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       Conformity assessment and certification of railway products in accordance with TSI /Technical Specification for Interoperability are specifications drafted by the European Railway Agency and adopted by the European Commission, to ensure the interoperability of the trans-European rail system/ and National requirements of the Republic of Latvia in a mandatory sector of accreditation scope including assessment procedures, rules and procedures for granting, validation, expansion or reduction of the scope of certification, suspension, cancellation or rejection of certification, conducted on the basis of the Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union according to the modular conformity assessment procedure described in Commission Decision 2010/713/EU of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council /hereinafter – Decision 2010/713/EU/ in compliance with the requirements of the standard EN ISO/IEC 17065 “Conformity assessment – Requirements for bodies certifying products, processes and services" /hereinafter – EN ISO/IEC 17065/.
       Depending on used module of certification the conformity assessment procedure may be different in each case, but in general, it consists following stages:

  1. Submission of application for certification of railway products by the Applicant to Certification body /form of application provided by Certification body/;
  2. Registration of application for certification in European Railway Agency Database of Interoperability and Safety /ERADIS/;
  3. Evaluation of the application for certification by Certification body, decision-making regarding mentioned application, development of cost estimate and forwarding of the decision to the Applicant;
  4. Assessment of technical documentation and preparation of reporting documentation based on the results of performed analysis;
  5. Execution of inspections/tests of railway products;
  6. Audits of quality management system of production of railway products, if such actions required by applied certification module;
  7. Evaluation of test results, assessment of QM checks /if performed/ and expertise of other evidentiary materials, as well as the decision-making to issue the certificate of conformity, or to refusing of issue of the certificate of conformity;
  8. Formal actions, registration in ERADIS and issuance of certificate of conformity, or forwarding to the Applicant the refusal to issue of the certificate of conformity;
  9. Execution of periodic control, if required by the certification module;
  10. Reviewing of complaints and appeals, if any.

       Certification of railway products in accordance with the requirements of GOST 31235-2004 “Passenger Cars After Overhaul Reconditioning Repair. Operational Safety Requirement" in the voluntary sector of accreditation scope, including assessment procedures, rules and procedures for issuing, confirming, expanding or reducing the scope of certification, suspension, cancellation or rejection of certification, shall be carried out in accordance with certification procedure PMG 40-2001 "Certification System for Railway Transport. Certification Order of Railway Products” /hereinafter – PMG 40-2001/ in accordance with certification schemes specified in Appendix A of mentioned procedure in compliance with the requirements of the standard EN ISO/IEC 17065.
       The list of conformity assessment modules/schemes of accreditation used by Certification body to perform conformity assessment of railway products is specified in the accreditation scope.
       Decision-making regarding application for certification of railway products takes from one week to two months, depending on the type of railway products but general terms of conformity assessment takes from two months to one year,depending on the type of railway products, preliminary work planning, readiness of the Applicant's technical documentation, availability of laboratory testing facilities and other external factors beyond the control of Certification body.
       The list of required technical documentation stated in the annex to the application for certification of railway products is indicated in each specific conformity assessment module referred in Decision 2010/713/EC or in Appendix B to PMG 40-2001 if certification is carried out according to certification schemes, however, by agreement with Certification body it can be provided as soon as it is ready during the conformity assessment of railway products. The complete list of all required documentation for the issuance of a certificate of conformity must be provided to Certification body no later than two weeks before mentioned issuance.
       Certification works are carried out on a contractual basis, which specifies the rights and obligations of the parties, the costs and terms of work, the procedure for remuneration, the responsibility of the parties, confidentiality requirements and other provisions related to execution of the contract. The contract can be made in Latvian, English or Russian language. In case of request of the customer, in addition to the contract, an agreement on confidentiality may be concluded with detailed confidentiality requirements concerning the relationship between the parties for performance of the contract for certification of railway products.
       In case of certification by conformity assessment modules manufacturer, ordering customer of railway products or their representative /entity registered in European Union/ can act as Applicant for certification. In case of certification by conformity assessment schemes any entity can act as applicant for certification can.
       Calculation of costs for certification works of railway products is made by drawing up of estimate based on the cost of the standard hour of a specific employee of Certification body, the labour intensity and urgency of work, the costs of sub-contract works, travel and transport costs, the need to purchase additional regulations, the costs for maintaining of accreditation and other direct or indirect costs associated with the implementation of the subject of the contract. Payment for work by the Applicant shall be carried out regardless of the results of confirmation conformity assessment.
       Check of quality management system of production of railway products is carried out in accordance with certification program developed by Certification body, which includes the evaluation of all stages of production of railway products including related QMS. If QMS of the Applicant used for the production of railway products is certified by an accredited Certification body, then Certification body takes this into account and evaluates only the production of railway products, without assessment of QMS elements.
       The certification reporting documentation is usually issued in Latvian language. If required, it could be developed in Russian or English; however, upon agreement with the customer, documents also can be translated into other languages.
       The forms of certificates of conformity, for cases of certification of railway products in accordance with TSI and National Technical Requirements are specified in Commission Implementing Regulation (EU) 2019/250 of 12 February 2019 on the templates for ‘EC’ declarations and certificates for railway interoperability constituents and subsystems, on the model of declaration of conformity to an authorised railway vehicle type and on the ‘EC’ verification procedures for subsystems in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 201/2011.
       For cases of certification of railway products in accordance with the requirements of PMG 40-2001 or Cabinet Regulation No 539 of June 17, 2009 "Rules for conformity assessment of tanks and containers intended for transportation of dangerous goods by railway" forms of conformity certificates are developed by Certification body, taking into account requirements of EN ISO/IEC 17065.
       Conjunctly with its partners, Certification body carries out certification of railway products in accordance with the requirements of Technical Regulations of EACU /Eurasian Customs Union/ TR TS 001/2011 "Safety of railway rolling stock" /hereinafter – TR TS 001/2011/. All assessment procedures, rules and procedures for issuing, confirming, expanding or reducing the scope of certification, suspension, cancellation or rejection of certification comply with the requirements of TR TS 001/2011, including registration of issued certificates of conformity in the Unified Register of issued certificates of conformity and registered declarations of conformity of EACU.

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