Successful auditing of ITD quality management

08/08/2018

Continuous monitoring and optimisation are a matter of course for ITD's high quality standards. This year, for example, a second monitoring audit was carried out at both our sites in July, which complies with the legal and normative specifications of DIN EN ISO 13485. With this year's audit, there was a transition to the now valid 2016 version.

The legally prescribed standards for quality assurance were assessed by medical device certification at the beginning of July in both Unterhaching and Johanniskirchen. The certification body checked our quality management system for compliance with and application of the legal and normative specifications of DIN EN ISO 13485:2016. Our company, internal and external processes, guidelines and much more were audited to check for compliance on a random sampling basis. After three days of audit, characterised by laws, guidelines, processes, documents and records, the overall result was determined and the final evaluation was certain: ITD GmbH's quality management system is appropriate, suitable and effective in accordance with the standards.

To be able to offer you consistently high quality, we will also undergo recertification through medical device certification again next year. Audits are then to be carried out in accordance with the newly applicable standard DIN EN ISO 13485:2016.