Quality Management

QUALITY, ENVIRONMENTAL PROTECTION AND INFORMATION SECURITY POLICY

Our mission is to contribute to the accomplishment of the basic human right of accessibility to quality, efficacious and safe medicines and medical devices, as well as to promote and enhance public and animal health through:

  • issuing marketing authorizations of solely quality, safe and efficacious medicines and medical devices,
  • providing adequate information in order to ensure a safe and rational use of issued medicines and medical devices, and
  • quality control of medicines and medical devices which is in full compliance with all the national and international laws and standards.

Our vision is to be a modern, efficient and socially responsible institution which is to become a leading one in the SEE region.

We shall accomplish our vision through effective and efficacious regulatory processes which are in compliance with the ISO 9001:2008 requirements, through:

  • establishment and maintenance of high level standards during evaluation of applications, laboratory quality control, and providing of an adequate information,
  • continuous education and employees’ competence development,
  • quality management system continuous improvement,
  • development of a strong organizational culture and recognizable image,
  • top management leadership in the vision accomplishment.

We believe we can meet all the challenges with our strength and stamina. Our performance is based on four basic principles:

  • Social responsibility – as an institution we are firstly and mostly dedicated to human and animal health protection so all our work, professional and scientific competence are devoted to patients in Serbia. We are responsible to our social environment, users of our services, employees and founders.
  • Leadership – we committed ourselves to setting high standards by our operation, to becoming a support to all the interested parties in respect of public health through knowledge and skills enhancement, as well as to ensure a complete vision accomplishment by modern management.
  • Trust – our further development is based on enhancement of mutual trust between us and our clients through joint performance and work transparency as well as on strengthening the belief in ourselves, i.e. our employees.
  • Quality – we are devoted to achieving the highest quality of our services so the additional value for our clients, partners and employees can be accomplished.

NATIONAL CONTROL LABORATORY QUALITY POLICY

The management of the National Control Laboratory determines the quality policy to ensure that a quality control of medicines and medical devices meet the stated and real users request as well as applicable laws and regulations.

National Control Laboratory aims to:

  • Provide quality services to their customers across Serbia, through professional and independent quality control of medicines and medical devices, relying on its integrity and integrity of subcontractors, creating additional value for clients, employees and society,
  • Permanently maintain the position of the most prominent laboratory for quality control of medicines and medical devices in the region,
  • Steadily increasing users’ satisfaction.

National Control Laboratory will accomplish these goals through introducing, monitoring and continuous improving the management system which is in compliance with the SRPS ISO/IEC 17025:2006 requirements by following activities:

  • Top management will be focused on good professional practice and the quality of services,
  • providing continuous quality of service,
  • proving our competence in performing quality control of medicines and medical devices through consistent implementation of management system,
  • employees will be trained on the quality documentation, and they will implement the quality policy and procedures in their work,
  • – management will be responsible for constant implementation of SRPS ISO/IEC 17025:2006 requirements and continuous improvement of management system.

ENVIRONMENT PROTECTION

Preventing pollution, saving resources and energy, reducing or phasing out hazardous substances, controlled waste management are ways in which Medicines and Medical devices Agency of Serbia demonstrates commitment to environmental protection. Concern for the environment is part of certified environmental management system and Quality management system. We are aware that we are not inheriting Earth from our Ancestors, we are borrow it from our children.
Agency performs regular tests of emissions in city collector and emissions of air pollutants. We point out that from the beginning of monitoring the results were far below the law limits. Measurements are made on the basis of External Monitoring Plan, according to which the monitored aspects are always different in order to achieve representative sample and gave the real insight to the environmental situation. Measurements are performed by authorized and accredited laboratories. Although the results are excellent the Agency will continue with monitoring in the future, with purpose to identify possible pollutions at the time and prevent degradation of environment and human health.
All generated waste in the Agency is collected at the source, classified, properly marked, stored and destroyed or recycled depending on whether it is a hazardous or non-hazardous waste. Agency is keeping records about all kinds of waste and informs Environmental protection Agency trough annual waste management report. We are point out with pleasure that Agency is the first institution in Serbia which provided information of types and quantities of waste to Environmental protection Agency, after adoption of the Rulebook of integral cadastre of polluters in 2008.
Rational use of energy in the Medicines and Medical devices Agency of Serbia is reflected on the appropriate behavior of employees – turning of the light and devices at the end of working day, using energy saving bulbs, using natural gas for space heating. Also, experts in the Energy Efficiency Agency of Serbia gave lectures to employees about renewable and nonrenewable energy sources; energy efficiency and ways of reducing the consumption of resources.
Internal communications in relation to issues of environmental protection is implemented trough trainings for raising the awareness of employees. These trainings are related to the necessity to protect the environment by using presentations, interesting articles, posters etc. In accordance with the mentioned above, employees learn about consequences of excessive resource consumption on the environment and costs incurred by unconscious behavior towards the environment.
We are proud of external communication which includes reporting to the Ministry of Natural Resources, Mining and Spatial Planning (reporting on the movement of hazardous waste) and Environmental protection Agency (reporting on the annual quantity of generated waste, reporting on air and water emissions). In addition to statutory requirements, Agency also works to raise public awareness. Agency participated in the action in purpose to inform and educate the public on handling treatment of drugs with expired date, organized by City Secretary for environmental protection which was realized in cooperation with the students of Belgrade Polytechnic College.
Also, employees of the Agency each year participate in the action „Clean Serbia“, organized by the Ministry of Natural Resources, Mining and Spatial Planning on the occasion of 05th June- International environmental protection day.
International cooperation was established with Environment Agency for England and Wales, as well as membership in working group on hazardous waste, which is part of International Organization for solid waste.


Customer satisfaction questionnaire

So far, Medicines and Medical devices Agency of Serbia made a great effort to ensure continuous development of regulatory performance, in order to assure that only quality, efficacious and safe medicines and medical devices are available to patients in Serbia.
One of the main goals of certified quality management system is continuous improvement of service quality. Also, intensive cooperation with all stake holders contributes to this improvement. For that purpose we have prepared a questionnaire to determine if all customer requirements are met, as well as how customers are satisfied with the quality of service.
We think that the opinions of our clients, as well as the comments and suggestions may contribute to the improvement of the quality management system, and overall efficiency of the Agency.
In case you have not already been contacted by e-mail, the questionnaire can be downloaded from the Agency’s website, fill in and sent by mail, email or fax to:

Ass. prof. Gordana Pejovic PhD, sp.
Quality Management Manager
Medicines and Medical Devices Agency of Serbia
458, Vojvode Stepe Street , Belgrade 11221, Republic of Serbia
Email: gordana.pejovic@alims.gov.rs
Fax: 011 3951 181

Please note that you can fill out the questionnaire anonymously.
Thank you for your cooperation and useful suggestions.

QUESTIONNAIRE