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This session explores the cooperation between standards bodies and regulators, focusing on how standards bodies engage with regulators to identify their needs. It provides an overview of the regulation of Quality Infrastructure in the Russian Federation, including new legislation on standardization.
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Using standardization tools for achieving the objectives of priority projects by national regulators. Russian experience Wellington NZ 8-9 April 2019
Using standardization tools for achieving the objectives of priority projects by national regulators. Russian experience Session 3 – working together; cooperation between standards bodies and regulators
Section 1.Standards bodies engage with regulators to identify their needsNew legislation on standardization in Russia
Basic overview of the regulation of Quality Infrastructure in the Russian Federation STAKEHOLDERS: State, Society, Business Accreditation Federal Law “On accreditation” Conformity assessment Federal law “On technical regulation” Metrology Federal Law “On ensuring uniformity of measurements” Certification bodies Test laboratories ISO 17000 series standards Metrology standards Standards on safety and quality Standardization Federal law “On standardization in Russian Federation”, valid from 2016
Regulators involvement in standardization according to the Federal law “On standardization in Russian Federation” • Defining requirements and the directions of the standardization development in the established field of activities Developing together with national standardization body perspectives programs of standardization for the priority fields Possibility of direct referencing to the standardization documents in the normative acts issued by the regulators Forming sections on standardization when developing documents of strategic planning, including state programs of the Russian Federation.
Section 2.Examples of initiatives by standards bodies:References to standards in regulators’ acts
Long history of referencing to standards in regulators acts In Russian Federation it has started with standardization in….. healthcare Back to the 19th century Sergey Botkin, great Russian therapist worked out so called “nastavleniya” or “guidances” for the military medical officers that set up detailed instructions on different procedures for surgery and medical healthcare services. Later the direct references to these “standards” appeared in the documents of State department of healthcare of the Russian Empire
Example #1. Direct references to national standards in the normative acts issued by regulators • Act of the Ministry of communication on unified biometric system has direct references to national standards on biometric data exchange format • Act of the Ministry of finances has direct references to national standards on two-dimensional barcode symbols for payments by individuals • Act of the Ministry of culture has direct references to national standards on accessibility of museums for disabled people • Act of the Ministry of health on patient’s data has direct references to national standards on cryptographic protection of the information As per January 01, 2019 there are 104 direct references to nationals standards in the normative acts by Russian regulators. Almost 20% are the references to the national standards harmonized with ISO or IEC standards
Example #2. Lists of standardization documents approved by regulators • Governmental decreedd.04.11.2017 N 2438-р, approving the list of national standards (GOSTs) that are mandatory to be used to ensure the safety of road traffic. • the list includes 21 standards, mandatory to be used • Governmental decreedd.26.12.2014N 1521, approving the list of national standards (GOSTs) that are mandatory to be used to ensure safety in building and construction • the list includes 78 standards, mandatory to be used While direct references in regulators acts can describe different fields and scopes of regulation, the lists of standardization documents approved by regulators refer only to safety requirements
Section 3.State priority projectsStandardization and regulators
State Priority Projects 2025 Standardization indicators and actions as tools to reach the goals of priority projects Пр Digital Economy SME support Export support Cities Ecology Safe and quality roads Demography Health Education Science Culture
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