Avoiding conflict of interest and maintaining confidentiality is a challenge for both the laboratory and the accrediting body. Arrangements must be in place to avoid conflict of interest and undue pressure, and policies and procedures to maintain confidentiality.

ISO/IEC  17025:2005 describes the term “arrangement” as a broadly defined document, rather than a spelled out, step-b -step procedure. Confidentiality  requires a  procedure, as well as a policy. Electronic storage of data and transmission of results has become increasingly important for protecting customers’ information. Orientation of new employees is to include training on both issues of conflict of interest and confidentiality. However, this type of training is not just for new employees, and must be held on a continuing basis.

These issues impact interactions with both internal and external custom­ers. Employees cannot share customer information. They must be insulated from undue pressures that could com promise the quality of laboratory data. Laboratory staff needs to be shielded even from internal customers, so that they do not feel the pressure to report results that meet requirements  for release of product.

Conflict of interest

Conflict of interest is an issue for all laboratories, but especially for a very small laboratory, as well as an accrediting body. Section 4.14 .1 of ISO/ IEC 17025:2005 requires that internal audits be “carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.” This require­ment is a challenge for a one-person laboratory. Therefore, some of these laboratories choose to hire an outside consultant for the audit, while others perform it themselves. The standard permits the latter choice as long as the audit is through and complete.

An accrediting body has to address possible conflicts of interest between 1ts assessors and the laboratories. Technical experts in a highly special ized field can be limited to a relatively small number of people, and, therefore, it is possible for an assessor to have had some contact with a laboratory previously. It is important that the accrediting body maintain a record of conflict of interest for their assessors, so that all conflicts are transparent. In addition, the laboratory has an opportunity to object to the assessor based on concerns for conflict of interest. Assessors also must not promote their consulting or training services to the laboratory.

Undue Pressure

Laboratory staff needs to be shielded from undue pressures. Pressures can come from both internal and external sources. Where a labo­ratory is part of a larger organization, the organizational arrangements are to be such that departments having conflicting interests (e.g., production, financing, or commercial marketing) do not adversely influence the laboratory’s compliance with the requirements of ISO 17025:2005.

Management wants the laboratory to be responsive to customers’ needs without creating undue pressures on staff to meet unrealistic deadlines. The laboratory is not to engage in any activ­ities that may endanger the trust in its independence of judgment and integrity in relation to its testing activities.

Some laboratories have only cus­tomer  service staff interact directly with customers as a safeguard of shielding laboratory stalf from undue pressure. This approach can be challenging when technical questions arise or relate to turnaround time . Customer service must still be able to serve as the conduit between the customer and the laboratory.

If the customer is submitting a complaint, then the laboratory  must follow its policy and procedure for ISO/ IEC 17025:2005, section 4.8. The laboratory must also have a policy that forbids gifts and gratutities to avoid even the appearance of conflict of interest.

Confidentiality

Customers need to be assured that policies and procedures are in place to protect their confidential information. Is some information alright to share and not others? What constitutes confidential information needs to be defined.

All information provided by the customer is to be kept confidential unless a customer specifically waves confidentiality. This rule applies even to instances where a customer is seeking help from a technical expert to improve performance. Waiving confidentiality is for a specific situation rather than generalized to all future situations.

The transmission of electronic results must be secure, so as not to risk violating confidentiality.  Final results are only to be released to the customer or a designated customer representative.

Confidentiality becomes an issue when customers wish to observe and audit the analysis of their samples. All information relating to other customer s must not be accessible when an auditor is onsite at the laboratory.

Assessors must also review records with proprietary  information that pertains to the laboratory or the labo­ratory’s customers, onsite. The as es or is required to keep this information confidential.