Quality management systems certification

The audit of quality management system as a form of the conformity assessment is applied in "Register CERTATOM" to carrying out:

- the conformity assessment of production with the established requirements for a time of operation of the issued certificate of conformity;

- the conformity assessment of the quality system with the subject of activity in the field of use of nuclear energy, to the conditions defined in approval documents of the regulation body;

- the conformity assessment of quality systems with the models determined by Technical regulations in legislatively adjustable areas;

- the conformity assessment of readiness of production with the guaranteed release of qualitative production within an assessment of corporate suppliers on procedures of the end user of production, for example, SE “NAEK "Energoatom" (Ukraine);

- the evaluation of technological availability for launching the production into manufacturing (a zero point);

- the stage-by-stage conformity assessment of documentation of the quality management system at a stage of implementation for specific manufacturing.

The criterion for conformity assessment includes:

- the specificity of object under the evaluation;

- the obligatory requirements of Technical regulations, license conditions, norms, rules and safety standards;

- the requirements to control systems established by the international standards and standards of IAEA.

Due to the introduction of the national standard DSTU ІSО 19443:2018 " Quality management systems - Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS)", “CERTATOM LLC" as accredited body for certification of quality management systems (QMS) according to DSTU ISO 9001, as part of voluntary certification, introduces in practice QMS certification of suppliers for nuclear power plants for compliance with DSTU ISO 19443. The National Agency for Accreditation of Ukraine with its letter of 07.03.2019, 201 No. 3-1/3-0847 confirmed the possibility of conducting voluntary certification, referring to the Law of Ukraine “On Accreditation of Conformity Assessment Bodies”.

Prior to the adoption of this standard as a national one, the standard of the organization “Register Certatom”, the SOU RSA-004, was developed and adopted, which is an identical translation of the ISO 19443 standard.

In addition, in order to ensure an objective and complete assessment of compliance with the new performance criteria of suppliers of quality management systems, CERTATOM LLC developed the standard SOU RSA-004-1:2018 “Implementing a classification approach to ensuring product quality based on risk-based analysis” as a methodological addition to the sow RSA-004.

The schemes and procedures of quality systems audit and recording of results are defined by standards of "Register CERTATOM" and/or standards of the organizations – end users of production, contractual (contract) documents for providing services of evaluation.

The list of the enterprises which have passed the conformity assessment of quality systems by the auditors of the Register is placed on the page “Register of CERTATOM”.