All laboratories undergoing scheduled surveillance visits as part of the ISO 15189 Plus™ program are advised of the following change to the criteria for escalating minor non-conformance to major non-conformances between assessment events.
The ISO 15189 Plus™ program consists of the following types of scheduled assessment visits:
Following full assessment visits, laboratories are required to submit evidence demonstrating correction of major non-conformances, and action plans to correct minor non-conformances within the next two years. These plans are reviewed as part of the surveillance visit to verify if those corrective actions were effectively carried out.
As of April 1, 2019:
For mid-cycle surveillance visits, if at the time of an assessment visit, a non-conformance is observed to a requirement previously assessed as a non-conformance, and circumstances have not changed (same reason for non-conformance), a major non-conformance will be assessed.
In the past, this scenario may have yielded a repeat minor non-conformance. The change has been made to reflect the expectation that minor non-conformances be resolved within two years of the initial assessment.
A revised Position Statement will be posted to the IQMH website on April 1, 2019.