Deputy Head of Federal Accreditation Service Sergey V. Migin Approximation of accreditation systems of European Union and Russia

Fundamentals of accreditation in Russia 2 Concept of establishing a unified national accreditation system in the Russian Federation, approved by Order of the Russian Federation Government № 1760-r of October 12, 2010 The activities of the national accreditation body and its interaction with the accredited bodies are intended to be harmonized with international and European requirements, including those set forth in the Regulation No. 765/2008 of the European Parliament and the Council of the European Union of July 9, 2008 and international standard ISO/IEC 17011:2004 “Conformity assessment. «General requirements for accreditation bodies accrediting conformity assessment bodies». Decree of the President of the Russian Federation No. 86 of January 24, 2011 On the uniform national system of accreditation To form the Federal Service of Accreditation empowering it with the function of forming of the uniform national system of accreditation and control of activities of accredited bodies.

3 International recognition A national accreditation system is a fundamental element of a nation's quality infrastructure and support for international acceptance of conformity assessment results on exported products. Accreditation of competent conformity assessment bodies, whether they be laboratories, inspection bodies or certification bodies, provides the marketplace with the confidence that decisions based upon accredited results will be proper and cost effective." Peter Unger, ILAC Chair

4 International cooperation

5 Project with Europe

6 Approximation of EU and RF Accreditation Systems. First stage Thomas Facklam EA chair and Project Director of the project “Approximation of EU and RF Accreditation Systems” RusAccreditation has been founded to act as the sole national accreditation body in RF. The employees of RusAccreditation, namely its leading persons Mr. Savva Shipov (head of RusAccreditation) and Mr. Sergey Migin (deputy head of RusAccreditation) are competent and dedicated persons to work towards the ultimate goal to develop RusAccreditation into a accreditation body which is competent to serve the complete accreditation needs of all stakeholders in the Russian Federation – the government, industry, users and conformity assessment bodies for all areas of conformity assessment. Additionally RusAccreditation and its accreditation system should be designed in a way that its rules and requirements are in approximation of the EU accreditation system and being able to fulfill the requirements of EA and the international accreditation arena represented by IAF and ILAC enabling RusAccreditation to be accepted under the respective multilateral agreements for mutual recognition of accreditations and conformity assessment results provided under accreditation. RusAccreditation worked closely together with the project team of EA to prepare for to achieve the goal described above. The activities in that respect are divided into the establishment of the legal framework of accreditation in Russia and the further development of the accreditation system of RusAccreditation. The basic law defining accreditation in the RF have been established taking into account the proposals which has been drafted by the EA team in close consultations with RusAccreditation which allows for that the accreditation system applied by RusAccreditation is in approximation of the EU system, provided the text of the accreditation law is applied in that direction.

Decrees of the Government of the Russian Federation 7  Decree of the Government of the Russian Federation dated of July 14, 2014 № 653 « On approval of the methodology determine the fees for the examination submitted by the applicant, the accredited person documents and information, field examination of the conformity of the applicant, accredited persons accreditation criteria and the maximum fees for the examination are presented the applicant, the accredited entity of documents and information field examination of the conformity of the applicant, accredited persons accreditation criteria»  Decree of the Government of the Russian Federation dated of June 17, 2014 No 553 «On features of accreditations of the legal entities and individual entrepreneurs carrying out interlaboratory comparisons for an assessment of quality of the researches (tests) and measurements conducted by test laboratories (centers) regarding structure of the documents required for accreditation, as well as an order of assessment of compliance of the applicant to criteria of accreditation»  Decree of the Government of the Russian Federation dated of May 15, 2014 No 436 «On the adoption of regulations on the commission on appeals at federal accreditation service»

Decrees of the Government of the Russian Federation 8  Decree of the Government of the Russian Federation dated of June 5, 2014 No 519 «On adoption of general terms of implementation of accreditation and procedure of competence confirmation of the accredited person, including general terms of carrying out of documentary assessment of compliance of the applicant, accredited person to criteria of accreditation and general terms of carrying out of on-site assessment of compliance of the applicant, accredited person to criteria of accreditation, as well as terms of the separate administrative procedures at implementation of accreditation and procedure of competence confirmation of the accredited person»  Decree of the Government of the Russian Federation dated of June 9, 2014 No 535 «On adoption of regulations on features of accreditation of the foreign organizations in the national accreditation system»  Decree of the Government of the Russian Federation dated of July 1, 2014 No 604 «On the adoption of rules of formation and maintaining of the register of accredited persons, register of accreditation experts, register of technical experts, register of expert organizations and granting data from the specified registers»  Decree of the Government of the Russian Federation dated of June 18, 2014 No 559 «On adoption of regulations of inclusion of legal entities into register of expert organizations»

Orders of the Ministry 9  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 287 «On adoption of the technique of selection of experts in accreditation for performance of work in the field of accreditation»  Order of the Ministry of economic development of the Russian Federation dated of May 30, 2014 № 329 «On the adoption of regulations on structure of data on results of activity of the accredited persons, on changes of structure of their employers and on competence of these employers, on changes of technical equipment, submitted by the accredited persons to federal accreditation service, the order and terms of submission of such data to federal accreditation service by the accredited persons»  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 293 «Оn establishment of the order of carrying out of verification of the expert opinion, act of on-site examinations, act of examination regarding compliance to requirements of the legislation of the Russian Federation on accreditation in the national accreditation system»  Order of the Ministry of economic development of the Russian Federation dated of 30 May, 2014 № 326 «On approval of accreditation criteria, of the list of documents confirming the compliance of applicant and accredited entity’s with accreditation criteria, and the list of regulatory documents in the field of standardization, the compliance with which ensures the applicants’ and accredited entities’ conformity with accreditation criteria»  Order of the Ministry of economic development of the Russian Federation dated of May № 322 «On adoption of the list of violations, which at implementation of the federal state control on activity of the accredited persons do not result in discontinuation of accreditation»

Orders of the Ministry 10  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 286 «On the adoption of regulations on the accreditation commission of federal accreditation service»  Order of the Ministry of economic development of the Russian Federation dated of May 30, 2014 № 325 «On adoption of requirements to the technical expert and the order of inclusion of individuals into the register of technical experts and removal of individuals from the register of technical experts»  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 284 «On adoption of forms and lists of data containing in the expert opinion, the act of on-site examination, the act of examination»  Order of the Ministry of economic development of the Russian Federation dated of May 30, 2014 № 331 «On adoption of the order of information disclosure on the amounts of the payment determined according to the technique of determination of the amounts of payment for carrying out of examination of documents and data submitted by the applicant, the accredited person, carrying out of exit examination of compliance of the applicant, the accredited person to criteria of accreditation»  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 291 «On adoption of the list of fields of certification of experts in accreditation»  Order of the Federal accreditation service dated of 10 July 2013 № 2567 «On the federal accreditation service’s public council»

Orders of the Ministry 11  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 292 «On adoption of the order of establishment of the fact of discrepancy of the expert in accreditation or technical expert to requirements to the expert on accreditation or requirements to the technical expert according to the results of assessment of documents submitted by the applicant, accredited bodies»  Order of the Ministry of economic development of the Russian Federation dated of May 22, 2014 № 283 «On adoption of the character image of the national accreditation system and order of application of the character image of the national accreditation system»  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 285 «On adoption of the list of specialization fields of technical experts»  Order of the Ministry of economic development of the Russian Federation dated of May 23, 2014 № 285 «On approval of the list of specialization fields of technical experts»  Order of Federal accreditation service dated of April 8, 2014 N 905 «Annulling several orders of the federal accreditation service»

12 Approximation of EU and RF Accreditation Systems. Second stage Thomas Facklam EA chair and Project Director of the project “Approximation of EU and RF Accreditation Systems” The second part of the project to develop the accreditation system further is on the way based on constructive cooperation with the personnel of RusAccreditation and the EA team. It is envisaged that during 2015 the accreditation system of RusAccreditation will be further developed and a management system will be fully implemented – trainings and study visits will complete the project plus activities for awareness rising for governmental authorities and other stakeholders. Based on the work already carried out by RusAccreditation – its leadership and personnel – it will be able to develop into the national accreditation body of the RF eligible to become signatory to the respective MLA and MRA. However it is recommended that a follow up project is implemented to support the development further.

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