What does this mean?

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. Design can be of hardware, software (or a mixture of both) and can be of new services or modified services.

These requirements apply to the product that will be supplied to the organization's customers including any packaging (see RFI/043). They are not intended to apply to tooling or anything that might come into contact with the product but is not shipped with the product. However, imposing similar controls over the design of such items may be desirable.

Before design commences there is either a requirement or simply an idea. 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 service design process but can be applied also to the 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. Design is often a process which strives to set new levels of performance, new standards or create new wants and as such...