4.2 Documentation requirements 4.2.1 General: The quality management system documentation shall include— (a) documented statements of a quality policy and quality objectives; (b) a quality manual; (c) documented procedures required by this Schedule; (d) documents needed by the manufacturer to ensure the effective planning, operation and control of its processes; (e) records required by this Schedule, and where this Schedule specifies that a requirement, procedure, activity or special arrangement be "documented", it shall, in addition, be implemented and maintained. For each type of medical device or in vitro diagnostic medical devices, the manufacturer shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation. The manufacture shall prepare documentation for device or in vitro diagnostic medical devices in a form of a Device Master File containing specific information as referred to in Fourth Schedule.