The ISO 13485:2016 Internal Auditor learning path is modular. You can follow the training in all combinations. ISO 13485:2016 learning path and combination discount Please talk to a member of our training team on +31 (0) or via if you have any questions in regards to the online exam and your training course. If, however, you decide not to complete the exam, you will still be awarded with a Certificate of Attendance. Upon successful completion of this exam you will be awarded a Certificate of Achievement alongside your Certificate of Attendance. The exam takes approximately 80 minutes, is comprised with 40 multiple choice questions and you have up to 30 days to complete it – including one opportunity for a re-take. You are strongly advised to choose a time and a place where you will not be disturbed, and where you have access to a reliable internet connection. The exam is done online which means you can choose when and where to complete it. We will email your exam log-in details when you’ve finished the course.
You can now qualify for a Certificate of Achievement, by passing the assessment requirements, including an end-of-course online exam, you’ll improve your professional profile and be able to: Gain a Certificate of Achievement for this course To find out more, please visit our training auditor qualification page here. Qualification:This course forms part of our Auditor Qualification programme. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live. You can attend this training course classroom based and online. Online training courses: Connected Learning Live This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.
It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2018.ĭelegates learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS).
This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. An ineffective audit can mean severe consequences resulting in process failure, patient dissatisfaction and regulatory noncompliance.