Because the equipment produced is so sophisticated and, besides, affects directly human health, quality of our products is the major concern of the company. Our primary goal is satisfaction of our customers, both the patients who want a qualitative diagnostics, and the medical personnel who need easy-to use modern equipment with maintenance service.
As for the quality of the products Roentgenprom company accomplishes the following tasks:
- Guarantee a high technical level of the products for maximum qualitative diagnostics and maximum possible safety of the patients and the medical personnel; to keep this level constantly growing.
- Make our equipment most convenient in use.
- Organize and constantly improve maintenance of the equipment.
For successful accomplishment of the above tasks Roentgenprom company sets as prior the following directions:
- The design of the produced equipment to be constantly improved, new technical solutions to be found.
- Only high quality accessories to be used; further cooperation with providers as for the quality of the products supplied.
- Further improvement of the production organization.
- Further improvement of the quality control of the products.
- Improvement of ergonomic characteristics of the products.
- Better writing of performance instructions and other papers for medical personnel containing information about the use of the equipment.
- Maintenance perfection.
- Improvements in management to control product quality and make its performance efficient.
Quality improvement is the responsibility of the business executives as well as of the heads of all departments and individual workers.
The JSC «Roentgenprom» quality management system meets ISO 9001:2000 requirements, that is confirmed by the certificate of conformity given by international certifying body SGS Switzerland SA in 2002 ( ISO 9001-2000) and EuroCAT Institute for certification and testing in 2006
(DIN EN ISO 9001:2000). The system covers design/development, production, installation, servicing and distribution of x-ray devices.
In 2004 the EuroCAT Institute for certification and testing (Germany) carried out successfully audit of JSC «Roentgenprom» quality management system on conformity to EN ISO 13485:2003 requirements for quality management systems of medical equipment manufacturers.
The JSC «Roentgenprom» product Low-dose digital scanning fluorograph with x-ray protective cabin FMcs- «ProScan» fulfills requirements of the European community directive 93/42/ЕЕС on medical devices ( «СЕ»). The certification with assignment of СЕ-mark to a product is carried out by EUROCAT Institute for certification and testing (Germany). FMcs-«ProScan» became the first x-ray medical device produced by Russian manufacturer received СЕ-mark as confirmation of high level product safety.
In 2006 EC-certificate («EC-Certificate» ) and the right of СЕ-marking were given by Institute on certification and testing EuroCAT to Universal digital radiographic unit ARgC-RP «ProGraph» and Unit for digital fluorography APCF-01-«AMICO» ( Enclosure of EC-Certificate, Medical devices ) as confirming of their conformity to requirements of European community directive 93/42/ЕЕС on medical devices.
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