Recently I wrote a paper in my Doctoral-level Applications of Systems Theory course about evaluating gaps in ISO9001 and how to fill the gaps. This series of posts is taken from that paper, including references, in order to start a conversation about the future of ISO9001 and quality in general. I welcome your comments here, let's have a great discussion!
Introduction
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.
Operational Feasibility
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.
References
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.
