KAREV INTERNATIONAL MEDICAL CERTIFICATION INC. All companies/individuals whose applications have been received are treated equally and impartially in all circumstances, regardless of their geographical location, size, and the associations or organizations to which they are members. and it is the most important principle to provide reliable service based on objective data without considering the interests of any institution or person.
In order to achieve this, KAREV has analyzed possible conflicts of interest through the risk management process and has taken the necessary measures. The continuous assessment of ensuring its impartiality is made at the Impartiality Committee meetings held at least once a year.
In accordance with the requirements of the accreditation standards and the relevant mandatory documents, it has ensured that the people involved in the decision-making mechanism are different from the people involved in the conformity assessment process.
KAREV senior management undertakes not to have any positive or negative impact on the conformity assessment decision process, to terminate the conformity assessment process when it detects a situation that may affect its impartiality, and to refrain from any behavior that may damage the reputation of the organizations it serves.
KAREV provides the necessary resources to carry out all conformity assessment activities in an authorized, transparent, impartial, independent and impartial manner. We undertake and undertake that we take full responsibility for all our obligatory duties regarding the regulations we are assigned, the standards we are accredited, the relevant annexes of these regulations and standards, and all areas where we carry out conformity assessment activities.
With regard to conformity assessment activities, KAREV does not engage in any activity that would conflict with the independence of its decisions and assessments. It is not the designer, manufacturer, supplier, installer, commercial purchaser, owner, commercial user or maintainer of the products for which they are evaluated, nor is it the owner, authorized representative or partner of these segments. In addition, it is not directly related to the products subject to conformity assessment and other products (such as a competitor brand or manufacturer) that are in competition.
KAREV senior management ensures that all information (technically and commercially) coming from the applicant organization and determined within the organization will be protected at every stage of the conformity assessment process. All information, documents, papers and documents sent to us from the organization at all stages related to the transactions for which service is provided are considered confidential and the necessary protection is provided by us.
KAREV company employees are also personally responsible for protecting this information they have and keeping it confidential. KAREV has guaranteed confidentiality with a confidentiality agreement signed by all its employees (internal and external). Even if the working period of all employees is completed, these confidentiality obligations continue.
KAREV and its staff adhere to the principle of openness in all certification, testing and verification activities, and in communication with the relevant business and other parties; adopted within the framework of confidentiality principles. KAREV personnel, with the exception of notified bodies, competent authorities for medical devices in member states, or personnel responsible for the commission, must comply with the rules of professional secrecy while performing their duties. Property rights will be protected. The ultimate responsibility for information exchange with the competent authority and accreditation body rests with top management.
All employees who are or are not involved in the certification process with a confidentiality agreement; undertakes to carry out the relevant process according to the requirements of the signed contract and to implement the confidentiality requirements in all steps of this process.
KAREV and all its employees; It keeps confidential all kinds of written and verbal information received from companies and related parties related to certification and inspection activities.In accordance with the contracts it has signed, it shares this information with TÜRKAK and the Ministry of Health upon request.Sharing with other third parties is done only by court order. When KAREV has to give information to third parties due to a court decision, it definitely notifies the relevant customer.
KAREV has restricted access to confidential information to authorized persons. In addition, documents containing confidential information are stored in secure areas.The server/computer where the information is stored is also protected against outside infiltration with special protection programs. In the event that the task is terminated at any time, the relevant personnel shall immediately, without any copies or records, return all equipment, documents and records concerning the institution served during the term of the task. Personnel shall return all copies and summaries of all submitted documents and all other notes, written records, photographs, drawings and other materials made or provided by them. KAREV guarantees the return of the documents (electronic and/or printed documents) provided by the conformity assessment personnel regarding the service provider, with the service, confidentiality and impartiality agreements made with the personnel.
DOCUMENT NO FR.01
PUBLICATION DATE 02.09.2021
REV.DATE:09.12.2022 - REV. NO: 01