ABSTRACT

A change is a situation where performance of any of the process parameters increases or decreases to a level outside the previously accepted tolerances. A planned and authorized change may be made to the design of a product or service which requires changes to be made to the fulfilment processes. As a quality management system (QMS) is a systemic perspective of the organization, it follows that a change in any of its elements will influence other elements as everything is connected within a functioning whole. Depending on the nature and extent of the change, information on the change may be as simple as a verbal instruction from the process owner or a dossier of documented information of considerable size which requires a dedicated task force to implement. The documented information to be retained is the results of the review that is carried out after the change has been made.