assess conformity to the product and process standards as per provisions of these rules; (vii) inform the manufacturer about the observed non-compliances during audit, if any, and provide a copy of the audit report to the manufacturer; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 96 of 248 (viii) when any major non-compliance is observed during audit by the notified body which may affect quality of the device, it may provide reasonable time to rectify the non-compliance followed by compliance verification of the manufacturing site; (ix) The notified body, after assessment and verification, shall submit detailed report giving its findings on each aspect of audit along with its recommendations after completion of audit to the State Licensing Authority and a copy of the same to the manufacturer.