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to make sure that the process is implemented and maintained effectively.to make sure that the processes are meeting the planned arrangements and regulatory requirements that the company has identified for the process in the QMS, and any requirements that the ISO 13485:2016 standard has in place for that process.As per clause 8.2.4 of the standard, the internal audit is there to perform two functions: To better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 13485:2016 requirements state about why we do internal audits. What does ISO 13485:2016 require the internal audit to do? Although audit checklists are not stated as a requirement in the ISO 13485:2016 standard, they are a widely used and important tool to make sure that when you perform an internal audit on a process, you do not miss any elements of that process. The ISO 13485:2016 requirements are very clear that this is a critical element of your QMS and, since you want to know how your processes are functioning, your internal audits become a key resource. One of the most important checking tools in a Quality Management System (QMS) for medical devices, or any management system, is the internal audit.