Infinity Cert International Ltd. is the legal entity responsible for certification activities; reference to INFINITY CERT INTERNATIONAL LTD. in this Policy and Public Statement refers to these legal entities.

INFINITY CERT INTERNATIONAL LTD. Chief Executive Officer (CEO), and Employees fully understands the importance of impartiality in undertaking its Certification activities. INFINITY CERT INTERNATIONAL LTD. will therefore ensure that in all its dealings with clients or potential clients all employees or other personnel will remain impartial.

• To ensure that impartiality is both maintained and can be demonstrated the following principles have been established:
  INFINITY CERT INTERNATIONAL LTD. Certificates are only issued following a review by an independent authorized and competent member of the management team (who has not been involved in the audit) to ensure that no interest shall predominate.
• INFINITY CERT INTERNATIONAL LTD. does not offer (and has never offered) management system consultancy or any other form of consultancy to companies or individuals.
• INFINITY CERT INTERNATIONAL LTD. does not offer (and has never offered) an internal audit service to its certified clients.
• INFINITY CERT INTERNATIONAL LTD. does not own or have any interest (financial or otherwise) in any other company that offers certification or management system consultancy services.

INFINITY CERT INTERNATIONAL LTD. does not have (and will not form) any relationships with companies who offer consultancy or other services that can be construed as having an impact on the certification services provided by INFINITY Cert. Any proposed relationship between INFINITY CERT INTERNATIONAL LTD. and any other company will undergo a risk assessment by the Committee for Impartiality prior to that relationship being formalized. Any current relationships with companies, organizations and individuals will be risk assessed on a regular basis to ensure that the relationship does not impact upon the impartiality of the certification process.

– Individuals employed by or otherwise contracted to INFINITY CERT INTERNATIONAL LTD. are required to document and record their current and past relationships with all companies. Any situation past or present which may present a potential conflict of interest is required by INFINITY CERT INTERNATIONAL LTD. to be declared. INFINITY CERT INTERNATIONAL LTD. will use the information to identify any threats to impartiality and will not use that individual in any capacity unless they can demonstrate that there is no conflict of interest.

– INFINITY CERT INTERNATIONAL LTD. will not allocate a member of employees to a management system audit where any past relationship has existed. Exceptionally and at the discretion of the Chief Executive Officer an individual may be allocated to a management system audit where a past relationship has existed but there has been no relationship for a minimum of 2 years.

INFINITY CERT INTERNATIONAL LTD. does not and will not offer any commission, (‘finders fees’ or other inducements) to any individual or company in respect of referrals of clients unless:

1. The terms and conditions of any such referral are clearly established and can be demonstrated and it can also be demonstrated that the fee is for a referral and the fact that a commission has been paid will in no way affect the outcome of an audit.
2. A risk assessment (to establish the potential for an unacceptable threat to impartiality) has been carried out on the process through which any such payment is made to an individual or organization requesting the commission for referrals.
3. All such payments are documented, recorded, and traceable and accompanied by a purchase order and invoice.

• INFINITY CERT INTERNATIONAL LTD. does not offer specific training to any company in respect of implementing a particular standard for that company. Any training offered by INFINITY CERT INTERNATIONAL LTD. is general in nature and available to all companies or individuals who wish to attend.
• INFINITY CERT INTERNATIONAL LTD. will ensure that it is not linked or marketed in any way which links it with the activities of a management system consultancy and will take appropriate action should any such link be identified.
• Auditors and others involved in the certification process are not and will not be put under any pressure and will not be influenced in any way to come to a particular conclusion regarding the result of an audit.

Threats to impartiality could include but are not limited to the following:

– Self-interest threats: threats that arise from a person or body acting in their own interest. A concern related to certification, as a threat to impartiality, is financial self-interest.

– Self-review threats: threats that arise from a person or body reviewing the work done by themselves. Auditing the management systems of a client to whom the certification body provided management systems consultancy would be a self-review threat.

– Familiarity (or trust) threats: threats that arise from a person or body being too familiar with or trusting of another person instead of seeking audit evidence.

– Intimidation threats: threats that arise from a person or body having a perception of being coerced openly or secretively, such as a threat to be replaced or reported to a supervisor.

All threats to impartiality are reviewed at the annual Advisory Council meeting. The council shall have access to individual(s) who have experience and knowledge relating to medical devices, in order to get expert opinions. All potential sources of conflicts of interest that are identified, whether they arise from within ICI or from the activities of other persons, bodies or organizations are documented on the ICI risk register. This register is reviewed and records of the review are kept in the form of meeting minutes (Advisory Council Meeting Minutes are addressed in the ICI Head Office Manual).

ICI and any part of the same legal entity does not offer or provide any management system consultancy services including internal audit services for its certified clients.