I Want To
Volume 8 · Issue 6 · May 2003
The Ground-Floor View of ISO 9001 from AQC
Have You Overcome Two Challenges to "QMS Thinking
Why have organizations been slow in transitioning to ISO 9001:2000? There
are two challenges with its use that may be holding your organization
and many others back in any number of ways. Those two challenges are:
- Less than effective communication about, and promotion of, the value
and benefits to Top Management in most organizations of transitioning
to ISO 9001:2000.
- The inability of many of those responsible for a quality management
system (QMS) to design, sustain and improve that system so it is elegantthat
is, simple but usefulto those who need to use it to gain that
value and those benefits. As a result, it is difficult to revise those
QMSs to make them elegant without expending a great deal of resources.
THE OUTLOOK has drawn this conclusion from the perspectives of
attendees at ASQs Annual Quality Congress (AQC) in Kansas City May
19-21 and a meeting of the US Technical Advisory Group (TAG) to ISO Technical
Committee 176 on May 20, 2003.
The real challenge facing the ISO 9001 user community is in implementing
a truly useful and profit-generating QMS in a world where Top Management
doesnt always see the value of making the effort and where most
personnel view the QMS as one more bureaucratic burden to be avoided or
"short-cutted" however possible. The lack of support from above
and below in many organizations makes the task of those in the middleresponsible
for implementing, maintaining, monitoring and improving the systemmore
challenging, because the QMS is more likely to end up becoming bureaucratic,
burdensome and costly without benefit.
The goal must therefore be to overcome these challenges and buck the
trend that began with the growth in popularity of ISO 9001/2/3 in the
early 1990s. The trend began with initial success stories from corporations
that were quality leaders and implemented ISO 9001/2 with tremendous improvement
in processes and reductions in variation.
This led many organizations to implement QMSs and obtain registration
without understanding what they were supposed to be doing, which often
resulted in conforming to the individual "shalls" without integrating
the pieces into a system. This made continual improvement difficult
and optimization almost impossible.
Facts About the Two Challenges
These two challenges and their impact were initially identified from
previous information gained from a variety of sources, plus additional
facts gained in Kansas City and thereafter in May 2003. Facts gained in
Kansas City and shortly thereafter include:
- The delay in transitioning was discussed at the May 20 TAG meeting,
with the issue of Top Managements perceptions raised for the first
time. Gene Barker, Boeing Technical Fellow with Boeing Commercial Airplanes
and a member of the Registrar Accreditation Boards (RAB) Board
of Directors, raised a concern that had not been previously discussed
regarding the transition. Barker indicated that the lack of support
for transitioning in many organizations is somewhat attributable to
the difficulty management representatives and others responsible for
QMS implementation and maintenance have had in effectively communicating
with Top Management in a way that would gain management support for
revising the QMSs. "In many organizations, Top Management doesnt
see the point of revising the system and registering to ISO 9001:2000,
because the management rep or whomever would handle the revisions and
transition is not telling management what they need to hear," related
Barker. "Top Management in most organizations understands the value
of the existing system, although they may not have a clear sense of
what value it is providing day-to-day. But when you ask them for more
resources to change the way things are, they are not very receptive
in many companies because the request is being made without data that
show how making these changes will benefit the company in concrete terms.
Financial terms. Productivity terms. Customer retention terms. Sales
increaseseven employee retention levels. Top Management faces
a lot of people seeking funding, human resources and management support
for a lot of programs, and the ones that make sense to Top Management
and will provide real benefits to the organization are going to gain
buy-in from management. But when you tell them you need to revise the
quality management system and increase auditing costs to get a new certificate
because of a new standard, that doesnt fly unless you show management
real results that will come from making these changes and committing
the resources. And it is harder to gain management support and commitment
today than it was in 1995 or 1996, because profit margins for many organizations
are tighter; concepts like Six Sigma and lean are the buzz words today."
- Baskar Kotte of Quality Systems Enhancement, Inc., indicated that
10-12% of his firms 100+ clients do not plan to maintain their
registrations after the transition period ends, while approximately
half of the remainder already have ISO 9001:2000 certificates and the
rest will be there by December 15, 2003. This doesnt mean that
the 10-12% think the 2000 edition is a bad idea, or they would not continue
to use the consulting firms services. In fact, the vast majority
plan to transition their QMSs to ISO 9001:2000, but without going through
a full registration reassessmenttheir organizations do not see
the value of the certificate.
- As of May 14, 2003, 18.1% of all ISO 9000 certificates held by US
organizations were for ISO 9001:2000 registration. While this report
from the Quality Digest Registration Database may not capture
all ISO 9001:2000 registrations due to a lag in reporting by registrars
and delays in the issuance of new certificates after an assessment is
completed, it conveys the sense that many organizations are waiting
until the last minute to transition their registrations, if not their
systems. If this were being done to make the greatest degree of improvement
to QMSs before the third-party evaluation, the low percentage would
be great news. But some of this delay appears to be the result of procrastination
by organizations that will do the bare minimum to satisfy the registrar
auditors, rather than to provide a system employees and management will
consider value-added. This sense was confirmed by consultants, auditors
and even user experts, some of whom acknowledged that their organizations
or ones they knew of were resisting the imperative to transition and
to do so in a productive way.
- THE OUTLOOK discussed motivation for transitioning with quality
professionals from organizations using the standards, from consultants
and from registrar auditors. It was found that there is so far a lack
of customer demand for ISO 9001:2000 outside the aerospace, automotive,
telecommunications and a few other sectors, most of which are requiring
suppliers to register QMSs that conform with sector-specific requirements
that align with ISO 9001:2000. The good news: most organizations outside
those sectors that transition by December 15 will be doing so for reasons
other than a customer "holding a gun to our heads". The bad
news: customers that saw value in the use of ISO 9001/2 by their suppliers
either no longer see the value of mandating its use, with or without
registration, or are assuming their suppliers will do the right thing
without being directed to do sobut some arent.
- Management representatives, QMS implementers and quality managers
do not have proper preparation and training to implement and maintain
effective systems. The lack of effective communication with Top Management
noted above is a symptom of this wider problem. Even after attending
training on ISO 9001:2000 and overseeing QMS implementation and maintenance
with the 1994 editions of ISO 9001/2/3 and even with ISO 9001:2000,
many management reps do not understand exactly what their role should
be and how to effectively fulfill that role. For example, many do not
understand what documentation is really required, what would be useful
for their organizations to maintain and/or improve and how forms and
other documentation should be written not just to satisfy ISO 9001,
but to provide useful tools to personnel and management. Then there
are the reports for Management Review meetings, which frequently are
written in terms that are clear to quality professionals but not to
Top Management, or the internal audit reports provided to various levels
of management, which talk in term of nonconformities to subclauses rather
than system issues and the impacts they create on the organizations
performance. This issue was raised by a training and consulting organization
at AQC, Excel Partnership, Inc., which has reacted to this problem in
many organizations by creating a course designed to help individuals
gain and/or improve the skills needed for management representative
success. An article on this issue will appear in July 2003.
Why Doand ShouldOrganizations Register?
THE OUTLOOK does not endorse the need for registration unless an
organization and its system will gain value from the external assessment.
However, many of you are from organizations that are registered/pursuing
it or provide services to organizations that do.
What follows is a revisit to a topic that has been covered in previous
articles, although what follows is reinforced and/or modified as a result
of discussions and presentations at AQC. The topic: Why do organizations
register to ISO 9001 and what are the only reasons they should? There
are many reasons why, but the followinglisted in "order of
merit"remain the key motivating factors:
- Pursuit of continual improvementRegistrar auditors cannot
provide consulting services during audits, but they can evaluate the
effectiveness of your QMS beyond mere conformity with ISO 9001s
baseline requirements. Granted, the purpose of audits is to ensure the
QMS is effective, satisfies ISO 9001s requirements and is geared
to the pursuit of continual and effective QMS improvement. Auditors
cannot tell you what to do to improve your system, because that would
compromise their objectivity in auditing the results of system changes
based on their recommendations. However, an auditor can be asked to
identify QMS weaknesses that are not ISO 9001 nonconformities, but do
represent opportunities for improvement, or to verify the effectiveness
of process improvements made by the organization by, for instance, following
guidelines in ISO 9004. Any organization that wants third-party audits
expanded to pursue effective continual improvement is making real use
of the objective assessment that it is likely paying a significant amount
for. The result would be an ever-improving system geared to listening
to the voice of all stakeholders. Although a continually improving system
does not guarantee product improvements and innovations or a growing
market share, it does mean enhancing the fertile ground of the corporate
environment for competitive growth.
- Verification of system effectivenessToo many organizations
view registrar audits as a test to be passed, even if it means "pulling
all-nighters to learn the subject matter only to forget it after the
exam", rather than as opportunities to find out if the system is
as good as it is supposed to be and why. In line with the fertile ground
analogy, a third-party audit (or even an internal audit) should be viewed
as an automotive tune-up rather than a doctors check-up. The difference
between them is significant. Most people get tune-ups so that worn parts
are replaced and less-than-efficient systems are fixed so the car runs
better. By comparison, most people go for a check-up hoping the doctor
finds nothing wrong. Organizations that tell their registrars that they
expect the auditors to really check out the system and identify areas
that need to be tuned upand that direct employees to cooperate
with the auditors in identifying and reporting areas that are not working
as well as they shouldwill get more meaningful results from their
assessments than organizations that just want a clean bill of health.
When the organization and its management are committed to using and
improving the system and the auditors find areas that need improvement,
the audits will be worthwhile. The cost of registrar services will be
roughly the same amount either way.
- Demonstration of management commitmentIn any type of
organization, most employees will do only what is expected of them unless
Top Management makes clear that an activity or approach is important
to the organization and its people. THE OUTLOOK has heard frequently
of companies where Top Management decided that the organization would
pursue registration and then paid little or no attention to the QMS
once this had been achieved. Under these circumstances, most employees
only paid attention to the QMS when the auditors were coming. The fear
that Top Management would be annoyed by a bad audit report prompted
an effort to use the system and make sure all the documentation was
in order. However, in organizations where Top Management makes clear
that it values the QMS and its use, where members of Top Management
use the system and participate in its maintenance and improvement and
where registrar audits represent a commitment of resources to ensure
the system is effective, employees will treat the QMS as important because
Top Management considers it important. This is especially true in large
organizations where Top Management cannot observe day-to-day activities
in widespread facilities, making registrar audits a means to seeing
what is occurring throughout the organization. To summarize, this means
that, if you want everyone else in the organization to take the QMS
and the auditing of it seriously, Top Management has to treat them seriously.
- Industry recognitionIf organizations pursue QMS implementation
and registration because it is considered an industry-recognized sign
of effective management practices, it is Top Managements responsibility
to take the system seriously and ensure that adequate resourcesincluding
staff timeare allocated to implement and maintain effective processes.
Organizations too often have pursued registration and treated the resulting
QMS as a finished project to be relegated to the quality managers to
deal with, rather than something everyone has to use and continually
improve, including Top Management. If the goal is only to get a certificate
to show peers, your organization is wasting its time and money and,
eventually, the unused or underused system will prove a burden rather
than a tool for enhanced competitiveness. The danger is complacency
("the system is good enough, so leave it as-is") and ignorance
of what a QMS can really do if designed, implemented and used correctly.
This is the wrong reason for implementing an ISO 9001-conforming QMS.
Your motivation should be to attain an effective management system that
meets and exceeds the requirements for registration.
- Global competitionAlmost all organizations now seek
to have their products gain a foothold in new markets while maintaining
or growing their share in existing markets. An indication of your organizations
ability to provide a product according to the customers product
specifications is ISO 9001 registration. It means that a third party
has verified that the management system meets or exceeds internationally
recognized baseline criteria. In effect, ISO 9001 registration has become
a distinguishing characteristic in international trade. Thus, if a customer
in Shanghai needs a product it has never purchased before that three
companies worldwide make, and two can meet the customers needs
in terms of product quantity and price, then a deciding factor for the
customer may be the ISO 9001 registration status of the two. The danger
is if the certificate represents a great system that is not used or
is used ineffectively, the product being sold could be inconsistent
in meeting the new customers needs, and the customer may go to
the other company next time. A certificate alone will only allow you
one chance with a potential customer. It will take an effective QMS
to provide product that will meet customer needs, produce customer satisfaction
that increases over time and reduce profit-eating variation and waste.
- Public recognitionIn late December 2000, some organizations
rushed to obtain ISO 9001:2000 registration, often to claim they were
first in their field to do so and gain publicity. They thought having
a certificate and noting registration on their letterhead and in banners
at their facilities would bring customers running to their doors. But
the registered system will have marketing value over time only if the
system reflects what the organization does and helps ensure that its
processes and output (product) always meet or exceed minimum expectations
of management and customers. If the system is "tossed aside"
when the publicity ceases and a sudden rush of new customers doesnt
happen, then the organization will not only have wasted its time, money
and effort in obtaining registration, but it may have damaged its reputation
by making claims to improved quality that will not stand up when the
registered system is not used. ISO 9001 is not a magic wand but a set
of guiding principles laid out in generic requirements that must be
followed over the long-term for an organization to function consistently
to meet or exceed customer expectations and remain competitive.
- Regulatory requirementsThere are some sectors, such
as medical devices, where registration to ISO 9001 or a sector-specific
standard aligned with it is one way to satisfy regulatory requirements
for organizations that want to sell their products in certain countries
or regions. (Note: reports out of ISO Central Secretariat are that balloting
of the Final Draft International Standard of ISO 13485, Medical
devicesQuality management systemsRequirements for regulatory
purposes, concluded with its approval internationally, although
it is only partially aligned with ISO 9001:2000.) In reality, an organization
registering to ISO 9001 or a sector standard to satisfy regulatory requirements
usually already has a QMS that exceeds the requirements of the standard.
Regulatory bodies accepting registration as a means to verify QMS conformity
are simply using this approach in place of other forms of inspection
or auditing to which the organization was previously subjected. The
pressure of regulatory oversight is likely to drive the effective implementation,
maintenance and use of a management system, although it remains up to
individual organizations to go beyond the minimal requirements in improving
their processes. The danger here is that fear of making changes that
might imperil regulatory compliance will lead to stagnation of processes
and slippage over time.
- Customer requirementsHistorically, contractual requirements
that suppliers become registered to ISO 9001/2 in order to obtain/retain
business with a customer have been the most well-known reason why organizations
have implemented QMSs and sought registration. It is also the reason
most often responsible for systems that look good on paper and pass
registration audits but prove to be a bureaucratic nightmare, less than
effective or disregarded by the organization except when internal and
registrar audits are scheduled to occur. Customers began to require
registration of their suppliers to reduce the number of second-party
audits a supplier had to endure (and customers had to pay for) and/or
to provide a third-party verification of the suppliers procedures.
Indeed, if Top Management, the quality managers and the process owners
use a customer requirement for registration as the leverage to make
critical changes that will improve the organizations processes
and that would otherwise be difficult to accomplish, then this is an
excellent motivating factor. However, many suppliers previously took
the quick route to registration, seeking to do no more than the minimum
to satisfy customer requirements. Or worse, some actually paid no attention
to what was really being sought by the customer and directed implementation
teams or outside consultants to build a system without ensuring the
system met the needs of the organization and those using the system.
In fact, as noted above, outside a few sectors where major customers
are mandating continued registration to ISO 9001:2000-based sector-specific
requirements (e.g., aerospace, automotive, telecom), THE OUTLOOK
has been unable to uncover many instances of customers issuing letters
or contracts to suppliers specifying registration to ISO 9001:2000 by
and after December 15, 2003. It is likely that this is a result of customer
realization that mandating registration without further enforcement is
not sufficient to gain benefits that surpass the cost to the suppliers
The expectation of many customers is likely that most suppliers will
transition without being told to and those that do not will be judged
on their ability to meet product and customer specifications, such as
defect-free product delivered on time, after their ISO 9001/2:1994 certificates
are withdrawn on December 16.
Facing the Reasons and the Challenges
The point of this examination of the 8 reasons above is to determine what
you and your organizations course of action needs to bewhether
your organization has made the transition, is in the process of doing
so, is in a sector where it can put it off or plans not to make the transition
as far as registration goes or not at all. This is particularly important
in light of the two challenges identified and discussed above.
As the QMS user community moves toward a post-ISO 9001/2:1994 era, it
is important to evaluate what reasons underlie the implementation, maintenance
and use of an ISO 9001:2000-registered or -conforming QMS in your organizationor
The future success of your organization may count on an effective QMS.
So, you need to ask yourself (or your management rep and quality managers)
the following questions:
- Are the reasons we sought and maintained registration to ISO 9001:2000
or another QMS standard/set of requirements the right reasons and the
best ones for our organization? If so, are there other reasons that
should motivate us and actions we should be taking? If not, how do we
change the system and our organizations thinking so that we move
forward for the right reasons?
- Have we effectively communicated about and promoted the value and
benefits of transitioning to ISO 9001:2000 to Top Management? If not,
what can we do to improve our skills?
- Is our QMS "elegant"? If so, what can we do to make the
system more useful and easy-to-use to process owners and all employees
in our organization? If not, how can we simplify the system to reflect
what we do and how we do things and do so in a way that helps employees
do their jobs without creating work? In either case, can we use the
system to reduce costs and improve organizational performance?
- Are we using process management to eliminate the waste from processes
and assure a seamless interface between processes? Do we have the right
metrics in place for measuring process performance and have we established
aggressive improvement goals for a few of these metrics?
- Do our customer satisfaction measures identify areas for improvement?
And are plans in place and tracked by Top Management to capture these
These are important questions, and THE OUTLOOK will be providing
coverage in coming months that will try to address these issues in a way
that will help organizations improve their systems, no matter how effective,
efficient and well-used they are.
To start, some discussions at and subsequent to AQC merit examination.
Craig Johnson, a member of the US TAG, related a conversation he had at
AQC subsequent to Barkers comments to the TAG meeting. "The
best perspective I heard at AQC on this problem of overcoming Top Management
resistance to transitioning came from a conversation I had with Jack West,
Chair of the US TAG, at the Quality Press reception," recalled Johnson.
"We were talking about the process approach in general when Jack
said, Banks provide the major pressure for a process approach within
"I had never heard this before and asked him to explain. Jack explained
that banks want to know that a borrower can be a good steward of other
peoples money, as evidenced by the processes it has in place to
assure the lender of the organizations good stewardship. When the
stewardship of a business is in doubt, advisors urge the manager to drill
deeper than the ISO 9001 requirements to identify processes that drive
profit and determine how those processes are linked to the management
system. The interrogation skills of the advisors need to be sophisticated
and grounded in many years of successful business experience."
Johnson assumes that Top Management is concerned about its organizations
fiscal credibility but may not appreciate its dependence on the process
approach. "The true challenge could be to show organizations how
ISO 9001 can be used to strengthen the link between the processes that
drive profit and QMS requirements. This might convince large and small
organizations that an elegant QMS is critical in order to maintain their
capacity to grow on borrowed money, which is how many businesses operate."
In addition, Barker addressed two questions that were posed to THE
OUTLOOK at the TAG meeting by Bob Peach, who has been a US delegate
to ISO/TC 176 since its founding, was the initial Convenor of the Working
Group responsible for ISO 9004 and was a Founder and the first Chairman
Peach: When making the transition, should an organization expect
to see a change in QMS structure shortly, so Top Management will see
Barker: Hopefully, you will see a reduction in the
resources required of the system when processes are streamlined in
making the transition. Customer satisfaction takes longer and will
require the "quality organization" to release control.
Peach: Do the customer satisfaction measurements an organization
chooses make a difference to Top Management?
Barker: YES! What gets measured gets worked on, and
a portion of the customer satisfaction measures needs to cover relationships.
This is especially true for service-related activities, but even manufacturers
have sales organizations. You need to know if the customers enjoy
dealing with these people and their support administrative activity.
"The one thing that keeps coming to mind is the lack of understanding
of Business Process Management, and how it supports the objectives of
quality, by many quality assurance professionals," added Stanley
H. Salot, Jr., President/CEO of Business & Quality Process Management,
Inc. "This, along with their lack of ability to communicate the value
of Business Process Management to the executive management team, are a
major part of the problem."
Salot indicated that a related issue is the "education aspects"
of ISO 9001:2000. "We should keep in mind that the 1987 and 1994
editions were based on the simple concepts of stated requirements4.1,
4.2, 4.3 etc. The initial standard was laid out so that a basic technical
approach could be taken to achieve the desired results. On the other hand,
ISO 9001:2000 is nothing like its origin. It is like going from high school
directly to graduate school without stopping for an undergraduate degree.
I expect much more training will be made available soon for both QA professionals
and Top Management and, as the need of organizations for international
standards continues to mature, many of the organizations that skipped
the undergrad degree will come back into conformity and registration with
Finally, Sandy Liebesman, leader of the PSI, emphasized the opportunity
that organizations may be missing. "Within the TAG, we have discussed
how ISO 9001:2000 gives the opportunity to provide value-added improvements
that affect the bottom-line. There is a strong emphasis on management
involvement, continual improvement and preventive action. These new areas
of focus provide Top Management with opportunities to affect the bottom-line
in a positive way. Quality can play a strong role in this, but the message
is not being heard."
Despite the discussions in Kansas City and the conclusions drawn, there
is a need for more information from organizations about what they are
doing and on what do they need more guidance and assistance. You need
to be heard so that THE OUTLOOK can ensure that future coverage
will focus on your situation and your needs. There is an easy-to-complete
survey available from INFORM that you are asked to complete and return
call 703-680-1436 and ask for a copy. Your responses will provide a significant
amount of information that will assist in shaping the type of guidance
and information contained in future issues.
For now, consider how effective your QMS is and how effective you are
in meeting the two challenges. The goal must always be continual improvement,
no matter what the starting point is.