Automotive Quality Systems Handbook, Second Edition

The standard requires the organization to control design and development of the product and of manufacturing processes.
What does this mean?
With the addition of manufacturing processes, this requirement now has two dimensions: product design and process design, and while both have many similarities, there are also some differences. It is not intended that the word process replace the word product in Section 7.3. Those requirements of Section 7.3 that apply to process design are indicated separately, so if it is not stated that the requirement refers to product design or process design, assume it refers to product design.
Product design can be as simple as replacing the motor in an existing vehicle with one of a different specification, or as complex as the design of a new automobile or any of its subsystems. Product design can be of hardware, software (or a mixture of both) and can be of new services or modified services. Before design commences there is either a requirement or simply an idea. Product design is a creative process that creates something tangible out of an idea or a requirement. The controls specified in the standard apply to the product and process design process. There are no requirements that will inhibit creativity or innovation. In order to succeed, the process of converting an idea into a design that can be put into production or service has to be controlled. Product design is often a process which...