Self-study Course for Personnel

24-page training booklet, test and certificate


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.

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