The principal enactment with regard to conformity assessment in the Russian Federation is Federal Law No. 184-FZ “Concerning Technical Regulation” dated 27.12.2002
According to this law:Confirmation of conformity is documentary certification of conformity of the products or other objects to the requirements of technical regulations, provisions of standards, codes of practice or contract terms;
||Serial production||Batch of products|
|Validity term||Up to 3 years||Not limited in time|
|Effect||For all products specified in the certificate and manufactured during the validity term of the certificate||Only for this batch of products with certain serial numbers (the batch is limited by the contract or another document a reference to which is given in the certificate)|
|Inspection control||At least once a year||Not conducted|
|Production audit||Audit is required as it is necessary to assure the production’s stability (it may be not conducted in the presence of the certificate of conformity of QMS requirements ISO 9001 or if the analysis has been conducted before)||Not required as the subject of analysis is only one batch of products which has been already manufactured|
|Russian system of certification||Country of origin||Code of certification body||Code of certification type*||Certificate’s sequential number|
А — compulsory certification of the batch of products
В — compulsory certification of serial production of goods
С — voluntary certification of the batch of products
H — voluntary certification of serial production of goods
Pursuant to cl. 3.7 of “Certification Procedure of Goods in the Russian Federation” the inspection control over the certified products is carried out at certification of serial production during the whole validity term of the certificate at least once a year in the form of regular and unscheduled audits which include testing of product samples and other checks necessary to confirm that the saleable products still conforms to the established requirements confirmed during certification.
Results of inspection control are documented by the act which presents assessment of sample tests results and other checks, makes a conclusion about the status of the certified goods’ production and maintainability of validity of the certificate issued. The Act of Inspection Control is to be kept by the certification body and its copies are sent to the applicant (manufacturer, seller) and to the organizations taking part in the inspection control.
According to results of the inspection control the certification body may suspend or invalidate the certificate in case the product’s non-conformity to the requirements of regulatory documents subject to control during certification as well as in the event of:
Declaration of conformity
Declaration of Conformity is the document in which the manufacturer or the seller certifies that the product suppliable or saleable by him/ her conforms to the requirements envisaged for such product (hereinafter – the established requirements).
The Declaration of Conformity is accepted with regard to the products enlisted in the List of Goods Subject to Compulsory Confirmation of Conformity in the Form of Declaring (RF Government Decree No 982 dated 1.12.2009).
Only Russian manufacturers (sellers) or organizations registered in the Russian Federation as legal entities and representing interests of relevant foreign manufacturers (sellers) are entitled to accept the Declaration of Conformity.
The manufacturer (seller) accepts the declaration of conformity based on the documents confirming conformity of the products to the established requirements.
Such documents include:
The Declaration of Conformity may be accepted as for serial production of goods as for a batch of a certain volume.
The Declaration of Conformity accepted by the manufacturer (seller) is subject to registration in the accredited certification body.
The certification body checks accuracy of the accepted declaration and registers it or informs about necessity to correct non-conformities detected.
Registration of the Declaration of Conformity is performed by assigning a registration code containing identification designation (code) of the certification body and sequential number of the declaration of conformity according to the register maintained by the certification body to it.
The Declaration of Conformity accepted in accordance with the established procedure and registered by the certification body has legal force on equal terms with the certificate of conformity.
Registered Declaration of Conformity entitles the manufacturer (seller) to place the conformity mark on the product.
Control over the products with the accepted and registered declaration of conformity is exercised by federal executive authorities (not by certification bodies). i.e. inspection control in this case is not provided.