ISO 13485:2003 Auditor $299.95
This course is for you if:
- You want to quickly and efficiently learn how to audit to ISO 13485:2003,
- You want to upgrade your expertise from auditing ISO 13485:1996 to ISO 13485:2003,
- You want to upgrade your expertise from auditing with the guidance ISO 19011:2002 to ISO 19011:2011,
- You do NOT have time to allocate 2 days to take an ISO auditor class,
- You want to train more of your staff on auditing economically and without having to immobilize them in a class for a full day,
- It can be taken from anyone's workplace or from home through the Internet.
- It has "save and exit" features so that you can do it at your own pace (a couple of sections per day...).
- It starts with a comprehensive ISO 19011 Video presentation that provides an overview of the auditing process and techniques.
- The cost ranges from $254.96 for group training of 10 or more employees (each student receives his own login and password) to $299.95 for individual training. This is an average 60% cost savings on comparable class courses.
- It uses quizzes and case studies that give very good exposure on various types and classes of medical devices.
- It provides excerpts of the International Standard ISO 13485:2003 and uses ISO 19011:2011 to give guidance on auditing quality systems. All standards excerpts used in the web-based training are provided online (view only)with permission from ANSI. Regulations excerpts are provided through the U.S. FDA, and the FAA and AS9100 with the permission of SAE International. All the theoretical aspect of auditing is covered according to the guidelines of RAB (Registrar Accreditation Board). Practical training with trained auditors, such as participation in an audit is necessary before you can audit effectively after taking this class.
- It uses a continuous evaluation method with on-going quizzes and case studies to facilitate the information retention.
- If your final average in the ongoing evaluation is equal or greater to 70% you will be issued a training certificate that you can print for 16 hours of training or 1.6 Continuing Education Unit (CEU) on auditing 13485:2003 using ISO 19011.
- If your final average in the ongoing evaluation is less than 70%, you will have to take a final exam and score above 70% to be issued the training certificate.