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W. Edwards Deming

"Everybody here has a customer. And if he doesn't know who it
is and what constitutes the needs of the customer...then he does
not understand his job."

"Your study of the consumer--what he finds right and what he
finds wrong--and your innovation are all bound up together. It
will affect design and redesign of your product or service."

"Inspection with the aim of finding the bad ones and throwing
them out is too late, ineffective, costly. Quality comes not from
inspection but from improvement of the process."

"Price has no meaning without a measure of the quality being

"People are entitled to joy in their work and a sense of

"Purchasing should be a team effort, and one of the most
important people on the team should be the chosen supplier--if
you have a choice-- picked on the basis of his record of

"Putting out fires is not improvement. Finding a point out of
control, finding the special cause and removing it, is only
putting the process back to where it was in the first place. It
is not improvement of the process. You are in a hotel. You hear
someone yell fire. He runs for the fire extinguisher and pulls
the alarm to call the fire department. We all get out.
Extinguishing the fire does not improve the hotel. That is not
improvement of quality. That is putting out fires."

"There is no excuse to offer for putting people on a job that
they know not how to do. Most so-called 'goofing off'--somebody
seems to be lazy, doesn't seem to care--that person is almost
always in the wrong job, or has very poor management."

"Education in simple but powerful statistical techniques is
required of all people in management..."

"People work in the system. Management creates the system."

With ongoing-and sometimes contradictory-messages emanating from multinationals and some standards institutions, many business owners have been left wondering which standard to follow. by Amy Zuckerman Claude Hetu is mighty relieved that his Ontario forgingcompany can switch from ISO 9000 to QS-9000 registration with ease and at no extra cost. On the other hand, Robert Peuperbaugh, president of a small
Michigan cutting-tool company, finds the emergence of the Big
Three's QS-9000 quality program "frustrating" at best.
What Hetu and Peuperbaugh, both auto industry suppliers, are
reacting to is the hybridization of the ISO 9000 international
quality management program.
Multinationals like the Big Three have created an industry-
specific version of ISO 9000 called QS-9000. Major truck
manufacturers like Freightliner, Mack, Navistar, Paccar and
Volvo/GM have adopted QS-9000. Other industries, specifically
steel and metal tooling, are reportedly spinning off their own
versions of QS-9000.
But the changes on the ISO 9000 and related quality fronts
don't stop with the automotive, steel or metal-tooling
industries. In electronics, both Motorola and Hewlett-Packard are
waging a worldwide campaign for reform of the ISO 9000
registration system. Mobil Oil's quality staff has raised alarms
publicly that international standards development is becoming
increasingly political, with some multinationals apparently
hitting at their competition through the International
Organization for Standardization technical committees. And
McDonnell Douglas has questioned using ISO 9000 in lieu of
military specifications.
Curt Reimann, director for quality programs at the
government-sponsored Malcolm Baldrige National Quality Award,
says the 1995 Baldrige Criteria are further than ever from the
ISO 9000 approach. The intent, he says, is not to purposely
differentiate the Baldrige from ISO 9000 but to offer companies
what the Baldrige committee believes they need to create a full
quality process. This includes more emphasis on strategic
business issues, high performance and business results.
The European Union, in the meantime, is moving ahead with
plans to create its own European quality program that will be
based more on a Baldrige than an ISO 9000 approach. ISO 9000
methodology will be included in the EU plan, but the ISO 9000
certificates may be abolished or downplayed. EU officials expect
to have a proposal before the European Commission sometime this
There are ongoing efforts within the ISO to better
administer the standard on a worldwide basis. The ISO recently
authorized a memorandum of understanding to the International
Accreditation Forum giving that organization the green light to
create international rules binding accreditation bodies.
These are only a handful of the developments worldwide in
the international standards arena. Since the ratification of the
General Agreement on Tariffs and Trade, new programs and mandates
come to the fore almost daily. For example, the Japanese plan to
make ISO 9000 registration mandatory for all software
manufacturers planning to do business in Japan.
Of more immediate concern to American small-businesspeople
is how to cope with developments on the automotive, electronics
and European fronts. The following summarizes what is taking

ISO 9000 vs. QS-9000

In September, the Big Three unveiled their first-ever common
quality program, QS-9000. The program utilizes an ISO 9000
quality assurance base coupled with industry-specific guidelines
drawn from the auto industry's former quality programs: GM's
North American Operations Targets for Excellence, Ford's Q-101
Quality System Standard, Chrysler's Supplier Quality Assurance
Manual and GM Europe's General Quality Standard for Purchased
General Motors was the first to mandate QS-9000 for its
North American suppliers, Chrysler followed suit, and only Ford
is holding back until QS-9000 is more established. General Motors
and Chrysler have plans to introduce QS-9000 to their European
suppliers this winter and to the worldwide operations down the
line. Ford is also looking into introducing QS-9000 to its
European suppliers.
Because QS-9000 is still very much in its infancy, the rules
governing the program are in constant flux. So much flux, in
fact, that the editor of a major automotive trade magazine has
trouble keeping QS-9000 stories current. Any auto supplier or
related industry supplier should be aware of a number of factors
when pursuing QS-9000:

* New GM North American suppliers have until Jan. 1, 1996,
to comply with QS-9000, while long-time suppliers have a
deadline of Dec. 31, 1997. Chrysler suppliers have until
July 31, 1997, to earn QS-9000 certificates.

* ISO 9000 certificates, alone, will not be accepted.

* The Big Three are pursuing acceptance for QS-9000 outside
of the United States. To date, Great Britain and the
Netherlands have given their approval. Blanket European
acceptance of the certificates (in lieu of ISO 9000
certificates) is expected.

* ISO 9000 registrars must earn the Big Three Code of
Practice of Quality Systems Registrars to issue QS-9000
certificates. Training of registrars is ongoing, and Big
Three representatives have been in Europe scouting
reinforcements. Only registrars that have earned the Code of
Practice can issue QS-9000 certificates.

* So-called hybrid or transplant companies--specifically
Honda North American and Nissan North American--are not
adopting QS-9000 for their suppliers.


In a joint effort, Motorola and Hewlett-Packard have
gathered the support of 37 major electronics companies worldwide
to push streamlining of the ISO 9000 registration process.
Companies include AT&T, Xerox, Digital Equipment, Microsoft,
Matsushita Electric Corp. of America, Philips Electronics,
Whirlpool, Bausch & Lomb, Stala Oy (Finland) and many others.
Richard Buetow, quality chief at Motorola, explains that his
company and Hewlett-Packard have formed "a marriage of
convenience" to push for creating a new system that would cut
back on the amount of work ISO 9000 registrars perform in a major
corporation. The companies that have signed the so-called
"supplier's declaration of conformity" are seeking approval from
the European Union, the ISO and other major international
standards institutions to eliminate plant-by-plant ISO 9000
registration. They want one-stop registration based on internal
manufacturer certification.
Although loathe to criticize the Big Three's efforts, Buetow
says he is concerned with the decision to continue with an
altered version of the ISO 9000 registrar system. Because so many
electronics companies supply the Big Three, he says they will
have to earn QS-9000- and work within that registrar system-at
the very time so many electronics giants are trying to alter it,
he says.


In a series of reports issued throughout 1994, EU standards
officials announced their intent to downplay the for-profit
aspect of European quality and re-emphasize the quality process.
To this end, they intend to reinforce the fairly new European
Quality Award. If all goes as planned, national accreditation
bodies will operate under the jurisdiction of Jacques McMillan,
chief of the Senior Standards Policy Group for Directorate-
General III for Industry. They will no longer operate for profit
or compete with each other.
In a fall interview in Brussels and in subsequent
interviews, McMillan and quality associate Antonio Silva Mendes
insist the EU does not intend to "kill" ISO 9000. Their concern
has been the rampant commercialization of the international
quality program and the fact that many European companies have
complained that ISO 9000 hasn't lived up to its advertising hype
as a quality tool. McMillan and Mendes consider the standard a
good quality base but not adequate as a total quality process.
"A lot of people thought we were trying to kill ISO 9000,"
says McMillan. "Now people are understanding the message. We're
not trying to kill it; we're trying to save it.
"One problem industry faces is that they shouldn't do things
that don't give them added value. They shouldn't pay for things
that don't give added value. I get into fights with certifiers
and consultants who have found a good market [in ISO 9000]. But
if industry pays for services that provide no added value, then
that's not a good quality market."
Because of such issues, McMillan has found multinationals
"fed up with having to face different [ISO 9000] regimes from
different organizations. Insofar as their internal audits are as
good as any others, they're not prepared to play ball with the
[ISO 9000] registrars."

ISO officials react

Although QS-9000 has the ISO's support and EU officials'
backing, there are those in the ISO 9000 "community" watching the
hybridization of the international standards program with some
concern. These experts include Willen Deken, deputy director of
the Dutch Council for Certification (RvC); Reg Shaughnessy,
international chairman of the ISO TC-176 committee that creates
the ISO 9000 series; and Peter Ford, secretary of TC- 176.
They all concur that ISO 9000 is, and should be, a living
and evolving standard that meets industry needs. On the other
hand, they worry that the trend toward a more industry-specific
approach may lead to ISO 9000 dissolving as an international
Of QS-9000, Deken said the RvC was "glad to follow their
rules" if the U.S. car companies wanted to add industry-specific
guidelines to an ISO 9000 base. But he also worried that the
industry-specific approach would "splinter the [ISO 9000]
program. That will mean higher costs. But it's up to the market
to decide."
Shaughnessy, who is based in Toronto, admits there is
"pressure worldwide" to make the ISO 9000 series more
"industry-specific and more prescriptive." However, he feels "the
standard's strength has been to hold the line at a minimum number
of practices. If decentralization continues, it will undermine
the international [approach]."
Shaughnessy's not as concerned about QS-9000 as long as they
retain third-party auditing. "QS-9000 is more product-specific,"
he says. "But they've built in [that aspect] as supplementary. If
the supplementary were to become dominant, that would take away
from a generic system."
Citing the example of medical devices--an industry with very
specific product needs and requirements--he says TC-176 has
struggled to keep this grouping under the ISO 9000 standards
umbrella. If this industry and others start forming separate
versions of ISO 9000, he argues, we would be back to the same
pre-ISO 9000 picture. "There's no question that if we
decentralize, we've lost it," Shaughnessy explains.
On the other hand, Shaughnessy says it will take solid
leadership to keep ISO 9000 centralized. He points out that ISO
Secretary General Larry Eicher has assigned Christian Fabre to
oversee the ISO system. "He's there to do the job effectively,"
says Shaughnessy.
As things now stand, member countries advise the Geneva-
based ISO about their preferences vis-a-vis the standards series.
These issues come before the ISO council, and amendments and
revisions eventually eke their way into the world. For instance,
it took seven years for the 1994 revisions to be made public,
with many more revisions to the standards series in the works.
This laborious process has not always suited industry groups,
hence the creation of QS-9000 and possible QS-9000 spin-offs.
Shaughnessy says he does see the need for more emphasis on
employee involvement--a total quality management approach--to be
included in the ISO 9000 process. However, he does not see the
standards "going the way of the awards for excellence."
As for revisions to the actual standard, Peter Ford of TC-
176 says there is an ongoing effort to harmonize the vocabulary
document-what he calls 8402. There will be more "support
technology," including development of standards for auditing and
how to write a manual.
Ford is witnessing increased sales in the 9004-1 (formerly
9004) document, the support document that explains the ISO 9000
process. "That's a significant shift," he says, explaining that
9004 used to be 5 percent to 10 percent of series sales. "Now
9004-1 sales are almost equal to 9001."
Like Deken and Shaughnessy, Ford hopes the answer won't
amount to the dismantling of the ISO 9000 system. "There's a
difference between using the standard as a base and translating
it into the vernacular," he explains. "If we lose the global
aspects, maybe we've created more of a monster than an asset."
Some prefer a change Motorola's Buetow, a long-time
critic of ISO 9000, says his company is a firm believer that
one's future should be determined by the marketplace, not by some
bureaucratic process. "The bureaucratic process gets life because
people get scared that if they don't have it, they don't do
business," he explains. "People have used the word "blackmail"
[in reference to companies being coerced into earning ISO 9000
Quality expert Pat Townsend considers ISO 9000 the baby of
old-line quality types with slide rules in hand, who are mostly
interested in conformance to specifications. "They've taken good,
simple tools like statistical process control--which mainly
involves the ability to do arithmetic--and made them mysterious,
mechanical and expensive," he says.
These so-called old-liners were left out in the cold by the
quality revolution of the 1980s, which went far beyond simple
conformance to spec, says Townsend. "When ISO 9000 came down the
pike, these guys saw it as a safe refuge from the far-reaching
and really interesting quality efforts that had left them
behind," he explains. "Suddenly there was a new, numbers-driven
bandwagon that looked a lot like their old, familiar bandwagon."
As far as Townsend is concerned, ISO 9000 would not have
been created if the Europeans didn't need a means of slowing down
the Japanese and American quality juggernaut.
"The Europeans, who were lagging behind Japan and the United
States in the quality movement, saw ISO 9000 as a way to catch up
with their global competitors," Townsend explains. "It buys them
some time to get their products into the world market and
establish product standards. And-though this may not have been
the intent-in effect, it imposes barriers on North Americans and
Asians seeking entry into the European market."
In terms of the future, Townsend has long predicted the
eventual disintegration of ISO 9000 as currently constructed. He
agrees with Buetow's now-famous criticism that ISO 9000 as a
quality process breeds consistency, not quality. That, in effect,
someone can create cement life preservers and still earn an ISO
9000 certificate if the manufacturing process is a consistent

Industry reaction

With these ongoing--and sometimes contradictory--messages
emanating from multinationals and some standards institutions,
it's no wonder that business owners are sometimes left scratching
their heads.
Robert Peuperbaugh, president of the 30-employee Joint
Production Technology in Macomb, Michigan--a manufacturer of
specialized cutting tools--feels caught in the middle between ISO
9000 and QS-9000. Highly frustrated that after his company earned
Ford's original quality certificate Q-101, and then the successor
Q-1, the Big Three, and Ford in particular, are again "changing
"We're floundering because there's no real guide [to
QS-9000]," explains Peuperbaugh. On the other hand, he says he's
been "too busy to worry about it."
At Gananoque Steel Forging in Gananoque, Ontario, Canada,
company president Claude Hetu is encouraging his 177 employees to
complete QS-9000 registration by the end of 1996. Hetu says
Gananoque Steel Forging is lucky to have embarked on ISO 9000
preliminaries--mainly preparing documentation of work
procedures--without getting so far along in the registration
process that a switch over to QS-9000 would prove costly.
Many companies, especially companies unrelated to the Big
Three, believe in ISO 9000 and will continue to pursue the
quality process no matter what the European Union or
multinationals decide. One such company is Yankee Environmental
in Turners Falls, Massachusetts, an eight-employee manufacturer
of computerized environmental instruments.
Yankee General Manager Mark Beaubien, who has worked on
streamlining ISO 9000 documentation methodology, says the
company's primary interest in ISO 9000 "is to do it for our own
quality. We believe in it. We're an instrument company, so
quality is very important to us."
And at Simplex Technologies in Portsmouth, New Hampshire,
where about 700 employees manufacture cables for the
telecommunications industry and the U.S. government, Quality
Manager Russell Miles believes that their ISO 9000 certification
only improved a solid documentation system the company maintained
for many years of meeting military and customer specifications.
"We're very pleased with our quality system," says Miles.
"We have to make sure our procedures are ISO and military
compliant, but that's not a big deal for this company."

About the author . . .

Amy Zuckerman is author of ISO 9000 Made Easy: A Cost-Saving
Guide to Documentation and Registration {AMACOM Books, 1995).

ISO 9000

The International Organization for Standardization was founded in 1946 in Geneva, Switzerland. "ISO" refers to the Greek word, isos, meaning "equal".

The International Organization for Standardization develops manufacturing, trade and communications standards for use around the world.

ISO receives input from government, industry and any other interested parties before developing a standard which is composed up of a number of different elements. All standards developed by ISO are voluntary; no legal requirements force countries to adopt them. The choice to register is voluntary. Benefits ascertained from compliance are numerous.

Some benefits are:

  • Improved documentation
  • Greater quality awareness
  • Positive change within the company
  • Higher perceived quality from customers
  • Improved customer satisfaction
  • A better competitive edge
  • Better product flow
  • Reduced scrap
  • Improved communication channels

ISO 9000 contains five standards. The main objective is to increase the confidence companies have in the quality systems of their suppliers. These standards define the elements needed to achieve this recognition. These standards are:

  • ISO 9000-1
  • ISO 9001
  • ISO 9002
  • ISO 9003
  • ISO 9004-1

These standards are grouped into two categories: guidance and conformance standards.

ISO 9000-1 and ISO 9004-1 are guidance standards. 9000-1 is the road map to the other standards and 9004-1 includes information about quality management.

The other three standards ISO 9001, 9002 and 9003 are called conformance standards. These are the standards customers are trying to meet and conform to.

ISO 9001 is the most comprehensive and consists of all elements in the production process. It commonly applies to manufacturing, service, and processing industries.

ISO 9002 is the same as 9001 but does not cover the design process.

ISO 9003 has the fewest requirements. Companies that are supplied designs from their customers conform to this standard. It deals with requirements for controlling any problems found during final inspection and testing. This standard applies to companies and distributors whose products or services are less complex or can be evaluated by testing and inspection.

ISO deals with four types of documentation.

  • Quality Manual-States the company's policy and components of the quality system.
  • Procedures-General operating procedures. Describes what is to be done, where, why and by whom.
  • Work Instructions-Detailed requirements for specific tasks.
  • Records-Proves the quality system is doing what it is intended. This includes files, specifications, drawings and other forms.

Basically, all ISO and QS 9000 entails is a system in which you say what you do, do what you say, record what you did, check on the results, and act on any differences in the output. These standards are common since answers to problems plaguing the industry used to achieve consistent results!

Breitenberg - 3/6/95

The Quality System Requirements Standard (QS-9000) was developed by the Chrysler/Ford/General Motors (GM) Requirements Task Force with input from suppliers and other interested parties. The goal for this standard "is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain". Previously each company had their own expectations for supplier quality systems and corresponding assessment documents. QS-9000 is a harmonization of Chrysler's Supplier Quality Assurance Manual, Ford's Q-101 Quality System Standards and General Motors' NAO Target for Excellence, with input from the truck manufacturers. Section 4 of ISO 9001 (1994) has been adopted in its entirety and serves as the foundation for this standard. The standard also includes additional interpretations and supplementary quality system requirements which have been harmonized among the so-called "Big Three " auto companies.

The QS-9000 standard applies to all internal and external suppliers of production and service parts and materials. Design responsible suppliers must meet all the requirements of QS-9000. Suppliers without design responsibility are exempted from those sections. All requirements of QS-9000 are to be incorporated into the supplier's quality system and described in the supplier's quality manual. Conformance to QS-9000 will be evaluated using the process described in Appendix A of the standard. Third party registration to QS-9000 will be accepted from registrars: (1) who are specifically accredited to perform QS-9000 registration by customer-recognized national accreditation bodies; and (2) who comply with the "Code of Practice for Quality System Registrars" described in Appendix B of the standard. In addition, auditors who perform QS 9000 audits must have completed and passed special training requirements; and the scope of a third party registration must include all products and services supplied to one or more of the companies subscribing to QS-9000.

Memoranda of Understanding (MOUs) between accreditation bodies or registrars are not acceptable for meeting this requirement. Currently the national accreditation bodies which are recognized by Ford/Chrysler/GM are: ANSI/RAB in the United States; the Dutch Council for Certification (RvC), and the National Accreditation Council for Certification Bodies (NACCB) in the United Kingdom.

General Motors and Chrysler have already indicated that they will require third party registration by their primary suppliers and have provided them with a time table for completing that registration. Ford is still considering the issue of third party registration and has indicated that-while it will accept third party registration-it will not require it at this time.

In addition to the Big Three, the QS 9000 standard has also been adopted by Freightliner, Mack Trucks, Navistar, PACCAR, the Transportation Manufacturing Corporation, and Volvo GM Heavy Truc

by Bruce R. Gardner, CQE, CQA
With the current interest in ISO 9000 (eye-so nine thousand)standards, some organizations have sought to replace or modifytheir improvement programs to meet the ISO standards. This hasbrought an apparent reduction in interest in so called TotalQuality Management (TQM) initiatives. But is this diversionjustified by market forces or simply wishful thinking on the partof beleaguered organizational management?     The intent of the ISO 9000 series requirements is simple.The standard requires that a basic quality system be implementedto ensure customers that suppliers have the capabilities andsystems to provide quality products and/or services.     The benchmark for TQM models is the Malcolm Baldrige Nation-al Quality Award (MBNQA) criteria. A major goal of the MBNQA isto increase US competitiveness worldwide. The MBNQA is essential-ly a search for "role models" with superior records of quality.     The foremost exponent of organizational change which empha-sizes quality as the principle philosophy is Dr. W. EdwardsDeming. In his 1986 book, Out of the Crisis, Dr. Deming warnedthat the western world needs a "transformation of the Americanstyle of management" and not merely a "reconstruction" or "revi-sion." He further pointed out that this new way "requires a wholenew structure, from foundation upward."RequirementsISO 9000     ISO 9000 series requirements are clearly defined, but howthe requirements are to be met is left largely to the organiza-tion. Clear documentation of all work processes affecting qualityis required, but that documentation can be written as workinstructions, basic training for employees, attached as a rideron a particular manufactured item or service, or even displayedas a process flow chart in a work area.     The ISO 9000 series concentrates almost exclusively onresults criteria, although process criteria may meet some ISO9000 series requirements, depending upon the lead assessor.Registering to the ISO 9000 series probably requires the leastchange in organizational involvement. A traditionally-managed,mass-inspection oriented organization could readily be registeredto meet the standard.MBNQA     MBNQA guidelines are dependent on documentation. An organi-zation committed to basing its quality initiative upon the MBNQAguidelines must expect a high level of documentation in manyareas.     MBNQA guidelines are somewhat more results-oriented thanprocess-oriented, but the organization is required to follow bothresults and process criteria. MBNQA requires specific organiza-tional involvement and change.Deming-inspired TQM     Deming-inspired TQM is much more open than MBNQA or ISO9000. It has no firm requirements other than to meet and/orexceed customer needs through an understanding of the organiza-tion and the effects of current management practices. It expectsthe senior managers of an organization to consider managementstyle through a scientific examination of Dr. Deming's 14 Obliga-tions of Management, and then apply the points in a mannerappropriate to their organization.     Dr. Deming expects senior managers to establish a con-trolled, customer-focused, continuously improving organization.That kind of organization has requirements, but in practice theorganization must define these requirements to be in harmony withDeming-inspired TQM. That is, form should follow function.Documentation showing how processes are to be accomplished isnecessary. It is up to an organization to document processes soas to communicate effectively to those who need to know.Deming-inspired TQM involves the most organizational involvementand organizational change of the three approaches.ISO 9000 Compared to MBNQA   MBNQA is a larger overall system than the ISO 9000 series.Spreading knowledge about quality to other organizations is notan ISO 9000 series requirement, but it is a clear requirement ofthe MBNQA. The ISO 9000 series has no requirement for qualityleadership benchmarking. It makes no provision for employeerecognition and performance, employee morale, quality-resultsbenchmarking, customer-relationship management, andcustomer-satisfaction benchmarking.   While the ISO 9000 series is the smaller system, there areseveral requirements of that series which are given limitedattention in MBNQA guidelines. Document control is at the heartof the ISO 9000 series, but mentioned only in passing in MBNQArequirements. Product identification and traceability is a much
larger part of ISO 9000 series requirements than in the MBNQA

ISO 9000 Compared to Deming inspired TQM

The ISO 9000 series has clear requirements compared to
Deming-inspired TQM. For instance, ISO 9000 series requirements
dictate that contract review be addressed in very specific terms,
while a Deming-inspired TQM leaves the details entirely up to the
organization. Deming-inspired TQM does not explicitly require
design control, document control, and product identification and
traceability. Requirements in those areas are derived from
specific customer needs rather than by fiat.

Dr. Deming urges companies to: drive out fear, eliminate
slogans and exhortations, eliminate management-by-objective,
remove barriers that rob people of pride in workmanship, and
institute education. The ISO 9000 series does not address these

Theory and Application Comparison

Deming-inspired TQM emphasizes the concept of a new manage-
ment theory (or philosophy) to a greater degree than either MBNQA
or the ISO 9000 series. Managers must understand the theory and
apply it appropriately.

ISO 9000 is a quality system based largely on traditional
quality control theory, identifying elements such as design
control, supplier control, process control, inspection management
and training to achieve quality results for the customer. It also
includes the idea of continuous improvement of the system.

MBNQA guidelines are a mixture of traditional theories--plus
the theory developed by Crosby, Deming, Feigenbaum, Juran and
others. MBNQA guidelines emphasize application of various pieces
from the theories behind the approach.


A Deming-inspired TQM initiative requires the substantial
commitment of personal time and resources of senior managers in
transforming the organization. Quality cannot be just another
aspect of the business; it must become the way business is con-
ducted. A Deming-inspired TQM organization is a learning organi-
zation. It has a philosophy or theory of how to function. Dr.
Deming points out, "There is no learning without theory." He goes
on to say, "Experience alone teaches nothing. If we have a
theory, then experience can help us to learn."

While ISO 9000 series registration requires support and
involvement by senior management, it is not a transformation
initiative. ISO 9000 does not require a transformation of manage-
ment practices but it does require continuous improvement of the
system through corrective action to prevent repeat mistakes.

After an organization has become effective through TQM
transformation and has become a learning organization, the use of
MBNQA quality criteria can be an excellent way to improve an
already-effective organization.

It would be a mistake for an organization to conclude that
ISO 9000 and TQM are interchangeable. Curt Reimann, Administrator
of the MBNQA, in his study of the two found that only about 10%
of the MBNQA requirements are covered by the ISO 9000 standards.
He says that the issues that are essential to company survival,
such as competitiveness and customer satisfaction are not covered
by ISO 9000 at all. He concludes that because it is a standard,
ISO 9000 can only require the basic minimum. If the standard were
to require all the elements of MBNQA, he says, it would be unen-
forceable. Registrar's costs for certification would exceed
$50,000 per assessment instead of the current $10,000 to $20,000.
That is, of course, if you can find enough trained assessors to
send into the field.

It would appear that ISO 9000 has a place in a TQM organiza-
tion. It provides a framework for a quality system that meets
minimum requirements. The real push, and the real difficulty,
remains the organizational transformation to TQM. While working
on ISO 9000, organizations which lose sight of the goal of
transformation do so at their peril. Long term survival will
require transformation to TQM. But as Dr. Deming has said,
"Survival is not compulsory."

Clause 4.1



To comply with this requirement there must be a written Quality Policy for the organisation. This Quality Policy document must be signed by the current management for the location or site in question. It must also be ensured that the Quality Policy, the objectives and the statement of intent are established and identified in the Quality Manual.

The following criteria must be fulfilled:

  • The company has a brief but comprehensive Quality Policy.
  • This Quality Policy should be included in the Quality Manual as well as being on public display.
  • Quality Objectives have been established by management and there is a statement outlining the intent to deliver against these objectives.

The company must ensure that:

  • The Quality Policy is communicated throughout the organisation.
  • All employees, at all levels, receive the same message from management. All statements relating to quality that are in documents, training manuals, advertising literature, etc. must be consistent with the Quality Statement.
  • Any changes must be issued in a controlled manner and must be properly communicated to all employees.

It is now necessary for companies to clearly establish goals and appraise the needs and expectations of customers. As the goals will change and evolve these could be documented and expressed in a quality improvement plan which must be thoroughly examined at management reviews. (discussed below).


To satisfy this requirement the company must ensure that:

  • The Quality Manual contains an Organisational Chart.
  • The Organisational Chart is current, authorised and issued as a controlled document.
  • The management function responsible for quality is clearly identified.
  • The responsibilities and authority of the Quality function are clearly defined.

Responsibility and authority under this clause have been extended to cover product processes and quality system non-conformances. This now places greater emphasis on internal quality system activities such as internal quality audits, corrective/preventative actions and management review.


The company must ensure that:

  • Adequate resources are provided to allow the effective and efficient operation of the Quality Management system.
  • All personnel involved in the verification of the quality of work have sufficient training and resources to allow them to carry out their duties.
  • All operations involved in the verification of work are identified.
  • Training records are maintained to provide evidence demonstrating that suitable training has been provided.
  • Training records are treated as Quality Records and managed as such.
  • Establish a clear division between the responsibility for the work and the responsibility for performing assessments. Until recently it was normal to have these different tasks carried by different groups reporting to different managers but there is no reason why self checking cannot be employed with the same person performing both roles but work must also be subjected to independent verification.
  • Adequate training is provided to do both roles and keep the roles separate.

Resources required must be adequately identified in the quality system: for example Human Resources will be identified under clause 4.18 (Training) and Calibration under clause (4.11)


The company needs to ensure that:

  • A member of the management team is clearly identified as the person with responsibility for implementing and maintaining the requirements of ISO 9000.
  • This authority is formally defined by some method such as job description, organisational chart or Quality Manual.

The management representative must be a member of the management team. A formal mechanism must exist to facilitate the management representative to report to management on system, process or product failures with a view to continually improving the quality system. The standard suggests that the Management Representative be the liaison person with external parties.


According to ISO 9002 management are required to assess the suitability and effectiveness of the quality system, at regular intervals, so that they may identify areas where improvements can be made.

It is suggested that:

  • All affected groups are represented at management review meetings.
  • The review process is described in the Quality Manual.
  • Minutes of meetings are kept, to show what decisions were made and who was responsible for their implementation.
  • Reviews are held at regular intervals (at least once per year).
  • Evidence needs to be provided for external auditors to demonstrate that reviews are planned, effective and that corrective action decisions are made and implemented. It should be noted that the last section of this particular ISO 9002 requirement specifies that records of management reviews are required.
  • Management review records should be treated as quality records and managed at such.

The review must now, in addition to assessing the continuing suitability and effectiveness of the system, determine whether the stated quality objectives have been achieved. This can only be done by agreeing objective targets for quality system improvements and assessing if these have been achieved.

Clause 4.2


Clause 4.2 covers the quality system of the organisation and it's documentation. Initially the system organisation is dealt with and recognised to be part of TQM (Total Quality Management). Output from each function or part must meet agreed customers' requirements, be they internal or external.

The quality system is understood to be interrelated aspects of:

  1. Suppliers' needs and interests.
  2. Customers' needs and expectations.

Therefore a well-planned and managed quality system has to be defined and documented, which are dealt with by quality plan and quality manual sub-clauses. The quality system and plans should be documented in enough detail so that suppliers and customers can understand it and audit the quality system themselves.

This clause requires that the different parts of the company recognise that they are both customers of and suppliers to other parts of the organisation as well as to external customers.

Sub-clause 4.2.1 now makes a Quality Manual an essential part of the quality system it also requires that other documented procedures are referenced from this document. This means that a Quality Manual is now mandatory and must reference all the operating procedures either directly from the text or through a cross reference matrix or table.

Sub-clause 4.2.2 requires that procedures are consistent with our Quality Policy and should reflect the complexity of the work/processes and skills/training required.

The documented procedures must be relevant to the stated quality policy. Where a company can demonstrate through adequate training or other records the acquisition of skills/training by all relevant personnel, detailed procedures are not mandatory; for example personnel who have achieved qualifications through apprenticeship schemes may not require detailed procedures or work instructions.

Sub-clause 4.2.3 requires a company to undertake quality planning as appropriate to the organisation and that this should be defines and documented.

Clause 4.3


This is the clause that the majority of companies have most difficulty with. Some make the mistake of assuming that this clause applies to the relationship between the company and it's vendors when in fact it applies to the relationship between the organisation's front end and clients/customers.

The 1994 version of ISO 9002 places a much greater emphasis on Contract Review.

Where the sales of product and services are covered by contracts there must be clear evidence of a review of terms and conditions.

Attention should be paid to the following:

  • Ensuring requirements are agreed and clearly understood by all involved parties.
  • Checking that all parties have the necessary resources, organisation and facilities.


Verbal contracts must be agreed before acceptance implying that some positive confirmation of order requirements must be made. In practice this could be achieved using fax confirmation messages or logging verbal orders and confirming them back to customers over the phone.


This is a new addition to the ISO 9002 requirement for contract review. The company must have a mechanism for internal communication of all contract amendments ... this could be achieved by reviewing ongoing contracts at the daily production meetings by putting a system in place whereby Scheduling, Planning and Production would be alerted to all changes.

Clause 4.5


This requirement has been updated in the 1994 version (operational since 1 March, 1995.)


  • Clause 4.5 deals with how documentation should be treated. All documents in must be checked before issue or re-issue after revision. Documents must be positioned so that all persons concerned have easy access to them. A master record file has to be kept.
  • People responsible for revision and issuing of documentation must be identified.
  • Sub-clause 4.5.1 clause requires that documents of external origin such as standards and customer drawings are controlled.
  • Sub-clause 4.5.2 requires that all obsolete documents be adequately identified and that all such documents which are held for reference purposes should be suitably identified.
  • NOTE 10 of ISO 9002 states that documents can be in the form of any type of media such as hard copy or electronic media. If the system is totally electronic then there has to be sufficient availability of hardware (terminals, etc.) to facilitate personnel in accessing procedures, work instruction and records.
  • The procedure for document control must clearly identify who has authority to authorise read and / or write access to controlled documents.
  • All electronic document and data systems must have adequate security / backup procedures.

Clause 4.6


Clause 4.6 deals with purchasing. In the procurement of materials or external services, quality need to be assessed in respect to agreed specifications.

Assessment of subcontractors (i.e vendors or suppliers), ensures that all have the capability of supplying materials or services of the required quality. A formal assessment of capability is needed, possibly through an audit of a subcontractor's quality or by way of other evidence. Documented evidence on formal assessments is required.

Purchasing data when placing orders should amount to a formal procedure that ensures all necessary information is given to a vendor. Communication links are a central here and a record of performances is needed.

Sub-clause "Supplier Verification at Subcontractor's Premises"

This sub-clause requires that all details in relation to product verification and the method of product release by the supplier at the subcontractor's premises is described on the purchasing documents.

Clause 4.7


Control of Customer-Supplied Product

Clause 4.7 deals with purchaser supplies. Here, purchaser means our external customers. In manufacturing the external customer may make "Free Issue", which is where they provide materials for incorporation in products they ultimately buy back.

The onus is on the issuer to check quality, but this does not absolve us from knowingly incorporating poor quality components into finished product.


Clause 4.8



This clause deals with product identification and traceability. A manufactured product must be traced through the various stages of its production and delivery. This is crucial to help identify the stage and hence the cause of any product failure. Where different products are similar or identical they must be identified using a method of labelling or coding.

Note: In the case of a mail-order/telesales business this clause may apply to mail, cheques, registration forms, etc.

Clause 4.9


The company must be able to demonstrate that the overall process (sales right through to delivery to the end user) is in control.

There are many significantly different processes in both the manufacturing and service sectors. Accordingly only principles are set out in Clause 4.9, details having to be put in place by each organisation.

The main point is that process steps need to be identified and a plan to implement needs to be declared and documented.

The process must be carried out in a controlled way, so that plans / procedures / instructions are to hand, equipment and personnel used are adequate and that the general conditions are amenable to achieving the plans.

To ensure that a process is carried out in a controlled manner the process must be well documented and the staff well trained.

Clause 4.10


Many changes have been made in the 1994 version of ISO 9002

This clause addresses inspection and testing for incoming goods, in-process and final inspection.

Inspection of incoming materials must be directed by a sampling plan which details the selection of materials for inspection / testing from each received batch. Results must be documented, describing material inspected, number of rejects, reasons for rejection and corrective action.

In-process inspection similarly needs to be dealt with, tying in with clause 4.8 "Product Identification and Traceability".

Upon completion all products must undergo clearly specified final inspection.


Sub-clause is a new addition and reads as follows... "In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided". This deals with the practice of ship-to-stock based on certificates of conformance or other recorded evidence of conformance of product or service.

Clause 4.11


This clause may not apply if test and measuring is not used, but make sure not to overlook the fact that items such a weighing scales require calibration and that in the past some auditors have required that steel rules be calibrated..


This clause covers inspection, measuring and test equipment. It deals with the equipment used in inspection and testing, ensuring that it is suitable for its purpose. Frequency of calibration of equipment used in manufacturing should be based on stability, purpose and degree of utilisation. Records of maintenance work must be retained. Recalibration must be in line with official standards or , where this is not the case, with a clearly documented method.

In order to satisfy this part of the requirement, we must ensure that all equipment used to verify or measure product is subjected to our management control system. All this equipment must be identified and registered and we must have a process for putting all newly acquired equipment on the register.


  • A calibration and maintenance system is in place. A starting point is a calibration register of equipment coupled with the location capital asset register.
  • Trained personnel are available to operate the necessary procedures.
  • No unregistered or overdue equipment is used.
  • Evidence is provided which confirms that procedures are effective.
  • All weighing machines are calibrated.
  • Procedures allow for the use of personal equipment or equipment on loan or trial.
  • Equipment which does not need to be calibrated is identified.

Clause 4.12


This clause deals with inspection and test status. There needs to be an indicator that states what tests a product has been through and whether it passed or failed.

In order to satisfy this part of the requirement, the company must:

  • Have a system or method for identifying the inspection and test status of the product at all relevant stages in the process.
  • Ensure that the system used is defined as part of the process specification or is written documented work instructions.
  • Ensure that the personnel who operate processes related to this segregation system are trained in the discipline required to maintain it.
  • Ensure that only products that have passed the required inspection and tests are shipped, put into use, or installed.

This clause also refers to sub-clause 4.13.2 "Review and Disposition of Non-conforming Products."

  • The responsibility for review and authority for the disposition of non-conforming product shall be defined.
  • Non-conforming material shall be reviewed in accordance with documented procedures and it may be:
  • Reworked to meet the specified requirements:
  • Accepted with or without repair or concession:
  • Regarded for alternative applications:
  • Rejected or scrapped.

Clause 4.13


  • This clause stresses the control of non-conforming product. The aim here is to ensure that non-conforming product is not used by mistake. Non-conforming material must be isolated and clearly identified.
  • Every non-conforming lot should be accompanied by paperwork detailing the reasons for failure.
  • Defects and claims should be sent to vendors without delay.

Clause 4.14


This clause provides for detailed and timely documentation of corrective actions taken. Time must be taken to learn from mistakes but, strictly speaking, clause 4.14 wants avoidance of mistakes to be achieved following analysis of quality records, service reports and customer complaints. In all cases corrective action must be monitored.

To satisfy ISO 9002 requirement 4.14, the Company must:

  • Establish and document a system for investigating the cause of defective products or processes.
  • Establish a system for ensuring that appropriate corrective action is decided upon and implemented.
  • Ensure that responsibility for corrective action is clearly defined.
  • Establish and document procedures for analysing the business.
  • Keep records of all complaints and follow-up actions.
  • Correct any deficiencies before they can cause defects in products or processes.
  • Establish and document a process to ensure that corrective actions are implemented in an effective manner.
  • Keep records of defects, the investigation of their cause and the corrective actions.
  • Establish and document a process that ensures procedure amendments, resulting from corrective actions, are recorded and that work methods are changed to reflect the changes in amended procedures.

Clause 4.15


  • A policy must be set for handling, storage and packaging.
  • Handling of products, i.e. when loading and unloading, must be done with due care for the product.
  • Storage areas must be clean and the environment properly controlled (for example, heat, humidity, light.)
  • Access to storage areas should be controlled. Controls should be implemented to identify slow moving, obsolete, deteriorated and damaged items (some of these may not apply in all cases but scrap should not be allowed to accumulate).
  • The company also needs to ensure the protection of the quality of product after final inspection and test.

Clause 4.16


This clause covers quality records and is of an administrative nature.

Quality records are the routine control and reporting documents that show the progress of the quality management system.

Quality records should be kept over a reasonable length of time and stored in a safe secure area.

The following are key records to be kept:

  • Audits of the quality system.
  • Calibration of test and measuring equipment
  • Analyses of process control data.
  • Records of corrective actions.
  • Customer complaints.
  • Records of concessions (deviations).
  • Training records.


Records may be in the form of any type of media, such as hard copy or electronic media.


Procedures must exist for backup / security of all records on electronic media.

Clause 4.17


Planned and documented checks on the implementation and operation of the Quality Management System help to confirm that it is being operated correctly and effectively.

Internal Quality Audits must be conducted on a regular basis.

Coverage, schedules and standard procedures for each audit must be pre-determined.

Records must be kept, such as the following:

  • Deficiencies found.
  • Corrective action required.
  • Time agreed for corrective action to be carried out.
  • Personnel responsible for corrective action.


The auditor(s) must be independent of the areas being audited.

The results of such audits must form an integral part of the input to management review activities.

Clause 4.18


Clause 4.18 underlines the need for training. Training of personnel is concerned with the competence of personnel to do their assigned task.

Where a lack of skills of qualifications is found, staff need to attend internal or external training courses.

If a member of staff is new to the task then efforts must be made to train them.

Staff performance needs to be regularly appraised and recorded.

Know-how must be kept up to date enabling staff to operate adequately the equipment that they are responsible for.



Clause 4.20


Clause 4.20 stresses the value of measurement using statistical techniques.

Statistical techniques should be used to assess the following:

  • Reliability such as longevity and durability.
  • Process control / capability studies.
  • Determining quality levels and thus inspection plans.
  • Data analysis, performance assessment and defect analysis.

4.20.1 Identification of Need. The term "where appropriate" has been deleted from this clause and the supplier is required to identify the need for statistical techniques in order to control and verify process capability and product characteristics.

4.20.2 Procedures. The supplier shall establish and maintain documented procedures to implement and control the statistical techniques identified.

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