Oscar Boscarol srl developed its Quality system accordingly to ISO 9001 (Quality Management Systems) and ISO 13485 (Medical devices – Quality Management Systems). The company acts and behave in compliance with all National laws besides European and local norms (when requested) referring to medical devices design, production, commercialization and after sale service. Particularly, the company aims to wholly follow and respect what required by 93/42/CEE European norm, ever since its first issue up to all revisions, modifications and later additions together with all reference rules and guidelines in due course. With the new Medical Device Regulation MDR 745/2017 coming into force, we are working to make our products
compliant to the new requirements.
Our organization has always been involved in a process that might respect the environment and constantly applies measures and activities aiming the utmost level of eco-sustainability. Design and homologation of our medical devices comes from a pretty scarce compliance to customers queries and law requirements of many devices. One of Oscar Boscarol Company first goal has always been to design and manufacture specific products for this particular field, continuously updated in order to satisfy both customer and legal requests and prerequisites. The entire company organization is involved in a process dealing with continuous improvement where the customer’s satisfaction represents an indefeasible value.
Oscar Boscarol company has defined its quality management system as strategic mean to:
COMPANY CERTIFICATION CHRONOLOGY
93/42/CEE directive on medical devices came into force in Italy in 1998 setting all conformity requirements related to medical devices. Such prerequisite is mandatory by law and was recognised by the Countries of the European Community. CE mark is one fundamental prerequisite for the commercialization of medical devices, accordingly to their risk class, classification and destination of use.
Vack in 1996 the Oscar Boscarol srl got ISO 9001 certification which was achieved as a valid instrument to improve organization, planning and the image of the company both on international and national market places. This new quality management system allowed the Company’s Management to establish documented processes and procedures in order to manage all the internal activities and reach records of penetration in the market and allowing to register nine international patents on specific devices. The Oscar Boscarol srl has always believed in the continuous improvement concept and thanks to its quality policy, together with an accurate resource and strategies management oriented to the marketplace needs has rightly achieved its place as leader in the field.
Such certification was a peculiar step in the company growth, in fact right at the end of the year 1997 all of the devices were considered compliant to the requirements in due course, thus complete with the CE mark.
The first certificate was issued by the DNV, Det Norske Veritas notify body.
SGQ revision and the application of new norms occurred in the year 2000, well in advance with respect to the proper effectiveness of the new norms. The certificate was obviously extended to ISO13485:1996 auxiliary norms.
In 2003 the company Board of directors decided it was time to change DNV notify body with the Italian IMQ in the occasion of the extension to the new norms ISO13485:2002: this choice was motivated by the research of an Italian notify body which also had a laboratory on its own, aiming to reduce management global expenses besides the products homologation cost.
In 2005, after the new self-referring norm came into force, the Company successfully passed the audit for the certification issue, thus becoming one of the few Italian companies having reached this goal well in advance.
In December 2007 the notify body was changed again to TÜV SÜD Product Service GmbH, by which the Company is currently certified.
Since aSeptember 2009, after the renewal audit performed by the TÜV SÜD Product Service GmbH notify body, the Oscar Boscarol company is certified accordingly to the new ISO9001:2008.
CONFORMITY CERTIFICATE
CE CERTIFICATE