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 >> Complete Starter Package >> Item 4: Employee Training
Self-study Course for Personnel
24-page training booklet, test and certificate
Sample Pages (click to enlarge)
For Self-study or Group Training
Since 1996 this has been the most popular ISO 13485/FDA QSR general orientation course on the market. The booklet is intended for distribution to all personnel for self-study or group training. The course:
  • Explains the benefits of ISO 13485 quality system
  • Explains how the quality system works
  • Instructs personnel how to use the system
  • Reviews the requirements of the standard
  • Helps personnel to prepare for the ISO 13485 certification
    and/or FDA audits
  • Provides a short multiple-choice test
  • Includes a certificate of completion
Now in its fourth edition, and with over 20,000 copies sold, this course is established as the preferred choice for company-wide ISO 13485/FDA QSR training.
Purchase Options
  • Included in Template Documentation package and pre-loaded into subscription software (SaaS)
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  • Included in Template Documentation package and pre-loaded into Purchase-To-Own software
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Three editions
  • Light
  • Standard
  • Professional
>> Editions and Feature Chart
Related Information
>> Complete Starter Package >> Part 11 Certificate >> Validation Certificate >> Editions and Feature Chart >> Installation Options
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