What’s the best way to deal with ISO internal audits? Keep calm, follow a consistent approach, and consider ample time for preparation. This is only a brief account. When it comes to ISO 13485 Standard, you need to understand the complexities of the standard before performing the internal auditing program. If you are responsible for planning and executing internal audits for your organization, you might know how much planning and effort is required to monitor a Quality Management System or QMS designed for medical device manufacturing and maintenance.