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Quality Assurance Policy

Quality Management

Systematic quality issues in Medika started in 2001, when the process of creating a Quality Management System according to ISO 9001 was initiated, which was crowned with a certificate in 2002. By meeting the requirements of ISO 9001, Medika's business has gained a new, powerful backbone for the effectiveness of all business processes with special emphasis on activities within the logistics segment. 

The principles of Good Distribution Practices (GDP), which have already been aligned with all the logistics processes of Medika, have been applied in this way through international standards and have enabled effective monitoring and improvement of processes and operations.

Four years later, the project for the introduction of the Environmental Management System was launched in accordance with the international standard ISO 14001. The environmental management system was integrated into the already existing Quality Management System and ISO 14001 certification was obtained in this same year. Moreover, in the years that followed, the integrated Quality Management and Environmental Management System has been constantly developed and improved. As Croatia approached its full membership in the European Union, the legal frameworks related to the sales of products from Medika's portfolio were altered.

Additional changes brought new developments in the area of Good Distribution Practice (EU GDP) and Good Manufacturing Practice (EU GMP). As a result, the need for further alignment and improvements in the area of quality management has been identified, and in 2013, a thorough review of the existing integrated Quality and Environmental System began. 

As part of the changes that have been initiated, we have started implementing the Good Manufacturing Practice (EU GMP) as well as adapting the Quality and Environmental System to new Good Distribution Practices (EU GDP) requirements as a result of changes in regulations related to medicinal products, medical devices and other products.

As a result of successful adjustments, in 2014, Medika gets a production license, a GMP certificate and a GDP licences and certificates for all its locations. Due to regular inspection visits by various government institutions and regulatory bodies, oversight inspections of certification bodies, external audits by suppliers and other business partners, and continuous self-inspection activities, an integrated Quality and Environmental Management System, including ISO 9001, ISO 14001 and GDP requirements, GMP requirements is constantly being upgraded and updated.

The efforts of Medika to continuously improve its Quality and Environmental Management system are reflected in employee's ongoing training, risk management, acquisition of additional competences from various quality management systems and constant search for more contemporary and effective solutions intended for effective monitoring and improvement of the process.