3. The authorized person shall:
(a) Establish and implement a Quality Control program for the diagnostic and interventional radiology equipment clinically used in the diagnostic radiology facility.
(b) Ensure that the established QC program includes, the corresponding tests and criteria specified in Appendix I as a minimum.
4. The authorized person shall ensure the availability of the necessary resources for the proper implementation of the established QC program.
5. In addition to the scheduled QC tests defined in the facility’s QC program, the authorized person shall ensure that diagnostic and interventional radiology equipment undergoes QC tests, as follows:
(a) At the time of acceptance, commissioning and relocation of the equipment, prior to their clinical use on patients, the QC tests in Appendix I that has the frequency of ”During Acceptance” shall be carried out.
(b) After any major maintenance or modification procedure that could affect the protection and safety of patients the QC tests in Appendix I that has the frequency of ”Annually” shall be carried out.
(c) After any major maintenance or modification procedure that could affect the protection and safety of patients the QC tests in Appendix I that has the frequency of ”Annually” shall be carried out.
(d) After any installation of new software or modification of existing software that could affect the protection and safety of patients the QC tests in Appendix I that has the frequency of ”Annually” shall be carried out.
6. In case the results of the QC tests show that a diagnostic or interventional radiology equipment performs out the respective tolerance limits defined in this specific regulation, the authorized person shall ensure that the equipment will not be clinically used until all the necessary corrective measures are taken, and after it has been verified that its performance is within the respective tolerance limits.