In these two-day workshops, you will gain the knowledge and skills you need to audit your quality system to the ISO 13485:2016 standard. Course topics include updates to the ISO 13485 standard, ISO 13485:2016 requirements, auditing principles, and techniques for conducting effective audits. You'll also receive hands-on practice using auditing tools and techniques and have ample opportunities to get answers to questions you have about conducting IOS audits.
Class objectives include the following:
Certifications from Purdue University will be given to all attendees at the completion of the two-day workshop.
Attendees should bring a copy (hard copy or downloaded copy) of the ISO 13485: 2016 Standard with you to class. If you do not have a copy, one can be purchased at this website: https://www.iso.org/home.html
Who should take this training? All personnel involved in conducting or supporting ISO internal audits!