Steps to ISO 13485
- Learn about the ISO 13485 Standard
- Perform an ISO 13485 Gap Analysis
- Plan your ISO 13485 Implementation project
- Train your organization on ISO 13485
- Document your Quality Management System
- Implement your QMS and conduct business
- Audit your QMS using Process Auditing
- Registration Audit
You will need to get some general training on ISO 13485, so you understand what you need to do in your company to meet the requirements of the standard.
- Buy a Copy of the Standard that’s right for you!
- ISO 13485:2009 & Erratum
- ISO 14971 Risk Management for Medical Devices
- Learn about the standard:
2. Perform Gap Analysis
Perform a Gap Analysis to determine where you need to change your existing QMS.
Gap Analysis Options:
Create a Project Plan
- Begin with our FREE ISO 13485 Project Manager’s Guide
4. Educate Your Organization
All of your employees will need to be trained to work with the ISO 13485 Quality System.
- Online Employee ISO 13485 Training
- PowerPoint Presentation & Training Materials
5. Design & Document
Design and document your ISO 13485 Quality Manual and Procedures. The biggest portion of the project is looking at your current processes and redesigning them to address all of the requirements of the standard. Once you have modified or developed processes to meet the standard, you will need to control those processes. Documenting the processes as Quality System procedures is part of this control.
6. Use & Improve Your QMS
Once your system is developed and documented, employees will follow the procedures, collect records, and make improvements to the system. For approximately three months or more, your organization will run the QMS, collecting records.
7. Audit the QMS Performance
Use and improve your QMS – Is it working? You will conduct internal audits to see how your system is working and to improve it. This prepares you for an Audit by a Registrar.
8. Achieve Registration
Use our ISO 13485 All-in-One Documentation & Training Package and implement your system yourself. It includes what you need in order to save time and money and be successful.
To achieve registration, you will need to select a Registrar who will perform a Registration Audit.