Accreditation

Accreditation is a confirmation of a compliance of a legal entity or individual entrepreneur with the established accreditation criteria, serving as an official certificate of its competence. The legal institution of accreditation works in many countries of the world according to the uniform rules established by the international standards.

IN THE RUSSIAN FEDERATION THE FORMATION OF A UNIFIED NATIONAL ACCREDITATION SYSTEM WAS INITIATED IN 2011 IN ACCORDANCE WITH THE DECREE OF THE PRESIDENT OF THE RUSSIAN FEDERATION FROM JANUARY 24, 2011 № 86, WHICH PROVIDED FOR THE ESTABLISHMENT OF THE NATIONAL ACCREDITATION BODY – THE FEDERAL SERVICE FOR ACCREDITATION. THE RELEVANT POWERS ARE EXERCISED BY THE OFFICE FROM 1 NOVEMBER 2011. THE MAIN TASK OF THE FEDERAL SERVICE FOR ACCREDITATION IS TO DETERMINE WHETHER THE ORGANIZATION IS COMPETENT ENOUGH IN ORDER TO CHECK THE QUALITY AND SAFETY OF PRODUCTS, AS WELL AS TO MONITOR THE COMPLIANCE IN THIS AREA.

An important step in the development of the Russian accreditation system was the adoption of the Federal law № 412-FL dated December 28, 2013 "on accreditation in the national accreditation system", which provided the basic legislative conditions for accreditation in accordance with international standards. The law defines the functions and procedure of interaction of participants of the national system of accreditation of the Federal service for accreditation, the Ministry of economic development of the organizations performing works on conformity assessment and ensuring the unity of measurements, the experts, involved in the accreditation, the appeal Commission and the Public Council under the Federal service for accreditation.

In order to implement the provisions of law № 412-FZ in 2014, 12 resolutions of the Government of the Russian Federation and 20 orders of the Ministry of economic development of Russia regulating certain aspects of accreditation were adopted:
  • the Federal law "on amendments to the Federal law" on accreditation in the national accreditation system " and certain legislative acts of the Russian Federation regarding improvement of the accreditation procedure"(adopted by the state Duma on March 17, 2017 in the first reading; scheduled for adoption in 2018);
  • resolution of the Government of the Russian Federation " on amendments to certain acts of the Government of the Russian Federation»;
  • order of the Ministry of economic development of Russia "on amendments to some orders of the Ministry of economic development of Russia on accreditation in the national accreditation system»;
  • order of the Ministry of economic development of Russia "On amendments to the order of Ministry of economic development of Russia of 30 may 2014 № 326 "On approval of accreditation criteria, the list of documents confirming compliance of the applicant, the accredited person to accreditation criteria and list of documents in the field of standardization, compliance with which applicants, accredited persons and ensures their compliance with the accreditation criteria».

The developed amendments are aimed at improving the individual mechanisms of the accreditation system and eliminating gaps in its normative regulation, clarifying the requirements for accredited persons and experts on accreditation. In addition, they provide additional tools to combat unscrupulous accredited persons, as well as the intermediary organizations that issue fake certificates of conformity and test reports, which will further improve the efficiency of the market for conformity assessment.

NORMATIVE DEVELOPMENT AND IMPROVEMENT OF THE INSTRUMENTS OF ACCREDITATION AND MONITORING THE ACTIVITIES OF ACCREDITED PERSONS ALLOWED TO REMOVE FROM THE MARKET A SIGNIFICANT NUMBER OF UNSCRUPULOUS ACCREDITED INDIVIDUALS: FOR THE PERIOD FROM 2011 TO 2017 THE NUMBER OF TEST LABORATORIES WAS REDUCED BY 30%, THE NUMBER OF CERTIFICATION BODIES BY 40%.

Another task within the framework of the formation of the uniform national accreditation system was the provision of its international recognition through the membership of the Federal service for accreditation in two largest international associations – International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF).

As part of the process to of joining the Federal service for accreditation in the ILAC, from 9 to 19 November 2016 was conducted the audit for the Russian system of accreditation of experts in the Asia-Pacific organization for accreditation of laboratories. In June 2017, during the annual joint meeting of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) and the Pacific Accreditation Organization (PAC), an Agreement was signed on mutual recognition of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC MRA). The accession of the Federal service for the accreditation to the Agreement on the mutual recognition of the International Laboratory Accreditation Cooperation (ILAC MRA) was held without further assessment 11 July 2017. The official announcement of the accession of the Federal service for accreditation to the ILAC MRA Agreement took place within the framework of the annual meetings of IAF and ILAC in Vancouver (Canada) at the end of October 2017.

Besides, in December 2014, the Federal accreditation service filed an application for the full membership of the International Accreditation Forum (IAF). All necessary work on joining this Association is planned to be completed by 2019.

Another important activity of the Federal service for accreditation on the international arena is the development of integration in the field of accreditation in the Eurasian region. In 2014, a Memorandum on cooperation between the national accreditation bodies of the CIS member States and organizations of seven States – Armenia, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia and Ukraine was signed in Moscow, in accordance with which the establishment of  a regional Association of accreditation bodies of these States is provided. In September 2014 was held the first meeting of the Council of heads of national accreditation bodies, formed in accordance with the Memorandum, in which the representatives of six CIS countries took part.

In addition, within the framework of the international cooperation the Federal accreditation service signed a number of bilateral agreements with national accreditation bodies of the partner countries. First of all, such agreements include the opportunity of exchange the experience and study the best practices of foreign accreditation bodies, cooperation in the field of personnel training, as well as the mutual participation in accreditation and inspection procedures conducted by the partner organizations. Subsequently, the bilateral memorandums will form the basis for agreements on mutual recognition of the results of accreditation conducted by the relevant national accreditation bodies.

Bilateral memoranda were signed with 14 national accreditation bodies.
  • Slovak national accreditation service, 24 October 2013;
  • Accreditation Bureau of the Socialist Republic of Vietnam, 12 November 2013;
  • Kyrgyz center for accreditation under the Ministry of economy of the Kyrgyz Republic, 23 December 2013;
  • National accreditation center of the Republic of Moldova, 23 December 2013;
  • National accreditation Agency of Ukraine, January 24, 2014;
  • Institute of accreditation of the Republic of Macedonia, 30 September 2014;
  • Quality Board of India, 11 December 2014;
  • National quality infrastructure system / Greek accreditation body, 7 July 2015;
  • Mongolian Agency for standardization and Metrology, 23 July 2015;
  • National accreditation body of Spain, 1 November 2015;
  • Serbian accreditation body, 2 November 2015;
  • National accreditation body of the Federal Republic of Germany, 16 may 2016;
  • National accreditation center of the Islamic Republic of Iran, 28 March 2017;
  • China national accreditation service for conformity assessment, 2 August 2017.


In addition, Federal Service for Accreditation is a monitoring body for the implementation in Russia of the principles of the good laboratory practice of the organization for economic cooperation and development (GLP OECD). The principles of the GLP OECD are recognized in many countries of the world and apply to non-clinical testing of chemicals and their compounds contained in medicines, pesticides, cosmetics, veterinary drugs, food and feed additives, as well as chemicals for industrial use. Most actively the principles of GLP are applied in OECD member countries of OECD for testing of chemicals for industrial use, pharmaceuticals and pesticides. At present, the normative legal base that is necessary for the functioning of the GLP system in the Russian Federation has been fully adopted.

FEDERAL SERVICE FOR ACCREDITATION IS EMPOWERED FOR THE ACCREDITATION OF TESTING LABORATORIES (CENTRES) FOR THE STATUS OF GLP LAB, TO MAINTAIN A PUBLIC REGISTER IN ACCORDANCE WITH THE PRINCIPLES OF GLP TESTING LABORATORIES (CENTRES), AS WELL AS TO MONITOR THE COMPLIANCE OF THE ACCREDITED PERSONS THE PRINCIPLES OF GLP . FOR TODAY 10 TEST LABORATORIES (CENTRES) PASSED THE ASSESSMENT OF CONFORMITY WITH GLP PRINCIPLES AND INCLUDED IN THE STATE REGISTER OF THE FEDERAL SERVICE FOR ACCREDITATION. IN ADDITION, ON OCTOBER 24, 2013 THE FEDERAL SERVICE FOR ACCREDITATION SIGNED AN AGREEMENT ON THE COOPERATION IN THE FIELD OF THE GOOD LABORATORY PRACTICE WITH THE SLOVAK NATIONAL ACCREDITATION SERVICE.

An important activity of the Federal service for accreditation is also the involvement in the priority project "Systemic development of international cooperation and exports" in order to increase the proportion of the research of Russian products in the Russian test laboratories in accordance with the methods that are recognized abroad, by the key commodity groups with the aim of introducing to the foreign markets. For these purposes, on the basis of the subordinate Federal service for accreditation, the coordination centre on implementation of the principles of good laboratory practice and the OECD in order to ensure the reliability and comparability of the research results is being created.