On July 15 at 12:00 p.m. ET, AAMI is hosting a webinar on "How to Audit Quality Better and Save Time with the Process Approach." In this webinar, you will learn how to apply a simple, seven-step approach to auditing medical device quality systems. The documentation tool you will learn is called a "turtle diagram."
Using the process approach to auditing is required by Clause 0.3 of ISO 13485:2016, the international quality management standard. The process approach also has the added benefit of eliminating the need to create and maintain a regulatory audit checklist.
Learning this method of auditing is more broadly applicable to any process area than using checklists, and therefore it is the ideal method for new auditors to learn first. The process approach creates structure for the interviewing of auditees and writing a summary report.
Once you have completed this one-hour webinar, you will be able to complete a turtle diagram and write an audit summary for any process from shipping to sterilization validation.
- What is an audit checklist?
- Disadvantages of using checklists
- What is the process approach?
- How to create a turtle diagram
- Examples of turtle diagrams
- Converting a turtle into a report