Inspection of production
"CERTATOM" LLC, as an organization performing the functions of the Technical Secretariat for standardization in the field of hydrogen energy, TC 197 "Hydrogen technologies", developed and put into effect the standard SOU RSA 008-15916:2023 "Hydrogen technologies. Safety principles and requirements" (hereinafter - the Standard).
This Standard is developed as a modified version of the international standard ISO/TR 15916:2015 "Basic concepts regarding the safety of hydrogen systems", with the inclusion in the content of the standard of the requirements of national standards harmonized in Ukraine (DSTU) and the requirements of normative legal acts (Technical regulations, norms, rules safety).
The standard defines the basic principles and safety requirements set forth in the international standard ISO/TR 15916 for the use of hydrogen in its gaseous and liquid forms, as well as for its production, transportation, storage and consumption in any of these or other forms (hydrides).
The key principles of the security requirements defined in the Standard are:
- unique properties of hydrogen affecting safety conditions;
- the priority of ensuring security to the levels that the public considers acceptable;
- adoption of economically justified constructive (engineering), technological and organizational decisions from the point of view of safety;
- application of risk-oriented thinking, aimed at reducing the risks of violation of safety conditions and limits.
The standard is used for the purposes of voluntary assessment of compliance (certification) of the used equipment and technologies with the national requirements established in the DSTU ISO/TR 15916, the NPA of Ukraine, harmonized with international standards for safety requirements, as well as for:
- training of the subjects of activity with the principles, safety requirements and their application at all stages of design, manufacture, and use of the equipment used for hydrogen technologies (the start of such training will be informed additionally);
- familiarization of consumers of products produced as a result of the application of hydrogen technologies with established safety measures for the formation of sustainable consumption of final products and services obtained as a result of the application of hydrogen technologies.
In the conditions of fierce competition both on the domestic and foreign markets, enterprises and organizations are forced to actively look for ways to increase the attractiveness of products and services in the eyes of consumers, as well as to increase the efficiency of their own production and management systems.
In the system of conformity assessment in the field of hydrogen technologies of the CERTATOM Register, the standard SOU RSA-008-1:2023 "Schemes of certification of products related to hydrogen technologies in the system of the CERTATOM Register" was developed and put into effect.
This standard is aimed at increasing the trust of consumers and society in the quality of products, systems, technologies that produce and use hydrogen, as well as in the reliability of the results of assessing the conformity of such products.
Product certification in the system of conformity assessment in the field of hydrogen technologies "Register CERTATOM" is a third-party conformity assessment procedure established by the standards of the organization (SOU RSA), which demonstrates to consumers, representatives of regulatory authorities and other persons that any configurations of hydrogen-containing systems, equipment , devices and components, which are established by the standards of DSTU ISO/TR 15916 and SOU RSA-008-15916, meet the established consumer and safety requirements.
The objects of certification in the System are products that:
- produced in Ukraine in accordance with the regulatory documents in force in Ukraine (hereinafter - ND);
- imported into Ukraine and marked by the manufacturer as corresponding to the ND valid in Ukraine;
- is imported into Ukraine and is not marked by the manufacturer as complying with the regulatory documents in force in Ukraine, but can be identified as such, which in terms of indicators can be correlated with the requirements of the ND in force in Ukraine for similar products.
List of certified products:
- equipment for hydrogen production (hydrogen generators, electrolysis plants, etc.);
- equipment of systems and means of compression, liquefaction of hydrogen (compressors, pumps, etc. equipment);
- equipment for storing and transporting commercial hydrogen (vessels, cylinders, gas stations, etc.);
- hydrogen consumption equipment in various configurations (use) (fuel cells, boilers, etc.);
- components (components) of hydrogen systems: hydrogen storage, supply lines, pipelines, connections and seals, valves, non-return valves and flow regulators, pressure relief systems, hydrogen detection components.
The scope of consumer requirements subject to confirmation of compliance is determined by the Customer and may be limited by individual requirements of the standards based on the principle of adequacy of costs necessary for:
- reducing the risks of loss of reputation, causing damage, as a result of market appeal or use of low-quality or potentially dangerous products that do not meet the requirements,
- fulfillment of the requirements set forth in the procurement/tender documentation or in the contract for the supply of products.
Description of the applied certification schemes:
Type 1a Scheme - according to this scheme, one or more product samples are subjected to the determination procedure.
The body for conformity assessment/certification (hereinafter referred to as the CAB) issues a type certificate confirming the conformity of the type of product with the requirements and characteristics established in regulatory documents, as well as at the request of the Customer - a certificate for a single product or several samples presented for initial confirmation of conformity - a certificate of conformity to the approved type
Type 1b Scheme - this scheme implies certification of the entire batch of products based on the results of analysis of product documentation, selection, identification of samples and product tests.
Type 3, 5 Schemes
The schemes provide for the periodic selection of product samples at the place of production and the determination of their characteristics to verify that the products released after the initial confirmation of conformity meet the requirements set out in the type certificate.
The criteria for determining the frequency and scope of inspection control are the level of potential danger of products, the results of product certification, the volume of output, and the presence of a certified quality (production) system.
The general procedures for providing and maintaining the validity of product certification documents used by the CAB meet the requirements of the DSTU EN ISO/IEC 17065:2014, DSTU EN ISO/IEC 17067:2014 and other CAB documents and consist of the following main stages:
- informing the customer about certification schemes;
- submission and consideration of an application for certification;
- preparation for certification;
- certification of products for compliance with established requirements;
- preparation of the certification report;
- making a decision on certification;
- supervision of products, production and manufacturer's QMS.
In the course of certification, the declared products are checked for compliance with the requirements of all necessary standards and other ND in accordance with the scope specified in the application, in accordance with the certification criteria provided for in the work plan.
Verification of compliance of objects of conformity assessment/certification with the requirements of ND is carried out by analyzing and evaluating the indicators (characteristics) of products based on the results of tests conducted by the Testing Laboratory (TL).
During product certification, its testing is entrusted to competent TL, which interacts with CAB on contractual terms.
For more detailed information, contact e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
The management system certification body of the Limited Liability Company "CERTATOM Conformity Assessment Body" (abbreviated - CERTATOM, MSCB) provides quality management system certification services in accordance with the requirements of the international standard DSTU EN ISO/IEC 17021-1:2017 Compliance assessment. Requirements for bodies that audit and certify management systems. MSCB is accredited by the National Accreditation Agency of Ukraine (accreditation certificate No. 8О111 from March 19, 2019 to March 18, 2024).
At implementation of activities for certification of MSCB "CERTATOM" is guided by the principles which promote trust and include: impartiality (declaration of impartiality), competence, responsibility, openness, confidentiality (declaration of confidentiality), response to complaints (procedure "appeals and general questions"), risk-oriented approach.
MSCB "CERTATOM" certifies management systems for compliance with the DSTU EN ISO 9001:2018 Quality Management System standard. Requirements in the following sectors of the economy:
• Machines and equipment;
• Chemicals, chemical products and fibers;
• Base metals and finished metal products;
• Electrical and optical equipment;
• Information technologies;
• Engineering services.
It is possible to examine certification process here.
Apply for certification of a management system to the requirements of DSTU EN ISO 9001:2018.
Examine terms of granting, refusal, support, re-certification, suspension, renewal or cancellation of certification, expanding or reducing the scope of certification here.
Clarification regarding the recognition of certificates
All certificates issued by MSCB "CERTATOM" for compliance with the requirements of DSTU EN ISO 9001:2018 in the above-mentioned sectors of the economy are marked with the IAF MLA mark based on an agreement with NAAU.
IAF MLA mark IAF MLA is a globally recognized indicator that demonstrates compliance with international standards and requirements. For product manufacturers and service providers, IAF MLA is an opportunity to differentiate themselves from competitors that produce low-quality products and provide low-quality services.
Consumers gain confidence in goods and services that have a mark of conformity or are accompanied by a certificate of conformity. IAF MLA ensures that such goods and services meet quality and safety standards, regardless of where they are manufactured or provided.
MSCB "CERTATOM" certifies management systems in compliance with the DSTU ISO 19443:2019 standard
We draw the attention of manufacturers/suppliers of products who plan to cooperate with European and Ukrainian customers in the field of nuclear energy, that MSCB "CERTATOM" also carries out certification in the above-mentioned sectors of the economy for compliance with the requirements of DSTU ISO 19443:2019 Quality management system. Specific requirements for the application of ISO 9001:2015 by nuclear sector organizations supplying products and services important for nuclear safety. More detail in CERTATOM news here,here and here
Taking into account the identity of the requirements, the work on the certification of the SMC for compliance with the DSTU EN ISO 9001:2018 and DSTU ISO 19443:2019 standards can be combined, which will allow the Customers to reduce the time and financial costs of certification.
Apply for certification of a management system to the requirements of DSTU ISO 19443:2019.
LLC «OOS «CERTATOM» performs works on of conformity assessment of production and quality systems at the Ukrainian and foreign enterprises by the managing office (in Kiev) and departments:
- regional offices in Lviv, Ivano-Frankivsk, Sumy, Nikopol, regular authorized representatives in Sambor (The Lviv Region), Zhovty Vody, (The Dnepropetrovsk Region), Kramatorsk (Donetsk Region), Zaporozhye;
- specialized affiliated branch in Kharkov – the Technical center of qualification and an assessment of a service life (ETC KORO).
As the conformity assessment body of production «CERTATOM» was created in 1997 on the basis of «The state center of regulation of quality of supplies and services». «OOS «CERTATOM» is accredited and registered in national System of UKRSEPRO since 1997 as certification body of production and quality systems.
In 2010 «CERTATOM» was separated as independent legal entity – limited liability company «Conformity assessment body «CERTATOM». The trademark and the «CERTATOM» trading stamp are registered in State department of intellectual property of MON of Ukraine.
CERTATOM LLC is accredited (accreditation certificate No. 8O111) at the National Accreditation Agency of Ukraine as the Certification Body for Management Systems in accordance with the requirements of State Standard EN ISO / IEC 17021-1: 2015 in the field of State Standard ISO 9001:2015”
Since 2020, «CERTATOM» has been performing the functions of the Technical Secretariat for standardization in the field of hydrogen energy TC 197 "Hydrogen technologies". Since 2021, «CERTATOM» resumed the functions of the Technical Secretariat for Standardization in the Field of Nuclear Energy - TC 197 SC 2 "Nuclear Energy and Radiation Protection" (former TC 79 "Atomic Energy").
LLC CERTATOM carries out the conformity assessment of the equipment (thermal-mechanical, electrotechnical equipment, radiation equipment, pipeline fittings, pressurized equipment etc) manufactured by the enterprises of Ukraine for the NPP of Ukraine, the Russian Federation, India, Iran, Turkey.
Conformity assessment of the equipment is carried out in the form of acceptance and inspection procedures according to the Quality plans agreed with manufacturer. Such form of conformity assessment called inspection.
Inspection (supervision of production process) is carried out for the purpose of conformity assessment of production according to procedures which provide planning and implementation of supervision of manufacturing quality directly on production site.
The need of carrying out such assessment for the Ukrainian NPP is defined by:
- p. 7.5.6 of NP 306.1.190-2012 "General requirements to control system of activity in the field of nuclear energy use";
- p. 7.3 of NP 306.1.182-2012 "Requirements to a control system of activity of the operating organization (operator)";
- SOU NAEK 024:2012 standard "Management of purchases of production. The conformity assessment system of production which is purchased by the operating organization. General provisions".
Content and amount of works according to production compliance, carried out by LLC CERTATOM, is defined by requirements of the following sections (points) of standards of National Nuclear Energy Generating Company "Energoatom":
- p. 5.5.1, 5.5.2, 5.5.4 of SOU NAEK 024:2012 – of types of production to which requirements for conformity assessment are established;
- p. 6.33 (sp. 4), 7.4.4 SOU HAEK 024:2012 – regarding coordination of quality plans of manufacturing of the ordered production, definition and establishment of the status of control points to whom control will be carried out with participation of representatives of LLC CERTATOM. At the same time coordination of the quality plan with the Customer (NPP) is an indispensable condition;
- p. 5.2, 5.5, 5.6, section 7 of SOU NAEK 039:2013 "Management of production purchases. Product conformity assessment system. Conformity assessment of production at manufacturing phase" and p. 6.5 (p. 1,2,5), 7.4.1, 7.4.3 of SOU HAEK 024:2012 – regarding conditions, work order and registration of conformity assessment results of production.
Conformity assessment in the form of acceptance includes check of a condition of the procedures applied by manufacturer and control of production compliance (including control of observance of technological processes) to the requirements established in codes and regulations of nuclear energy use and other RD, WCD, TPD, EDD, the delivery contracts and execution of the relevant documents.
The work order according to compliance of production in the form of acceptance includes:
- consideration of WCD on production which is subject to conformity assessment;
- consideration and coordination of plans of quality for production which is subject to conformity assessment;
- conducting manufacturing readiness check of manufacturers for the manufacturing start which is subject to conformity assessment;
- participation in sampling of the materials and semi-finished products used at manufacturing of production within Customer orders;
- participation in conformity assessment of production in the form of control which is carried out in the coordinated delay points and stop points (in critical control points of technological process);
- participation in acceptance and qualification tests, acceptance tests;
- conducting acceptance inspections.
The results of conformity assessment of production in the form of acceptance are:
- the registered quality plan, which contain: registration number and date, name, designation, appointment, safety class, serial numbers (passport numbers, certificates on production) or other identification signs of production, the signature of the persons participating in monitoring procedure and dates of each control point, the conclusion about compliance (non-compliance) of production to the mandatory established requirements with the indication of designation of the normative document, the information about the persons who were carrying out the conformity assessment of production in points of a delay and survey (full name, position, organization), their personal signatures certified by stamps or the seals (in the provided cases).
- Certificate of acceptance inspection.
For the equipment for the Ukrainian NPP "The certificate of acceptance inspection" which is registered in "the Register of CERTATOM" is issued.
- Certificate of conformity.
According to the results of acceptance inspection, the certificate of conformity registered in "the Register of CERTATOM" is also issued.
The cost of conformity assessment services of serial production, spare parts and accessories is defined according to the fair market price of similar services (from 1,5% to 3,5% of production cost). As for technologically intensive equipment the cost of services is determined by standard labor costs of LLC CERTATOM, minimum necessary for performance of work.
LLC CERTATOM has permanent representatives in the following cities: Kiyv, Kharkiv, Ivano-Frankivsk, Lviv, Sambor, Sumy, Nikopol, Dnipropetrovsk, Kramatorsk and also carries out conformity assessment of production in other cities.
Additional information about conformity assessment in the form of acceptance You can receive from the qualified staff of LLC CERTATOM.
The basic rules of appeal, complaints and divergences proceeding, received by inspection body from suppliers or other parties are established by document OI МСЯ-08-15.
Voluntary certification allows conformity assessment of production to separate requirements of normative documents (norms, rules, standards, TS on production) which are specified by the Commissioner of works in the Certification Application order. In such case, specific requirements which are obligatory for application in the systems important for safety of the NPP, such as seismic stability, radiation resistance, functions retention at external influences, etc., in most cases need not to be included in the Application order for certification that doesn't meet the requirements of production supply conforming to all requirements of norms, rules and the NRS standards at all.
In "Register CERTATOM" the production used on the NPP in the systems important for safety (SIS) is certified on the modules identical to modules of system of UkrSEPRO on compliance to all indicators (defined in TS on production) which are obligatory to application in SIS. The legitimacy of independent conformity assessment (certification) of production important to safety on all indicators (which are obligatory for implementation in SIS NPP) was confirmed by the letters of State Committee of Ukraine for Technical Regulation and Consumer Policy (20.10.06 No. 9285-5-10/17) and SNRIU (03.10.06 No. 15-12/5311).
After the exclusion of article No. 10 of the Law of Ukraine "About permitting activities in the field of use of nuclear energy" (by the Law of Ukraine No. 1874-VI of February 11, 2010), the need of certification of production (the elements important for safety of the NPP), as well as a selection of conformity assessment system is defined by contract terms of delivery and standards of the end user – the operation organization “NAEK "Energoatom".
The certification scheme of production is defined in the document OS-PSP.01/11 "Certification scheme of production".
The basic rules of consideration of the appeals, complaints and disagreements, received by the conformity assessment body from suppliers or other parties are specified in OS-MSY.08/14 "Methods of proceeding of appeals, complaints and controversial issues"