Format
During the five days of this course, you will cover background of the ISO 9000 and ISO 13485 standards, and go through every phase of the audit—from planning to follow-up—so you will be able to lead your own audits efficiently and effectively.
This course makes extensive use of workshop and hands-on activities. The format of the course is designed to let you apply the knowledge you gain in a way that replicates the working environment of the medical device industry.
Materials
Note: All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (item #T13485).
In addition, all students will receive a course material packet on-site.
Additional Notes
Note: Due to stringent international standards guidelines, a maximum course enrollment is strictly enforced. If you are told you are on a waiting list or have registered and not received a confirmation letter prior to the course, contact ASQ immediately to verify your status before you make travel arrangements.
