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.