Control of records: Records shall be established and maintained to provide evidence of conformity to the requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The manufacturer shall retain the records for a period of time at least one year after the date of expiry of the medical device or in vitro diagnostic medical devices as defined by the manufacturer, but not less than two years from the date of product release by the manufacturer. 5.0 Management responsibility 5.1 Management commitment Top management of the manufacturer shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by— (a) communicating to the employees the importance of meeting customer as well as statutory and regulatory requirements; (b) establishing the quality policy; (c) ensuring that quality objectives are established; (d) conducting management reviews; and (e) ensuring the availability of resources. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 138 of 248 5.2 Customer focus Top management of the manufacturer shall ensure that customer requirements are determined and are met. 5.3 Quality policy Top management of the manufacturer shall ensure that the quality policy:— (a) is appropriate to the purpose of the manufacturing facility; (b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system; (c) provides a framework for establishing and reviewing quality objectives; (d) is communicated and understood within the manufacturer's organisation; and (e) is reviewed for continuing suitability