Quality policy
Nobil Metal gets another quality certification
On 26th January 2006, Nobil Metal S.p.A., one of the leading companies in the dental sector, received certification for the ISO 13485 self-supporting standard, following the audit carried out by the body Certiquality.
This standard refers in detail to the operation of medical devices and certifies that the company uses a quality management system based on procedures, recordings and "documented requirements" which ensure that the product characteristics comply with risk analysis management system.
The C.E.O. of Nobil Metal S.p.A., Giuseppe Venturini, commented "This certification completes a demanding journey for our company, which began in 1998, initialising a regulated and certified quality system in order to be able to give greater guarantees to our clients".
The certification is a further guarantee that manufacturers of custom-made medical devices provide to users of Nobil Metal products; it gives the certainty that the products used by them have been tested for their patient safety, according to controlled manufacturing procedures.
This standard refers in detail to the operation of medical devices and certifies that the company uses a quality management system based on procedures, recordings and "documented requirements" which ensure that the product characteristics comply with risk analysis management system.
The C.E.O. of Nobil Metal S.p.A., Giuseppe Venturini, commented "This certification completes a demanding journey for our company, which began in 1998, initialising a regulated and certified quality system in order to be able to give greater guarantees to our clients".
The certification is a further guarantee that manufacturers of custom-made medical devices provide to users of Nobil Metal products; it gives the certainty that the products used by them have been tested for their patient safety, according to controlled manufacturing procedures.
CE Certificates
There are two CE marking certificates, one for each Medical Device "family".
The number 0477 after the CE mark identify the Notified Body who issued the marking: eurofins. The certificates validity is of 5 years from emission date.
Nobil Metal is proud to have obtained the new certification according to EU Regulation 2017/745 (MDR).
ISO Certificate
Nobil Metal Certificate complying with international ISO 13485 "Medical Devices – Quality Management Systems" standards. The certificate validity is of 3 years from emission date. The Notified Body who issued the certificate is Certiquality. Certiquality is recongnized by the IQNet international circuit.
Declarations of Conformity
These declarations certify that Nobil Metal products meet the essential requirements of Annex I Directive 93/42/EEC and following changes., the applicable provisions of Directive 93/42/EEC and following changes. and the applicable technical standards.
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CE MARKING NOBLE AND NON-NOBLE ALLOYS AND SOLDER
Noble and non-noble alloys and solders for porcelain, resin and universal. -
CE MARKING FOR NON-PRECIOUS ALLOYS
Non-precious dental alloys for casting, laser melting and CAD/CAM milling. -
CE MARKING FOR DENTAL CERAMICS AND BONDING
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CE MARKING FOR ATTACHMENTS
Attachments and anchoring systems for dental use. -
CE MARKING ADHESIVE FOR DENTAL USE
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CE MARKING PMMA
Discs and blocks in PMMA for temporaries -
CERTIFICATE ISO 13485
Development, manufacturing and sale of alloys, products and accessories for dental use. Manufacture of semi-finished products in several materials by CAD/CAM system for dental technicians. -
DECLARATION OF CONFORMITY ALLOYS AND SOLDERS
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DECLARATION OF CONFORMITY NON-PRECIOUS ALLOYS
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DECLARATION OF CONFORMITY CERAMICS AND BONDING
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DECLARATION OF CONFORMITY LV ATTACHMENTS
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DECLARATION OF CONFORMITY LV KON AND LV KON PLUS
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DECLARATION OF CONFORMITY LV PER
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DECLARATION OF CONFORMITY ACCESSORIES LV ATTACHMENTS
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DECLARATION OF CONFORMITY ADHESIVES
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DECLARATION OF CONFORMITY PMMA