Diagnosis, prevention, medicine

Quality policy 2016-2017


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:

Our products are used for the diagnosis of socially dangerous widespread throughout the world infectious diseases (HIV/AIDS, hepatitis, syphilis, TORCH-infections, etc). 

Qualitative diagnosis is one of the most important barriers for preventing the spread of infections. TORCH-infections, etc). 

More than 25 years our employees are working to steadily improve and manage our product quality and have achieved significant results in this field.

Our team consists of highly qualified specialists in the field of biotechnology, chemistry, engineering, marketing and management. 


The main goals of our company are:

To ensure safety, sustained high quality of our products in accordance with consumer's expectations,  established and legislative requirements.

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. 


The main tasks of our company in goals achievement are:


1. Providing of  high quality products in accordance  to customer's and legislative requirements.

2. Diversification of enzyme immunoassay test kits in accordance to the dynamics of customer's requirements on 20-25 items.

3. Establishment of new relationships and collaborations with research institutes, centers and companies of Ukraine and  abroad in the sphere  of company interests.

4. Increasing of sales by expansion of sales market, product quality and competitiveness improvement.

5. Development of the export potential of the company.

6. Development and implementation of complex measures  to improve sensitivity and specificity of test kits  for diagnosis of HIV infection, hepatitis and syphilis.

7. Preparation the DIA-HIV-Ag/Ab enzyme immunoassay test kit to the WHO Prequalification of In Vitro Diagnostics Programme.

8. 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. 

9.To improve the quality of the supplied raw materials and services by more careful selection of suppliers and development of input control approaches.

10. 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

11. To implement  step-by-step modernization  of production and scientific facilities, measurement technology devices and infrastructure facilities of company.

12. To develop working environment of the company.

13. To improve professional skills and competence of staff steadily.

14. To motivate the personal interest of employees and their responsibility for the product quality.

15. To ensure  the conformity of the Quality Management System  with  ISO 13485 Standard, Directive 98/79/EC on in vitro diagnostic medical devices, National Standard (“Technical regulations on in vitro laboratory diagnostic medical devices”).

16.To ensure a process approach and conformity of each subdivision work  with the requirements of Quality Management System.


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. 


Chairman of the Board             A.Shevchuk