Now, let’s consider the MDSAP Audit Roadmap process.  The Auditor will follow each of the seven process chapters below.

The audit sequence covers four primary processes:

1) Management
2) Measurement Analysis and Improvement
3) Design and Development
4) Production and Service Controls

The audit process also covers one enabling process:

5) Purchasing

There are also two supporting processes:

6) Device Marketing Authorization and Facility Registration
7) Medical Device Events and Advisory Notices Reporting

Each Chapter Process (1 through 7) contains multiple audit tasks that are to be verified/confirmed during the audit.  Each audit task references the applicable clause of ISO 13485:2016.  Included are specific regulatory requirements from the five participating countries.

Throughout the audit there is a focus on risk management and linkages between the processes.