On the provision on the procedure for the application of standardized assessment schemes (confirmation) of compliance with the technical regulations of the Customs Union
Regulations on the procedure for the application of standard evaluation schemes (confirmation) of compliance with the requirements of the technical regulations of the Customs Union
The regulation on the application of standardized assessment schemes (confirmation) of compliance with the technical regulations of the Customs Union was developed in order to implement the provisions of the Agreement on common principles and rules of technical regulation in the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation of November 18 of 2010.
With regard to products, the requirements for which are established by the technical regulations of the Customs Union (hereinafter - technical regulations), conformity assessment carried out in the form of confirmation of conformity (declaration of conformity, certification), registration, including state, examination, assessment of suitability, testing, state control (supervision) and (or) other form. Conformity assessment in the form of registration, examination, assessment of suitability, state control (supervision) and (or) in another form is established by the developer in specific technical regulations, taking into account the specifics of the product, as well as the object of technical regulation (for example - electromagnetic compatibility and other), the degree of risk of harm and is carried out by the relevant authorized bodies of the States members of the Customs Union.
State registration of products is carried out by bodies and institutions authorized in the field of sanitary and epidemiological welfare of the population with registration of a certificate of state registration. For products subject to state registration, the primary form of conformity assessment is the declaration of conformity.
State registration of production facilities is carried out by the authorized body of a member state of the Customs Union on the basis of an application for state registration of a production facility.
The choice of forms and schemes of conformity assessment should be based on the total risk from an unreliable conformity assessment and harm from the use of products that have passed the conformity assessment. When choosing forms and schemes, the following main factors should be considered:
degree of potential hazard products;
the sensitivity of the specified indicators to changes in production and (or) operational factors; the sensitivity of the specified indicators to changes in production and (or) operational factors;
status of the applicant (manufacturer, manufacturer authorized person, dealer, service);
the adequacy of the evidence of the degree of compliance costs and to assess compliance with the objectives of technical regulations.
Confirmation of conformity is carried out in the form of certification or declaration of conformity according to standard schemes. Certificates of conformity can be used as evidence when accepting a declaration of conformity, registration and approval (approval) of a product type, if this procedure is established in the technical regulation.
A typical conformity assessment scheme is a set of actions (elements), the results of which are used to make a decision on conformity (non-conformity) of products to the requirements of technical regulations. In general, such actions (elements) can be considered:
registration of the declaration of conformity; - application of a single mark of circulation of products on the market of the Member States of the Customs Union (hereinafter - the application of a single mark of circulation);
Analysis of technical documentation should be an integral element of each type scheme and may include:
analysis to identify products;
analysis to determine the suitability of technical documentation for conformity assessment;
The composition of the technical documentation confirming the conformity of products to the requirements of technical regulations is established in a specific technical regulation, and in general, may include:
specifications / descriptions (if available);
operational documents (if any);
the list of standards interconnected with the technical regulation the requirements of which the given product meets (when the manufacturer uses them);
description of the adopted technical decisions confirming the fulfillment of the requirements of the technical regulation, if the standards interrelated with the technical regulation are missing or not applied;
protocols of acceptance, acceptance and other tests carried out by the applicant and / or accredited testing laboratories (centers), confirming the conformity of products to the requirements of technical regulations;
documents confirming the safety of products in accordance with the laws of the Customs Union and the States members of the Customs Union;
certificates of conformity for management systems;
certificates of conformity or test reports for raw materials, materials, components or component parts of the product; other documents confirming the safety of products.
The study of the product design can be carried out by analyzing the technical documentation on which the product is manufactured, the results of the calculations, testing of experimental product samples.
Product type testing can be done by:
sample studies for planned production as a representative product representative;
analysis of technical documentation, sample testing of products or critical components of products.
Production assessment can be represented by the following main types:
analysis of the state of production;
management system certification.
Production control is carried out by the manufacturer to ensure the stability of compliance of the technical documentation produced and the requirements of technical regulations.
Registration of declarations of conformity is carried out according to the notification principle in accordance with the procedure established by the Commission of the Customs Union.
Inspection control is carried out only as part of certification and may include:
testing samples of certified products;
analysis of the state of production;
inspection control of a certified management system.
Control over products whose compliance is confirmed by a declaration of conformity is carried out within the framework of state control (supervision).
In order to provide the applicant with the right to choose the most appropriate scheme for confirming conformity in a technical regulation for a specific product, it is recommended to establish several typical schemes equivalent to the degree of evidence of compliance with the requirements of technical regulations taking into account the conditions of their use.
Depending on the typical certification scheme, conformity assessment in the form of certification is carried out by an accredited product certification body, an accredited certification body for management systems certification included in the Unified Register of Certification Bodies and Testing Laboratories (Centers) of the Customs Union (hereinafter referred to as Product Certification Body, on certification of management systems).
Depending on the typical conformity declaration scheme, conformity confirmation in the form of conformity declaration is carried out on the basis of own evidence and (or) evidence obtained with the participation of the product certification body, management system certification body, accredited testing laboratory included in the Unified Register of Certification Bodies and testing laboratories (centers) of the Customs Union (hereinafter - accredited testing laboratory).
Storage of technical documentation... The storage procedures for technical documentation, including documents confirming compliance, are established in a specific technical regulation. In general, technical documentation, including documents confirming compliance on the territory of the member states of the Customs Union, should be stored on:
products from the manufacturer (authorized by the manufacturer) for at least 10 years from the date of withdrawal (termination) from the production of these products;
batch of products (single product) from the seller (supplier), manufacturer (authorized by the manufacturer) for at least 10 years from the date of sale of the last product from the batch.
Documents and materials confirming the results of certification are stored in the certification body that issued the certificate of conformity for at least 5 years after the expiration of the certificate of conformity.
The above documents should be provided to state supervisors upon request.