The online ISO 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 of this web-based course is $379.95 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 ISO13485 and uses ISO 19011 to give guidance on auditing quality systems. The standards excerpts are provided online (view only) with permission of ANSI. 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. 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. CALISO will send you login and password information by Email within 24 hours of your purchase. 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 15,000 trainees in the US and worldwide. The standard and regulations are provided online under licensing of the American National Standard Institute , or courtesy of the Federal Drug Administration (FDA).
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