Assessment of conformity with technical regulations. General provisions

Affirmation of conformity
execution and registration ofthe document (declaration of conformity and/orconformity certificate) on the basis of thedecision that wasmade after the relevant (necessary) conformity assessment procedures that have proven compliance with the established requirements.
Declaring of conformity

the procedure whereby the producer or the authorized person document-wise certifies on his own responsibility that the product meets the requirements of the legislation.

Declaration of conformity
is a document that is ordinarilyexecuted by the company-producer or a seller under their own responsibility. This documentensures that the quality of productsmeets the requirements of the legislation.

The main parameters of the product areindicated in the declaration: producer, number and volume of the lot, the documents, on whichbasis the products are imported to Ukraine (if it’s import), information on conformity with technical regulations, DSTU (State Standards of Ukraine), TU (technical specifications) etc., information on conducting the sanitary-epidemiological examination of the Ministry of Health and conducted tests on conformity with stated quality.

To register the declaration of conformity
is a necessary part of the process of conformity assessment of products on the territory of Ukraine.

Declaration is a document with which the supplier or producer confirm the provided information that the production process and the composition of the products conform to the Ukrainian and international norms and standards. The necessity to obtain the declaration of conformity is one of the methods by which the possibility of import of goods of inadequate quality is blocked.

Declaration of Conformity
is issued on the basis of technical documentation, affirmation of specific product’sconformity with requirements of the valid normative documents and technical regulations for it. These documents include a general description of the product, producttest protocols thatwere compared on the basis of tests conducted with required intervals in accredited testing laboratories, normative documents on the specified requirements for a particular type of product, and alsothe conformity certificates and the protocols oftests of raw materials and completion materials.

The registered Declarationis entered in the registerof declarationsin a obligatory manner, in this registerthe conformity assessment body notes the following information: the account number of each declaration and its expiration date, the name of the products’ producer (authorized representative of the organization, supplier), the name and designation of products, technical regulations and normative documents to whichthese productsconform, the information on the possibility of applying a mark of conformity, as well as additional information (such as presence  of the conformity certificate and its number and expiration date). Declaration of Conformity has to be released on the website of conformity assessment body that registers the document.

Conformity mark
1. Form, requirements The following was established:
  • the image of the conformity mark (see Figure 1 (a)) for products that meet all the requirements of the normative documents and are subjected to obligatory certification in UkrSEPRO system;
  • image of the conformity mark (see Figure 1 (b)) for products that meet the requirements of the normative documents and are not subjected to certification, but may be certified under the initiative of the organization - applicant.
Designation code (185) of the Conformity assessment body that certified the product (service, process) is applied below the graphic image of the conformity markin the frame in Figure 1.

Figure 1. Conformity marksof certified products (services, processes)that are subjected to certification in UkrSEPRO system

The size, shape, technical requirements for the application of conformity marks (Figure 2) of certified products in UkrSEPRO system are given in ISO 2296.

Figure 2. Sizes of theconformity mark in UkrSEPRO system

It was established that the image of theconformity mark (Figure 4) for products that meet all the requirementsof the normative documents and is certified in the LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD»;

Figure 3. Conformity mark of certified products
(Service, process) in the LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD» system

The size of the conformity mark must ensure its clarity and intelligibility.

The image of the conformity mark can be done by any technological means that provide the clarity and intelligibility of the image for the duration of storage or service (application) of products.

2. The rules of use.
The company has the right to use the conformity mark after receivingthenumber of the products conformity certificate registered in the registry of UkrSEPRO or LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD». The conformity mark of certified products is applied to the part of the products, container,packaging, accompanying documentation. The place of the conformity mark on products, containers, packaging is defined by the company, which has received the right to use it. The mark conformity of certified service (process) is provided on the accompanying documentation for this service (process). In case of impossibility of applying the conformity mark on the accompanying documents or the impossibility to accompany services (process) by this documentation, the conformity mark can be supplied by the executorof certified service (process) in promotional materials for this service (process). In this case, such use of conformity mark is stipulated in the license agreement between the LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD»and the applicant. If the conformity certificate is temporarily suspended, the marking of products, containers, packaging, accompanying documentation and advertising materials with the conformity mark is prohibited.If the conformitycertificate iscancelled,the applicant loses the right to use the conformity mark. Application ofthe conformity mark on the business cards of the applicant's workers is prohibited.

The use of theconformity mark without the right to do it, or the use of marks, symbols, other signs that even partially imitatethe conformitymark  of LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD»is prohibited.

The order for products declaring Conformity assessment procedures that are recommended in the technical regulations (Technical regulations of the conformity assessment modules, approved by the Resolution of Cabinet of Ministersof Ukraine No. 1585 d.d.October 3, 2003.) can be chosen from the following modules:

  • Module A − Internal control of production;
  • Module A1 − internal control of production and controlled tests of the product;
  • Module A2 − internal control of production and controlled testsof the product at random time intervals;
  • Module B − type checking;
  • Module C – conformity, which is typical on results of the internal control of production;
  • Module C1 −conformity, which is typical on results of the internal control of production and testing of products;
  • Module C2 −conformity, which is typicalon results of the internal control of production and testing of productsat random time intervals;
  • Module D −conformity, which is typical thoughassurance of the adequate quality of production;
  • Module D1 −insurance ofthe adequate quality of production;
  • Module E −conformity, which is typical though assurance of the adequate quality of products;
  • Module E1 −assurance ofthe adequate qualityof final control and testing of the product;
  • Module F −conformity, which is typicalon the results of the inspection of products;
  • Module F1 – establishing the conformity of production on the result of the check;
  • Module G −conformity of product unit;
  • Module H −assurance of full quality;
  • Module H1 −assurance of full quality and design checking.

ORDER OF DECLARATION

1The order for declaring products in general includes:

  • submission of the application by the declarant (producer or authorized representative/person administering the products into circulation, or supplier) on the entry of the declaration of products conformity in the system registry and its registration;
  • provision of the declaration of conformity (for theseries orlotof products) with a set of documents and their expertise;
  • making decision on the possibility (or impossibility) of entry of the declaration of conformity in the system registry.

2 The declaration of conformity is issued for products, requirements for which are established by the relevant technical regulations, taking into account the requirements of Technical regulations of theconformity assessment modules (hereinafter – TR).

3 Documentation, presented to the declaration of conformity, must contain the following information:

  • the name and address of the producer;
  • the general description of the product;
  • technical design and production drawings, circuit of elements, subassemblies, circuit diagrams;
  • description and explanation regarding drawings and circuits and those regarding the use of the product;
  • the operating instructions;
  • the results of design calculations, tests;
  • test protocols, conformity certificates and other documents for conformity assessment;
  • a list of normative documents that have been applied for conformity assessment;
  • technical conditions (for domestic producers)
  • copy of the agreement ofproducer with the authorized representative – resident of Ukraine to perform certain actions on behalf of the producer while conduction of the conformity assessment of products (hereinafter – the authorized representative) (if necessary);
  • a copy of a power of attorney of authorized representative from the producer (if necessary).

4 Entering of the declaration in the register of LLC  shall be made within 7 days on the basis of the examination of the provideddocuments for conformity assessment of products with the requirements of TR, completeness and validity of the execution (if there no inconsistencies were detected). Upon detection of any remarksthe period is extended by the time required for elimination of remarks. The Information on the published declaration is updated on the site of LLC.

5If the declared goods are covered by several TP, and theLLC enters the declaration of conformity of products with separate one of themin the register, then in the extended informationtheLLC indicates a list of TR with which these products must comply with.

In case when the conformity of products is not confirmed by all of the TR requirements,which apply to it, the LLC makes a record of the impossibility of applying the conformity mark for products in thegraph “Information …”.

The conformity mark is applied to products only after the affirmation of its conformity with all TR, which apply to it.

The order of declaring products (conformity assessment according tomodule A – Internal control of production)

1 At conduction of the assessment of products for conformity with technical regulations according to module A, the declarant shall submit to the LLC an application for registration of the Declaration of Conformity, set of technical documentation and declaration of conformity (hereinafter – the Declaration). In the application, the declarant must indicate (specify) the module or the combination of modulesaccording to which the assessment of product’s compliance with technical regulations is or was conducted.

2 The set of the technical documentation includes:

  • the general description of the product;
  • technical design and production drawings, circuit of elements, subassemblies, circuit diagrams;
  • description and explanation regarding drawings and circuits and those which regarding the use of the product;
  • thelist of standards from the list of national standards, optional use of which is wholly or partly can be seen as proof of product conformity with regulations. In the case of partial application of the standards,its provisions, whichwere applied, are specified in the technical documentation;
  • the results of design calculations, tests;
  • technical specifications, duly registered (if any);
  • test protocols etc.

If the documents aresubmitted bythe authorized representative,power of attorney for the right to declare products must also be submitted.

3Declaration of Conformity (for the seriesor lots of products) is executed in Ukrainian language and should contain:

  • references to the technical regulation(s);
  • information on the identification of the instrumentation or equipment;
  • the name and address of the producer and, if necessary, the name and address of his authorized representative;
  • reference to harmonized standards or equivalent requirements, affirming the conformity of the instrumentation or equipment with the requirements ofTechnical Regulation(s);
  • the date of issuance of the Declaration of Conformity;
  • signature, surname and initials of the person who executed the declaration.

The declarant must indicate (specify) in the application the module or the combination of modules on which is carried out or was carried out the assessment of product’s compliance with technical regulations.

4According to the results of review of the application and the provided documentation the agreementon conduction ofwork on conformity assessmentis prepared.

5The set of technical documentation is to be analyzed. The list of indicators for analyze ofdocuments is given in the Report on the analysis of the documentation set, in which the results of the analysis arealso recorded anda description of the nature of the deviations, if any. If results of the analysis of the documentation arepositive,the LLC continues to work; if there are anyremarks–the work is suspended until the declarant does not eliminate all remarks.

6Based on the results of the documentation analysis the decisionis made, stating the procedure ofthe assessment of products with therequirements of the Technical Regulation(s).

7If there are no violations or deviations,a decision on registration of the declarationis prepared, otherwise – the decision of refusal of registration of the declaration.

8Upon refusal of the registration of the declaration, the declarant has the right to:

  • re-apply with all necessary documents, which will allow to make a positive decision on registration of the declaration;
  • submit to the LLC the set of documents for conformity assessment according to other modules (for example, with an issue oftype checking certificate);
  • appeal to theLLC or to the Central executive body on the technical regulation;
  • appeal againstthe decision of the LLC in court.

9The register of declarations is made by adding them to LLCRegister, which is made not later than 7 days (if no inconsistencies were detected).Upon detection of any remarksthe period is extended by the time required for elimination of remarks.

10The LLC publishes the information about the registered declarations on its Web-site no later than the day after the day of its registration. If LLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD»refuses to enter the declaration in its registry, such information is also indicated on the Web-site. If the declared goods are covered by several TP, and theLLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD» enters in the register a declaration of conformity of products with one of them, then in the extended informationtheLLC «RESEARCH AND PRODUCTION ENTERPRISE» «DIN LTD»indicates a list of TR with which these products must comply. In case when the conformity of products is not confirmed by all of the TR requirements,which apply to it, the LLC makes a record of the impossibility of applying the conformity mark for products in thegraph “Information …”. The conformity mark is applied to products only after the affirmation of its conformity with all TR, which apply to it.