Originally published in 1966, this was the first commercial template documentation for ISO 13485 (then also known as EN 46001). Now in its third edition, and with over 3,000 copies sold, it has helped thousands of companies to achieve 21 CFR 820 compliance and ISO 13485 registration (requirement for CE Marking). It is by far the most popular and proven package on the market.

This documentation defines a quality system that is simple, intuitive, and free from excessive paperwork, making it easy to operate and maintain. Although simple and streamlined, it is a complete quality system that fully covers all 21 CFR 820 and ISO 13485 requirements (when not the same, the more stringent standard takes precedent). Several sample documents are included in the PDF files in the sidebar. To view more documents and all electronic forms integrated into XISOX, sign up for free trial.

The implementation tutorial is there to help you edit and customize the documentation to fit your company. It comes in the form of extensive notes and tips inserted directly into the documents. These notes:

• Identify and explain the requirements which are being addressed in the particular section of the document,
• Alert you to sections where you may need to make changes, and
• Discuss alternative approaches and solutions that may be more suitable for particular industries or types of companies.

It is like having a consultant anticipating your questions and helping you in real time as you are customizing the documentation.