Diagnosis, prevention, medicine

Quality policy 2018-2019

PJSC SPC DIAPROPH-MED is the greatest manufacturer of wide range ELISA kits for the infectious diseases diagnostics in Ukraine.


In defining the Company`s Quality Policy, we are considering the following:

v  Our products are used to diagnose the socially significant worldwide infections such as HIV/AIDS, hepatitis, syphilis, TORCH infections, etc.

v  Proper diagnostics is one of the most important barriers to the infections spreading.

v  Our company for more than 25 years constantly improves the quality of manufactured products and has significant achievements with this regard.

v  Our team is high qualified specialists in biotechnology, chemistry, technology, marketing and management.


The main objectives of our company:

- To ensure safety, consistently high quality of our products in accordance with the customer requirements, established and regulatory requirements.

- Maintain and extent leadership in developed markets and achieve a sustainable authority on new markets due to the extension of the product range, the high quality of the supplied products, and predicting the customer requirements.


The main tasks of the company, aimed at achieving the objectives:

1. Provide customers with quality products in full compliance with their requests and expectations, as well established and regulatory requirements.

2. Extend the ELISA kit range, accounting the consumer requirements, by 20–25 assays.

3. Establish new contacts and arrange co-working with research institutes, centers and enterprises in the scope of the Company`s activities in Ukraine and abroad.

4. Develop the export activity of the enterprise.

5. Ensure the development of new approaches and their implementation in order to further increase the performance of test kits for HIV infection, hepatitis and syphilis diagnostics.

6. Prepare for the WHO prequalification DIA-HIV-Ag/Ab.

7. Reduce the costs of production and other processes due to defects and nonconformities through more efficient management and use of resources, personnel involvement, corrective and preventive actions, optimization of production and risk assessment.

8. Improve the quality of raw materials and services through more mindful selection of suppliers and their evaluation, improvement of incoming control methods.

9. Identify new reserves for improving product quality by increasing the stability and effectiveness of technological processes, as well reducing lot-to-lot variation. To improve the acceptance criteria for intermediate products.

10. Conduct a phased modernization of production and scientific equipment, measuring devices, as well the Company infrastructure facility.

11. Improve the Company work environment.

12. Continuously improve the professional skills and competence of personnel.

13. Motivate the personal interest and their responsibility for quality at all levels of the organization.

14. Ensure that the Company`s quality management system complies with the requirements of ISO 13485, Directive 98/79/EC on in vitro diagnostic medical devices, the Ukrainian Technical Regulations for In Vitro Diagnostic medical device.

15. Ensure the process approach and the compliance of the work of each unit with the requirements of the quality management system.


To perform the tasks, the Quality Management System has been developed, documented and implemented in the Company.

The Chairman of the Board and the Board are responsible for the implementation of the adopted Quality Policy, the effective functioning of the enterprise, the compliance with the requirements of the quality management system and the maintenance of its effectiveness.

The company's management undertakes to find all the necessary resources to implement the adopted Quality Policy, implement the initiative of the employees, and stimulate their personal interest and responsibility for the results of the work, the quality of products and processes at all the Company levels.

On the other hand, every employee shall realize that the good-faith fulfilment of their duties is a guarantee of our common success and well-being of everyone.