Certifications

8853 S.p.A. has a quality system that complies with the following standards

  • EN ISO 9001:2015 (for the design, production and distribution of alloys for dental use, goldsmithing and semi-finished products for goldsmithing)
  • EN ISO 13485:2016 (Quality Systems - Medical Devices).

Such a system aims to ensure quality in the design, manufacture and sale of dental alloys in general, and of the VALCAMBI DENTAL dental line, in particular.

In fact, the quality system, insofar as it complies with the requirements of EN ISO 13485:2016, also meets the particular requirements for the design, development, manufacture and sale of medical devices. All this has enabled 8853 S.p.A. to CE mark its products in the specific sector of dental alloys in accordance with the requirements of Directive 93/42/EEC of 14 June 1993 and subsequent amendments.

The same quality is ensured for the design, manufacture and sale of semi-finished products for goldsmiths, thanks to the compliance of the system with the EN ISO 13485:2016 standard.

The certification of the quality system of 8853 S.p.a. and the suitability for CE marking of the products have been attested by the Notified Body BUREAU VERITAS, one of the most prestigious in the world, which has issued a CE Certificate, with EN ISO 13485:2016.

The same organisation carries out strict checks over time on the work of 8853 S.p.A. and on the maintenance of the quality levels achieved.

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