If your business needs to comply with both ISO 9001 and ISO 13485 Standards, this manual is for you. It addresses requirements of both Standards. For easy reference, requirements of ISO 9001 standard are in black font and medical requirements are in blue.

This set includes:

- Integrated ISO 9001 / 13485 QMS Manual,
- Quality Policy,
- Quality Objectives Matrix, and
- QMS Manual review checklist.

Order your copy today!