3.18.2 Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). 3.19 Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 4. 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.