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.