QMS requirements

“ Implications of not conforming with QMS requirements”

means that personnel must be aware of the consequence of deviating from standard procedures and processes. This starts with having an understanding of the processes they are involved with, and the associated quality risks. This involves understanding the reason certain standard procedures are in place, and why the laboratory has adopted their quality policies and set specific quality objectives. Personnel will then understand the identified risks and risk treatments (controls to reduce the risk) that are in place, and that the deviating from procedures and authorisations is a nonconformance. This results in a possible undesired outcome to quality. The implication is a nonconforming event that needs resources to investigate, where corrective actions could be costly. Work may need to be repeated, which could result in loss of reputation, customer confidence or income.