Top management is responsible for ensuring that customer requirements and applicable regulatory requirements are determined and met.
Customer and Regulatory Requirements
This places the ultimate burden of the customer and regulatory requirements on the top level management. These things are fairly easily accomplished. In chapter 7 we will discuss design and development.
The User Requirements Document
The first document required in design and development planning is the user requirement document, or the user needs. Beyond being the foundation for product design and development this document provides the evidence that we have determined the customer requirements. If design and development is done properly, we will have a market approval of some type, providing the evidence that regulatory requirements have been met.
Management Review
In addition, management review (See Chapter 5.6), should cover customer complaints, which ensures that management is aware of customer issues and that the customer requirements are being met.