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Russia – Interim Measures on Inspection Control, Sampling and Other Activities Due to Covid-19

June 2020

June 2020 Updates

Russia

Russia - Interim Measures on Inspection Control, Sampling and Other Activities Due to Covid-19

Effective May 14, 2020

The Ministry of Industry and Trade of the Russian Federation and the Ministry of Economic Development of the Russian Federation, with the participation of the Federal Accreditation Service, have developed extended recommendations on temporary measures for the issue of inspection control, sampling and other scheduled work, taking into account the difficult epidemiological situation associated with the spread of coronavirus infection (COVID-19).

The expanded recommendations stipulate that in respect of valid certificates of conformity for serial production, if the next scheduled inspection control falls for the period from March 15 to December 31, 2020, the certification body may decide to postpone the inspection control for up to 6 months.

With regard to certificates of conformity for serial products whose validity period expires from March 15 to December 31, 2020, as well as for certification of new products that have slight differences in design (formulation) and production technology that do not affect its safety, by the authority for certification, a new serial certificate can be issued.

Inspection control of certified products, including analysis of the state of production, according to such certificates of conformity should be carried out in a period not exceeding 6 months from the date of cancellation of the measures provided for in these explanations.

In the case of serial certification of products, sampling can be carried out by the representative of the applicant (manufacturer) at the finished goods warehouse having an appropriate level of competence, under the remote control of a certification body using video-conferencing. The certification body must ensure the documentation of the remote sampling procedure, as well as the storage of the video recording materials of the procedure in the certificate of compliance.

Extended recommendations allow the possibility of conducting an analysis of the state of production by conducting a remote assessment and analysis by the certification body, combined with a documentary assessment of the manufacturer’s quality management system, which allows establishing the manufacturer’s ability to consistently ensure that certified products comply with the mandatory requirements of technical regulations, the necessary conditions for the implementation of the production process, complying with the established requirements, up to the removal of any restrictions related to the distribution of COVID – 19.

Remote assessment is carried out without going to the manufacturer’s place of business using video-conferencing, using remote identification of individuals, premises, equipment and geolocation of the place of business by the manufacturer. A remote assessment is not carried out if such a format for conducting the assessment creates unacceptable risks of an objective assessment of the state of production or the compliance of the applicant’s management system (audited organization) with the established requirements.

Until December 31, 2020, the extended recommendations may equally be applied by certification bodies in relation to foreign products and products manufactured in the Russian Federation, if the applicant applies accordingly. Compliance by accredited persons and applicants with the provisions of these recommendations will be regarded by Rosaccreditation as compliance with established requirements without applying administrative responsibility measures in accordance with the Code of Administrative Violations, as well as without suspension (termination) of accreditation of accredited persons.

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