Quality management
In order for the construction, operation or decommissioning of nuclear installations to be licensed, their quality management systems must be licensed by CNCAN.
Licensing of quality management systems in the nuclear field is mandatory for design, siting, procurement, construction, installation, commissioning, operation, decommissioning or preservation activities for products, services and systems classified as important to the safety of the nuclear installation.
Licensing of quality management systems
Legal requirements
Licensing of the quality management system in the nuclear field is mandatory for design, siting, procurement, construction and installation, commissioning, operation, decommissioning or preservation activities for products, services and systems classified as important to the safety of nuclear installations (Art. 24 of Law no. 111/1996, republished, as subsequently amended and supplemented).
Licensing of the quality management system by CNCAN is a precondition for licensing the construction, operation or decommissioning of nuclear installations (Art. 18(k) of Law no. 111/1996, republished, as subsequently amended and supplemented).
Licensing stages
For CNCAN to issue the licence for the quality management system:
The applicant must implement and maintain a quality management system appropriate to its field of activity, in accordance with the set of regulations approved by CNCAN through Orders No. 65-76/30.05.2003, as subsequently amended
The applicant must submit to CNCAN an application for licensing of the quality management system, accompanied by the documentation described under "Required documents", and pay the related fees and tariffs set out in the “Regulation on fees and tariffs”, Annex 6
The quality manual and the procedures for the management and functional processes must meet the requirements of the norms approved by the CNCAN President through Orders No. 65-76/30.05.2003, as subsequently amended, as appropriate to the activity carried out
The audit performed by CNCAN at the licence applicant must show that the applicant has properly implemented the provisions of the quality manual and of the procedures for the management and functional processes approved by CNCAN, and that the implemented quality management system functions properly
CNCAN issues the licence for the quality management system appropriate to the field of activity, if the licensing requirements are met.
During the licence period, the licence holder must submit the documents listed below for approval.
Required documents
1. Standard licence application identifying the activities carried out in accordance with the norms approved by CNCAN through Orders No. 65-76/30.05.2003. The application shall be drawn up according to Annex No. 1 to Order No. 65/30.05.2003
2. Standard questionnaire completed according to the activity carried out, with the minimum content set out in Annex No. 2 to Order No. 65/30.05.2003
3. The quality manual and the procedures for the management and functional processes
4. The procedure for classifying structures, systems, equipment and components according to their importance to nuclear safety and the specifics of the activity carried out, and the procedure for the graded application of the quality management system requirements according to this classification.
5. The procedure for drawing up the quality plan, for organizations that manufacture products, provide services, or carry out construction and installation, commissioning and decommissioning activities in the nuclear field
6. The annual internal audit plans and the external audit plans
7. The document designating the person responsible for establishing and monitoring the implementation of the quality management system and the staff of the quality management unit, as applicable, together with the certificates/licence previously obtained from CNCAN
8. The list of staff of the organizational entity with responsibilities for the independent assessment of the quality management system, together with the certificates previously obtained from CNCAN
9. The document designating the person coordinating the construction and installation, commissioning or decommissioning activity, as applicable, together with the certificates previously obtained from CNCAN
10. The document designating the person coordinating the management self-assessment activity for quality management systems for the operation of nuclear installations, as applicable, together with the certificate previously obtained from CNCAN
11. Copy of the organization's Certificate of Registration with the Chamber of Commerce and Industry
12. Copy of the company's Articles of Association and of the decision of incorporation
13. Copy of the payment orders for the fee and tariff provided for by Law no. 111/1996, republished, as subsequently amended and supplemented, for licensing of the quality management system for the requested field, in accordance with the Regulation on fees and tariffs for the licensing and control of nuclear activities, published in the Official Gazette of Romania No. 80/30.01.2004.
Payment of fee and tariff