Certifications

8853 S.p.A. offers its customers and patients all the guarantees of safety as it is equipped with a quality system that complies with the following regulations:

  • UNI EN ISO 9001:2008 (for the design, production and distribution of alloys for dental, jewellery and semi-finished products for jewellery).
  • EN ISO 13485:2016 (Quality systems - Medical devices)

The system aims to ensure quality in the design, manufacture and sale of dental alloys and also meets the requirements for the design, development, manufacture and sale of medical devices. This has allowed 8853 S.p.A. to CE mark its products in the specific sector of alloys in accordance with the requirements of Directive 93/42/CEE of 14 June 1993 and subsequent amendments.

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

The certification of the quality system and the suitability of the products for the CE marking have been certified by the Notified Body TÜV Product Service GMBH di Monaco, in Munich, one of the most prestigious in the world, which has issued an EC Certificate, con EN ISO 13485:2016. Over time, the same body carries out strict controls on the company's operations and on maintaining the levels of quality achieved.

8853 S.p.A. also has a UNI EN ISO 9001:2000 certified quality system that allows it to design, produce and market products that comply with Annex II of Directive 93/42/CE and are identified with CE 0123.

He is also a member of the Responsible Jewellery Council, a non-profit organisation that guarantees the use of "conflict free" metals.

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