Independence and impartiality, declaration of interests

EMKI-cert Kft. is aware that it must carry out its certification activities impartially in accordance with Chapter 5 of ISO 17021-1: it is responsible for the impartiality of the certification activity as a whole and must not allow any pressure to compromise its impartiality, be it commercial, financial or pressure from other sources. The Managing Director and Quality Management Manager of EMKI-cert Kft. demonstrates this commitment by working out processes to handle conflicts of interest and ensuring objectivity in the certification activity. EMKI-cert Kft. strives to make its decisions at all levels without influence and at the highest professional level.

The top management of EMKI-cert Kft. makes a declaration of interests, in which it declares that it has no interest in the manufacture of medical devices and related activities. The declaration of interests can be found at the bottom of this page.

EMKI-cert Kft. does not involve subcontractors in its certification activities according to the ISO 13485 standard, so it has completely eliminated the related risks.

EMKI-cert Kft. publishes its policy on impartiality in the General Policy for its employees and clients and is open to discussing their comments.

EMKI-cert Kft. does not have any relationship with the organization providing advice on management systems that threatens its impartiality and independence. In the course of its activities, it does not discriminate in any way between clients using the services of different consulting organizations and does not promote the use of the support of any such organization.

Similarly, it rejects the allegations of conflict of interest made by the consulting organizations that promise faster, cheaper, and easier administration for clients. If EMKI-cert Kft. notices this, it first calls in writing on the consulting organization to stop disseminating the misleading information and to publish a correction. If this does not happen, EMKI-cert Kft. will legally enforce the measure.
The Impartiality Body is a periodic body of EMKI-cert Kft., whose task is to summarize the information related to the impartiality of the certification body with the involvement of interested parties in order to establish that EMKI-cert Kft. that the requirements set out in Chapter 5 of the ISO 17021-1 standard are met during the activities of EMKI-cert Kft.

The main interested parties identified in the activities of EMKI-cert Kft .:
- employees of EMKI-cert Kft
- clients of EMKI-cert Kft
- users, services and their professional representations purchasing products manufactured by the clients of EMKI-cert Kft.
- government bodies with official authority in the field of EMKI-cert Kft