(iv) ensure that manufacturing site and products c...

(iv) ensure that manufacturing site and products comply with prescribed standards referred in rule 7; (v) not provide training or consultancy to the manufacturers whose site is being audited; (vi) ensure that their auditors possess required qualification and expertise in the relevant field for carrying out assessments of manufacturing site and medical device that they are undertaking; (vii) establish and maintain procedure and record which demonstrate its compliance with quality management system.