Management's declaration on the requirements of impartiality
Institut pro testování a certifikaci, a.s. (ITC) is a third party entity that is independent of the manufacturer and a product in relation to which it carries out conformity assessment activities. It is also independent of any another economic operator with an interest in the product and any competitor of the manufacturer.
ITC as the notified body NB 1023 is organized and operated in such a way as to guarantee the independence, objectivity and impartiality of its activities. The NB 1023 requires their internal and external staff to communicate to the NB 1023 all facts known to them, which could cause them to find themselves or the NB 1023 in conflict of interest.
The aim of the NB 1023 is to perform the conformity assessment activities of the medical devices with the highest degree of responsibility so as to ensure, in accordance with the results of the individual assessments, high quality standards of medical devices and thus the safety of patients and users of the devices.
Employees of the NB 1023 do not use any means leading to a threat to impartiality in conformity assessment activities, not even from the position of the Board of Directors of the company Institut pro testování a certifikaci, a.s., executives of the company ITC-SERVIS spol. s r.o. nor from any of managing functions.
The commitment to impartiality is considered as one of the most important aspects ensuring the confidence in the conformity assessment activities carried out by the NB 1023.
Mechanisms are in place to ensure that managing persons and other people working in the NB 1023 have been exempted from any inappropriate commercial, financial or other internal and external pressures that could adversely affect their judgment.
The NB 1023 perceives the need to increase the conformity assessment requirements, including increasing the demands on the professional and technical competence, independence and impartiality of the ITC as a whole, members of its management and all employees.
Conditions have been created by the management of the NB 1023 as a third party entity that are independent of the economic operator which is interested in conformity assessment of the product, service or system, or of any competitor.
The conformity assessment carried out by the NB 1023 is and will continue to be organized and implemented in such a way as to guarantee the independence, objectivity and impartiality of its activities.
The NB 1023 has established procedures that effectively ensure the detection, examination and resolving any case where a conflict of interest could arise and could jeopardize impartiality.
The NB 1023 makes efforts to ensure that all current staff, internal, external, subcontractors and, where appropriate, other stakeholders follow the above specified principles and internal procedures implemented by the NB 1023.