Services to conformity assessment bodies

In 2005, government set a course for the accelerated joining of Ukraine to the processes of European integration as unconditional priority for Ukraine. One of the priority directions of European integration is the gradual harmonization of Ukrainian legislation according to the European one. In order to harmonize the technical regulation of the admission and circulation system for the products, the Law of Ukraine “On Technical Regulations and Conformity Assessment Procedures” was adopted in December 2005. This Law stipulates the legal and organizational basis for the development and implementation of technical regulations and conformity assessment procedures.

Gradual replacement of the state national certification system, “UkrSEPRO”, with the conformity assessment system has been begun: Technical regulations have been adopted to replace certification rules in the UkrSEPRO system. The UkrSEPRO system was completely canceled at the end of 2017.

The system for evaluating the products conformity with the requirements of Technical Regulations in Ukraine is built on the basis of the European model; not only state-owned but also private companies received the rights to be accredited and designated as conformity assessment bodies.

Establishment of conformity assessment bodies in Ukraine is formed within extremely short time period, which is undoubtedly associated with certain risks and complications. Thus, quite often state conformity assessment bodies have an excellent material and technical resources, reputation and history, however they experience difficulties in a competitive environment and have small success in the development of cooperation with foreign notified bodies. At the same time, private organizations are more successful in attracting customers, however, they may suffer from a lack of experience and reputation.

Since 2007 “Cratia” has been providing services for mandatory and voluntary product certification. We study the effective European legislation and actual trends, which allows us to understand in advance and professionally prepare for the adoption of the relevant Ukrainian legislative acts. We participate in international regulatory educational events and conferences both as learners and speakers. We exchange experience and have personal contacts with European notified bodies, associations and leading experts. We are ready to offer our knowledge, experience and contacts to the national conformity assessment bodies.

The development and implementation of the marketing plan involves our assistance in developing strategy for the services promoting, image making, implementing rules and procedures for the staff, developing the material and technical resources and extension of the scope of business activities. We offer:

  • Analysis and optimization of information (presentations, brochures, website);
  • Compilation of articles, reports, expert opinions;
  • Organization and moderation of seminars;
  • Choice of Business Association and assistance in joining to it;
  • Recommendations and help for participation in exhibitions;
  • Choice of equipment for the development of testing laboratory;
  • Recommendations and new directions development plan, etc.

Signing of Agreements on Recognition of the conformity assessment results with European notified bodies creates the additional opportunities to simplify and accelerate admission of the products to the Ukrainian market. Availability of such agreements is a strong competitive advantage for the national body, and also allows it to perform effective exchange of experience and knowledge. We have contacts with more than 30 EU notified bodies, we understand the requirements for the Ukrainian partner and are ready to accompany the process of signing the Agreement both institutionally and legally:

  • Identification of first priority notified bodies, search for contacts and initiation of negotiations;
  • Carrying out negotiations and meetings;
  • Support of the Due Diligence process;
  • Development of specific procedures for the information exchange;
  • Legal support in signing the Agreement on Recognition.

Audit, extension and improvement.The designated conformity assessment bodies are accredited by NAAU for compliance with the State Standards of Ukraine (DSTU) EN ISO/IEC 17021 (certification of quality management systems), ISO/IEC 17025 (requirements for the laboratory competence), and EN ISO/IEC 17065 (products certification). We offer:

  • Independent audit of the designated body for compliance with these standards;
  • Development of the plans of corrective and preventative actions, risk analysis;
  • Analysis and development of the documents for extension of the scope of accreditation;
  • Staff training, etc.

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.

We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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