The integrated quality management system implemented at Pharmamed-mado d.o.o. is based on the requirements of Good Distribution Practice (GDP) for wholesale trading of medical products, as well as the international standards ISO 9001:2015, ISO 14001:2015, and ISO 13485:16.

The goal is to fully meet the quality requirements of all involved processes and products.

A more detailed focus on ISO 13485:16 achieves greater alignment of the company’s processes and operations with legal requirements and standard requirements throughout the life cycle of the medical product.

Processes and activities within the quality management system are documented in the Quality and Environmental Management Manual, standard operating procedures, work instructions, and regulations, which clearly define the scope and sequence of activities, associated responsibilities, authorities, and methods of control and verification.

The quality and environmental management policy and the established principles of managing the integrated system apply throughout the organization and pertain to all operations.