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ISO 13485 AUDITOR, ISO 13485 AUDITOR TRAINING, ISO 13485 AUDITOR COURSE
Online ISO 13485:2003 Auditor Training ($299.95
Links to the new 2016 GMP (21CFR820), ISO 13485:2016 Standard, ISO 13485:2016 Auditor, and to the ISO 13485:2016 Lead Auditor courses.
-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,
online ISO 13485:2003/ISO 19011:2011 auditor training is the solution:
- 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 employes (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 ISO13485:2003 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 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.
- 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.
download the ISO 13485 Auditor course outline
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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. 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 30,000 trainees in the US and worldwide. The standards and regulations are provided online under licensing agreements.
Testimonial on this ISO 13485 Training Online course:
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."
Hagmann - ISO Coordinator of Baxter Healthcare
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
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
To take the
http://www.caliso9000.com/courses/ISO13485AUDITOR/SignUp.asp), and enter
your personal information that will be used in
the training certificate.
Go to the
login screen; enter your User ID and password.
be presented with training slides followed by
quizzes, after taking a quiz, click on the score
button to proceed.
retake quizzes again, but you can go back and
look at previous slides by using the
help buttons for each quiz question, and
documentation examples for each training slide.
otherwise designated, all quiz questions are
within the context of ISO 13485:2003 and ISO
The training is optimized for ALL recent Internet browsers
- Go to the
pre-signup screen (http://www.caliso9000.com/courses/ISO13485AUDITOR/PreSignUp.asp), select a User
ID that you can remember easily, enter your
password and invoice #.
- If you are
part of a group of users, go to the signup screen
Download the course outline
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