1. Management System Part I: Quality System

2. Management system Objectives To understand the importance of a management system to ensure effectiveness of a regulatory programme and its upgrading

3. Management system Core functions of the RA Preparation of regulations and guides Authorization Inspection Enforcement Competent work requires clear allocation of responsibilities, and structured and systematic processes

4. Management system Structured and systematic written procedures facilitate Legality Equality Objectivity Efficiency Openness (and thus confidence in) of regulatory processes

5. Regulatory processes Legality Legislation and regulations need to be complied with in all regulatory processes Equality All “customers” are treated in equal manner Similar matters are solved in the same way

6. Regulatory processes Objectivity Rules for transferring the treatment of a matter to an other officer in case of legal incompetence Efficiency Standardised processes streamline the conduction of the programme Openness Regulatory control procedures are transparent and “tolerate” outside criticism

7. Management system Management system = Quality system Designation of responsibilities and interaction within the organization Documentation of policies, functions and procedures Maintenance of records of regulatory authority functions Maintenance of information and data Assessment of programme efficiency Feedback to improve the programme

8. Quality system General Structure and content is organization dependent Quality system can not be transferred, it shall be created from the needs of each organization Quality system describes existing functions and procedures and establishes a system for their systematic improvement

9. Quality policy; Statement on quality Manuals on organization level functions and procedures Manuals on department-specific functions and procedures Work instructions, laboratory handbooks, etc. Quality system

10. Quality policy Basic values and vision for Overall mission of the organization Conduction of work Personnel policy Management Public communication etc. Developed and signed by senior management

11. Organization level functions Examples of Quality Manual topics Quality system Designation of responsibilities and interaction within the organization Rules of administration and finance Main and supportive functions Personnel administration Quality assessment

12. Department level functions Examples of Quality Manual topics Designation of responsibilities Procedures for main functions  Review of license applications  Conduction of inspections  Practice-specific procedures for control  Procedures to be followed in case of an accident/incident Preparation of guides Information collection and dissemination

13. Assessment of operations Self Assessment Usually annually, feedback to strategic planning Should cover all activities Results assessed by senior management Quality Award Criteria or other similar criteria can be used

14. Assessment of operations Internal audits Internal audit programme Management reviews on audits Annually Organization level Department level External assessment of operations E.g. IAEA International Regulatory Review Team (IRRT)

15. Accreditation of services Technical services provided, e.g. Personal dosimetry Gamma measurements Analyses of different radionuclides (H-3, Sr-89, Sr-90, Pu-238, Pu-239-240, Pu-241, Am-241, Cu- 242, Cu-243-244, Rn-222, U-234, U-238, etc.) Whole body counting Measurement and analytical services used for dose monitoring should have a formal accreditation

16. References IAEA-TECDOC- 1090 Quality assurance within regulatory bodies, IAEA, 1999

17. Excercise Quality System Which would be the most important topics for internal guidance (Quality Manual) for a new Regulatory Authority being established?