The internal audit is often a hot topic during the regular audit especially in small companies. The meaning of internal audits tends to be underestimated and neglected.

The internal audit is often a hot topic during the regular audit especially in small companies. The meaning of internal audits tends to be underestimated and neglected.

The implementation or the change from one QMS to another eQMS must be well planned and structured. It needs heavy endurance and support from the management and all users over the entire change period!

From the perspective of a lead auditor for ISO 13485 and 9001, I am exposed to many different quality management systems and company

The IVDR, which came into effect on May 26, 2022, introduced significant changes and more stringent regulations for in vitro diagnostic devices.