Railway Transport Equipment Certification Procedure Application for railway

Railway Transport Equipment Certification Procedure Application for railway transport equipment certification Application review, expert examination of supporting documents; the decision on the application is sent to the applicant Railway transport equipment testing at an accredited test centre Analysis of production conditions or certification of the quality system or manufacturing system (if stipulated by the certification protocol) Railway Transport Equipment (RTE) Certification Consideration of admissibility of the Certificates of Conformity held by the applicant Expert review of test results and other evidentiary material; decision on issuing a certificate of conformity (or denying such a certificate) Executing, registering and issuing a certificate of conformity and licence for using a mark of conformity (or denial of a certificate) Presenting information on the results of certification Supervisory control Consideration of appeals

1. Submitting an application for RTE certification to the Registry of Certification for Federal Railway Transport (RC FRT) Submitting an application for RTE certification with an RC FRT authority For a newly developed RTE For mass produced RTEs List of documents Application for certification Engineering order for building an RTE prototype; Specifications; Factory testing programme; Factory testing protocol; Package of design and technological documents considered (the volume must be approved by the RC FRT); 7. Package of operating documents considered; 8. Acceptance certificate for acceptance testing; 9. Time plan for acceptance testing; 10. Acceptance testing programme; 11. Acceptance testing protocol (report) 12. Certificate of acceptance committee; 13. Action plan for eliminating the defects discovered by the acceptance committee (and documents confirming its implementation, if available); 14. Notice of completion of tests and proper approval of the reference set of design documents for mass production of the RTE prototype; 15. Pilot batch testing certificate; 16. List of critical elements and assemblies (CEA); parts (CP) and technological processes (CTP); 17. Certificates for CEA, CP and CTP; 18. Correspondence table; 19. Document of approval of the manner and place for applying the mark of conformity by the RC FRT and the Federal Railway Agency of the Russian Federation. 1. Application for certification 2. Specifications; 3. Package of design and technological documents considered 1. 2. 3. 4. 5. 6. (the volume must be approved by the RC FRT); Package of operating documents considered; Acceptance (qualification) testing protocol (report) Certificate of the acceptance committee; Action plan for eliminating the defects discovered by the acceptance committee (and documents confirming its implementation, if available); 8. Results of scheduled and routine testing; 9. Correspondence table; 10. Completed Manufacturing Conditions Assessment Questionnaire 11. List of critical elements and assemblies (CEA); parts (CP) and technological processes (CTP); 12. Certificates for CEA, CP and CTP; 13. Manufacturing rate and cost per production unit; list of organisations to which the products are supplied; 14. Statistical data on the results of acceptance testing by the RTEs over the last year (No. of RTEs produced, No. or RTEs rejected, major defects and measures for eliminating them); 15. Data on reclamations; 16. Document of approval of the manner and place for applying the mark of conformity by the RC FRT and the Federal Railway Agency of the Russian Federation. 4. 5. 6. 7.

2. Application review, expert examination of supporting documents; sending the decision on the application to the applicant The application meets the specified requirements The application does not meet the specified requirements Application review at RC FRT For mass produced RTEs List of documents 1. 2. 3. 4. 5. 6. 7. 8. Certification status (mandatory or voluntary); Certification protocol; Term of certification; Sampling procedure and sampling volume for certification testing; Procedure for analysing production conditions; Conditions of supervisory control; List of additional regulatory and technical documents to be presented for certification works; List of testing centres (laboratories), where certification tests can be carried out For a newly developed RTE 1. Sending a request to the applicant indicating a lack of required documents and data. 2. A request for available data on failures, reclamations and other defects discovered during the operation of the RTEs to be certified to the involved departments and directorates of the Federal Railway Transport Agency of the Russian Federation or railway services Sending a request to the applicant indicating a lack of required documents and data.

3. RTE testing Making a testing contract Sampling Employing a testing centre (laboratory) or other competent organisation for RTE testing RC FRT Test centre (laboratory) accredited for technical competence and independence Sending samples for testing Test report is signed by authorised specialists of the testing centre (laboratory) Test centre (laboratory) accredited for technical competence Labelling of collected samples Test report is signed by authorised specialists of the testing centre (laboratory) and representatives of the RC FRT who control testing In the absence of a testing centre accredited for technical competence and independence For mass produced largesized RTEs Applicant organisation (testing is carried out using certified equipment and validated measuring instruments) Identification of RTE samples Testing of RTE samples Sending original test reports to the RC FRT Test report is signed by specialists of the testing centre who performed the testing, the applicant’s representatives and a representative of the RC FRT

4. Analysis of production conditions or certification of the quality system or manufacturing system (if stipulated by the certification protocol) Management of the enterprise under investigation Analysis of production conditions, review and analysis of design and operation documentation regarding the RTE to be certified 1. Testing the RTE to be certified within the scope of acceptance or routine testing 2. Audit group has the right to check any control operations stipulated by regulatory and technical documents pertaining to the production site under investigation. 3. The audit group has the right to request acceptance testing certificates for the RTEs under certification and remarks of the applicant’s technical control service for review and analysis Production conditions analysis results Production conditions analysis certificate Audit group (specialists of the RC FRT plus, if necessary, experts and specialists of other relevant authorities) RC FRT

5. Consideration of admissibility of the Certificates of Conformity held by the applicant RC FRT carries out the following: Identification of objects under certification Verifying the power of the agency issuing the certificate of conformity Verifying the conformity of test methods with the methods used at the FRT CS Verifying the conformity of regulatory requirements specified in the certificate with the regulatory requirements accepted at the Federal Railway Transport Certification System (FRT CS) Analysing the sampling certificate and certification testing reports Acknowledging a foreign certificate of conformity or a certificate of conformity issued by another Russian certification system Verifying the power of the agency carrying out certification testing Determining the scope of additional tests required and the need for analysis of the production conditions Foreign certificate of conformity or a certificate of conformity issued by another Russian certification system Issuing a certificate of conformity in the format established by the FRT CS Certificate of conformity in the format established by the FRT CS is not issued

6. Expert review of test results and other evidentiary material; decision on issuing a certificate of conformity (or denying such a certificate) RC FRT develops a correspondence table Results of all the tests performed, conformity assessments, and works for admitting the certificates of conformity held by the applicant A comprehensive report is developed at RC FRT Results of analysing production conditions, quality assurance or production system certification (if such certification was performed) Decision about issuing the certificate Grounds for denying the certificate

7. Executing, registering and issuing a certificate of conformity and licence for using a mark of conformity Positive Confirmation of RTE conformity with the regulatory requirements (based on certification results) Negative 1. The certificate validity period is established by the Establishing the certificate validity period Issuing a certificate of conformity, a licence for using the mark of conformity and labelling the RTE with a mark of conformity and a market access certification mark RC FRT taking into account the validity periods of the regulatory documents, the RTE’s specifics and the validity period of the quality system or production certificate (if it is included in the certification system), as well as the RTE service life. 2. The validity period of a certificate for an RTE batch or an individual RTE is not established. Sending the applicant a justified certificate denial A certificate of conformity should normally include the following: 1. Registration number and name of the certification authority issuing the certificate of conformity; 2. Registration number in the Registry of Certification System and the accession number of the certificate of conformity form 3. Name and designation of the certified RTE, including the designation of the document according to which the RTE is manufactured and supplied (schemes, specifications); 4. Codes according to classifiers of technical and economic information; 5. Designations and clause numbers of regulatory documents conformity with which has been certified; 6. Name and address of the certificate of conformity holder; 7. Area of application of the conformity certificate (mandatory, voluntary); 8. Grounds for issuing the certificate of conformity (number of the accreditation certificate of the test centre (laboratory), number and date of the test report; details of certificates of conformity issued within other certification systems, production condition anallysis data, certification of the quality system or production system, etc. ); 9. List of parts and components comprising the RTE and subject to mandatory certification (they may be provided in an appendix); 10. Place and means of labelling with a conformity mark and market access certification mark; 11. Type and periodicity of supervisory control

8. Presenting information on the results of certification Information on certification results may include: Lists of certified RTEs with numbers of conformity certificates, their validity periods, as well as the place and means of labelling with a conformity mark Information about suspension and revocation of conformity certificates Lists of enterprises that manufacture certified RTEs Information about claims and reclamations with respect to certified RTEs, results of considering the appeals submitted Lists of enterprises having a certified production system or quality system Lists of test centres (laboratories) that carried out certification testing

9. Supervisory control RC FRT Analysing information about the quality of certified RTEs obtained from the certificate holder, railways and other stakeholders Checking that no changes influencing the RTE safety profile have been made to the RTE design and production technology used during certification Random testing (where necessary) of RTEs in operation Enterprise audit including production (quality system) analysis, product testing Analysing the results of scheduled or routine tests in accordance with the requirements of regulatory documents pertaining to the certified RTE Analysing the results, executing reporting documents and making decisions based on supervisory control results The certificate retains validity The certificate is suspended until the factors causing the discovered defects are eliminated The certificate is revoked and subsequent certification begins after the factors causing the deviations are eliminated Taking corrective measures RC FRT Certificate holder Suspension of the conformity certificate and licence (agreement) for using the mark of conformity Determining the quantity and location of RTEs sent to consumers and deviating from specified requirements Notifying certification stakeholders Notifying consumers and other stakeholders about suspension of RTE use and informing them about the procedure for eliminating the defects discovered Establishing the period for taking corrective actions and controlling their performance by the certificate holder Eliminating the defects on the spot or providing for return of the RTE the manufacturer for modification

10. Consideration of appeals Initial consideration of appeals at the RC FRT Hearing the appeals at the Appellate Council of the FRT CS or FRT CS Headquarters Application to the relevant judicial authorities in accordance with the legislation of the Russian Federation