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

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 Approval:

• Application petition, (sample form-red parts need to be filled)
  
• Article 9 (a) - Official documents indicating that the manufacturer conducts active and registered commercial activities,
• Article 9 (b) - Documents indicating persons authorized to represent the organization and statement of signature or signature circulars of these persons,
• Article 9 (c) - Manufacturer’s ISO 9001 Certificate or a Quality Management System Certificate which is valid on the international level,
• Article 9 (ç) - A document taken from Turkish Accreditation Agency certifying that the quality management system document of the manufacturer has been given by a certification agency that is either accredited by Turkish Accreditation Agency or by an accreditation agency which is present in the Mutual Treaty of International Accreditation Forum, (please see Note 2 below)
• Article 9 (d) - Quality manual and related procedures of the manufacturer, which include organizational structure, duties, authorizations and responsibilities of divisions, competence and qualification requirements for technical personnel and arrangements regarding procurement management and control system,
• Article 9 (e) - Equipment list requested to be within the scope of approval (please see Note 3 below),
• Article 9 (f) - A report which has detailed information about types, properties and safety classification of equipment that are in the list, list of regulations, codes and standards used in the manufacture of these equipment, if exists certificates and stamps, information on the facility where manufacturing will take place, adequacy of the infrastructure of manufacturer within the scope of the work to be carried out, production system including software and past experience and tools of the manufacturer (please see Note 4),
• Article 9 (g) - Bank receipt of authorization fee (please see Note 5 below),
• Article 9 (ğ) - If exist, authorization certificates from other countries’ regulatory authorities about related activities.

NOTES:

1. Documents should be submitted in hardcopy and electronic copy form. Electronic copies of application documents should 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 document requested by item Article 9 (ç) 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

3. 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 ….. …..

4. The requested report should be a single comprehensive report, which should include each of the following in bold under separate headings.

• Type and characteristics of the equipment listed: In this section, the main features of the equipment which is planned to be manufactured within the application scope should be written.
• Regulations, codes and standards used in the manufacture of the equipment: Regulations and related code and standards such as IEC, TS EN, GOST used in the manufacturing process should be specified.
• Certificates and stamps of the equipment (if exists): In this section, if exists, the certificates and authorized stamps which belong to manufacturer should be stated. Moreover, for equipment within the application scope, markings on this equipment and certificates related this equipment should be mentioned.
• Information about the facility, where the manufacturing takes place:

• Facility/plant addresses owned by the manufacturer and where manufacturing will be carried out must be clearly stated in the application letter or in this part of the Report.
• This section should include information on the location of the facility, the surface area occupied, the layout of the production line and departments, the capacity of the production line, work flow diagram, and the tasks belonging to the departments.

• Competence of the manufacturer's infrastructure, production systems including software, machines used during manufacturing and past experience: In this context,

• In terms of infrastructure;

(a) Number of blue collar and white collar employees, number of shifts, the list of personnel involved in special processes and their certificate names, validity of these certificates (For instance, welding personnel certificates, NDT personnel certificates, certificates of high voltage staff etc.),

(b) The capacities, types, models, and other information deemed as necessary for the machines, testing and measurement devices used in the manufacturing line, if there is a laboratory; the capacities, types, models, last calibration dates and the next calibration dates, and other information deemed as necessary of the testing and measurement devices should be indicated.

• In terms of software; software used in manufacturing process, work flow process and quality management systems should be stated.
• For the equipment which is planned to be manufactured within the application scope, work flow diagrams indicating the stages of manufacturing process should be mentioned.
• With regard to past experience, information regarding the similar projects that were taken place and equipment that manufactured before should be provided.

The report and other documents should be submitted as signed and stamped. Submission of a brochure or a presentation of manufacturer will be beneficial for the manufacturer approval process. Submission of the electronic version of application document as a searchable format is important.

5. 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: “C-4.01.02 – Company Name” for manufacturer approval
• Title of the payment: “C-4.02 – Company Name” for renewal of manufacturer approval
• Title of the payment: “C-4.02 – Company Name” for expansion of manufacturer approval scope

NDK Services and Transaction Fees

The service fee must be deposited into the aforementioned bank account before the beginning of the official review and assessment of your application documents. 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.

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