Railway Transport Equipment (RTE) Certification Railway Transport Equipment Certification Procedure...
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Transcript of Railway Transport Equipment (RTE) Certification Railway Transport Equipment Certification Procedure...
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