Quality Management System


The Quality Management System functioning in Polfa is implemented, maintained and verified to ensure product quality at every stage of its manufacture – starting from procurement of raw and packaging materials through verification, quality control, storage and distribution.

The system has been implemented based on the requirements of standards EN ISO 9001, EN ISO 13485 and legal regulations. As a result of the assessment of conformity of the manufactured medical devices with the requirements of Directive 93/42/EEC, conducted with the participation of a notified body, Polfa Lublin S.A. obtained the right to mark them with the CE mark. Meeting the requirements of Quality Management is confirmed by the certificates held.