The terms establish, implement, maintain and improve are used in the standard as though this is a sequence of activities. They imply that a QMS is first of all designed, then put into effect and once operational is maintained and subject to continual improvement. This chapter examines the four requirements of clause 4.4.1, namely: establishing a quality management system including processes needed; maintaining a quality management system; implementing a quality management system and continually improving a quality management system. Before implementing a QMS, it is necessary to determine the changes that may need to be made in the way the organization creates and retains its customers to become more effective and conform to the requirements of ISO 9001. Demonstrating that the QMS has been implemented may be accomplished by presenting evidence from an internal audit that the QMS is a valid representation of reality.