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Online "ISO 13485:2003 / ISO 19011 AUDITOR TRAINING"

(Only $279.95!)

Who should take this online training?
  • 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 10011-1 to ISO 19011:2002.
  • 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.

We also offer ISO 13485 Training and ISO 13485 Lead Auditor Training.

ISO/TS 13485:2003 / ISO 19011 Auditor Training is the solution:
  • It can be taken from anyone's workplace or from home through the Internet without any time limit to complete the course.
  • It has "save and exit" features so that you can do it at your own pace (a couple of sections per day...).
  • After registration, there are no time limits on when you can start or complete the course. You have complete flexibility in taking the course around your schedule.
  • The cost ranges from $237.96 for group training to $279.95 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 ANSI/ISO/ASQ Q9001-2000 and uses ANSI/ISO/ASQ ISO 19011 to give guidance on auditing quality systems. Both standards are reprinted with permission of the American Society for Quality and ANSI. 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 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.

Worldwide Course Recognition:
Our 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 15,000 trainees in the US and wordwide. The standard and regulations are provided online under licensing of the American National Standard Institute (ANSI), the American Society of Automative Engineer (SAE), or courtesy of the Federal Drug Administration (FDA).

Employees of some of the following corporations are using this online training:
Philips Medical andBaxter Healthcare . ...

Testimonial our auditor classes:

"I just completed the Interactive online training for the new ISO 9000:2000 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

Signup & Training Instruction

Step
1

REGISTRATION

Upon registration using Visa, America Express, or MasterCard (PO purchases are available for corporate accounts), you will receive an invoice, an E-mail notification with the password to be used to login to take the class. Fax the PO to (714) 484-3014.

THE 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.

Step
2

Go to the PRE-SIGNUP SCREEN, select a User ID that you can remember easily, enter your password and invoice #. 

Step
3

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. 

Step
4

Go to the LOGIN SCREEN; enter your User ID and password. 
  • You will be presented with training slides followed by quizzes, after taking a quiz, click on the score button to proceed.
  • You cannot retake quizzes again, but you can go back and look at previous slides by using the "Previous" button.
  • You have help buttons for each quiz question, and documentation examples for each training slide.
  • Unless otherwise designated, all quiz questions are within the context of ISO/TS 16949:2002 and ISO 9004:2000. 
  • The training is optimized for Microsoft Internet Explorer 5.0+ and Netscape 4.5+
Suggestions and Recommendations:
  • Even if your connection appears to be slow, do not click on buttons such as "submit", "Login" or "Score" twice.  
  • Empty your disk cache on a regular basis to optimize the performance of your browser.
  • For ease of readability, select "Verdana" as your display font.
  • Do not disable cookies.
  • If you are planning to leave the training for more than 20 minutes, "Save and Exit". The training session times-out after 20 minutes of inactivity.
  • If you get an "Invalid Amount" message during registration, try a different credit card first. Some credit cards do not allow certain e-business transactions.
  • Order copies of the ISO/TS 16949:2002 standards from ASQ or American National Standards Institute.
 
 

Courtesy of CALISO

 
     
 
Course Outline for ISO 13485:2003/ ISO 19011 Auditor

Course objective
This course has been specifically designed to meet the needs of the Medical Device Industry and is for individuals responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485 for quality assurance. It provides in-depth understanding of the ISO 13485 Audit Process.

Course length
2 days are required to complete the ISO 13485 auditor course

Who should attend?
This is the ideal course for anyone who wants to quickly and efficiently learn how to audit to ISO 13485:2003, upgrade his/her expertise from auditing ISO 13485:1996 to ISO 13485:2003, and upgrade his/her expertise from auditing with the guidance ISO 10011-1 to ISO 19011:2002.

The structure of the training is as follows:
1. DEFINITIONS
2. TYPES OF AUDITS
3. AUDIT OBJECTIVES
4. ROLES AND RESPONSIBILITIES
5. AUDITOR ACTIVITIES
6. INITIATING THE AUDIT
7. PREPARING THE AUDIT
8. EXECUTING THE AUDIT
9. WHAT THE AUDITOR IS LOOKING FOR
10. AUDIT DOCUMENTS
11. AUDIT TECHNIQUES: TELL ME/SHOW ME
12. AUDIT TECHNIQUES: AUDIT PATH
13. AUDIT TECHNIQUES: GRADUAL ELEVATION
14. AUDIT TECHNIQUES: SAMPLING
18. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP
19. MEDICAL DEVICE CASE STUDIES

Worldwide Course Recognition:
Our 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 15,000 trainees in the US and worldwide. The standard and regulations are provided online under licensing of the American National Standard Institute (ANSI), the American Society of Automotive Engineer (SAE), or courtesy of the Federal Drug Administration (FDA).

Course requirements
If you are not familiar with the ISO 13485:2003 standard, it is recommended to take the ISO 13485:2003 training course first.
The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.

Certificate requirements
The course uses a continuous evaluation method with on-going quizzes to facilitate the information retention. If your final average is equal or greater to 70% you will be issued a training certificate. If your final averag evaluation is less than 70%, you will have to take a final exam and score above 70% to be issued the training certificate.