It is common practice, according to ISO/IEC 17011, for the accreditation body (AB) to sample the activities of the conformity assessment body (CAB) when conducting the assessment. This is done under the understanding that in some cases it is not realistic to cover the entire scope of CAB activity. Selecting an appropriate sample through risk-based thinking is considered sufficient to establish whether the organization adheres to the requirements of the relevant level 3 standard or standards.

Of course, as risk-based activities go, there is always the possibility that we, as assessors, will miss some nonconformities. There are some mechanisms in AB’s processes to minimize such risks, such as getting a full, broad analysis from the CAB on any non-conformities that were raised. However, these are not foolproof. Healthy communication with other bodies is crucial to have a bigger picture and establish a continuous monitoring of CABs. Here are some examples of such providers of information:

Complaints and inquiries from customers – Although it is our policy to refer complainants to the relevant CAB first, there are some flags that can be raised from such communications. For example, ambiguity of the scope, contract or report, changes made to a standard method or issues regarding confidentiality. Such inquiries, even if handled by the CAB to the satisfaction of the complainant, should directly affect the risk analysis concerning the assessment of the organization, to the extent of conducting a surprise assessment or a document-based assessment regarding the requirements of the relevant clause in the specific field in which the subject was raised or it’s general application in the CAB’s activities.

Parallel assessments from regulators and other interested parties – Not all regulators rely exclusively on the assessment activities of the AB to assess laboratory activities, and apply an inspection system of their own, with emphasis on specific methods and adherence to regulatory requirements. Such assessment systems are usually field-specific. As such, the sample of activities assessed is taken from a smaller population of activities, and may certainly include activities that were not recently assessed by the AB. Such issues as required accuracy, sensitivity and measurement uncertainty and scope of the validation (i.e method limits) done by the laboratory may be raised. Other interested parties may raise other subjects such as problems with impartiality and confidentiality.

Proper communication between the AB and the mentioned parties is crucial, and provides a way to further the supervisory activities of the AB. However, there are some conditions for such a mechanism to be effective. The role of the AB needs to be fully understood by the interested parties, regulators and the CABs themselves. It should be clear that the supervision of the AB is not limited to the regular assessments, and if problems and issues are raised between assessment, it is not only allowed but expected that the AB examine such issues. Related to that, the strict confidentiality requirements between the AB and the CAB needs to be clear. This requires a level of trust from all sides. i.e, it is more than likely that the interested party will not get a report on how the CAB addressed and corrected the issue and would only get a response from the AB that the issue was corrected. Furthermore, it should be understood that the AB is not targeting one CAB or another. If the reason for the issue is ambiguity of the requirements, these should be clarified to all relevant CABs, either directly by the AB or the body (regulatory or otherwise) that is in charge of these requirements.

If the role and scope of responsibility of each of the interested parties is clear, and issues are handled with respect to all concerned sides, including the customers of the laboratory (who should be the major benefactors of CAB accreditation), such cooperation will benefit all sides, and all but ensure the clarity or requirements for such CABs and the continued improvement of the CABs activity.