This course helps you understand ISO 13485 requirements. You’ll apply and interpret ISO 13485 clause-by-clause and know what’s different about this standard from ISO 9001. The course is especially designed for auditors, supervisors, and managers in the medical device industry.
Learn about ISO 13485 and ISO 9001 requirements, interpret the ISO 13485 standard, and apply these requirements to your work would by completing a series of lessons, illustrations, diagrams, interactive exercises and quizzes.
Auditors, supervisors and managers in the medical device industry
Medical device industry experience is helpful.
A handy Desk Reference (student textbook), QualityWBT Glossary, and other resources
More than 20 downloadable handouts such as: an ISO 13485 checklist, study tips, a before-class assessment, and after-class objective.
Online access to ISO 9000 (vocabulary standard) granted with the purchase of this course.
Certificate of Completion