Impartiality Policy

The Certification International (TCI) is committed to the principles of impartiality embodied within the ISO 17021 standard for offering  management systems certification. We understand the importance of impartiality in carrying out our management system certification activities, manage conflict of interest and ensure the objectivity of our management system certification activities. TCI retains authority and responsibility for decisions made regarding its activities.

TCI have a process to identify, analyse, evaluate, treat, monitor and document the risks related to conflict of interests arising from provision of certification including any conflicts arising from its relationships on an ongoing basis. Where there are any threats to impartiality, TCI will document and demonstrate how it eliminates or minimizes such threats and document any residual risk. Policies and procedures are non-discriminatory and are administered in a non-discriminatory way. TCI makes its services accessible to all applicants.

TCI does not provide certification services to related body. All personnel in TCI either internal or external are required to declare that they are free from any undue commercial, financial, or other pressures, which could affect their impartiality. Personnel who have provided consultancy within two years to the organization seeking certification are not employed to take part in any part of the certification process. Contracted personnel are required to reveal any situation which may present a conflict of interest.

TCI ensures that different people take decisions on certification to those who carry out the audit. No services are provided by TCI that might be considered as having a conflict of interest.

TCI does not audit or certify activities that it has itself performed.

TCI ensures that the activities of related bodies do not affect the confidentiality, objectivity and impartiality of its certification. TCI avoids any situation that would create a conflict of interest arising from the activities of any related body, especially if the related body might have a vested interest in the outcome of any assessment process. If a conflict of interest is identified, TCI does not provide certification to any related body.

TCI ensure that nothing is implied that would suggest that certification would be simpler, easier, faster or less expensive if any specified personnel or organization providing consultancy were used. TCI activities are not presented as being linked with the activities of any organization providing consultancy.

TCI and its auditors shall not be involved in the design, manufacture, construction, marketing, installation, servicing or supply of the medical device, or any associated parts and services.

TCI and its auditors shall not be involved in the design, construction, implementation, or maintenance of the quality management system being audited.

TCI and its auditors shall not be an authorized representative of the client organization, nor represent the parties engaged in these activities.

TCI auditors shall not be having a financial interest in the client organization being audited (e.g., holding stock in the organization)

TCI auditors shall not be employed currently by a manufacturer producing similar/competitive medical devices.

TCI auditors shall not be a member of staff from a research or medical institute or a consultant having a commercial contract or equivalent interest with the manufacturer or manufacturers of similar medical devices.