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Quality management

For Sirona, as the dental technology leader, a functioning quality management program is essential to economic success.

Products and services of high technical quality and innovation set the standards in the market. Compliance with international standards is required by our partners and customers. In order to fully meet these requirements, Sirona has implemented a process oriented quality management program, which focuses on our partners and customers.

The directive 93/42/EEC dated June 14, 1993, which pertains to medical devices, serves as the framework of Sirona's quality management program. All EU member countries are subject to this directive and implementation is enforced by national laws in each country. The directive confronts all manufacturers and distributors of medical devices within the European Economic Area (EU + EFTA) with the same requirements. Certification according to DIN EN ISO 13485 and according to Annex II to the directive 93/42/EEC provides proof of the highest quality, reliability and trustworthiness. Annual auditing by the TÜV Product Service technical inspection agency in Munich ensures continual improvement of our quality management system.

Sirona takes on the daily challenge of ensuring and constantly optimizing its high standards of quality. The Sirona quality management program provides employees with a well honed tool to meet the high demands of being a true leader in quality and innovation.

Downloads

Certificate according to EN ISO 13485 498 kB

Certificate according to ISO 13485 CMDCAS 129 kB

TUEV-Certificate-Anhang_II_engl_2015 494 kB