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:
2) Measurement Analysis and Improvement
3) Design and Development
4) Production and Service Controls
The audit process also covers one enabling process:
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.