Laboratory (ISO/IEC 17025)

In Ukraine, the mandatory accreditation of the testing and calibration laboratories for compliance with ISO / IEC 17025 has been introduced. Subjects to the Standard are all medical laboratories, testing laboratories specialized in the quality control of medicinal products, medical devices, foods, and cosmetics etc. Testing laboratory can be both an independent organization and a part of the manufacturer, importer or distributor, medical institution, or conformity assessment authority.

The State Standard of Ukraine (DSTU), ISO / IEC 17025:2006 “General requirements for the competence of testing and calibration laboratories” has been introduced and is identical (IDT) to the ISO/IEC 17025:2005 international standard, “General requirements for the competence of the testing and calibration laboratories”.

ISO/IEC 17025 allows laboratories to demonstrate their competence by increasing confidence in their work, both nationally and globally. It also makes easier collaboration between laboratories and other authorities, promoting wider acceptance of the conformity assessment results between countries.

The accreditation body for testing laboratories in Ukraine is the National Accreditation Agency of Ukraine (NAAU), and the register of accredited testing laboratories is published on the Agency’s corresponding page.

In 2017, a new version of the Standard, ISO/IEC 17025:2017, has been enacted, gradual switch to which within 3 years was approved by the Order of NAAU dated December 22, 2017. In the new version, the most significant changes are the following:

• The scope of application covers all laboratory activities, including testing, calibration and sampling associated with further calibration and testing;
• A new structure has been adopted for harmonization with other existing standards of conformity assessment of the ISO/IEC 17000 series (e.g., ISO/IEC 17021, ISO/IEC 17065, etc.);
• A process approach conforms to the most recent standards, such as ISO 9001 (quality management), ISO 15189 (for medical laboratories) and the ISO/IEC 17000 series (standards for conformity assessment), giving particular emphasis on the results of the process instead of a detailed description of included tasks and steps;
• The standard stipulates the common usage of information technologies, i.e., computer systems, electronic records and publication of electronic results and reports, etc.

Cratia company offers services on analysis, development, implementation, accreditation and extension of the scope for the quality management system of testing and calibration laboratories in accordance with ISO/IEC 17025 including the following:

• Analysis and preliminary audit of the existing system, development of a strategy;
• Development (refinement) of procedures and documentation;
• Staff trainings;
• Validation of the testing and calibration methods;
• Organization of the equipment calibration;
• Preparation of documentation for accreditation and process control;
• Extension of the scope of accreditation.

In addition, we organize works on representation of the interests of the Ukrainian testing laboratory and support the signing of recognition agreements with accredited testing laboratories in the EU and other countries. Possibility of unilateral or mutual recognition of the results is the significant competitive advantage for the clients of such laboratory.