Quality Management System
Our commitment to the implementation and development of the quality system is contained in the Statement of Quality Policy and Security of Information and Quality Policy of the control body
The Institute deals with confidential information and documentation related mostly to the assets of its clients. Therefore, it is very important to provide protection and security of information from unauthorized access, or loss in high-risk situations. For this reason, the Institute continued development of quality systems and expanded the existing quality system to ISO 27001, Information security management system, and thus showed orientation towards continuous improvement of business operations. Institute for Medicines and Medical Devices has recognized the need to introduce ISO 9001 quality system into its business operation. In this manner, we want to emphasize our focus on clients’ satisfaction on one hand, and motivated, well-trained and professional Institute’s staff on the other. By preparation of supporting documentation of the quality system, all of the processes taking place in the Institute have been identified and they are followed by working instructions, so the entire system is documented. The system regulated in such manner enables us to control the entire course of providing services. It also includes preventive approach that aims to identify potential problems and inconsistencies.
The Institute is ISO 9001:2015 and ISO/IEC 27001:2013 certified, which makes it the first institution in the health system of Montenegro which applies the system of quality and information security management.
In order to continuously improve the quality system, the Institute has paid particular attention to the implementation of the standard specific for the operation of control bodies, which, after compliance with the requirements of the standard EN ISO/IEC 17020:2013 and the assessment by the Accreditation Body of Montenegro, resulted in obtaining accreditation. In this way, the Institute, as a control body type A, met the requirements of the aforementioned standard and thus confirmed its competence to perform tasks specified in the determined scope of accreditation that relate to: control of the documentation in the procedure for issuance of marketing authorisation, controlled substances, approvals and notification of clinical trials, assessment of spontaneous reporting of adverse reactions to medicines for human use.
In addition to implemented quality systems, with the aim of confirming the mode of operation and quality commitment, the Institute has won the “Oscar of Quality” as the absolute winner for organizations outside the territory of the Republic of Serbia. The “Oscar of Quality” is created according to the model of the EFQM Excellence Award and is awarded by the Foundation for Quality Culture and Excellence – FQCE in cooperation with the Serbian Chamber of Commerce and with support of the Ministry of Economy of Serbia.
By constantly investing in quality system we increase the awareness and responsibility of our employees, which enables us to use time and resources in the most optimal manner and thereby continuously contribute to raising the quality of the Institute’s work to a higher level.
The Institute for Medicines and Medical Devices has since its establishment been focused on clients’ satisfaction, and as it has been shown so far, surveys have produced the greatest results for the collection of information that we analyze and use to improve quality of our business performance and mutual cooperation.
As each your opinion, proposition and suggestion is important and welcome to us, with the aim of increasing availability and facilitating the completion of the survey, we have created several manners to complete it:
- Online survey that you may complete in just a few minutes and results of which we will automatically obtain.
- Electronic form in the word format that you may, after completing it, send via e-mail to firstname.lastname@example.org, or email@example.com, via fax to +382 20 310 581, to the address of the Institute, or bring it personally and put it into the survey box the Institute's premises.
- Paper form that you may complete upon arrival to the Institute and put it into the survey box.
You may also send the survey anonymously and all the data provided in the survey the Institute will use exclusively for the purpose of its evaluation, or a possible contact, and will not make it available to third parties.