Auditing requires extensive knowledge and experience including an “eye” to identify (potential) non-conformities, which is not always an easy task to fulfill for manufacturers. Thanks to our experience with auditing we are able to provide independent assessments, complete and clear audit reports, advice on possible improvement actions and assistance in planning of follow-up actions.
A basic requirement of a certified medical device company QMS is that an auditor may not audit their own work. This often means that internal audits cannot be performed by the company itself and must be performed by an external party. This is especially the case for small and medium sized companies.
Our role as an auditor is to help improve your quality management system or find potential gaps, which will ease your (re-)certification by the notified body. Additionally, a majority of medical device manufacturers outsource their development and production processes to specialized subcontractors. However, manufacturers continue to be fully responsible for the devices they put in the market under their own name. These subcontractors and other related critical suppliers must be regularly assessed, and this often requires auditing the suppliers. We perform supplier audits on behalf of the manufacturer and assess their fulfulling of the obligations as established in the quality agreement between the two parties. We offer to our clients: