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PJSC «Diaproph-Med» is the largest Ukrainian manufacturer of immunoassays for human and animal infectious diseases diagnosing.
Determining the quality policy of the company, we rely on:
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Our products are used for the diagnosis of widespread throughout the world infectious diseases (HIV/AIDS, hepatitis, syphilis, TORCH-infections, etc).
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Qualitative diagnosis is one of the most important barriers for preventing the spread of infections.
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More than 20 years our employees are working to steadily improve and manage our product quality.
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Our team consists of highly qualified specialists in the field of biotechnology, chemistry, engineering, marketing and management.
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The main goals of our company are:
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To ensure safety, sustained high quality of our products in accordance with consumer's expectations, established and legislative requirements.
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To retain and consolidate leadership on the market and to achieve a positive self-image in new markets by product expansion, high quality of products, customer's requirements realization, technical support improvement.
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The main tasks of our company in goals achievement are:
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1.
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Providing of high quality products in accordance to customer's and legislative requirements.
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2.
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Diversification of enzyme immunoassay test kits in accordance to the dynamics of customer's requirements.
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Establishment of new relationships and collaborations with research institutes and centers in the sphere of company interests.
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Increasing of sales and profits by expansion of sales market, diversification, product quality and competitiveness improvement.
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Development of the export potential of the company.
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Development and implementation of complex measures to improve sensitivity and specificity of test kits for diagnosis of HIV infection, hepatitis and syphilis.
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To make CE-certification of DIA-HIV-Ag/Ab enzyme immunoassay test kit (version 8).
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Reducing manufacturing and other processes costs, which could be a result of nonconformities and defective outputs production. This entails more effective resource management and using, personnel involvement, corrective and preventive actions.
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To improve the quality of the supplied raw materials and services by more careful selection of suppliers and development of input control approaches.
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To develop a new reserves of products quality improvement by stability and technology effectiveness increasing, and decreasing of intra- and inter-batch variations in product quality
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To implement step-by-step modernization of production and scientific facilities, measurement technology devices and infrastructure facilities of company.
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To develop working environment of the company.
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To improve professional skills and competence of staff steadily.
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To motivate the personal interest of employees and their responsibility for the product quality.
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To ensure the conformity of the Quality Management System with ISO 13485 Standard and Directive 98/79/EC , National Standard (“Technical regulations on in vitro laboratory diagnostic medical devices”) .
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To ensure a process approach and conformity of each subdivision work with the requirements of Quality Management System.
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For the goals implementation the Quality Management System was developed, documented and introduced in the company. Chairman of the Board and board of directors of the company are responsible for Quality policy implementation, operation of business, compliance with Quality Management System and maintenance of its effectiveness. The company's officials undertake to find the necessary resources in order to realize adopted Quality policy, to develop the staff initiative, to motivate personal interest of employees, their responsibility for the product quality.
On the other hand each employee must acknowledge that fulfillment of a commitment in good faith will lead to success in achieving goals and welfare.
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