Quality Policy of the Institute

In order to safeguard the fulfilment of the objectives and obligations of the State Institute for Drug Control (hereinafter referred to as the “Institute”), the Director hereby pronounces the Quality Policy of the Institute, having regard to:

  • customers (regulated entities), stakeholders and employees of the Institute;
  • effective legislation and regulations in the area of standardisation;
  • Statute of the Institute;
  • national as well as international position of the Institute;
  • ethical rules.

The Quality Policy is reflected in all activities carried out by the Institute and the Management of the Institute requires that each employee, within the scope of his/her powers, be involved in the fulfilment of the Quality Policy.

The objectives and tasks are achieved in compliance with the applicable legislation, while observing ethical rules, environmental conduct, and safety at work, transparently, predictably, with transparent documentation of the Institute´s operation, and with openness towards motions from the regulated entities and from the public.

The objectives and tasks are aimed at the fulfilment of the government policy in the area of public health and reflect generally recognised expert standards in the area of drug policy.

For the purposes of effective fulfilment of the Quality Policy, the Director has established the following long-term objectives of the Institute supporting the achievement of strategic goals further detailed in the Institute´s Strategic Plan for 2016-2020:

  • To provide services and execute activities set forth by legislative regulations at a high standard, within as short timelines as practicable, to increase customer and partner satisfaction, and to develop a positive image of the Institute. An indicator of the effectiveness of the quality management system is a regular evaluation of individual activities carried out by the Institute´s units with regard to achieving satisfaction of the customers and partners of the Institute.
  • To strive to achieve international recognition of the Institute´s operation not only within the scope of EU agencies. With regard to the aforementioned, to support active involvement of the Institute´s representatives in international cooperation within the scope of the European Medicines Agency (EMA), the European Commission (EC), the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM), the Council of Europe, and others, to systematically monitor their decisions and incorporate them in the activities of the Institute.
  • To fulfil the conditions necessary to safeguard the operation of the Institute in compliance with the principles of the quality management system and requirements set forth by the ČSN EN ISO 9001 and ČSN ISO/IEC 17025 standards in the sphere of laboratories.
  • To increase the effectiveness and efficiency of the quality management system, availing of functional information systems, modern management tools, internal audits, and to apply corrective actions and avail of opportunities for improvement.
  • To increase the qualification and professional competence of all employees and to safeguard their permanent professional growth through the identification of needs and implementation of training plans.
  • To use adequate motivation tools to stimulate the Institute´s employees who are the basic source for the fulfilment of the Institute’s tasks.
  • To maintain the necessary material, technical, and financial resources for constant process improvement.