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Quality Management Service

Since the very foundation of the enterprise, the quality service was always complying with the most advanced domestic standards.

Nowadays the orientation is performed to international, but still the most advanced standards. This is in the highest degree qualified personnel, latest scientific achievements in the sphere of control and research, use of the computer technologies. The enterprise uses process approach to quality management. It means that all processes are under controlled conditions and achieve the clearly defined goal, which in turn allows enterprise to manufacture the competitive products and in full extent satisfy the needs of our customers, increase the volumes of production and expand the markets.

Each process of created Quality Management System at JSC “Hemoplast” has peculiar features and comprises elements, which are also used by the leading companies in the world. For example, at the enterprise are widely used the control statistic cards, advanced methods of calibration of the means of the measuring instruments which guarantee the accuracy of measurements.

As a proof serves the elaboration and implementation of the complex system of quality management which meets the requirements of international standards ISO 9001: 2008, ISO 13485:2003, Directive of European Union  93/42/ЕЕС and is confirmed by international certificates of SGS company.

Proceed from this, the management of JSC “Hemoplast” has elaborated and confirmed the policy in the sphere of quality, which is directed to constant increase of quality and efficiency of all processes, covered by quality management system (technological, economical, commercial, marketing, personnel etc).

Implementing of the Quality Management System, complying with the several international standards, as well as study and use of progressive international experience has forced in a new fashion the approach to the improvement of technological processes and organization of the enterprise management.

Each lot of ready-made products is obligatory tested at research center. Manufactured sterile products are accompanied by the protocol of the history of lot manufacture, where the used materials, route of products  through sites during the process of manufacture and results of control are registered.

Products of JSC “Hemoplast” are certified in Ukraine by UkrSEPRO system and also in the Russian Federation and the Republic of Moldova, licensed in Ukraine, Russian Federation, Republic of Byelorussia, in European Union.

Quality service comprises:

-        research center;

-        technical control department;

-         quality department.

Research center carries out control of incoming products (raw materials, components) and ready-made products for compliance with the requirements of standards, sanitary condition of the rooms, equipment, personnel of production for compliance with the requirements of ISO 13485:2003.

It is equipped with modern equipment and instruments, which pass through the strict periodical metrological certification  and checking, and also possess highly qualified personnel, which allow to carry out sanitary-chemical, medical-biological, toxicological-hygienic, mechanical, functional tests according to the most advanced methods. Research center is accredited by National Accreditation Agency of Ukraine (accreditation certificate Nr. 2Т478 dated 29.03.2010).

Technical control department (OTK) carries out inspection control of production processes, technological operations and products (parts, units), organizes and ensures the traceability of the results of control of the parameters of processes and products.

Quality department constantly carries out the evaluation of the efficiency of the functioning of the Quality Management System on all levels and elaborates the proposals on its improvement, carries out periodical audit control of the Quality Management System, organizes the training of personnel of JSC “Hemoplast” in the sphere of quality, carries out works on registration and certification of the products in Ukraine and abroad.


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