Quality does not happen by chance; it must be designed into products and services, and any amount of inspection will not change their quality. It is therefore the processes which determine and provide products and services that holds the most potential for creating products or services of the utmost quality. This chapter examines the eight requirements of clause 4.4.1: determining processes needed for the quality management system; determining the inputs required; determining the outputs expected; determining process sequence; determining process interaction; determining the criteria and methods; determining methods needed to ensure effective operation; and applying the processes of the QMS throughout the organization. An approach for aligning the mission, vision and values with the needs of the stakeholders and for defining appropriate performance indicators is a stakeholder analysis. The stakeholder-driven method provides a close alignment between stakeholder needs and process activities. It can be time consuming and difficult to do but worthwhile.