Quality Policy of State Institute for Drug Control (SIDC) represents approach of top management and all employees to fulfil objectives, duties and competencies specified in the statute of SIDC
SIDC Quality Policy is oriented to:
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Carrying out services connected with control of the quality, safety and efficacy of medicinal products and medical devices,
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The continual improvement of effectiveness and level of provided services in relation to registration of medicinal products and performance of state supervision on the pharmacy sector,
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Respecting of ethical standards of performed services.
Basic requirement of the SIDC concept of quality is to perform activities determined by, the Institute statute effectively to provide services in high level to be in compliance with:
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valid national, and international regulations and relevant standards,
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Ethical Code,
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and satisfy the customer.
SIDC specified the following main quality objectives for achievement of the above mentioned top-priority tasks:
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To provide services of high quality in real short terms, effectively and with appropriate price relations
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Fulfil conditions for the performance of SIDC services and activities incompliance with criteria stated by STN EN ISO 9001, STN EN ISO 9004 and for activities of the Institute laboratories in accordance with requirements of STN EN ISO/IEC 17025,
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To participate in application of governmental quality policy in theSlovak Republic (The National Quality Programme of the Slovak Republic, 2009 - 2012).
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Effort for international recognition of the Institute activities within theEuropean Agency for the Evaluation of Medicinal Products (EMEA) and European Directorate for the Quality of Medicines (EDQM). In this context support active participation of its experts in an international co-operation mainly within EMEA, OMCL, PIC, WHO, OECD, and monitor decisions andaccepted documents of these bodies on regular basis.
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Create conditions for maintenance and improvement of quality system without exceptions in the framework of SIDC activities. Create administrative, personnel, and regulation conditions for systemic andeffective achievement of assigned goals.
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Create conditions for training and personnel development of the employees to understand and fulfil of established aims.
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Stimulate the satisfaction and performance of the personnel by good working environment and improve the system of their motivation.
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To cultivate relation of personal honour and involvement of personnel tothequality and adherence to principles of Ethical Code of SIDC's staff members.
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To guarantee effective internal communication and team work in applying toprocess approach of quality management system and to improve quality management system.
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To maintain feedback between the Institute and interested parties and follow the current needs with the aim of enhancing interested parties'satisfaction.
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To utilise all accessible forms of clients´ as well as personnel's surveys of satisfaction for the improvement of the SIDC's management system and the level ofservices.
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Permanently improve and develop the performance of the Institute,
The quality objectives in compliance with quality policy and permanent improvement should be a guarantee of the satisfaction of customers and interested parties.
Done in Bratislava, on November 1st, 2009
PharmDr. Ján Mazag
Director of SIDC
