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Online "ISO 13485:2003 LEAD AUDITOR TRAINING"

(Only $389.95!)

Who should take this online training?
  • You want to quickly and efficiently learn how to lead an ISO 13485:2003 audit,
  • You want to quickly and efficiently be trained on ISO 13485 (the standard), ISO 13485 (the vocabulary for the standard), and ISO 9004 (the guideline to implement the standard).
  • You want to be a lead auditor to conduct internal audits and supplier audits for your company,
  • You want to upgrade your expertise from auditing ISO 13485:2000 to ISO 13485:2003,
  • You want to upgrade your expertise from auditing with ISO 10011-1 to ISO 19011:2002,
  • You do NOT have time to allocate a 2-5 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 Auditor Training.

ISO/TS 13485:2003 Lead 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...).
  • The cost ranges from $331.46 for group training of 10 or more employes (each student receives his own login and password) to $389.95 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 ANSI/ISO/ASQ ISO13485:2003 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 ISO 13485 Lead Auditor training certificate that you can print for 22 hours of training or 2.2 Continuing Education Unit (CEU) on ISO 13485:2003 lead auditor training on ISO 13485:2003.
  • 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 lead auditor classes:

"I just finished the online ISO 13485 lead auditor training and wanted you know that two weeks ago I attended a 5-day $1500.00 lead auditor course. I actually got a better understanding of the new requirements from your online course, compared to some of the areas that the 5-day course left gray. I am disappointed that I did not know of the online training prior to investing the $1500.00, your online training is considerably less expensive, more comprehensive and I received and internationally recognized training certificate. I loved the convenience of being to be able to take it at my own pace and not having to take time away from work. I am going to have members of all our branches take this online class, to strengthen our audit team."

Mike Madewell - QA Director of Taylor Communications Inc.

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.
 
     
 
Course Outline for ISO 13485:2003 Lead Auditor Training

Course objective
This course is based on the quality management system (QMS) standard ISO9001:2008, the guideline document for implementing and improving QMS's
ISO 9004:2000, and the Fundamentals and vocabulary for QMS's ISO 9000:2005. It is also based on ISO 19011, which is a guideline document for auditing quality systems. The case studies in the later part of the course will be presented along with the applicable sections of ISO 13485:2003.

Course length
5-6 days (doing a couple of hours/day) are required to complete the ISO 13485:2003 lead auditor course.

Who should attend
Anyone who wants to quickly and efficiently understand and learn how to audit or lead an audit using the QMS and EMS auditing guideline to ISO 19011:2002.

Course includes
The structure of the training is as follows
1. THE STANDARD
2. THE PROCESS APPROACH
3. SCOPE
4. QUALITY MANAGEMENT SYSTEM
5. MANAGEMENT RESPONSIBILITY
6. RESOURCE MANAGEMENT
7. PRODUCT REALIZATION
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
9. DEFINITIONS
10. TYPES OF AUDITS
11. AUDIT OBJECTIVES
12. ROLES AND RESPONSIBILITIES
13. AUDITOR ACTIVITIES
14. INITIATING THE AUDIT
15. PREPARING THE AUDIT
16. EXECUTING THE AUDIT
17. WHAT THE AUDITOR IS LOOKING FOR
18. AUDIT DOCUMENTS
19. AUDIT TECHNIQUES: TELL ME/SHOW ME
20. AUDIT TECHNIQUES: AUDIT PATH
21. AUDIT TECHNIQUES: GRADUAL ELEVATION
22. AUDIT TECHNIQUES: SAMPLING
23. AUDIT COMPLETION AND CORRECTIVE ACTION FOLLOW-UP
24. INDUSTRY 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
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 average evaluation is less than 70%, you will have to take a final exam and score above 70% to be issued the training certificate.
 
 

Courtesy of CALISO