Conformity assessment is a process that demonstrates the compliance of a product, process, service, system, person or organization with specified requirements, in other words, this applies to procedures that demonstrate the compliance of a product with the requirements of a legislative document or a customer.
MODULAR APPROACH TO ASSESSMENT OF CONFORMITY IN UKRAINE
Conformity assessment is divided into "modules", which cover a limited number of different procedures applied to the widest range of products. Conformity assessment, according to the modules, is based either on the participation of the first party (the manufacturer), or a third party (the authorized body). The modules are associated with the product development stage or the stage of its production, or with the first and second stage together: as a rule, in accordance with the module, the product is subject to conformity assessment at the design stage, as well as at the production stage.
The modular approach in the European Union was introduced under the Global Approach to improve conformity assessment and subdivides conformity assessment into a number of modules, which differ in terms of:
- Stages of product development,
- The specified type of assessment,
- The person who conducts the assessment.
Decision 768/2008 / EC provides the general requirements that must be introduced in the field of harmonized European Community legislation. In this context, the Decision is determined by general principles intended for application in future versions of the Directive.
Such a common basis for product placement on the market establishes:
- General definitions;
- Obligations for economic entities (manufacturers, importers and distributors);
- Rules for the use of CE marking, thus ensuring confidence in products sold in the EU;
- criteria and procedures for notification of conformity assessment bodies;
- general conformity assessment procedures;
- Procedures for taking protective measures for products that pose a risk in order to ensure market safety. Products conformity assessment methods are selected among the modules according to the criteria approved in the EU Decree "On the modules used in the technical harmonization instructions for the various phases of the conformity assessment methods". The resolution provides detailed installations of the modules to be used at various stages of the conformity assessment procedure, and also the combinations of modules are thought out.
Directives establish for the manufacturer the possibility of choosing a certification scheme between those modules and their combinations that are provided for each product group.
As a rule, the product must be subjected to conformity assessment during both phases - design and production, before being placed on the market.
The manufacturer declares the conformity of the manufactured products to the basic safety requirements contained in the relevant EU Directives on their own responsibility or on the responsibility of a third party.
The declaration of conformity is a procedure by which the manufacturer or his authorized representative declares that the products introduced to the market comply with all the basic safety requirements that apply to it. Signing the Declaration of Conformity allows the manufacturer or its authorized representative to put a mark of conformity СЄ on the product. The Directives provide a list of documentation necessary for the preparation of a Declaration of Conformity.
The New and Global Approach directives establish basic safety requirements and conformity assessment methods for products. Conformity assessment by a third party is made by certification bodies. Certification bodies may be public or private, but must be independent and competent, as well as recognized in their countries and the European Union through the European Accreditation (European Accreditation Association).
In cases where the Directives provide for the possibility of a declaration of conformity of products by the manufacturer, he may at his request involve a notified (authorized) certification body. EU directives also contain articles on the protection of man, property and the environment. When an EU member state finds that products marked with С может may violate the safety of people, property and, in certain cases, the environment, it takes all possible measures to withdraw products from trade, prohibit their submission to trade, commissioning or use and restrictions on their free movement. When non-compliant products are marked with the CE mark, the EU Member State must also take appropriate action against who marked and prepared the Declaration of Conformity, and inform the Commission and other EU Member States about this.
In Ukraine, conformity assessment modules are applied taking into account the following principles:
- prevent the introduction into circulation of products that do not meet in particular the safety requirements for human life and health, property, and environmental protection;
- the use of modules depending on the stages of design and production of products;
- Conduct an assessment of product conformity at the stages of design and production of products prior to its introduction into circulation;
- a sufficient number of modules to ensure that products meet the established requirements, the choice of modules, taking into account the type of product, the presence or absence of a third party, production conditions;
- the inadmissibility of the use of too complex modules considering the goal of ensuring the compliance of products with the requirements established by technical regulations;
- the manufacturer must be able to choose between quality modules and product certification modules (unless a specific procedure is applied to ensure compliance with the requirements established by technical regulations). Resolution of the Cabinet of Ministers of Ukraine No. 1585 provides a description of the conformity assessment modules used in technical regulations. For conformity assessment, the modules A, A1, A2, B, C, C1, C2, D, D1, E, E1, F, F1, G, H, H1 are used.
Marking of products by a national conformity mark is performed by the manufacturer or, on his instructions, an authorized representative - a resident of Ukraine, who is determined by the manufacturer on the basis of an agreement with him to perform certain actions on his behalf under the conformity assessment of products, after positive results of production control before putting products into circulation, if otherwise not provided by the relevant technical regulations. If necessary, the technical regulations assume that the labeling is carried out by the person responsible for putting products into circulation.