Audit Response Instructions for Monogram/APIQR Clients

This document is a guide that outlines the minimum requirements for responding to audit nonconformances for Monogram/APIQR clients. It details the necessary components that must be included in an organization's response, which are Correction, Root Cause Analysis, Corrective Action, and Evidence. The guide emphasizes the importance of providing complete responses that address each identified nonconformance. It specifies that the correction must describe actions taken and their completion dates, while the root cause analysis should explain why the nonconformance occurred without attributing blame to individuals. Additionally, corrective actions must address the root cause and minimize the likelihood of recurrence, with evidence required for major nonconformances. The document also notes that responses must be submitted through the myCerts platform and that only completed actions will be accepted for review.