favorable comments constitute customer feedback that may result in improvements in the device, labeling, packaging or quality system. Also I would like to say that most important of all is management commitment. Management and employees should have the correct attitude if their quality system program is to be effective. As well I would like to share that if they follow this procedures, in their quality system it’s going to be an improvement and that, is essential for maintaining competitiveness.…...

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