Preparing for Your First ISO 13485 Audit or FDA Inspection with Confidence and Humility
For small to mid-sized companies facing their first ISO 13485 audit or FDA investigation, the process can feel overwhelming. With so much at stake, it’s natural to worry about getting everything right.
This course is designed to guide your team through the audit process, helping you approach it with confidence, preparation, and humility to learn and improve along the way.
We’ll cover what to expect during an external audit on your quality management system and how to organize your team and documentation effectively. You'll learn how to handle auditor questions with transparency, manage any findings, and foster a culture of openness—embracing the audit as an opportunity to improve rather than something to fear. We’ll also focus on how to remain calm under pressure and viewing the audit as a partnership in achieving compliance, not just a pass/fail test.
By the end of this course, you’ll feel better equipped to navigate your first ISO 13485 or FDA audit with grace, focusing on continual improvement and teamwork. This is ideal for companies new to the audit process, especially those committed to building a strong quality management system from the ground up.
