ABSTRACT

A quality management system (QMS) functions through the interaction of its elements and this interaction is caused by the transmission of information between them. Every process is triggered by information, and each activity within it is dependent on receiving the correct information to produce the correct outputs whether the information is conveyed by instruments, verbally, non-verbally or in a document. Standards define the acceptance criteria for judging the quality of an activity, a document, a product or a service. Competence may depend on the availability of documentation. A document is appropriately identified if it carries some indication that will quickly distinguish it from documents of the same type or purpose and enables its timely retrieval from storage media. The document availability requirement applies to internal and external documents alike even though there is a separate requirement for external documents to be controlled.