Remote production site audit for EAC certification

Remote production site audit for EAC certification


The recommendations that were developed in March 2020 are no longer applicable.

The new recommendations stipulate that in regard to existing certificates of conformity for serial production, if the next scheduled inspection control is to be performed 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 expires from March 15 to December 31, 2020, as well as for certification of new products that have slight differences in design and production technology that do not affect its safety, the certification body can issue a new serial certificate.

Inspection control of certified products, which includes an analysis of the state of production, for such certificates of conformity should be carried out within 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 hat have an appropriate level of competence, under the remote control of a certification agency using video-conferencing. The certification agency must ensure the documentation of the remote sampling procedure, as well as the storage of the video recording material of the procedure in the certificate of conformity.

Extended recommendations allow the possibility of conducting a production analysis by remote assessment and analysis, together 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 of products that meet established requirements, until the removal of any restrictions data with the distribution of COVID – 19.

Remote assessment is carried out without going to the manufacturer's place of business, the assessment is carried out using video-conference communication, 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 production assessment or the compliance of the applicant's management system (audited organization) with the established requirements.

For products that are being put into circulation for the first time, depending on the certification subject, certification schemes for a batch of products or for single products can be applied. The certification agency may carry out sampling of products in a temporary storage warehouse, customs warehouse, in the vehicle capacity. Samples of products that are first put into circulation can be independently selected by the applicant (manufacturer), imported into the Russian Federation in accordance with customs procedures as samples intended testing and measurements and submitted to the certification agency with the transfer of the certificate of sampling.

If it is not possible to carry out inspection control or move it to another day, in order to confirm the conformity of products with current certificates, it is recommended not to cancel or suspend the certificates of conformity for such products for the period of maintaining the epidemiological situation.

Until December 31, 2020, the extended recommendations may equally be applied by certification agencies with regard to foreign products and products manufactured in the Russian Federation, if the applicant applies accordingly. Compliance by accredited organizations and applicants with the provisions of these recommendations will be regarded by Federal Service for Accreditation 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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