FINAS follows the requirements of the standard SFS-EN ISO/IEC 17011:2017 (Conformity assessment. Requirements for accreditation bodies accrediting conformity assessment bodies). The requirements of this standard mainly apply to accreditation bodies. However, a part of the requirements applies to the assessment process and those requirements concern the assessed body also.
The new requirement of the standard SFS-EN ISO/IEC 17011:2017 is, that accreditation body shall require the assessed body to analyze the cause of the non-conformity found during the assessment and in the cause analysis the assessed body shall examine the extent of the non-conformity. The updated summary form, which FINAS has taken into use in February 2020, guides the assessed body to take these requirements into account.
We want to stress this new procedure to our customers. If during the assessment a non-conformity is found, the assessed body shall make a root-cause analysis by also analyzing the extent or the effect of the non-conformity on its activities; for example, the assessed body needs to analyze the effect of incorrect results on issued results during that certain period of time. In addition to the root-cause analysis, the assessed body shall describe the corrective actions taken within a defined time frame (agreed in the end of the assessment).
In addition to the corrective actions the assessment team assesses the root-cause analysis and the outcome of the extent examination. If the assessed body has not analyzed the extent or the effects of the non-conformity to its activities, the assessment team will make a request to add the missing analysis.