Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit . Learn about the standard. Perform Gap analysis of your current QMS in line of the ISO13485. Then create your project plan and trained your staff about the standards and check regularly the results. 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.
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. To achieve registration, you will need to select a Registrar who will perform a Registration Audit.