1. To create an awareness of the problem solving issues related to management issues.
2. To provide an understanding of the Tools of Management
You are the Quality Manager of a company manufacturing fine, woven fabrics and have been approached by a potential customer who wants you to make fabric structure suitable for wound care. However, to do this you must have a CE mark on the product. Since products for medical use are out of your core competences, you need to determine if this opportunity is going to be of organizational benefit.
What you have been asked to do is investigate the process of CE marking products for the Managing Director.
Write a report of approximately 1000 words (3-4 pages of 12pt double space) to contain the following.
&acirc;€¢ What is a CE Mark?
&acirc;€¢ What is a Device Directive?
&acirc;€¢ How does the CE Mark necessitate a Quality System such as ISO 9000?
&acirc;€¢ What is Total Quality Management?
The focus of the report is what the impact of this new product would have on manufacturing. Ignore such issues as clean room environments and pay particular attention to TQM as being the core concept and key issue.