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Management System for the Safety and Security of Radiological Practices

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5. The authorized person shall establish, implement, sustain and continuously improve an IMS which, among others:

(a) Ensures compliance with the applicable regulations and regulatory provisions;

(b) Clearly defines the organizations safety and security policy;

(c) Establishes goals, strategies, plans and objectives for the organization that are consistent with the organization’s safety and security policies;

(d) Seeks the integration of the elements of the management system;

(e) Demonstrates the organization’s management commitment to safety and security;

(f) Ensures that safety and security is embedded at all organizational and operational levels;

(g) Ensures that processes and procedures are developed and effectively managed to achieve the organization’s goals without compromising safety and security;

(h) Integrates safety, health, environmental, security, quality, human, organizational, societal and economic elements, so that safety and security are not compromised;

(i) Ensures that a strong safety and security culture is fostered and sustained at all levels of the organization through appropriate management arrangements.

(j) Integrates all the key elements for safety and security from any previously implemented management system; and

(k) Anticipates abnormal events to prevent safety-threatening events as effectively as possible and provides instructions for the case that any such should occur.

6. The authorized person shall ensure that the implemented IMS:

(a) Includes appropriate arrangements to record decisions concerning the organization’s management and activities;

(b) Includes appropriate arrangements to record the planned and systematic actions necessary to build confidence regarding the compliance with all safety and security requirements;

(c) Includes the necessary provisions for the resolution of conflicts that arise from the decision-making processes that affect safety and security;

(d) Defines the structures, processes, responsibilities and internal and external communication channels of the organization;

(e) Includes provisions and requirements for independent review of the decision-making processes that affect safety and security;

(f) Includes appropriate arrangements for the identification and analysis of any change that may have significant safety or security consequences, including changes in the organization or cumulative effects of minor changes.

7. The authorized person, irrespective of the organization’s size or the scale of its activities, shall ad-dress in the implemented IMS, at least, the requirements which are set in the corresponding international quality management standards, such as ISO 9001.

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13. The authorized person shall ensure that the IMS processes are in line with the organization’s objectives, plans and strategies related to safety and security.

14. The authorized person shall ensure that the IMS processes are developed and managed in such a way that:

a. The compliance with the related requirements does not compromise safety and security;

b. The responsibilities for safety, security and quality are clearly specified, and assigned to competent individuals;

c. Their sequence and interrelationships are specified;

d. The supporting documentation is preserved;

e. The related documentation is consistent with the organization's documents; and

f. The results of the assessment of the implementation performance, and of the efficiency and effectiveness of the processes and procedures are recorded.

15. The authorized person shall ensure that updates or modifications of the IMS processes, and new processes are designed, verified, validated where relevant, approved and applied in a way that does not compromise safety and security.

16. The authorized person shall ensure that the implemented IMS specifies appropriate evaluation, inspection, testing, verification, and validation procedures, as well as the related acceptance criteria and responsibilities for aspects concerning safety and security.

17. The authorized person shall ensure that any process that may have safety and security consequences is implemented under controlled conditions.

18. The authorized person shall ensure that approved and updated IMS procedures, instructions and plans concerning safety and security are applied, which have been validated before their first use and are periodically reviewed by authorized personnel.

19. The authorized person shall ensure that:

(a) Production, monitoring, measuring, and testing equipment is appropriately maintained to enable the verification of compliance with the applicable requirements of operational aspects with a safety and/or security impact; and

(b) Procedures for checking, calibrating, and maintaining monitoring, measuring, and testing equipment are defined in the IMS to ensure the reliability of the related measurements.

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Last update: 11 June 2023

Management System for the Safety and Security of Radiological Practices

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Section 18

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