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ISO 9000 Overview Article The
ISO to know By
Craig Cochran ISO
9001 has attracted its share of critics through the years. The
criticism has been well deserved, since the standard was often
incorrectly applied and resulted in little more than additional
bureaucracy and paperwork in many organizations. ISO
9001:2000, however, is a completely different animal. The new
standard, fast approaching its first birthday, makes a significant
departure from earlier versions of the international quality model.
Industrial engineers would be wise to understand and embrace ISO
9001:2000, since it paves the way for true process improvements and
competitive advantage. Before
we get too deep into the facts of ISO 9001:2000, let’s step back
and examine the purpose of quality system models in the first place.
Quality system models sprang from the need to provide a generic
framework for ensuring the quality of products. The models were
generic, meaning they could be applied to any kind of organization
(in theory, anyway). The meat of the models were the requirements --
written as “shalls” -- that were organized around the various
disciplines touching on quality assurance and quality control.
Examples of these disciplines include inspection and test,
calibration, identification and traceability, and control of
nonconforming products. More
than anything, quality system models ensured the consistency of the
system for producing a product, which was intended to ensure the
quality of the products themselves. In reality, the link from
consistent systems to quality products was not always strong. The
quality system for many organizations took the form of a “big
honking binder” of procedures, lampooned so effectively in Dilbert
cartoons: unwieldy, seldom used, and overly concerned with passing
audits.
Shift
in focus So
how is ISO 9001:2000 different from earlier quality models? The
first significant difference is that the standard is much more
concerned with the broader purpose of the organization. Quality is
still a theme, but it is recognized as only part of the formula for
success. In fact, the very name of the standard has been changed to
reflect the shift in attention: ISO 9001:2000 is referred to as a
quality management system, instead of simply a quality system. The
addition of the word management is subtle but important. The message
is that the standard concerns true management of the organization,
not simply having written procedures that are expected to guide
processes. Managing is the key. A
large part of managing the organization is understanding the
strategic and competitive environments within which the organization
exists. ISO 9001:2000 provides a link to these high-profile subjects
through its requirements for leadership by top management, customer
satisfaction, measurable objectives, and training about the ways
that individuals contribute to measurable objectives. The
second big difference in the standard is that it places much less
emphasis on documented procedures and documentation in general (see
“big honking binder” above). Only six documented procedures and
three documents are explicitly required. At minimum, documented
procedures must be established to address:
Top
management is due for a wake-up call courtesy of the ISO 9001:2000
standard. Earlier versions of ISO 9001 were notably weak in what
they required of top management, and top management was happy to
oblige. Management reviews of the system included top management
representation, and the quality policy was generally authored and
approved by top management, but those two activities were often the
only tasks that executive managers carried out within the scope of
the management system. All that has changed. Leadership
by top management is a huge theme of ISO 9001:2000. Section 5 of the
standard, “Management Responsibility,” is notable for the first
three words of each of its subsections: “Top management shall.”
This puts the responsibility for carrying out the requirements
squarely on the shoulders of top management. Some of the specific
responsibilities include:
One
of the biggest complaints of earlier versions of ISO 9001 was that
the standards didn’t require anything in the way of real results.
As long as you had written procedures and had evidence that the
procedures were followed, you were fine. Critics loved to drag out
the old cliché about life preservers: “The plant manufacturing
concrete life preservers passed its ISO audit with flying colors!”
This was an oversimplification, but it did have some validity. This
is where the standard makes an especially strong link to strategy.
Since top management is responsible for ensuring that objectives are
established, they would be wise to make sure everyone bases their
objectives on the strategic direction of the organization. Voila!
Now there is a method for communicating what is most important to
the organization and making sure everyone is acting on it. What
could be more strategic than this? Customer
satisfaction is a theme that permeates nearly every paragraph of ISO
9001:2000. In fact, customer satisfaction is so important that it is
shown as one of the three primary outputs of the management system
(along with continual improvement and the organization’s
products). This is quite a milestone since previous revisions of the
standard did not even use the term “customer satisfaction.” In
essence, ISO 9001:2000 requires that the organization do two things:
determine methods for obtaining data on customer perceptions and
determine methods for using this data. ISO
9001:2000 prescribes no specific data-gathering methods, but it is
implied that the methods will include those that are proactive. The
term “perceptions” implies a full range of reactions to the
organization’s products: positive, negative, and whatever falls in
between. In other words, analyzing complaints alone would not
satisfy this requirement. Some methods organizations may use to
gather information about customer satisfaction include: u
Previous
versions of ISO 9001 were quite weak on the analysis of data for
decision making. Basically, the earlier versions of the standard
said, If you have the desire to analyze data, and feel comfortable
doing so, then by all means analyze the data. Organizations had the
right to choose whether or not they wanted to do this despite the
glaring fact that analysis of data is one of the most critical core
management functions. ISO
9001:2000 mandates that organizations collect and analyze data to
drive continual improvement. The standard provides some specific
areas in which data must be collected and analyzed: customer
satisfaction, conformity to product requirements, trends of
processes and products, and suppliers. The organization must provide
evidence that it has analyzed data and used this process to help
achieve continual improvement. Continual improvement, along with
customer satisfaction, pops up in every corner of the new standard.
The vocabulary document for quality management systems, ISO
9000:2000, defines continual improvement as the “recurring
activity to increase the ability to fulfill requirements.” In
other words, always looking for ways to get better. Unfortunately,
ISO 9001:2000 narrows the focus of continual improvement to say
“The organization shall continually improve the effectiveness of
the quality management system….” With this statement, the
standard sets the bar a bit on the low side. Obviously, continually
improving the effectiveness of the organization’s system is not
necessarily the same as continually improving the organization’s
performance. This is the one significant shortcoming of the ISO
9001:2000 standard. Organizations still have the choice to aim high
and apply continual improvement on a broader front in an effort to
improve overall performance. Why would an organization choose not to
do this? Since the other requirements of the standard so easily
facilitate a more strategic approach to continual improvement,
managers would be fools not to embrace this.
Competency-based
training The
requirements for training are some of the most radically changed
(and most radically improved) portions of the ISO 9001:2000
standard. Organizations are now required to define their rationale
for training, and this rationale is the required competency. The
standard defines competency as a mix of education, training, skills,
and experience needed to perform effectively in a job. Training
based on competency requirements implies a customized approach to
delivering training, which is very different from the
one-size-fits-all approach that many organizations were accustomed
to using. Boiling the requirements into their essence, here is what
organizations will be expected to do:
One
of the most significant parts of the new training requirements is
something that’s easy to miss: awareness training on the
significance of jobs and functions and how individuals contribute to
measurable objectives. This is what tells employees why their jobs
matter. If someone is strapping boxes or driving a forklift, she
probably doesn’t have an automatic understanding of how her
activities impact warranty claims or inventory turnover. However,
her activities obviously do matter. This is another critical link to
strategy. In fact, it’s a ready-made communications pipeline for
getting all employees on the same sheet of music as top managers and
the direction of the organization.
Opportunity
for IEs Industrial
engineers are in a unique position to facilitate many of the systems
required by ISO 9001:2000. IEs have a broad perspective on the
organization, a perspective that most managers lack. The balance of
human, material, equipment, and environmental variables provides IEs
with a 30,000-foot view of the organization. This perspective is
invaluable when approaching the disciplines outlined in ISO
9001:2000. The experience in setting measurable objectives and
performance goals, long a part of most IEs’ job descriptions, will
be a boon to the organization. Most business organizations have
plenty of financial metrics, but few that reflect internal
performance and efficiency. This, of course, is a core competency of
IEs and a critical link in the organization’s pursuit of overall
performance improvement. By
taking the lead in ISO 9001:2000 implementation and transition
efforts, industrial engineers will find that their jobs become more
strategic and more visible to top management. Instead of being
chiefly concerned with tactical issues, IEs leading the way on ISO
9001:2000 will become strategic thinkers, influencing decisions at
the highest levels of the organization. What could be more
attractive for an industrial engineer? Nothing, unless you are
especially enamored of performing time studies.
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