Description

Here we present an example of Audit Management Procedure, fully aligned with the requirements related to internal audits according to Iso 13485 and 21 CFR 820. Internal audit is an essential process for medical device manufacturers with a certified quality system and having an appropriate Audit Management Procedure is of essential importance.

Internal audits serve as a proactive measure to assess the effectiveness of quality management systems, identify areas for improvement, and mitigate potential risks. With our Audit Management Procedure, organizations can streamline their audit processes, enhance transparency, and demonstrate a commitment to regulatory compliance and product quality.

Crafted by regulatory experts, our procedure encompasses all essential elements specified in Iso 13485 and 21 CFR 820, ensuring alignment with international standards and regulatory expectations. From defining audit objectives and scope to conducting audit activities and reporting findings, each step is meticulously detailed to facilitate efficient and effective audit management.