ISO 13485:1996 And ISO 13485:2003 Auditor Training Class In Medical Device Industry

Offer ISO 13485:2002 and ISO 19011 auditor training Class for performing quality management systems in medical devices industry

ISO 13485:2003/ISO 19011 Auditor Online Training Class

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

ISO 13485:2003/ISO 19011 Auditor Online Training Course length

2-5 days are required to complete the ISO 13485:2003/ISO 19011 training class.

Who should attend ISO 13485:2003/ISO 19011 Auditor Class?

This is the ideal course for any employee or manager who wants to learn how to audit to ISO 13485:2003, and 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.

ISO 13485:2003/ISO 19011 Auditor Online Training Class Includes

• Definitions
• Types of audits
• Audit objectives
• Roles and responsibilities
• Auditor activities
• Initiating the audit
• Preparing the audit
• Executing the audit
• What the auditor is looking for
• Audit documents
• Audit techniques: Tell me/show me
• Audit techniques: Audit path
• Audit techniques: Gradual elevation
• Audit techniques: Sampling
• Audit completion and corrective action follow up
• Medical device case studies

ISO 13485:2003/ISO 19011 Auditor eLearning Benefits

• Course can be taken from home or at work through the Internet
• Complete the course at your own pace
• There are no time limits so you have flexibility in taking the course around your schedule
• Use quizzes as a continuous evaluation method and to facilitate course content retention
• Provide the exact excerpts of the International Standard and regulations ANSI/ISO/ASQ Q9001-2000 and use ANSI/ISO/ASQ ISO 19011 information to give guidance on auditing quality management systems

ISO 13485:2003/ISO 19011 Auditor eLearning Course Approval

This online training course is approved by the German Registrar RWTUV-USA. The certificate bears all the approvals. We have been selected by the ISO 9000 Registrar RWTUV of Germany to support the training of their clients worldwide (http://www.rwtuvusa.com).

ISO 13485:2003/ISO 19011 Auditor Online Training Course Requirements

If you are not familiar with the ISO 9000:2000, it is recommended to take the ISO 13485:2003 training class first. The training is optimized for Microsoft Internet explore 5.0 or higher and Netscape 4.5 or higher.

ISO 13485:2003/ISO 19011 Auditor Training Certificate

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.

For more questions about the training classes online visit our FAQs. If you are already registered, click here.

PO and DD 1556 purchases are available for corporate and Federal Government account; fax the PO to (510) 814-7318. And, online courses are provided by Caliso Consulting LLC.