Qualification of TSOs

1. Qualification of TSOs Some ideas for discussion Aix-en-Povence, April, 25th 2007

2. TSOs • scientific and technological organizations • public or private (in this case, usually non-for profit) • provide technological services and solutions for regulators or operators • typically with strong activities in research & development

3. TSOs • calibration • tests • inspections • reference materials • examination and assessment of personnel • design review • studies • monitoring • risk assessment etc

4. TSOs • from mining of uranium and other radioactive materials, • through all the combustible cycle, • the construction of power plants, their commissioning, operation, monitoring, decommissioning, • other uses such as in medicine and industry, waste management, etc.

5. TSOs • In many cases, TSOs are not only used by the nuclear regulatory authority • but they provide also services to others authorities, such as those responsible for the environment, the health or the labor and safety • and to operators and other interested parties

6. Qualification • Why? • Who? • How?

7. Qualification • is an important mechanism to give confidence to the use of TSOs in the nuclear sector, both for regulators, operators and the society in general

8. Qualification • the process to assess and evaluate those objective characteristics of an organization that are necessary to the provision of quality and reliable services, thus given confidence to the concerned interested parties who will use their services

9. Qualification • Qualification involves requirements related with : • the organization, • the processes and procedures, • the personnel and • the infrastructure available • is a specialized activity • requires a proper process

10. Qualification • It should be conducted • by personnel having the appropriate skills and training • following clear rules and procedures, • according to the good practices for that activity (uses conformity assessment techniques)

11. Some questions on qualification • who should conduct the qualification? • the regulator? • the scientific community, since they, in general, are science and technology organizations? • or can another entity do that work? • criteria against which the qualification is performed ? • usually, those criteria are set in standards or regulations

12. Some other concepts • accreditation is third-party attestation that an organization fulfils specified requirements and is competent to carry out specific tasks. • designation, is a governmental authorization of a conformity assessment body or accreditation body to perform specified conformity assessment activities under specific legislation or regulation

13. Qualification of TSOs • The use of accreditation combined with a designation mechanism could be a useful tool to avoid duplication of efforts and rational use of resources in support of a qualification process

14. REGULATOR DESIGNATES ACCREDITATION BODY DESIGNATES ACCREDITS CONFIDENCE Technical Supporting Organizations DELIVERS Technical services related with Processes/ Management System / Product/Personnel/ Laboratories and Tests Adapted from G. Drake - ISO

15. International agreements Excelency Metrology Regulation Conformity assessment Technical Regulations Metrological verification services Q Authorization procedures Certification National Institute of Metrology Suppliers Qualification Tests Suppliers Declaration of Conformity Calibrations services Standards Inspection Standardization compliance • International System • ISO • IEC • ITU Testing Laboratories Inspection Bodies Certifcations Bodies Accreditation International recognition Accreditation International credibility Adapted from MCT

16. Peer assessment and accreditation services Backup level of check. Often government or quasi-government bodies  These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes) Basis for MRAs • Policy • Regulatory Authority • Technical infrastructures affect: • manage risk; • be economically efficient; • assure safety and security; • ensure the public's confidence. Metrology (measurement and physical standards) Legal metrology (weights and measures) Scientific measurement (microbiological, chemical and non legal physical properties) - Generally a mixture of government owned or private laboratories and research interests International organisations (BIPM and OIML) Documentary standards A range of organisations may develop documentary standards. In the nuclear sector a regulatory authority make and define technical regulations IAEA International standardisation bodies (ISO, IEC, ITU etc) • Conformity assessment • This is the activity that provides demonstration that specified requirements relating to a product, process, system, person or body are fulfilled •  It can be: • 1st party • 2nd party • 3rd party Adapted from G. Drake - ISO

17. Adapted from MCT

18. Adapted from MCT

19. The criteria • can be useful to use the international standards and guides already developed for accreditation, supplemented with specific requirements applicable to the nuclear sector

20. The criteria • The use of international standards and guides • contributes to use of a common technological basis and • facilitates the implementation of the qualification process • using • knowledge and experience already consolidated, • taking advantage of the experience on other sectors • has the possibility of sharing experience and allow international comparisons

21. The result • A network of TSOs, all accredited in the same system and that can used by several regulatory authorities • Qualification on national basis compatible with other countries • Common basis for peer evaluation • International platform

22. Some issues • Some issues require special attention in the qualification process • the assurance of the independence of the provision of services by the TSOs • the mechanisms to avoid conflict of interests • the sustainability of the TSOs • the disclosure of technical information • the evaluation of the research and development activities • Many of them can be addressed in the accreditation process, trough proper setting of the criteria against which the accreditation is granted • Some others would be more consistently addressed in the designation process

23. Qualification Qualification

24. Qualification Qualification Qualification Criteria Designation Procedures Qualification rules Accreditation rules Competent Assessors/ Inspectors Accreditation body

25. Thank You! jose.augusto@sextanteconsultoria.com.br