3. Procedure for audit: The notified body shall carry out the audit in the following manner:— (i) technical review of respective documents as prescribed in the Fourth Schedule; (ii) on-site audit of the manufacturer's quality management system to establish conformity by examination of objective evidence, and that of sub-contractor wherever applicable, the requirements of the Fifth Schedule; (iii) establish conformity by examination and provision of objective evidences to the essential principles laid down by the Central Government from time to time; (iv) establish design conformity by review of the design documents during assessment of medical device to ensure its quality, safety, and performance; (v) record post approval changes, if any;