Certifications


Since it was founded, Sentinel has conducted business with the objective of:

• Providing clients with timely and reliable
  responses to satisfy their needs.

• Understanding in advance the client’s   expressed and unexpressed needs

• Persevering in the continuous improvement
  of its products  

• Optimizing human resources
• Ensuring the growth of its organizational
  structure, adequateness of procedures,
  processes and flow of information

• Developing the company through
  the improvement of results in terms
  of market presence and profits to reinvest
  in research and development.

Quality organizations

In fact, since 1998, Sentinel has had a certified quality management system and today it complies with the international regulations ISO 9001:2008, ISO 13485:2003 and EN ISO 13485:2012, the latter being specific to medical devices, including IVD.

The certificate obtained has been issued by the BSI (British Standards Institution), one of the most recognised certification bodies in the world; thus permitting Sentinel to meet the certification requirements at an international level.

Sentinel also promotes and sells its products in the US, having registered its products and manufacturing facility with the FDA.

Furthermore, in August 2006 it obtained certification ISO 13485:2003 CMDCAS standard, indispensable in order to sell products on the Canadian market.  


 



Sentinel products are registered worldwide in the following countries: Europe, India, Russia, Taiwan, Turkey, USA and other countries.





Certifications

Sentinel Registered as a manufacturer of In-Vitro Diagnostic Medical Devices in the following countries:  

- Italy, through the Italian Ministry of Health

- USA, listed as a registered establishment
  in the FDA  database  

- Brazil, through Anvisa, National Health
  Surveillance Agency

Sentinel is in possession of Certificates attesting to compliance with the following standards:

   ISO 9001:2008
Quality Management Systems Requirements

   EN ISO 13485:2012
Quality Management Systems Requirements for regulatory purposes

   ISO 13485:2003 CMDCAS
Medical Devices Regulations (SOR/98-282) for Canada

   BS OHSAS 18001:2007
Occupational Health & Safety Management System

   ISO 14001:2004
Environmental Management System

   Complying to 21 CFR 820
“Code of Federal Regulations“ FDA (U.S. Food and Drug Administration)

   Moreover Sentinel is a Corporate Member of the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine ) with a designated representative within the company.



   Sentinel is accredited as a Validated Supplier by the IRMM (the European Commission Institute for Reference Materials and Measurements) and sponsors the research program of CIRME, the University of Milan's Centre of Metrological Traceability in Laboratory Medicine.