Steps to ISO 13485

  1. Learn about the ISO 13485 Standard
  2. Perform an ISO 13485 Gap Analysis
  3. Plan your ISO 13485 Implementation project
  4. Train your organization on ISO 13485
  5. Document your Quality Management System
  6. Implement your QMS and conduct business
  7. Audit your QMS using Process Auditing
  8. Registration Audit

1. Learn

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.

2. Perform Gap Analysis

Perform a Gap Analysis to determine where you need to change your existing QMS.

Gap Analysis Options:

3. Plan

Create a Project Plan

4. Educate Your Organization

All of your employees will need to be trained to work with the ISO 13485 Quality System.

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.


Our All-in-One Certification Package is a proven, efficient system. It gives you all you need to prepare for registration – in one simple to use package.

Customer Review:

"I have just passed my ISO Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

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