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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.

• 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:
  • What is ISO 13485?
  • What are the Requirements?
  • What is Risk Management?

2 Perform Gap Analysis

Use the Gap Analysis Checklist to determine where you need to change your existing QMS.

• Gap Analysis Checklist?

3 Plan

Create a Project Plan to determine

• Begin with our FREE ISO 13485 Project manager's guide.
• Consider ISO 13485 Step-by-Step Workbook

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 Presentaion & Training Materials
  • Intro to ISO 13485 PPT
  • ISO 13485 Employee Newsletters

5 Design & Document

Design and document your ISO 13485 Quality Manual and Procedures The biggest portion of the project is looking at yor 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.

• ISO 13485 Quality Manual, Procedures, & Forms

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 imrpove it. This prepares you for an Audit by a Registrar.

• ISO 13485 Internal Auditor Training Materials
• ISO 13485 Internal Audit Checklist

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 acheive registration, you will need to select a Registrar who will preform a Registration Audit.

• ISO 13485 All-in-One Documentation & Training Package
• ISO 13485 Small Business Package