Section 1: Prime Responsibility for Protection and Safety
1. The authorized person shall retain the prime responsibility for protection and safety throughout the lifetime of the practice, and this responsibility cannot be delegated.
2. The responsibilities of the authorized person are not diminished by the appointment of a radiation safety officer, or by the use of qualified experts or technical support organization.
3. The authorized person shall ensure that any delegation of responsibly for the implementation of this regulation is documented.
4. The authorized person shall notify the NRRC of any intention to introduce modifications to any activity or practice for which they are authorized and shall not carry out any such modification unless it is authorized by the NRRC.
Section 2: Radiation Protection Program
5. The authorized person shall design and implement a Radiation Protection Program capable of ensuring that:
- Responsibilities assigned to authorized person and other person in Section 11 are met.
- An effective integration into the overall management system of the organization, as required in Section 12, is achieved.
- Measures, arrangements and processes required to guarantee compliance with the requirements in this regulation are implemented.
- Relevant instructions established by the NRRC in relation to the content and scope of the Program are met.
6. The documentation of the Radiation Protection Program shall be submitted by the applicant for assessment and approval by the NRRC, as part of the documentation required for authorization process.
7. The authorized person shall ensure that the documentation of the Radiation Protection Program is reviewed and updated in such a way as to reflect the actual state of the implemented measures, arrangements and processes.
Section 3: Radiation Safety Officer
8. The authorized person shall appoint a Radiation Safety Officer in accordance with criteria established by the NRRC.
9. The Radiation Safety Officer shall be tasked with assisting the authorized person in the implementation of radiation protection, overseeing the implementation of the radiation protection program and as official liaison with the NRRC for implementation of other requirement prescribed by the NRRC.
10. The appointment or replacement of the Radiation Safety Officer shall require approval from the NRRC.
11. The authorized person shall define the duties, responsibilities and powers of the radiation safety officer in writing.
12. The authorized person shall ensure that the radiation safety officer has sufficient authority to carry out the appointed tasks, that includes the authority to discontinue the authorized activity if safety or other operational requirement prescribed by the NRRC is compromised.
13. For any activity involving radioactive material of Category 1, the authorized person shall ensure the continuous presence of the approved Radiation Safety Officer throughout the duration of practice.
Section 4: Qualified Expert
14. The authorized person shall identify and made available the qualified experts for providing advice on the observance of this regulation when so required by the NRRC.
15. The qualifications of qualified experts shall be compatible with the assigned tasks and the levels of risks associated with the authorized activity or sources within the relevant practice.
16. When required by the NRRC, the authorized person shall inform about the arrangements made with respect to Articles 82 and 83 above.
Section 5: Technical Service Organization
17. The authorized person are fully liable for any safety implication that may arise from the authorized activities, and the liability is not transferable to any party including to their appointed Technical Support Organization.
18. The authorized person shall ensure that the appointed Technical Support Organization having appropriate recognition from the NRRC.
Section 6: Investigations and feedback of information on operating experience
19. The authorized person shall ensure that information on both normal operation and abnormal conditions that are significant for protection and safety is made available to the NRRC.
20. The authorized person shall conduct an investigation as specified by the NRRC in the event that:
- A quantity or operating parameter relating to protection and safety exceeds an investigation level or is outside the stipulated range of operating conditions;
- Any equipment failure, accident, error, mishap or other unusual event or condition occurs that has the potential for causing a quantity to exceed any relevant limit or operating restriction;
- The security of the radiation sources could be jeopardized by an unusual event or failures of protective measures and arrangements implemented to guarantee the security of radiation sources as provided in Regulation on Security of Radioactive Materials (NRRC-R-17).
21. The authorized person shall conduct an investigation immediately after an event and shall prepare a written record of its causes, or suspected causes, including verification or determination of any doses, received or committed and recommendations for preventing the recurrence of the event and the occurrence of similar events.
22. The authorized person shall communicate to the NRRC a written report of any formal investigation relating to events as prescribed by the NRRC, including exposures giving rise to doses exceeding a dose limit.
23. The authorized person shall immediately report to the NRRC any event in which a dose limit is exceeded.
Section 7: Regulatory Inspection of Facility
24. The authorized person shall permit access by authorized representatives of the NRRC to carry out inspections of their facilities and activities and of their protection and safety records, and shall cooperate in the conduct of inspections.
Section 8: Information Requested by the NRRC
25. The authorized person shall provide NRRC with any requested information in matters related to radiation protection and safety, following the specific requirements in the relevant instructions.