S.I.L.C., partly, thanks to the thirty years of collaboration with the main European manufacturers, but more especially from the accumulation of experience and know-how which it made its own, has always paid close attention to the quality standards in the widest sense of the term.
This attitude has been rewarded with numerous certifications and citations received over the last years:
| 1996 | Directive 93/42/CEE of 14.06.1993 L.D. n° 46 of 24.02.1997 and successive modifications. |
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Regulation that defines the conditions for authorising the commercialisation of products that guarantee the safety and the protection of the health of users of medical devices (realisation of technical documentation, CE mark, declaration of conformity). |
| 2000 | UNI EN ISO 9002 : 1994 |
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Regulation that defines the international requirements for quality management systems. |
| 2002 | UNI EN ISO 9001 : 2000 |
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The regulation that replaced the three previous norms ISO 9001, 9002 and 9003. |
| 2003 | UNI EN ISO 14001 : 2004 |
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The regulation that governs the Environmental Management and, that is, the passage from a
mere respect of the relative laws in force to an integrated management of company activity aimed at the
prevention and improvement of everything concerning the environmental impact. |
| 2004 | BS 7799-2 : 2002 |
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The exponential diffusion of automatic computerised systems and applications of e-business has highlighted
the importance of the security of information that transits on websites that carry out on-line activity. Above all, there is the obligation to respect the new disciplines concerning privacy (Leg. Dec. 196 of 30.06.2003) concerning the means of treating data and the minimum security measures requested. This gives rise to the BS 7799-2 certification that governs the protection of company information, guaranteeing confidentiality, integrity and availability, through the implementation of a Security of information management system based on the model of continual improvement (PDCA) typical of standards ISO 9001 and 14001. |
| 2006 | ISO/IEC 27001 : 2005 |
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At the end of 2005, the British Standard 7799-2:2002 was accepted by the International Organization Standardization (ISO) in the scheme of ISO/IEC 27001 certification, which, replacing the previous BS 7799-2:2002, has become the international standard for the certification of the Management Systems for Information Security |
| 2006 | OHSAS 18001 |
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The OHSAS 18001 (Occupational Health and Safety Assessment Series) certification defines the features and requirements of the
Health and Safety in the workplace management systems. This system envisages the formulation of precise objectives and specific policies for the health and safety of workers of a specific organisation, in particular aiming to: reduce the risk of accidents, increase prevention and controls to minimise the number of injuries, increase job satisfaction (internal client) and, more generally, improve the company climate. |
| 2007 | Excellence 2007 Event |
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A conference called THE NEW FRONTIERS OF EXCELLENCE was held on 19th June 2007 in the presence of the Chief Executive Officer of Certiquality (www.certiquality.it) and the Manager of the Mobility and Environment Agency during which Certificate of Excellence N°111 was awarded to S.I.L.C. S.p.A. for an effective integration of the Management System of quality (UNI EN ISO 9001), of the environment (UNI EN ISO 14001) and of Safety (OHSAS 18001). |
| 2007 | Authorisation for the production of medical surgical devices. |
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SILC obtains the authorisation for the production of medical surgical devices
(disinfectants, germicidal and bactericidal substances for human and environmental use)
from the Department of Innovation (Directorate General of Drugs and Medical Devices)
of the Ministry of Health. Enclosed is a copy of the decree (pdf). |
| 2008 | UNI EN ISO 13485:2004 |
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The regulation specifies the requirements necessary for the research, development,
production, sale and distribution, even domiciliary, of medical devices
(in this case, absorbent aids for incontinence), with relative after-sales service,
favouring the global harmonisation of the regulatory requirements connected to such devices.
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