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.
Course Objectives:
- Describe the history and purpose of ISO 13485
Recommended Background
- Management representatives, quality professionals, personnel functioning as internal auditors
Course ID
99999958
Location
Company Choice
Instructor(s)
Purdue University MEP
Competencies
Communication, Critical Thinking, Personal Effectiveness, Functional Auditing
Method of Delivery
Face to Face
Estimated Effort
4 hours
Cost
Negotiable