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Steps To ISO 13485

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.

Learn: Free Online Tutorial

2 Plan

Use the Gap Analysis Checklist as the basis for your implementation plan.

Plan: Gap Analysis Checklist

3 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. Quality Manual and Procedures

4 Audit

Use and improve your QMS - Is it working? 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 and management will formally review it. You will conduct. 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.

Internal Auditor Training Materials

Internal Audit Checklist