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 whose requirements are established by the technical regulations of the Customs Union, conformity assessment It is carried out in the form of confirmation of conformity (declaration of conformity, certification), registration, including state, examination, suitability assessment, testing, state control (supervision) and (or) another form. Conformity assessment in the form of registration, examination, suitability assessment, state control (supervision) and (or) in a different form is established by the developer in specific technical regulations taking into account the specifics of the product, as well as the subject of technical regulation (for example, electromagnetic compatibility and others), the degree of risk harm and is carried out by the relevant authorized bodies of the Member States of the Customs Union. Typical conformity assessment forms are given in Appendix A.
State registration of products is carried out by bodies and institutions authorized in the field of sanitary and epidemiological welfare of the population with the issuance of a certificate of state registration. For products subject to state registration, the preferred form of conformity assessment is the declaration of conformity. Typical schemes for state registration of products are given in Appendix B.
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 conformity assessment schemes should be based on the total risk from an unreliable conformity assessment and the harm from the use of products that have passed conformity assessment. When choosing forms and schemes, the following main factors must be taken into account: the degree of potential hazard of the product; the sensitivity of the given indicators to changes in production and (or) operational factors; applicant status (manufacturer, person authorized by the manufacturer, seller, supplier); the adequacy of the degree of evidence of compliance and the costs of assessing compliance with the objectives of the technical regulation.
Confirmation of conformity is carried out in the forms of certification or declaration of conformity according to standard schemes. Certificates of conformity can be used as evidence in the adoption of a declaration of conformity, registration and approval (approval) of the type of product, 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:
drawing a single sign of circulation of products on the market of the Member States of the Customs Union (hereinafter - putting a single sign of circulation);
Analysis of technical documentation should be an integral element of each model scheme and may include: analysis to identify products; analysis to determine the suitability of technical documentation to confirm compliance; project research.
The composition of the technical documentation confirming the conformity of the products with the requirements of the technical regulation is established in the specific technical regulation, and in the general case, may include: technical specifications / descriptions (if any); operational documents (if available); a list of standards interconnected with the technical regulation, the requirements of which correspond to this product (when used by the manufacturer); a description of the technical solutions adopted, confirming the fulfillment of the requirements of the technical regulation if standards interconnected with the technical regulation are absent or have not been applied; protocols of acceptance, acceptance and other tests conducted by the applicant and / or accredited testing laboratories (centers), confirming compliance of products with the requirements of technical regulations; documents confirming the safety of products in accordance with the laws of the Customs Union and the Member States of the Customs Union; certificates of conformity for management systems; certificates of conformity or test reports for raw materials, components, components or components of a product; other documents confirming product safety.
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 research can be carried out by: researching a sample for planned production as a typical product representative; analysis of technical documentation, testing of a product sample or critical product components.
Assessment of production 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 within the framework 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).
Procedures for the storage of technical documentation, including documents confirming compliance are established in specific technical regulations. In the general case, technical documentation, including documents confirming compliance in the territory of the Member States of the Customs Union, should be stored on:
products - from the manufacturer (the person authorized by the manufacturer) for at least 10 years from the date of withdrawal (termination) from production of these products;
a batch of products (single product) - from the seller (supplier), manufacturer (person 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 oversight bodies upon request.
The decision of the Commission of the Customs Union No. 621 of April 7, 2011