Establishment and Implementation of Quality Control (QC) Program in Diagnostic Radiological Facilities

2. This specific regulation applies to all diagnostic and interventional radiology equipment that may include but not limited to:

(a) Conventional radiography equipment;

(b) Fluoroscopy equipment;

(c) Diagnostic display screens/monitors;

(d) Bone densitometry equipment;

(e) Intraoral dental radiology equipment;

(f) Orthopantomography equipment (panoramic and cephalometric operation);

(g) Cone Beam Computed Tomography (CBCT) equipment for dental, maxillofacial examinations;

(h) Cone Beam Computed Tomography (CBCT) equipment and fluoroscopy equipment for use in operation rooms (O-ARMS);

(i) Computed Tomography (CT) equipment;

(j) Conventional mammography equipment;

(k) Computed (CR) and Digital (DR) mammography equipment;​

(l) Mammography display screens/monitors; and

(m) Interventional radiology & cardiology equipment.

The process by which it is verified that new installed medical radiological equipment, imaging and auxiliary equipment, systems, and components used in medical exposures, operates​ in accordance with the associated specifications and performance criteria and can be introduced into clinical practice. 

The process by means of which systems and components of facilities and activities, having been constructed, are made operational and verified to be in accordance with the design and to have met the required performance criteria. 

A Health professional recognized by the competent authority of the Kingdom.

The function of a management system that provides confidence that specified requirements will be fulfilled.

Part of quality assurance (QA) program intended to verify that structures, systems and components correspond to predetermined requirements.

The equipment (measuring devices, phantoms, test tools, etc.) used for the performance of the Quality Control (QC) tests.

A written set of procedures and activities established and implemented by a facility for the performance of the required QC tests to medical radiological equipment.

Testing or inspection to determine whether particular equipment or components perform within defined tolerance limits.

The limiting value above or below a measured or estimated value of a function or condition indicator must be found in order to be acceptable.

​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. 

​7. The authorized person shall ensure that the QC tests of the established QC program are performed by:

(a) Medical Physicist of the facility or under the supervision of a Medical Physicist; or

(b) The Medical Physicist may assign the performance of the QC tests to other members of the diagnostic radiology facility staff only if they have adequate training and the compe​tence to perform the tests. 

8. The Radiation Safety Officer of the diagnostic radiology facility shall ensure the proper implementation of the QC program.

9. The authorized person shall ensure that:

(a) Appropriate QC equipment and tools are used for the performance of the QC tests. 

(b) All the measuring equipment used for the performance of QC tests have a valid calibration certificate.

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10. The authorized person shall keep appropriate records of the implementation of the established QC program in the radiology facility including, at least, the following:

(a) Detailed description of QC tests included in the established QC program. 

(b) Periodic review of the QC program.

(c) Non-conformities identified during the performance of the QC tests and the associated preventive and corrective actions undertaken.

(d) Information on:

i. The preventive maintenance and servicing, 

ii. Any repair(s)

iii. Any major component replacement(s), 

iv. Any manufacturer’s upgrade(s), and

v. Any calibration of the diagnostic and interventional radiology equipment used in the qc tests.  

(e) Records and reports of the implemented QC program.

(f) Records of the results of the QC tests performed in line with the provisions of article 5.

11. The authorized person shall ensure that the records of the implemented QC program are available​ to the NRRC at all times.

12. The authorized person shall ensure that an annual QC report is prepared for all diagnostic and/or interventional radiology equipment of the facility, either separate for each of them or for a set of equipment which shall include, at least, the following information: 

(a) General information about the facility.

(b) Details of the personnel performing the QC tests.

(c) Detailed list of the QC equipment used for the performance of the QC tests.

(d) The calibration certificates of the measuring equipment used for the performance of the QC tests and the details of the reference sources used in QC testing.

(e) Information on the diagnostic or interventional radiology equipment tested including their type, model and serial number of the x-ray tube.

(f) Detailed list of the QC tests performed to the diagnostic or interventional radiology equipment, including:

vi. The date of performance of each QC test, 

vii. The data collected during each QC test, the related analysis result and the respective tolerance limit, 

viii. A conclusion regarding the performance of the diagnostic or interventional radiology equipment (acceptable or not acceptable),

ix. A description of any suggested preventive and/or corrective actions, if applicable  

x. The main findings of the QC tests and related recommendations.

13. In case an annual report is prepared for a set of diagnostic and/or interventional radiology equipment, the information of article 12 a-e may be provided only once, as applicable.  

14. The Medical Physicist shall review and approve the QC reports.

15. The Radiation Safety Officer shall ensure that the QC reports: 

(a) Are signed by the Medical Physicist who conducted or supervised the performance of the QC tests. 

(b) Are communicated to the authorized person and the main findings and conclusions are presented in detail.

16. The authorized person shall submit to the NRRC the annual QC report for the diagnostic or inter-ventional radiology equipment of the facility on an annual basis and within three (3) months of the specified QC dates.

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