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TNI Standards Guidance

Disclaimer: This material represents the opinion of its authors. It is intended solely as guidance and does not include any mandatory requirements except where such requirements are referenced. This guidance does not establish expectations of being implemented universally, exclusively, in whole, or in part.

This guidance does not establish or affect legal rights or obligations and is not finally determinative of the issues it addresses. It does not create any rights enforceable by any party in litigation with TNI, its accreditation bodies, or affiliated institutions. Any decisions made by TNI regarding requirements addressed in this guidance will be made by applying the applicable standards, policies or procedures to the relevant facts.

 

Module: Quality Systems


Subject: Conflict of Interest

Question 1

Is there a conflict of interest (or potential for conflict) where a third party assessor is hired to assess an organization, where that assessor or the organization to which they belong may also be hired to provide quality assurance or other laboratory improvement consulting to the laboratory being audited?

Yes, a conflict of interest could occur where an individual performing consultative services is hired as a third party assessor by an accrediting authority to perform a compliance assessment relating to the area that receives consultation.  It is the responsibility of the Accreditation Bodies to define responsibility for potential conflict of interest in the contractual agreement.  The 3rd party assessment firm is further responsible to disclose any potential conflict of interest to the Accreditation Body and the CAB.  Once disclosed, the AB is responsible to determine whether there is indeed a conflict of interest.   

Question 2

Is there a conflict of interest (or potential for conflict) where an third party assessor is hired to assess an organization, where a direct competitor of that assessor or the organization to which they belong may be hired to provide quality assurance or other laboratory improvement consulting to the laboratory being audited?

It is difficult to universally address this scenario with a “one size fits all” response; however in this example, it has been determined that without clear identified conflicts between the two competitors that could compromise the validity of the assessment, no conflict of interest would occur in this situation.  However, each case must be examined separately and an agreement must be reached between the assessor, the accreditation body and the laboratory that no conflict of interest is present in each individual scenario.

Question 3

If the answer to 1 or 2 is yes, please describe how much assistance qualifies as a conflict of interest, and where is this accounted for in the standard?

Any overlap between consulting services and compliance assessment performance is seen as a conflict of interest.  An individual or organization representing NELAC that has been assigned to perform an assessment to an organization should not provide any consultation services (“pre” or “post”) to the assigned organization for that specific assessment.

Concurrent consulting and compliance assessments could be construed as violating sections 3.6.4a, b, d, e, f, g and i of the 2003 TNI Standard.

Question 4

Is it the responsibility of the third party assessor or the accrediting body to determine if the potential for conflict of interest exists?

It is the responsibility of all involved parties to disclose where potential conflicts of interest occur.  The Accrediting Body is responsible for making the final determination if the conflict of interest truly exists.



References:

NELAC 2003 Section 3.6.4

Professional standards apply to every NELAC assessor, whether a government employee or an employee of a third party organization conducting assessments under an agreement with a NELAP accrediting authority.  Assessors that knowingly engage in unprofessional activity may be liable for punitive actions as initiated by the affected accrediting authority.

The Standard for Professional Conduct, as outlined in this section, are based upon 5 CFR 2635, “Standards of Ethical Conduct for Employees of the Executive Branch” and will be followed in NELAP related matters.  NELAC assessors shall:

  1. Have no interest at play other than that of the accrediting authority and NELAC during the entire accreditation process;
  2. act impartially and not give preferential treatment to any organization of individual;
  3. provide equal treatment to all persons and organization regardless of race, color, religion, sex, national origin, age, and/or disability;
  4. not use their position for private gain;
  5. not solicit or accept any gift or other item of monetary value from any laboratory, laboratory representative, or any other affected individual or organization doing business with, or affected by, the actions of the assessor’s employer or accrediting authority;
  6. not hold financial interests that conflict with the conscientious performance of their duties;
  7. not engage in employment activities (seeking or negotiating for employment) or attempt to arrange contractual agreements with a laboratory that would conflict with their duties and responsibilities as an assessor;
  8. not knowingly make unauthorized commitments or promises of any kind purporting to bind the affected accrediting authority and;
  9. attempt to avoid any actions that could create even the appearance that they are violating any of the standards of professional conduct outlined in this section.

 

Assessors are reminded that it is their responsibility to report to the affected accrediting authority any personal issues or activities that constitute a conflict of interest before an assessment occurs.  It is up to the affected accrediting authority to determine if the reported issues and activities regarding a specific assessor constitute, or be construed as, a conflict of interest.  Appeals of decisions made by accrediting authorities regarding such matters must be directed to the Executive Director of the NELAC, who shall make the final decision as to the merit of such appeals.

2009 TNI ISO V2M1 3.11

Consultancy (ISO/IEC 17011:2004(E) Clause 3.11)

Participation in any of the activities of a CAB subject to accreditation.
EXAMPLES:

  • preparing or producing manuals or procedures for a CAB;
  • participating in the operation or management of the system of a CAB;
  • giving specific advice or specific training towards the development and implementation of the management system and/or competence of a CAB;
  • giving specific advice or specific training for the development and implementation of the operational procedures of a CAB.

NOTE: Consultancy refers to the position or practice of a qualified person paid for advice and services and does not include information and assistance provide by governmental agencies.

2009 TNI ISO V2M3 4.3.5

4.3.5 ISO/IEC 17011:2004(E), Clause 7.5.3 a

Assessment team members shall not have provided consultancy to the CAB which might compromise the accreditation process and decision.

NOTE: Assessors are employed by or on behalf of accreditation bodies to determine the
competence of a CAB in meeting this Standard. The initial accreditation of a CAB is based
primarily on the findings and observations of assessors. In many accreditation bodies,
assessment team members can also be responsible for deciding the accreditation status of a CAB.

2009 TNI ISO V2M3 4.4

4.4 Standards of Professional Conduct for Assessors

4.4.1 ISO/IEC 17011:2004(E), Clause 7.5.3 b

In accordance with the provisions of 6.1.4, the assessment team members shall inform the accreditation body, prior to the assessment, about any existing, former or envisaged link or competitive position between themselves or their organization and the CAB to be assessed.