OUR AIM: TOTAL QUALITY

Managing a company that holds the responsibility to produce medical devices, requires a careful evaluation of the suitability to the market requests, to the production processes and related costs. This led the Directory Board to establish the quality management system according to the rules ISO 9001:2008 and ISO 13485:2004, defining the quality policy, the organizational structure, the responsibilities, the resources and the necessary instruments.

With this point of view, the primary purpose of quality policy is the satisfaction of clients and of their needs, obtained by the quality of products and services, respecting the guidelines and the binding rules. This means that we assure to our clients quality, safety, efficiency and reliability in time for our products.

 
By the implementation of its quality management system, FARO S.p.A. commits itself to:
  • constantly innovating and developing its products
  • satisfying the explicit and implicit needs of the client
  • providing a proven quality product, in the respect of laws and defined standards
  • going on to develop, at any organization level, the company culture of quality, in order to ensure the effectiveness of the implemented quality system and to aim at excellence because quality is a responsibility and a purpose of the management and of all the staff
  • assuring the accomplishment of a constant improvement, both on products and on company processes, in the respect of safety requirements for medical devices,the constant improvement must in any case be subdued to safety and effectiveness of out products
  • assuring the protection of the environment and of the health of its staff by the respect of laws and rules in force, upgrading plants and processes for a reduction of environmental impact and protection of staff safety, the commitments become process targets, that the Direction Board periodically checks in a documented way
Chief Executive Officer
Dr. Angelo Favonio
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QUALITY MANAGEMENT SYSYEM

Our organizational and productive structure applies a company quality system, in order to cope carefully with the always raising needs required by clients and by the regulations of European Community for the market we operate on.

FARO S.p.A. focuses on the various market needs, projecting and marketing products used in medical, electro-medical and dentistry fields, in its head office of Ornago (Monza-Brianza), with the aim of improving performance quality through the formalization and the subsequent optimal management of processes, that integrate the different departments of the company.

The fundamental concepts on which is based the reference model ISO 9001:2008 are essentially two:

  • to develop performances really corresponding to the users needs
  • to adopt instruments that ensure the constant system improvement
The practical involvements of these two concepts imply for FARO S.p.A.:

  • the adoption of an organizational model structured by processes
  • the appropriate documentation of all processes, according to the reference model
  • the systematic utilization of measure instruments that allow to evaluate in every moment the state of a process, and to project the improvement actions
  • the consideration in every process of all the elements required by the reference rule

QUALITY CERTIFICATIONS

ISO 9001:2015 Certification

FARO S.p.A. Quality System complies the ISO 9001:2015 Rule for the following activities: planning, production, marketing and assistance of products and fittings addressed to the medical, dentistry (instrumentation), dental technical and industrial fields.

PDF: Certificate N. 9120.FAR1 issued by CSQ (IMQ)
First issue: 1998-07-10
Current issue: 2018-07-19
Expiry date: 2020-03-24

PDF: Certificate N. 9124.FAR2 issued by CSQ (IMQ)
First issue: 1998-07-10
Current issue: 2018-07-19
Expiry date: 2020-03-24

Certification and Classification of products


FARO S.p.A. issues this page in order to help its clients to define the certifications of Medical Devices and number of registration to NSIS (New Health System Information) and CND (National Classification of Medical Devices) codes.

PDF: Certificate EC N.º 104/MDD
First issue: 1998-10-08download/qualita/FARO_0104_MDD_2019_03_19-1.pdf
Expiry date: 2023-07-30
Substitution date: 2018-07-31

DM Progress and Repertory Number CND
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