Haelvoet blog

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03-04-18 Company news




Haelvoet focuses on quality and safety: ISO 13485


Haelvoet is the proud owner of the ISO 13485 certificate (quality management system for medical devices) since February 2018.


Haelvoet has been subject to both a document audit and an implementation audit carried out by the German certification body TÜV-SUD. Under the guidance of our quality manager, the auditors checked whether the set up system fully met the requirements of ISO 13485: 2016. The audit report was positive and TÜV-SUD decided that Haelvoet could be nominated for certification.

The ISO 13485 certification is of course not an endpoint for Haelvoet. We have just successfully completed the recertification of the ISO 9001 and ISO 140001, these standards for quality management and environmental management have already been achieved by Haelvoet in the past. These certificates are important steps towards the systematic and efficient improvement of our organization, the processes, the products and the services in order to offer our customers optimal service at all times.