Technical regulation and standardization

Since 2003, the National Institute for System Studies of Entrepreneurships (NISSE) (actually from the moment of the validation of the Federal law of December 27, 2002 No. 184-FZ "On technical regulation") has performed methodical, informational and analytical ensuring in the reformed of technical regulation and the development of standardization.

The Russian pattern of technical regulation, significantly contributed by NISSE’s experts is to create an institutional prerequisites of diversification of the Russian economy due to the formation of the national innovation system and the recovery of "traditional" business sectors.

The new round of technical regulation development happened in the beginning of the 2010s with the transfer of a number of functions in technical regulation to the supranational level of the Customs Union and the Common market zone.

During the reform implementation period, NISSE’s experts have taken part in the realization of more than 30 projects and researches, among them are:

  • The analysis of the international experience of legal regulation ensuring activities of pharmaceutical inspections and the analysis of the documents fixing rules of carrying out the pharmaceutical inspections accepted within WHO (World Health Organization), the International Conference on Harmonization (ICH), PIC/S, and regulatory acts of the states - members of the Customs Union ,the Common economic zone and the European Union regulating the order of carrying out joint pharmaceutical inspections with pharmaceutical inspectorates of the states - members of the Eurasian Economic Union (customer - Eurasian Economic Commission).
  • The analysis of the application of the current technical regulations of the Customs Union in the states - members of the Customs Union and the Common Economic zone in terms of forms, charts and assessment procedures (confirmation) of products conformity (customer - Eurasian Economic Commission)
  • The analysis and development of suggestions to provide system- engineering solutions of system-112 with the requirements in place (customer - Ministry of the RF on Civil Defense, Emergency and Dire Straits).
  • Carrying out the comparative legal analysis of statutory regulations of the Customs Union and the Common economic zone, the state - members of the Customs Union and the Common economic zone in the sphere of accrediting. The analysis of international experience and policy advice on establishing uniform principles and rules of accrediting within the Customs union and the Common economic zone, including terms and extent of harmonization in the specified sphere (customer - Eurasian economic commission).
  • The development of the technical regulation of the Customs union For the safety of the equipment for children's playgrounds the Eurasian economic Commission (customer - Eurasian economic Commission).
  • The development of conceptual and basic methodology of activities of the Eurasian Economic Commission aimed at providing with the mandatory requirements of valid technical regulations of the Customs Union and obligatory for assessment (confirmation) of compliance (customer - Eurasian economic commission).
  • The development of the concept of the product’s circulation on the customs area of the Customs union, harmonization of the legislation of member -states of the Customs Union in the spheres of responsibility for not meeting the requirements of technical regulations and state control (supervision) aimed at meeting the requirements of technical regulations (customer - Eurasian economic Commission).
  • The development of the Federal State Reserve Agency’s standard on the procedure and terms of delivery, acceptance, storage and release of the state’s reserved coal at safe storage facilities (customer - Federal State Reserve Agency).
  • The research and implementation of approaches to target planning for the purpose of the development of the system ensuring industrial safety of the Russian Federation (customer – Federal Service for Ecological, Technological and Atomic Supervision).
  • The formation of the system of technical regulation in the Customs Union as the basis for further economic integration of the nations within EurAsEC and the CIS (customer - Ministry of Industry and Trade of the Russian Federation).
  • The development of informative and analytical materials concerned with analyzing the procedure of the working out of technical regulations, the statements of which affect the interests of Rosatom (customer – Federal state unitary enterprise “The Central Research Institute of Management, Economics and Information of Rosatom (TsNIIATOMINFORM)).
  • Carrying out the economic and legal analysis of the projects of technical regulations under development and their comparative analysis with the legal and normative base in place (customer - Ministry of Industry and Energy of the Russian Federation).
  • The analysis of the technical regulation state and the development of recommendations for its improvement (customer - Ministry of Industry and Energy of the Russian Federation).
  • The preparation of recommendations on the development of technical regulations (customer - Ministry of Industry and Energy of the Russian Federation).
  • The development and approbation of methodology for corruption assessment in the organizations which are engaged in licensing, certification, registration and inspecting in Russia (customer - IRIS Center of the University Research Corporation International (URCI) in College Park, Maryland).

At present NISSE offers services for the implementation of the whole range of expertise works in the sphere of technical regulation.

For public authorities:

  • the development of the technical regulation system concept in individual industries and spheres of activity;
  • the development of technical regulation drafts packaged with accompanying documents;
  • the development of the projects of national and international standards and codes of practice;
  • the independent comprehensive examination and assessment of current and being developed documents in the field of technical regulation (including regulatory impact);
  • the improvement and regulation of conformity assessment procedures;
  • the development of accreditation system of certification bodies (assessment (confirmation) of compliance) and testing laboratories;
  • polling surveys of subjects of legal relations in the sphere of technical regulation;
  • the creation of registers of the best available technologies;
  • optimization of government authority’s activity, authorized to exercise state control over the compliance of requirements of technical regulations;
  • other methodical and information-analytic support of the state policy implementation in the sphere of technical regulation and standardization.

For business, non-profit and other non-governmental bodies:

  • the criteria standard development of self-regulatory organizations;
  • formation support and on-going assistance for self-regulatory organizations in the manufacturing sector;
  • the development of corporate standards (organization standards);
  • giving advice to companies on the application of documents in the sphere of technical regulation and compliance with requirements of technical regulations, provisions of standards, sets of rules or terms of contracts
  • methodological support to ensure property accountability, including through to use of mechanisms of insurance in the sphere of technical regulation;
  • advising on technical regulation;
  • expert support for enterprises within the public discussion of the documents in the sphere of technical regulation.

In addition, the Institute provides expert support in related areas of government regulation, including, the field of industrial safety and labor protection, phytosanitary and veterinary control.

Key Experts

Share