Yes, MDSAP, while designed to satisfy audting requirements for five nations, can be a great tool to use to check inter-connected processes. This posting will share some observations with you to, possibly, help you be a more insightful auditor.
Quality Management systems audits, are, as you are aware, a management tool to help the organization understand the degree of compliance to specified criteria. Getting the auditee to tell you their story often helps you, the auditor, determine what the real issues are. This posting will share with you some of the observations I have made performing many audits over a period of 30 years.
Yes, the EU MDR is a very complex set of regulations. All designed with the intention of providing safe and effective medical devices for you and me. Is it the ultimate elephant? That is, how do you audit the EU MDR? One bite at a time? This posting will provide some insights into how to best make your time (as the auditor, or the auditee, as the case may be) most valuable, to your self and to each other.
