ABSTRACT

The requirements referred to in this section of the standard refer to the controls to be exercised over two of the principal processes: production and service delivery. These are the processes that are cycled repeatedly to replicate products and services to the same standard every time. The design process is a journey into the unknown, whereas the production and service delivery process is a journey along a proven path with what is expected to be a predictable outcome. The design process requires control to keep it on course towards an objective, the production and service delivery processes require control to maintain output to a prescribed standard.