Approval of Manufacturers of Equipment Important to Nuclear Safety for Nuclear Facilities

Authorization of Manufacturers of Equipment Important to Nuclear Safety

In accordance with Article 4, paragraph four, subparagraph (ç) of the Nuclear Regulation Law dated 5/3/2022 and numbered 7381 stipulates that “It is obligatory to obtain an authorization certificate from the Authority for the persons who manufacture equipment determined by the Authority for the activities within the scope of this Law.”

In accordance with Article 15, paragraph five, subparagraph (ç) of the Regulation on Authorizations Regarding Nuclear Facilities published in the Official Gazette dated 17/3/2023 and numbered 32135, the Organization that obtains a manufacturing approval shall have the manufacturing of equipment to nuclear safety carried out by manufacturers who have received an authorization certificate from the Authority.

The procedures regarding Manufacturer Authorization are carried out in accordance with the provisions of the Regulation on Supply Chain in Nuclear Installations published in the Official Gazette dated 1/8/2024 and numbered 32619.

Who shall obtain this Manufacturer Authorization Certificate?

In accordance with Article 15, paragraph six, subparagraph (a) of the Regulation on Authorizations Regarding Nuclear Facilities published in the Official Gazette dated 17/3/2023 and numbered 32135 stipulates that “Within the scope of the manufacture of the equipment subject to the approval of the Authority, the Organization shall have the manufacture of the semi-finished products of those determined by the Authority with a graded approach carried out by the manufacturers who have received an authorization certificate from the Authority.”

In accordance with Provisional Article 1, paragraph three of the Regulation on Authorizations Regarding Nuclear Facilities published in the Official Gazette dated 17/3/2023 and numbered 32135, the regulatory control regarding the manufacture of equipment and semi-finished products for the Akkuyu Nuclear Plant is carried out within the framework of the attached decisions of the Nuclear Regulatory Board dated 5/10/2022 and numbered 2022-61/4 and dated 20/9/2023 and numbered 2023-76/4. Accordingly, it has been decided that;

1. 49 equipment determined as a condition of Limited Operation Permit and semi-finished products of those with Safety Class 1,

2. Other equipment and semi-finished products with Safety Class 1,

3. Equipment with Safety Classes 2 and 3,

shall be manufactured by authorized manufacturers. Manufacturers within this scope are obliged to obtain a Manufacturer Authorization Certificate.

Manufacturer Authorization Application Documents and Application Guide

Documents required for application (Please see Note 1 below):

The following documents shall be submitted to NDK according to Regulation for the application for Manufacturer Authorization:

Application Petition, (Sample Form-Red Parts need to be filled)

Application Petition, (Sample Form- Red Parts need to be filled Renewal of the Authorization Manufacturer)

• Article 10- (1) a) Official documentation demonstrating active and registered commercial operations;
• Article 10- (1) b) Documentation verifying person authorized to represent, along with an officially approved signature declaration or circular;
• Article 10- (1) c) Details of the organizational structure, including the roles, responsibilities, and authorities of each unit;
• Article 10- (1) ç) Information regarding the scope of manufacturing activities for which authorization is applied; (Please see Note 2 below)
• Article 10- (1) d) Details of infrastructure relevant to the manufacturing scope, such as design, production, quality management, planning, software, equipment, and accredited measurement and testing facilities; (Please see Note 3 below)
• Article 10- (1) e) Information on prior relevant experience related to the manufacturing activities for which authorization is requested;
• Article 10- (1) f) Policies, procedures, and/or practices concerning security-related matters, including the establishment and maintenance of a security culture, implementation of training within this framework, adherence to a graded approach, and measures to prevent the use of counterfeit, fraudulent, and suspicious products;
• Article 10- (1) g) A document from the Turkish Accreditation Agency indicating that the management system certificates, including the ISO 9001 management system certificate, has been issued by certification bodies accredited by either the Turkish Accreditation Agency or by accreditation bodies accredited through under the Mutual Recognition Agreement of International Accreditation Forum; (Please see Note 4 below)
• Article 10- (1) ğ) Policies and/or procedures related to human resources management, supply chain management, nonconformity management, and change management.

NOTLAR:

1. Two copies of the application documents, a hard copy and an electronic copy, should be submitted to the NDK. Documents submitted as electronic copies must be searchable.

Receiver Name: Nuclear Regulatory Authority (Nükleer Düzenleme Kurumu)

Department of Nuclear Installations

Receiver Address: Devlet Mahallesi, 85. Cadde No:5 Çankaya/ANKARA/TÜRKİYE

Tel: +90-312-2899300

Fax: +90-312-2934719

Web: www.ndk.gov.tr

2. The equipment list should be presented, signed and stamped, each of the equipment to be manufactured on a separate line and showing the safety class (for example as 1, 2, 3 or 4 in accordance with OPB-88/97) according to the relevant legislation (such as OPB-88/97 for the Russian Federation). Other information required by the applicant regarding the equipment can be added to the list in separate columns. It should be prepared as indicated below:

[Safety Class] [Other Information That May Be Deemed Necessary]

Equipment x ….. …..

Equipment y ….. …..

3. The requested report should be a single comprehensive report, which should include each of the following in bold under separate headings. In this Report;

• Design: In this section, information on the type, technical specifications and drawings (2D, 3D models, etc.) of each piece of equipment planned to be manufactured within the scope of the application for nuclear facilities should be specified.
• Manufacturing, Quality and Planning: In this section;
• The address(es) of the facility owned by the applicant manufacturer and where the manufacturing will take place must be clearly stated in the application petition or in this section of the Report.
• The list of personnel involved in special processes and the validity dates of their certificates (welding, non-destructive testing, certificates of personnel working at high voltage, etc.) should be specified.
• It should include information on the general work flow diagram and the activities carried out in the departments.
• Workflow diagrams indicating the stages in the manufacturing process for each piece of equipment planned to be manufactured within the scope of the application for nuclear facilities should be submitted.
•  Information on the legislation used in equipment manufacturing and relevant codes and standards such as IEC, TS EN, GOST should be provided.

• Software: Information on the software used in the manufacturing process, workflow process and quality management systems should be presented.
• Equipment, Accredited Measurement and Test Facilities: In this section;
• The capacities, type, model and other required features of the machines and test and measurement devices in the production line must be specified.
• If there is a laboratory, the capacities, type, model and other required characteristics of the measuring and testing devices and their last calibration dates and next calibration dates must be specified.
• Information on similar experiences for the production: Information on similar projects in which it has previously participated and the equipment it has manufactured should be provided.

4. The document requested by Article 10- (1) g) of above list should be taken from Turkish Accreditation Agency (TURKAK).

For application procedure and fee information please contact:

Turkish Accreditation Agency (Türk Akreditasyon Kurumu)

Address: Mustafa Kemal Mahallesi, 2125. Sokak, No:1, Çankaya/Ankara/Türkiye

Tel: +90-312-410-82-00

Fax: +90-312-410-83-00

web: www.turkak.org.tr

5. In order for the evaluation process of the application to officially start, the service fee must be deposited into the Authority’s bank account. While depositing the service fee, please pay attention the any bank commission or similar deductions. If the bank deduction is occurred and manufacturer approval fee is deposited to the contracted bank with missing amount, the missing amount will be requested again.

Nuclear Regulatory Authority Bank Account Information:

Receiver Name: Nükleer Düzenleme Kurumu (Nuclear Regulatory Authority)

Receiver Address: Devlet Mahallesi, 85. Cadde No:5 Çankaya/ANKARA/TÜRKİYE

Bank: T.C. Ziraat Bank

Bank Division: T.C. Ziraat Bank Kamu Kurumsal Şube

Account Type: USD Account

IBAN: TR 37 0001 0017 4588 3930 2750 03

BIC/SWIFT Code: TCZBTR2A

Indicate one of the following as appropriate for your application type:

• Title of the payment: “A-3.06.02- Company Name” for manufacturer authorization
• Title of the payment: “A-3.06.03- Company Name” for renewal of authorization certificate

NDK Services and Transaction Fees

6. The application petition and all accompanying application documents must be signed and stamped by the person or persons authorized to represent the legal entity.

7. For other questions, you can send us an e-mail at “imalatci@ndk.gov.tr”

The List of Approved Manufacturers