Our operation

EMKI-cert Kft. carries out its certification activities in accordance with the requirements of the EN ISO 17021-1:2015 standard for the quality management systems related to the EN ISO 13485:2016 standard and the Regulation (EU) 2017/745 of the European Parliament and the Council for the certification of medical devices. The quality management manual of EMKI-cert Kft. covers the top management of the organization, the administrative employees, as well as the auditors, experts and periodic or ad hoc bodies involved in the certification activity.

EMKI-cert Kft. is an independent legal entity and legally responsible for its certification activity. Its liability in this respect is set out in the certification agreement with the client, which is legally enforceable agreement and ensures certification activities under the same conditionality for all clients.

EMKI-cert Kft. takes responsibility for the issuance or rejection, maintenance, renewal, suspension or for withdrawn certifications, as well as for its decision related tot he expansion and reduction of the certification of the certification scopes and for the restoration of suspended certificates. It has a procedure for issuing these decisions and provides the client with the opportunity to appeal against the decision, see appeal. EMKI-cert Kft. also takes responsibility for the confidentiality of all information received and generated by the client during the certification activity at all levels of the organization, including its committees and external bodies and persons who acting on its behalf.

EMKI-cert Ltd. has evaluated the risks associated with its certification activities and has taken appropriate measures to manage it and updates its risk evaluation at least once a year. The Certification Body shall evaluate annually financial data relating to its revenue from Certification and the income from any other activities and ensures that the impartiality of EMKI-cert Kft. is not threatened by any commercial or financial pressure either at its start or during its activities.

Regulatory documents:

• EN ISO/IEC 17021-1:2015 Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements (ISO/IEC 17021-1:2015)
• ISO/IEC 17021-3:2017 Conformity assessment - Requirements for bodies providing audit and certification of management systems -- Part 3: Competence requirements for auditing and certification of quality management systems
• ISO/IEC TS 17023: 2013 Conformity Assessment - Guidelines For Determining The Duration Of Management System Certification Audit 
• IAF MD 1:2018 IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization
• IAF MD 2:2017 IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
• IAF MD 4:2022 IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes
• IAF MD 5:2019 Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems
• IAF MD 8:2020 Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485)
• IAF MD 9:2022 Application of ISO/IEC 17021 in the Field of Medical Device Quality Management Systems (ISO 13485)
• IAF ID 1:2020 IAF Informative Document For QMS and EMS Scopes of Accreditation
• IAF ID 13:2017 IAF Medical Device Nomenclature (IAF MDN) Including Medical Device Risk Classifications

and other IAF and GHTF documents,

further the requirements for notified bodies under Regulation (EU) 2017/745 of the European Parliament and of the Council.