ISO 13485: 2016 Lead Auditor Training $399.95
This course is for you if:
- You want to quickly and efficiently learn how to lead an ISO 13485:2016 audit,
- You want to quickly and efficiently be trained on ISO 13485:2016 (the standard), the vocabulary and definitions for the standard.
- You want to be lead internal and supplier audits for your company,
- You want to upgrade your audit expertise from ISO 13485:2003 to ISO 13485:2016,
- You want to upgrade your audit expertise from ISO 19011:2002 to ISO 19011:2011,
- You do NOT have time to allocate 5 days to take an ISO 13485 lead auditor class with a typical cost around $1800,
- 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 with no time limit on when a registered trainee can start or finish. The certificates and courses are accessible online during 3 years.
- It has "save and exit" features so that you can do it at your own pace (a couple of sections per day...).
- The cost ranges from $339.96 for group training of 10 or more employees (each student receives his own login and password) to $399.95 for individual training. This is an average 70% 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 13485:2016 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. 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. Quizzes can only be taken once, and once completed cannot be accessed. Quizzes can only be taken once, and once completed cannot be accessed.
- If your final average in the ongoing evaluation is equal or greater to 70% you will be issued a ISO 13485 Lead Auditor training certificate that you can print for 32 hours of training or 3.2 Continuing Education Unit (CEU) on ISO 13485:2016 lead auditor training.
- 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.