Conformity Certification for the Ukrainian market
Conformity certification is a well-known and widespread form of attesting the quality of a product or service in Ukraine. It is a procedure by which an accredited certification body attests, by issuing a certificate, the conformity of a product or service to the requirements established for it.
Since 1st January 2018, the Decree of the Cabinet of Ministers of Ukraine "On Standardization and Certification" No. 46-93 has become invalid and, as a result, the State Certification System of Ukraine (better known by its former name - the UkrSEPRO system) has ceased to exist.
However, the abolition of UkrSEPRO does not mean the abolition of certification as a procedure in general.
How can the quality of products in Ukraine be certified from now on?
The abolition of the UkrSEPRO system does not exclude the possibility of assessing the quality of products; on the contrary, it makes it easier for producers to obtain it. The UkrSEPRO certificate has been replaced by a voluntary certificate of conformity issued by a certification body accredited by the National Accreditation Body of Ukraine (NAAU) to perform certification of products, processes, and services in accordance with the international standard DSTU EN ISO/IEC 17065 in force in Ukraine.
In the case of voluntary certification, the applicant determines the scope of the requirements for the products in coordination with the certification body. Voluntary certification may be applied by a manufacturer, vendor, consumer, authority or public organisation.
Declaration of Conformity for the Ukrainian market
If a product is covered by at least one technical regulation of Ukraine, the assessment of product conformity with the requirements of this technical regulation and the subsequent declaration of conformity are mandatory.
The declaration of conformity is another means of confirming the quality of products or services that is becoming increasingly popular due to changes in the Ukrainian legislation and harmonisation with European standards.
The basic difference from certification is that in the declaration of conformity the manufacturer (importer) or his authorised person (not the certification body) certifies on his sole responsibility that the products meet the requirements set out by the legislation.
The declaration of conformity is governed by:
-
The Law of Ukraine "On Standards, Technical Regulations and Conformity Assessment Procedures";
-
The Law of Ukraine "On the Rules of Conformity Attestation";
-
Technical regulations of conformity assessment modules and requirements for national conformity marking used in TR.
Ukrainian national technical regulations
Technical regulation (hereinafter RM) - a law or a legal act of Ukraine, which defines the characteristics of products or related processes and production methods, including relevant procedural provisions, with which compliance is mandatory. It may also include or contain requirements on terminology, marking, packaging, labelling, or labelling as they apply to the product, process or production method.
Currently there are about 95 national technical regulations in force in Ukraine.
The technical regulations of Ukraine are harmonised with the EU New Approach Directives in terms of technical requirements and conformity assessment procedures.
One type of product may fall under several Technical Regulations.
Declaration of conformity: how do you draw up a declaration?
A declaration of conformity is a duly documented statement by the manufacturer, by which he guarantees the conformity of products with the requirements established by law, based on the results of conformity assessment procedures.
The scope of the required procedures is established by the conformity assessment modules:
Module A - internal production control
Module A1 - internal production control and controlled product testing
Module A2 - in-house production control and controlled production testing at random intervals.
Module B - Type approval
Module C - Type approvals for internal control results
Module C1 - Type conformity with in-house production control and product testing
Module C2 - Conformity to type by results of internal production control and product testing at arbitrary intervals.
Module D - conformity to type by ensuring adequate production quality
Module D1 - ensuring adequate quality of production.
Module E - conformity to type by ensuring adequate production quality.
Module E1 - ensuring adequate production quality.
Module F - Type approval by product inspection.
Module F1 - Conformity to type by product verification.
Module G - Unit conformity.
Module H - Total quality assurance.
Module H1 - Full quality assurance and design verification.
For each product type there are modules regulated by Technical Regulation(s).
The general conformity assessment procedure in Ukraine involves the following actions:
-
identifying the Technical Regulation(s) under which the product(s) fall(s);
-
determining the conformity assessment procedure for the products;
-
determine the other regulatory requirements for the product(s);
-
determine whether an independent conformity assessment of the product(s) is required by an approved conformity assessment body (hereafter "CAB");
-
testing and ensuring that the products meet the requirements of the Technical Regulation(s) and selected standards;
-
carrying out the conformity assessment by the CB;
-
drawing up a declaration of conformity;
-
marking of products, packaging, and accompanying documents.
The declaration is drawn up directly by the manufacturer without carrying out the conformity assessment work of the Certification Body only for module A. The application of the other modules implies the intervention of an approved CB, after which the manufacturer also draws up a declaration of conformity after the issue of the corresponding certificates.
Ukrainian mark of conformity
A manufacturer (or a person authorised by him) who has certified his own products and obtained a certificate of conformity is entitled to use the mark of conformity or other acceptable indications of the existence of a certificate of conformity for advertising and other purposes that do not conflict with the legislation in force and do not mislead the consumer as to the certified status.
The right to use the conformity mark is granted to the applicant under a licensing agreement. If the applicant for certification is not the manufacturer of the products, but an authorised organisation acting on his behalf based on a power of attorney, the obligation to meet the marking requirements is imposed on the applicant.
The procedure for applying the national conformity mark for technical regulations is regulated by the Resolution of the Cabinet of Ministers of Ukraine of 30.12.2015 No. 1184.
The national conformity mark represents an unclosed base circle on the right side, with a stylised shamrock inside.
The conformity mark may be flat or embossed and must be in two contrasting colours.
The conformity mark shall be accompanied by the identification number of the designated conformity assessment body, if such a body has been involved in the production control stage, in the format UA.TR.YYY or YYY, where:
UA is the conventional designation of Ukraine in Latin letters;
TR - the notation, which means that the conformity assessment body has been designated to carry out work on conformity assessment of the requirements of technical regulations;
YYY - the identification number of the designated conformity assessment body.
How can CCIS-EXPERTISE help you?
-
Verification if the product is subject to certification/declaration in Ukraine and the choice of applicable regulations (regulations, norms, standards)
-
Full consultation and assistance in applying for the certificate, voluntary certification, etc.
-
Selection of certification body and accredited laboratory
-
Coordination of necessary types of testing in accredited laboratories / testing centre, including coordination of test preparations, organisational assistance in selection of test samples
-
Inspection assistance: preparation-audit including objective-performance comparison, and consultation on enforcement of regulations, translation and technical assistance, organisation of travelling formalities of the Ukrainian inspectors, interview with Ukrainian inspectors before, during and after factory inspection
-
Verification of marking and labels
-
Assistance in maintaining certification or declaration status (e.g. annual inspection and supervision or extension of product range and application of changes subject to regulatory approval)
-
Training about the details of the Ukrainian certification/declaration procedure (via Zoom or face-to-face)
-
Translation into Ukrainian of technical files, drawings, etc.