Process approach

This International Standard is based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a process.

For an organization to function effectively, it has to identify and manage numerous linked processes.

Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.

Source: ISO/FDIS 13485 Medical devices — Quality management systems — System requirements for regulatory purposes. 0.2 Process approach