- Quality Manual in MS Word format for ease of editing
- Procedures are written in MS Word and are ready for your customization
- Related Forms are written in MS Word or Excel
- Text to address each requirement of the ISO 13485:2016 Standard
- Very clear instructions in obvious Blue Text to show you where to customize your Manual and Procedures
- Required references to the recommended procedures and forms for your quality management system
- Intuitive architecture for easy Document Control
- We’ve numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485:2016 Standard. Registrars LOVE this feature!
- Procedure and Form numbers relate to the section in the Quality Manual.
- This is a downloadable product.
- You will also have the option of purchasing the files on a Jump-Drive during checkout but it is not necessary.
Which version is right for me?
Choose ISO 13485:2016 to create a new ISO 13485 Quality Management System
Choose ISO 13485:2003 to 2016 QMS Upgrade to modify your existing ISO 13485:2003 QMS to meet the ISO 13485:2016 requirements
Choose ISO 13485:2003 to 2016 QMS to modify your existing ISO 13485:2003 QMS to meet the ISO 13485:2016 requirements
If you plan to reconfigure your existing quality manual and procedures to meet the ISO 13485:2016 standard, use Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide templates or new verbiage on the new requirements.