Quality management system 4.1 General The manufacturer shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this Schedule. The manufacturer shall— (a) identify the processes needed for the quality management system and their application throughout the organisation; (b) determine the sequence and interaction of these processes; (c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective; (d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes; (e) monitor, measure and analyse these processes; and (f) implement actions necessary to achieve planned results and maintain the effectiveness of these processes. These processes shall be managed by the manufacturer in accordance with the requirements of this Schedule. Where a manufacturer chooses to outsource any process that affects product conformity with requirements, the manufacturer shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. Note: Processes needed for the quality management system referred to above shall include processes for management activities, provision of resources, product realization and measurement.