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QUALUTY POLICYPOLITIKA KVALITETA
QUALITY POLICY OF THE MEDICINES AND MEDICAL DEVICES AGENCY OF SERBIA
Quality Management System of the Agency has been certified by the world’s leading certification company SGS, with registered office in Zurich. This certification represents a confirmation of compliance with ISO 9001:2000 standard and refers to the following processes carried out within the Agency: providing issuance services for authorizations, approvals and certificates for medicinal products and medical devices, and the quality control thereof.
Introduction of Quality Management System to the Medicines and Medical Devices Agency of Serbia will satisfy all interested parties (patients, health-care professionals, manufacturers and distributors of medicinal products and medical devices, animal owners and other users of the Agency’s services), as well as the employees of the Agency themselves. The strength and success of the Quality Management System of the Agency is reflected by the fact that the management and other employees participate jointly in its development, which ensures that all of them identify with that system and work on its enhancement.
In line with the strict international requirements regarding the quality control of medicinal products and medical devices, a management system in accordance with the requirements of ISO/IEC 17025:2005 standard has been introduced to the National Control Laboratory.
QUALITY POLICY OF THE NATIONAL CONTROL LABORATORY
The National Control Laboratory management determines the quality policyin order to ensure that the services of quality control of medicinal products and medical devices it provides meet the stated and realistic requirements of the users, as well as the existing laws and regulations.
The National Control Laboratory aims at:
• assuring the quality of services provided to its users in Serbia through professional and independent quality controls of medicinal products and medical devices, relying on its integrity and the integrity of its subcontractors, creating the value added for the users, employees and the society.
• permanently retaining the position of the best-known quality control laboratory for medicinal products and medical devices in the region,
• continually enhancing customer satisfaction.
The National Control Laboratory shall meet these goals by introducing, monitoring and constantly improving the management system harmonized with the requirements of ISO/IEC 17025:2005 standard, whereat:
• the management will be focused on good professional practice and the quality of service,
• constant quality of service will be ensured,
• consistent application of the management system will prove its competence for performing quality control of medicinal products and medical devices,
• the employees will be familiar with the documentation of quality and implement quality policy and procedure in their work,
• meeting requirements of ISO/IEC 17025:2005 standard and permanent improvement of the management system will be the obligation of the management.