Слайд 1 - vniizht.ru

Download Report

Transcript Слайд 1 - vniizht.ru

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
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
(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
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.
1.
2.
3.
4.
5.
6.
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
Labelling of collected samples
Sending samples for testing
Employing a testing centre
(laboratory) or other competent
organisation for RTE testing
RC FRT
Test centre (laboratory) accredited for
technical competence and
independence
Test report is signed by authorised
specialists of the testing centre
(laboratory)
Test centre (laboratory) accredited for
technical competence
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)
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)
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
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.
Negative
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
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