Professional Documents
Culture Documents
management systems
Guidelines for performance
improvements
The ISO
9000:2000
series
by Dr. Lawrence A. Wilson
In brief
Until now, the most intensive use of the ISO 9000 family has centred
on the certification models primarily ISO 9001 and ISO 9002,
and, to a lesser extent, ISO 9003 to the detriment of the quality
management guidance given in ISO 9004 and its related standards.
ISO Technical Committee ISO/TC 176 is out to change that with
the ISO 9000:2000 series.
The emphasis on ISO 9000 certification, as opposed to using the
standards for quality improvement, has now been corrected. ISO
9001:2000 (quality system requirements) and ISO 9004:2000 (organizational performance improvements) have been expressly designed for optimal use in combination as a consistent pair.
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Background
ISO Technical Committee ISO/
TC 176, Quality management and
quality assurance, has recently
completed its first revision since
1994 of ISO 9004, which was published on 15 December 2000 by
ISO as ISO 9004:2000, Quality
management systems Guidelines
for performance improvements.
This guidance standard was revised by Working Group 18 of
Subcommittee 2, Quality systems.
In order to achieve maximum
consistency between ISO 9004:
2000 and ISO 9001:2000, the revision of the two documents was performed simultaneously by Working Group 18.
The joint revision process was
unique in that a project management approach was used to expedite the documents through a series of preparatory activities,
culminating in the actual writing
process being completed in only
three years. The Working Group
Project Manager (or Convener)
was Dr. Jeff Hooper, who di-
ISO 9004:2000
presents the quality
management system
as comprising many
inter-related processes
rected the effort to produce this
consistent pair of standards. Due
to the worldwide interest in the
revision of the two standards and
on behalf of SC 2, its Chairman
Dr. John Davies and Secretary
Charles Corrie, Dr. Hooper
maintained high visibility within
ISO/TC 176 during the revision
process.
Dr. Hooper was responsible for
a number of innovations, such as
the intensive use of electronic
communication (e-mail and Web
sites) to ensure that the revision
activities continued between international meetings.
Most readers will be familiar with the basics of ISO 9000 certification, even if the requirements of ISO 9001:2000 have evolved
considerably. But what is the born again standard, ISO 9004:2000
all about and what benefits is it expected to bring to the organizations that implement it?
Relationship between
ISO 9004:2000 and
ISO 9004-1:1994
The new ISO 9004:2000 is
clearly not an in-line or step-evolution descendant from the previous version, ISO 9004-1:1994,
Quality management and quality
system elements Guidelines. In
fact, there is very little relationship between the newly released
ISO 9004:2000 and its predecessor. A completely different approach has been taken regarding
the nature and application of the
technical content of ISOs new
version of ISO 9004.
Such a radical departure from
previous approaches was determined to be essential, in response
to:
the absence of user interest in
the 1994 version as a guide-
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ISO 9004:2000 as a
management tool for
improving the organization
in pursuit of continual improvement, and resultant organizational success. The concepts are
integrated within the clauses and
text of both standards. Whereas
the ISO 9001:2000 standard focuses on the provision of satisfactory product to customers, ISO
9004:2000 is directed toward performance improvement and the
satisfaction of all interested parties of the organization. Interested parties have a stake in the
success of the organization and
benefit in some way from the organizations success.
These quality
principles are:
management
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ISO 9004:2000 is
directed toward
performance
improvement and the
satisfaction of all
interested parties of
the organization
The guidance
in the standard
tends to convey
a representative set
of best practices
for management
consideration
Even though the two standards
have a consistent structural outline, most notable in the respective table of contents, ISO
9004:2000 does not cover the
same textual content as ISO
9001:2000. For example, a given
topic in ISO 9004:2000 may address the effective and efficient
improvement of all the realization and support processes in the
total organization to the satisfaction of all its interested parties. In
contrast, ISO 9001:2000 approaches the same topic with the
more limited scope of the effective improvement of the realization process as it relates to satisfying customer requirements.
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7) looks beyond ISO 9001 toward the pursuit of excellence by the organization,
Clause 5 Management
responsibility
Clause 6 Resource
management
Clause 6.1.1 Top management
should ensure resources necessary for its strategy and objectives
Clause 6.2.2.1 Resources include anticipated management and workforce succession needs
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The self-assessment
approach is not a
substitute for the
formal internal audit
process
Clause 7.2 Process review information includes market research, with sector/end-user
data
Clause 7.3.1 Besides specified
design factors, consider life cycle, usability, ergonomics, risk
Clause 7.3.2 Consider needs and
expectations of end-users, as
well as those of direct customers
Clause 7.3.3 Design review
should evaluate potential hazards or fault modes in product
use
Clause 8 Measurement,
analysis and improvement
Clause 8.1.1 Organization must
ensure the validity and purpose of measurements/data
add value
Clause 8.1.2 Measurements of
customer satisfaction are vital
for evaluation of the organization
Clause 8.2.1.1 Improvement areas can be noted from satisfaction surveys from interested
parties
Clause 8.2.1.2 Satisfaction data
may be from focus groups, sec-
Analyzing
nonconformities may be carried out by an individual or by
a corrective-action team
Clause 8.5.3 Management
should plan systematic mitigation of losses, by a loss prevention plan
Clause 8.5.4 Management
should create an environment
to involve people pursuing improvement
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Approaching
continual
improvement as an
investment will
result in sound
business decisions
Self-assessment is a judgement
based on a simple evaluation
made by knowledgeable people,
anticipated to be the top management, who go through a process of
asking and answering key questions. The assessment may or may
not require the assessor to go to
the pertinent site. The assessment
may be for all or a small part of
the system, may be done as convenient, by one person or several,
or may be used as a simple indicator to be combined with other
measures. Annex A has not been
developed to be used in competition with other self-assessment approaches.
Sample questions are provided
in the Annex. However, the user,
or the organization itself, may develop even more suitable questions, ones directly relevant to its
operations. In other words, using
Annex A as a guide, the user organization can tailor the questions
to its own concerns and interests
and use the answers to determine
approximately where it stands in
relation to where it wants to be.
Used over a period of time, the
management of the organization
can monitor apparent change, the
direction of the change and
whether the rate of change is as
expected or desired. Over time,
the degree of maturity of the quality management system and indeed the organization itself may
be observed and monitored.
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Summing up
ISO 9004:2000 has been developed as one member of a consistent pair of quality management
standards, the other member being ISO 9001:2000. Both standards are based on a set of quality
management principles that have
been integrated into the content
of each standard. ISO 9004:2000
permits the management of the
organization to go beyond the requirements of ISO 9001 to pursue
performance improvement of the
quality management system and
ultimately performance improvement of the organization itself,
thus benefiting the organizations
interested parties.
The recommendations and content of ISO 9004:2000 can be used
as a tool to move the organization
as far toward improved performance as desired by the management and permitted by the resources. The standard also has an
annex for guidance on self-assessment and one on a continual improvement process.