ISO 13485 certification



ISO 13485:2016 Lead Auditor Training PD631845
Fee: $399.95

Links to the new 2016 GMP (21CFR820), ISO 13485:2016, and to the ISO 13485 Auditor courses.  

-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 leadinternal and supplier audits for your company,

-you want to upgrade your auidt 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,

the online ISO 13485:2016 lead auditor training is the solution:

  • 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 1 year.
  • 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 ISO13485:2016 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 FAO 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.

Worldwide Course Recognition of SAE's CALISO online training:

SAE is among the world's leading standards developers that provides consensus standards and lifelong learning programs for the Automotive, Aerospace, and Commercial vehicle sectors. Since 1999, CALISO courses have been the most popular and most widely used training courses in English, with over 30,000 trainees in the US and worldwide. The standards and regulations are provided online under licensing agreements.

Watch a presentation of ISO 13485:2016

Testimonials on this ISO 13485 Training Online course:

"I just completed the Interactive online training for the new ISO Standard. I liked the fact that I was able to take the class at my convenience from my desk at work. I was able to allocate a few hours over a 4-day period to take the class. The layout of the on-line training was easy to follow. All of the standard requirements were in italics and an easy-to-understand "translation" could be found directly underneath. Also, since each section was followed by a short quiz the entire process didn't feel overwhelming."

Julie C. Hagmann - ISO Coordinator of Baxter Healthcare Corporation-Pleasanton Division

I have successfully completed this online training for ISO13485:2016 Lead Auditor and ISO9001:2015 Lead Auditor provided by CALISO. I would like to take this opportunity to thank CALISO for providing a really great, effective and challenging training. The training provided better understanding of the standards and how to apply them effectively in my organization. All training material was important and relevant to the course. It was a great experience! Once again I would like to Thanks CALISO for this effective training program! Looking forward to more training needs getting accomplished through CALISO.

Priti Patel-Quality Auditor-Prime Technological Services, LLC


Upon registration using Visa, American Express, or MasterCard you will receive an invoice, and an E-mail notification with the password and link to login and take the class. PO and DD 1556 purchases are available for corporate and Federal Government account.

Secure AreaTHE TRANSACTION IS SECURE:The credit card registration is done through a secure socket, so there is no risk for your credit card information, which is protected and cannot be intercepted.


If you register multiple users you will receive a password for each one of them.

To take the training:

  1. Go to the pre-signup screen , select a User ID that you can remember easily, enter your password and invoice #. 
  2. If you are part of a group of users, go to the signup screen, and enter your personal information that will be used in the training certificate. 
  3. Go to the login screen; enter your User ID and password. 
  4. You will be presented with training slides then quizzes, after taking a quiz, click on the score button to proceed. 
  5. You cannot retake quizzes again, but you can go back and look at previous slides by using the "Previous" button. 
  6. You have help buttons for each quiz question, and documentation examples for each training slide. 
  7. Unless otherwise designated, all quiz questions are within the context of ISO 13485:2016. 
  8. The training is optimized for ALL recent Internet browsers. To access videos your browser needs to allow Youtube access and popups.

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