However, even when such a view is adopted, many SMEs struggle to move from their initial state
to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO
9001 implementation projects in seven different SMEs. The SMEs have ranged in size from
approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of
sectors in Virginia, including manufacturing, distribution, and services. Based on our experience,
we developed a schematic of initial states of an organization in terms of the existence and
functionality of the QMS as shown in Figure 2. Throughout this paper, existence is equated with
the documentation required by the standard while functionality is equated with an effectively
operated QMS that leads to increased customer satisfaction and continuous improvement of
business results. A successful QMS must be fully functional and appropriately documented. With
that in mind, there are four main states in which SMEs can be located in the beginning of the
implementation process