Breadcrumb Home Frequently Asked Questions Audits FAQs How should AOs treat organizations with a legal address with no association to the company’s daily operations? How should AOs treat organizations with a legal address with no association to the company’s daily operations? Per IMDRF MDSAP WG N3, the AO shall audit all sites that will be recorded on the certificate. AOs can initially visit the site to confirm its activities and relationship to the QMS. Describe relationships/activities and site omissions in the audit report. Auditors should confirm if changes result in additions of sites to audit program. Non-operations/functional sites should not be audited/certified.