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Course Certified by Exemplar Global
Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
More ISO 13485 Training Options
Highlighted Topics
Requirements of the ISO 13485:2016 standard
Terminology for medical device quality management systems
Principles, processes, and methods of auditing
The Plan-Do-Check-Act (PDCA) methodology
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.
This is a three-day, instructor-led course available online or in-person. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.
Course feedback from a student, 2021The Instructor was able to simplify the standards and challenged our understanding of them through real-world examples.
Industry-leading accreditation and unparalleled experience
DEKRA Training (formerly AQS) offers a full range of training in support of organizational improvement and implementation of international management system standards.
This Exemplar Global-certified course for ISO 13485:2016 meets the training requirements for Exemplar Global Quality Management Systems Auditors and Provisional Auditors.
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