ISO 13485 certification

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Your satisfaction is guaranteed. If you register to any of our online courses and are not satisfied with the content, let us know within 30 days of registration, and BEFORE you complete the course or are issued the online certificate: we will refund 100% of the registration fee. We are confident, that like our many other trainees, you will like any course we offer, take some of our other courses, and also recommend them to others. We are proud of our achievement, and want to show it through the explicit satisfaction guarantee that other trainers cannot offer.

ISO 13485 TESTIMONIALS

ISO 13485 AUDITOR, ISO 13485 AUDITOR TRAINING, ISO 13485 AUDITOR COURSE

ISO 13485 AUDITOR REGISTRATION

Online ISO 13485:2016 Auditor Training ($299.95 only!)

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

-You want to quickly and efficiently learn how to audit to ISO 13485:2016,

-you want to upgrade your expertise from auditing ISO 13485:2003 to ISO 13485:2016,

-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 13485:2016 auditor class,

-you want to train more of your staff on auditing economically (saving over $500) and not immobilize them in a classroom,

the online ISO 13485:2016/ISO 19011:2011 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 3 years.
  • 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 13485:2016 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. 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. 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 training certificate that you can print for 16 hours of training or 1.6 Continuing Education Unit (CEU) on auditing 13485:2016 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.
Worldwide Course Recognition:

CALISO online training courses are recognized by all registrars and hiring companies as objective evidence of effective training on the particular standard and regulation. Since 1999, they have been the most popular and most widely used training courses in English, with over 20,000 trainees in the US and worldwide. The standards and regulations are provided online under licensing agreements.


Employees of some of the following corporations are using our online courses:

ISO 13485 PHILLIPS ISO 13485 GE ISO 13485 BAXTER ISO 13485 J J ISO 13485 THERMAGE

Testimonial on this ISO 13485 auditor 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

ISO 13485 AUDITOR REGISTRATION 

Upon registration using Visa, America 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 accounts; fax the PO to (509) 756-6053. 

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.

Secure AMEXSecure MASTERCARDSecure VISA

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 (http://www.caliso9000.com/courses/ISO-13485-2016-AUDITOR-TRAINING/PreSignUp.asp), 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 (http://www.caliso9000.com/courses/ISO-13485-2016-AUDITOR-TRAINING/SignUp.asp), 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 followed by 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 and ISO 19011.
  8. The training is optimized for ALL recent Internet browsers. To access videos your browser needs to allow Youtube access and popups.

User Links:

Download the ISO 13485 Auditor course outline

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