ABSTRACT

A quality management system should include all of the standard operating procedures (SOPs) that have been written to institutionalize best practice. First to be addressed are the composition and presentation of operational procedures, with attention then being turned to other types of documentation bound up with the development life cycle. Procedures transform such organizations, where highly competent professionals execute business processes from memory and close familiarity but where nothing is documented, to the managed model, where everything the organization does to run the enterprise routinely is written down. The document detailing the tape labelling information has been composed in the Descriptions database and a link to it “cut and pasted” into the procedure. If documents are to perform their intended role and if the various potential authors are to contribute consistent material, they must all have access to and abide by a defined documentation standard.