ISO 13485 certification

Online Training for ISO 9001, ISO 14001, ISO 13485, AS9100D, GMP, GLP, HACCP:

SAE International, offers the CALISO courses, the best and most popular training program for ISO standards and FDA regulations. With over 30,000 courses and certificates issued to corporate employees AND individuals, the CALISO online courses have many unique advantages:

  • The courses are CALISO approved and recognized by registrars and hiring companies as evidence of effective training on standards and regulations. They are not IRCA nor RABQSA/Exemplar approved. These costly and lengthy standard certifications are only useful to work for Registrars.
  • The Online Courses are very precise compared to other courses based on interpretations or paraphrasing of the standards and regulations.
  • They can be taken at one's own-pace, 24/7, from any computer with Internet and Youtube access, and not be 'stuck' in a classroom!
  • They have a 1-year time limit on when a registered trainee can start or finish an online course.
  • The training has a low failure rate as long as trainees take the time to read the course slides before answering quizzes in an open-book format.
  • Thanks to the online delivery, the courses are over 60% cheaper than live classes AND are Satisfaction Guaranteed. Click on any course link in the list to the right for more info. See the Online Course FAQs.

"I have been a returning customer of CALISO for several years now. I like the fact that I can take courses at any time and from any computer. CALISO's courses are challenging but cost-effective. (It is nice NOT to have to travel in order to keep my skills & knowledge level current). I have always found the course materials to be accurate and up-to-date, plus I earn CEUs for my continuing education... The staff at CALISO have always been friendly and supportive. Thank you! I would recommend any course provided by CALISO hands down!!"
Tracy Armstrong, QA Manager ISO Rep & Certified Environmental Specialist.

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Online Training for Standards and Regulations:

CALISO offers online training for ISO 9001:2015, FDA cGMP, FDA GLPs, ISO 13485, HACCP, ISO 14001 and other standards and regulations. The training uses excerpts of the exact text of standards/regulation, and will provide accurate training, free of distortions and misinterpretations of other training such as auditor or standard instructor-lead classes. We have Auditor training, and Lead Auditor training courses. They can be taken from the convenience of your office or your home, at your own pace, with a 1-year limit on completion, and with 60% cost savings on similar classes or courses. All standards excerpts used in the web-based training are provided online (view only) with permission from ANSI from which you can order ISO standards. Regulations are provided by the FDA GPO, and AS9100 with the permission of SAE International.

"Thank you very much for this 9001 Lead Auditor course and service. It beats going to a live class which is much less convenient and far more expensive......."
Charles Poirier - QA Manager - Knurr Inc.

Corporate ISO Training:

For organizations that wish to implement a company-wide standard or auditor training for their employees on QA, EMS, Regulatory Affairs, or Safety standards and regulations, we offer volume discounts for purchases of over 10 course licenses online, such as ISO 9001 Auditor courses. For 50 licenses a higher discount will be extended based on an RFP.

"I completed the auditor training today and received my Certificate. I really like the training format and quiz format. Easy to follow and understand. I would recommend the course to anyone who has a need to understand the transition to the 2015 standard."
VP of International Business Operations - Orion Registrar Inc.

Standard Certification Training:

CALISO fully assists companies that want to achieve compliance or certification to the following standards, and regulations: ISO 9001, ISO 14001, ISO 13485, AS9100D, IATF 16949, GMP, GLP and HACCP. Our courses were originally developed with TUV, the German Registrar. They are recognized worldwide by all reputable registrars and notified bodies.

"The online ISO 9001 Lead Auditor courses were extremely helpful to train our staff in different bases around the globe. Thank you for this great product..."
Sean Hilman - Global QA Director- SH.

"The GLP course was very useful for our organization. We managed to train more people cost-effectively and without locking them in a classroom for days! The ISO 19011 Auditing courses were also a nice complement to develop the audit teams."

Dr. Mered - Cell Banking Mgr. - Bayer Emeryville

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