railway transport equipment (rte) certification railway transport equipment certification procedure...

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Railway Transport Equipment (RTE) Certification ilway Transport Equipment Certification Procedu 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) 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

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Railway Transport Equipment (RTE)

Certification

Railway Transport Equipment Certification ProcedureApplication 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 accreditedtest centre

Analysis of production conditions or certification of the quality system or manufacturing system (if stipulated by the certification protocol)

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

1. Application for certification2. Engineering order for building an RTE prototype;3. Specifications;4. Factory testing programme;5. Factory testing protocol;6. 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.

List of documents

1. Application for certification2. Specifications;3. Package of design and technological documents considered

(the volume must be approved by the RC FRT);4. Package of operating documents considered;5. Acceptance (qualification) testing protocol (report)6. Certificate of the acceptance committee;7. 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

Questionnaire11. 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.

2. Application review, expert examination of supporting documents; sending the decision on the application to the applicant

Application review at RC FRT

The application meets the specified requirements

The application does not meet the specified requirements

For a newly developed RTE

For mass produced RTEs

List of documents

1. Certification status (mandatory or voluntary);2. Certification protocol;3. Term of certification;4. Sampling procedure and sampling volume for

certification testing;5. Procedure for analysing production conditions;6. Conditions of supervisory control;7. List of additional regulatory and technical documents

to be presented for certification works;8. List of testing centres (laboratories), where

certification tests can be carried out

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

Sampling

Labelling of collected samples

Sending samples for testing

Identification of RTE samples

Testing of RTE samples

Sending original test reports to the RC FRT

RC FRTMaking a testing contract

Employing a testing centre (laboratory) or other competent

organisation for RTE testing

Test report is signed by authorised specialists of the testing centre

(laboratory)

Test centre (laboratory) accredited for technical competence

Applicant organisation (testing is carried out using certified equipment and validated

measuring instruments)

Test report is signed by authorised specialists of the testing centre (laboratory) and

representatives of the RC FRT who control testing

Test centre (laboratory) accredited for technical competence and

independence

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

In the absence of a testing centre accredited for technical competence and independence

For mass produced large-sized RTEs

RC FRT

Management of the enterprise under investigation

Analysis of production conditions, review and analysis of design and operation

documentation regarding the RTE to be certified

Audit group (specialists of the RC FRT plus, if necessary, experts and specialists of other

relevant authorities)

Audit group (specialists of the RC FRT plus, if necessary, experts and specialists of other

relevant authorities)

Production conditions analysis results

Production conditions analysis certificate

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

4. Analysis of production conditions or certification of the quality system or manufacturing system (if stipulated by the certification protocol)

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 regulatory requirements specified

in the certificate with the regulatory requirements accepted at the Federal Railway Transport

Certification System (FRT CS)

Verifying the power of the agency carrying out

certification testing

Verifying the conformity of test methods with the

methods used at the FRT CS

Analysing the sampling certificate and

certification testing reports

Determining the scope of additional tests required and the need for analysis

of the production conditions

Acknowledging a foreign certificate of conformity or a certificate of conformity issued by another Russian certification

system

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

A comprehensive report is developed at RC FRT

Decision about issuing the certificate

Results of all the tests performed, conformity assessments, and

works for admitting the certificates of conformity held by

the applicant

Grounds for denying the certificate

Results of analysing production conditions, quality assurance or

production system certification (if such certification was performed)

7. Executing, registering and issuing a certificate of conformity and licence for using a mark of

conformity

Confirmation of RTE conformity with the regulatory requirements (based on certification results)

Positive Negative

Establishing the certificate validity period

Sending the applicant a justified certificate denial

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

1. The certificate validity period is established by the 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.

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 form3.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

Lists of enterprises that manufacture certified RTEs

Information about suspension and revocation of conformity certificates

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

Certificate holder

RC FRT

9. Supervisory control

Taking corrective measures

The certificate retainsvalidity

RC FRT

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

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

Determining the quantity and location of RTEs sent to consumers and deviating from specified requirements

Notifying consumers and other stakeholders about suspension of RTE use and informing them about the procedure for eliminating the defects

discovered

Eliminating the defects on the spot or providing for return of the RTE the manufacturer for modification

Suspension of the conformity certificate and licence (agreement) for using the mark of conformity

Notifying certification stakeholders

Establishing the period for taking corrective actions and controlling their performance by the certificate holder

10. Consideration of appeals

Consideration of appeals

Initial consideration of appeals at the RC FRT

Application to the relevant judicial authorities in accordance with the

legislation of the Russian Federation

Hearing the appeals at the Appellate Council of the FRT CS or FRT CS

Headquarters