What You Will Learn:
The main objective of the course is to familiarize you with the ISO 13485:2016 standard including the current revisions. The course provides a common-sense explanation of the requirements and will provide you with examples of how to comply.
The course will also highlight the changes from the 2009 standard and will assist you in transitioning your quality management system to comply with the revised standard.
Following each requirement are appropriate questions to ask during an internal audit. These questions will help prepare you to conduct your internal audits to the revised standard.
Once completed, you should be able to start the process of converting your current 13485 system and conduct internal audits.
Who should take the course?
Prospective internal auditors, Lead Auditors, Quality Engineers, Quality Managers, Management Representatives, anyone with ISO 13485:2016 responsibilities.
The estimated time it takes to complete this course is 6 hour. Upon completion of the overview, you will receive an ISO 13485:2016 Overview & Internal Auditor Training completion certificate.
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