Quality policy

                                         

The quality assurance service monitors the maintenance of the quality of products produced by the Unitary enterprise "FreBor" at a high level and ensuring its competitiveness.

Quality control is carried out at all stages of the product life cycle, including the stages of its development, production and sale; and is carried out through an integrated quality management system implemented at the enterprise.

                                                      

    4 laboratories that are part of the quality assurance service structure help the enterprise to control production processes and the quality of its products: analytical, microbiological and two production laboratories. 

The analytical laboratory solves the following tasks:
- organization and conduct of input control of raw materials,

- instrumental control of production environment factors,

- conducting tests of medical devices for compliance with sanitary and chemical indicators,

- determination of the mass concentration of acetaldehyde and ethylene oxide in aqueous extracts from medical products sterilized with ethylene oxide.

The microbiological laboratory of the Unitary Enterprise "FreBor" has passed the procedure of special accreditation for compliance with the criteria of the National Accreditation System of the Republic of Belarus and the requirements of STB ISO/IEC 17025 (certificate of accreditation dated 16.05.2005 BY/112 2.2734).

The list of duties performed by this laboratory includes:
- testing of finished products for sterility;

- testing of finished products for bacterial endotoxins;

- testing of finished products for toxicity;

- monitoring of the state of the production environment, equipment and personnel.

Production laboratories perform the following duties:
- organization and conduct of timely and accurate tests of components, assemblies, semi-finished products, medical devices;

- issuance of conclusions on the compliance of their quality with the requirements established in the technical specifications and technical regulatory legal acts.

The laboratories are equipped with modern equipment, measuring instruments and reagents.

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