FIGURE 2: Schematic of Initial States in terms of Existence and Functionality of ISO 9001 QMS
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No
documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the
prevalence of loose and informal working relationships. SMEs operating in this state are more
likely to rely on people rather than a system. In such situations, key personnel may resist
documentation for two key reasons “(1) documentation is considered a waste of time and (2)
documentation of processes and procedures makes the individual less dependable” [2]. SMEs in
this state perform some or all of the processes required by ISO 9001 and the QMS may function
fairly well. However, they are not willing and ready to document those processes unless there is
a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree,
however, the documents are generally not followed and do not necessarily reflect the actual
manner in which the organization undertakes its operations and management. This situation
highlights the fact that the mere existence of documentation does not necessarily lead to a
functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way
for SMEs to market their products and services but that implementation of the standard requires
stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and
functionality of processes and procedures that may or may not be required by ISO 9001. As
illustrated in Figure 2, this situation is closest to the desired state of full functionality (100%) of the
ISO 9001 QMS and full documentation (100%) of this functionality.
3. MOVING THE QMS FROM THE INITIAL STATE TO THE DESIRED STATE