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42 B u s i n e s s - I n t e g r a t e d Q u a l i t y S y s t e m s A p p r o a c h e s t o Q u a l i t y 43

3. Fragmented approach to the quality management system. The famous
“20 Quality Elements” defined in the first two editions of ISO 9001
offered an easier (almost a checklist) approach to developing a
quality management system. Unfortu-nately, few of the elements
can exist by themselves, but instead form parts of a unified system.
The fragmented elements do not describe how an organization
actually operates.
4. Not enough focus on human resources. Other than the requirements
for training, the first two releases of ISO 9001 dealt very little with
human resources and the needs of an organization’s employees.
An organization could actually have dangerous working condi-
tions or treat its employees unfairly and be registered in good
standing to ISO 9001.
5. Not enough emphasis on customer communication. Other than in the
area of resolving differences during the contract review phase, the
first two editions of ISO 9001 dealt very little with the importance
of customer communication. Organizations that had developed
the most successful quality management systems understood the
importance of keeping customer communication and satisfaction
at the forefront of everything they did. These organizations espe-
cially felt that the first two editions lacked the necessary focus.
6. An ISO 9000 quality management system does not improve product or
service quality. Expecting ISO 9000 to directly create improved
quality is somewhat like expecting the accounting system to
directly create profitability. In any case, disappointment has been
widely expressed about organizations with ISO-compliant qual-
ity management systems producing inferior goods or services.
7. Not enough emphasis on management using hard data in decision mak-
ing. Under the first two editions of ISO 9001, top management’s
involvement could be limited to periodic management reviews. In
some organizations, top management tried to relinquish control
over the quality management system by delegating this key man-
agement duty to the quality manager. This hands-off approach to
quality system management was often manifested in the lack of
consistent data collection and analysis.
8. Not well integrated with ISO 14001. Organizations that were
involved with audits of their environmental management system
encountered difficulties in integrating the system design and
auditing between ISO 14001 and ISO 9001.
9. Too prescriptive. The wide variety of goods and services provided by
the world’s various organizations has resulted in widely disparate
needs and expectations for quality management systems. As organi-
zations attempted to accommodate the ISO 9000 family of standards

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