In the view of the ISO, what is a quality management system? It's a series of components, logically linked, that when taken together give an organization the controls and measures it needs to manage and improve how it produces product. As you'll see with the descriptions of CMMI and Six Sigma, the Quality Management System (QMS) of ISO is a self-contained process improvement program.
Section 4 is divided into two parts and is used to establish the structural criteria for the QMS.
This section, as its label suggests, provides a series of general requirements that your QMS should possess. You'll see in later sections that this structure holds up throughout. All the sections are based on these criteria. Basically your QMS should support six elements:
Your QMS should identify the processes that your program will use. This is an explicit requirement. Often, organizations will rely on implied processes. They may see no need to define how they conduct daily business; they might think they know it so well that habit is enough, that they need no such reference. But with ISO—and this is true of most all process programs—the way of doing business needs to be documented. It needs to be externalized. If process is only implied, the organization has no choice but to leave it up to the individual to honor ...