ISO9001 has been used for more than a decade to help define and assess quality management systems in a variety of industries around the world. Various industry-specific versions of the standard exist that allow more focused attention when necessary while the main standard can be applied to virtually any type of company. Despite this widespread usage and near-universal recognition, there remain fundamental flaws in the design of the standard itself and in the implementation and maintenance of quality management systems that follow the standard. This paper will review several ways that the standard and its implementation could be improved by using system modeling.
The ISO (2008) defines a quality management system as a series of processes with inputs and outputs that define interactions. This process approach is stated explicitly in the standard and is the foundation of the implementation of the standard. Despite the proliferation of the standard over many years, however, there seem to be few companies that actually follow this process approach in their day-to-day operations. The author has personal experience auditing or working in six different companies where it was obvious that, despite some type of ISO9001 certification, the process approach was actually not followed as part of the normal operations of the company. For reasons explained later in this paper, 3rd party auditors are not motivated to report this fundamental failure in implementing ISO9001. This author believes that the problem does not lie with the auditors or the companies but with the standard itself.
Many companies, whether they have attained ISO9001 certification or not, do not organize themselves according to the process approach as defined in the standard. Regardless of the industry or type of organization, the most common structure remains the functional department organization. This type of structure can be seen in universities, governments, private businesses and non-profit organizations. Despite the application of ISO9001 in many of these types of organizations and the widespread exposure of the process approach worldwide there remains a lack of desire to implement this approach in most organizations. This author posits that this lack of desire is due to a lack of perceived value in this approach to help the organizations meet their objectives. This represents an operational failure in the current situation and the standard should be revised to address this failure and match the prevailing structure of the majority of organizations in the world.
An ISO9001 standard that is bereft of the process approach remains useful if the various clauses and requirements are applied directly to functional departments rather than through an artificial layer of process thinking. This concept removes the process layer while retaining the underlying functional layer and the higher system layer. The clauses and requirements, reorganized, would be very similar to a checklist for the various functions to follow in their daily work. In fact, Hoppmann, Rebentisch, Dombrowski & Zahn (2011) argue that checklists can be one way to effectively document knowledge and best practices. An ISO9001 standard that consisted of the latest best practices, arranged according to functional department checklists, would be much more valuable and easy to use than the process approach. It would be the interface between the functions and the system; the specific items would be clearly defined and would form the content of the standard.
The focus on processes alone can lead to sub-optimization, particularly if the processes are the focus of improvement activity (Conti, 2011). Conti’s concern is that this sub-optimization is not limited to the processes themselves but also affect overall performance. He asserts that this sub-optimization is due to a lack of systems thinking; this may be so but the application of an artificial layer of process thinking between the functional groups and the system hardly seems to be the way to bring the system into more focus. This author believes that the direct connection of the functions to the system, through the ISO9001 defined checklist, will lead to better results.
Conti, T. (2010). Systems thinking in quality management. The TQM Journal 22(4).
Hoppmann, J., Rebentisch, E., Dombrowski, U., & Zahn, T. (2011). A framework for organizing lean product development. Engineering Management Journal, 23(1).
ISO (2008). ISO 9001:2008 Quality management systems — Requirements. Geneva:Author.