The Board of Directors is appointed by a joint ministerial decision of the Ministries of Health and Finance with a 3-year term.
EKAPTY operates in accordance with the requirements of the ELOT ΕΝ ISO/IEC 17021 standard "Conformity assessment - Requirements for bodies monitoring and certifying management systems”, as well as the standard ELOT EN ISO/IEC 17065 “Conformity assessment – Requirements for bodies certifying products, processes and services” and has Civil Liability coverage for the certification activities it offers.
The body issues certificates of quality stating the compliance of products, services, processes and quality systems with the requirements of National, European and International standards and Legislation.
EKAPTY currently evaluates and certifies quality systems in accordance with the requirements of the standards EN ISO 9001, EN ISO 13485. It will soon be able to provide quality system evaluation and certification services, in accordance with the requirements of EN ISO 14001 - Environmental Management Systems, EN ISO 45001 - Occupational Health and Safety Management Systems and EN ISO 15224 - Quality Management System in Healthcare.
EKAPTY is an independent Certification Body of Quality Systems and Products. The independence and impartiality of EKAPTY is ensured by the legal framework of its establishment and operation, its financial independence (not subsidized-financed by the government), the operation of the Independent Certification Council (ICC) and its organizational structure. At the same time, the body ensures confidentiality towards its customers, at all levels of operation.
It should be noted that EKAPTY, in order to maintain its demanding operating standards and its cooperation with other bodies, relies on the experience and the know-how of its experienced and specialized personnel that staff the working groups at all stages of certification (technical and clinical evaluation of medical devices, inspections and on-the-spot checks, maintenance of certification, etc.).
