This workshop will provide you with a concise but detailed review of the new ISO 13485 Medical Devices Quality Management System standard. We will compare the 2016 version to the 2003 version, and explain the new requirements of the 2016 standard. We will also talk about transitioning from to the 2016 standard, including timing requirements. Activities include developing a ìList of Interested Partiesî for your QMS. There will also be time for questions and answers.
- Describe the history and purpose of ISO 13485
- Management representatives, quality professionals, personnel functioning as internal auditors
Purdue University MEP
Communication, Critical Thinking, Personal Effectiveness, Functional Auditing
Method of Delivery
Face to Face