Computerized

Medical Imaging
and Graphics
PERGAMON Computerized Medical Imaging and Graphics 25 (2001) 217±220
www.elsevier.com/locate/compmedimag

The bene®ts of total quality management

H.P.A. Geraedts a,*, R. Montenarie a, P.P. van Rijk b
a
Division for Radiology, Radiotherapy and Nuclear Medicine, University Medical Centre, E 01.334, P.O. Box 85500, 3508 Utrecht, The Netherlands
b
Nuclear Medicine Department, University Medical Centre, Utrecht, The Netherlands
Received 20 April 2000

Abstract
In this article, we will review the implementation of the ISO 9000 quality system in the Department of Nuclear Medicine. We will also
discuss the bene®ts of working with the ISO 9000 standards and explain why we have shifted our focus from ISO 9000 towards the EFQM
model. After an introduction concerning Total Quality Management and the EFQM model, we will describe how we have used the EFQM
model to date and how we intend to implement TQM in the future. q 2001 Elsevier Science Ltd. All rights reserved.
Keywords: Quality management; Nuclear medicine; EFQM; ISO 9000 certi®cation; Implementation

1. Introduction ing our perspective on quality management. We have decided

The Departments of Radiology, Radiotherapy and
Nuclear Medicine of the University Medical Centre in
Utrecht, The Netherlands, are combined within one decen-
tralised division. In 1995, our division initiated a strategic
planning process, resulting in a strategic vision and a
mission statement. During the planning process, the division
management concluded that development of an integrated
quality system was of great strategic importance to the three
departments of the division. Three motives prompted this
conclusion. First, due to government policy, our division
was faced with an increasing demand for medical activities
and decreasing budgets, making it essential to control both
quality and costs. Second, in the past many quality improve-
ment projects had been carried out, but due to the growing
interrelation between the different projects, an integral and
systematic approach was needed. Finally legislation has
recently been passed by which the Dutch government
requires health care organisations operate a veri®able qual-
ity control system. After reviewing existing methods for
design of quality systems, we chose to implement a system
of quality assurance in accordance with the ISO 9000 stan-
dards. In July 1997, we completed the implementation of
our ISO 9000 quality system within the Department of
Nuclear Medicine and obtained an ISO 9002 certi®cate.
Now, two years later, we have reached the limits of bene®ts
from the ISO-quality system and we are focussing on widen-
* Corresponding author. Tel.: 131-30-250-6083; fax: 131-30-251-3399.
E-mail address: h.geraedts@azu.nl (H.P.A. Geraedts).
0895-6111/01/$ - see front matter q 2001 Elsevier Science Ltd. All rights reserved.
PII: S 0895-611 1(00)00052-5
to adopt the principles of Total Quality Management (TQM).
In order to translate these principles into everyday practice, we
now use the Business Model for Excellence, developed by the
European Foundation for Quality Management ([1]). This
model may be considered complementary to the existing
ISO 9000 system for quality assurance.
2. Quality assurance according to ISO 9000 standards
About 10 years ago, the International Standardisation
Organisation issued standards for the design of quality
assurance systems. These so-called ISO 9000 standards
were originally designed for manufacturing of products,
but they are now used in a variety of organisations and indus-
tries. The standards offer suf®cient ¯exibility to be applied in
health care organisations. In addition, a nuclear medicine
department has many characteristics of a typical production
organisation. A quality assurance system as laid down by
the ISO 9000 standards has three main characteristics:
1. The principle focus is on the process of service delivery
itself, not on the outcome.
2. There is a systematic approach. This implies that working
processes and resources are identi®ed, and that the perfor-
mance is measured on a regular basis, using performance
indicators.
3. The system has to be veri®able by means of documents such
as a quality handbook, procedures describing the most
important working processes, standard operating proce-
dures/instructions, and the measurement of performance
218 H.P.A. Geraedts et al. / Computerized Medical Imaging and Graphics 25 (2001) 217±220
indicators. All documents need to be updated, authorised
and distributed according to standards for document
control. Any improvement in the work¯ow necessitates
an update of the speci®c procedure. Employees are
informed immediately when they receive the updated
procedure.
Working with an ISO 9000 system has a number of bene®ts.
First, processes within the organisation are transparent,
enabling controlled changes to be made. Furthermore,
processes are audited periodically by both internal and exter-
nal auditors. Both audits are obligatory for maintaining a valid
ISO 9000 certi®cate. Second, a strict document control proce-
dure is part of an ISO-quality system. This makes it possible to
create relevant procedures and protocols and to maintain them
within the organisation. Especially for technological depart-
ments such as nuclear medicine, maintaining relevant techni-
cal and working documents is vital for quality control.
Furthermore, an ISO 9000 quality system is quite suitable
for seeking continuous improvement by means of perfor-
mance indicators (PIs). The organisation has to decide
which performance indicators are relevant for monitoring its
processes and output. The next step is to set a minimum stan-
dard for each PI that is both reasonable and acceptable. Estab-
lishing the method and frequency of the measurements are
important factors. After these preparations, the actual moni-
toring of the PIs can begin. If PI results do not meet the given
standards, it may be necessary to take corrective measures.
The use of performance indicators can be a very confronta-
tional instrument for monitoring quality. Within the Depart-
ment of Nuclear Medicine, we have identi®ed four categories
of performance indicators: production, costs and ef®ciency,
process quality and customer satisfaction. An ISO quality
system is a stable system within a dynamic organisation.
The changes made in the ISO quality system are incremental
and incident driven. When a quality system is used for two to
three years, the bene®ts from the system revoke to the basic
bene®ts mentioned above. This means that in our division,
where we had our ®rst quality system certi®ed in December
1995, we are reaching the limits of the bene®ts of ISO. This
was the primary reason for considering a new quality manage-
ment model, preferably a model that complements our present
ISO 9000 system. The most important requirement for the new
model was its ability to focus on both organisational and result
aspects and their relationship to each other. These are elements
that a classic ISO quality system does not focus on but takes for
granted. We found our demands met in the model for TQM of
the European Foundation for Quality Management (EFQM
model).
3. Total quality management and the EFQM model
The European Foundation for Quality Management [2]
de®nes Total Quality Management as: ªAll manners in
which an organisation meets the needs and expectations of
its customers, personnel, ®nancial stakeholders and society
in generalº. This de®nition is fairly abstract since Total
Quality Management (TQM) can be considered a philoso-
phy rather than a model or a method. Many de®nitions are
therefore used to describe it. However, it is widely accepted
that TQM is based on three principles:
² customer focus; every decision is taken with the custo-
mers needs in mind;
² continuous improvement; continuous efforts to improve
the organisation, its products and its services;
² integral approach; TQM concerns every aspect of the
organisation.
Many tools, methods and models have been developed
world wide in order to give substance to the concept of
TQM. In Europe, the Model for Business Excellence, issued
by the European Foundation for Quality Management, has
gained broad acceptance among both pro®t and non-pro®t-
making organisations. With this model organisations can
evaluate their progress towards Total Quality. The EFQM
Model for Business Excellence consists of nine distinctive
areas, each representing a different aspect of the organisa-
tion. These nine areas are subdivided into areas concerned
with what results have been achieved (Results) and areas
concerned with how these results have been achieved
(Enablers). Fig. 1 shows the nine areas and how they are
related to each other.
The Model for Business Excellence serves as a useful
framework within which to structure quality improvement
efforts because of its integrated cycle for continuous
improvement. The cycle begins by carrying out a self-
assessment to see what Results are achieved at a given
moment. Based on these ®ndings, organisations can decide
what improving actions must be taken to strengthen one or
several Enablers, in order to achieve better results next time.
For example: if an organisation wants to improve People
(employee) satisfaction, it has to strengthen People Manage-
ment and also perhaps Leadership, and Policy and Strategy.
This can be realised by improvement actions in these parti-
cular areas.
After such improvement actions have been implemented,
the organisation again carries out a self-assessment in order
to see if the improvement actions have resulted in a better
overall performance. Based on this second assessment, new
Result areas can be selected for improvement, and so the
cycle begins again. At the end 1998, the management of the
Department of Nuclear Medicine launched a long-term
project to implement the TQM principles, by using the
EFQM model. The project commenced with a meeting for
all our employees, to inform them about TQM, the EFQM
model and the self-assessment, which will take place in the
second half of 1999. The department is presently in the
middle of a strategic planning process which ends with
Strategic Plan 1999±2004 and a long-term investment
 H.P.A. Geraedts et al. / Computerized Medical Imaging and Graphics 25 (2001) 217±220
Fig. 1. EFQM model for business excellence.
plan. Meanwhile a patient satisfaction survey has been
carried out and preparations are being made for the self-
assessment and the implementation of a work¯ow manage-
ment system. After the strategic planning has ended, in July
1999, a special task force will perform a self-assessment
according to the EFQM Model for Business Excellence.
The outcome of this self-assessment will be discussed in
several meetings with groups of employees. Based on
these discussions, a ®nal conclusion will be drawn concern-
ing the present position of the department on the areas of the
EFQM model. The management team will then decide
which areas will be the focal point for the next two years
so that speci®c improvement projects can be developed.
However, the EFQM is not only useful for future improve-
ment initiatives. Current improvement projects can also be
(re)prioritised and evaluated on the basis of the self-assess-
ment. It is important to emphasise that the role of the ISO
9000 system is unchanging. It will still be used for control of
all the critical processes within our department. The ISO
9000 system can be regarded as a solid basis for all future
TQM efforts.
4. Conclusions
Total Quality Management is an excellent model to use
after successful implementing of an ISO 9000 Quality
system. The EFQM model makes it easy to enlarge the
quality management viewpoint and to take an objective
look at your organization and the results it achieves. It
helps to relate the different aspects of the organization to
one balanced viewpoint. Furthermore it helps to set priori-
ties in the improvement projects, and it is an adequate model
for evaluation of the achieved improvements.
Please note that the references given below are not
directly related to the text of the article, they should there-
fore be considered as suggestions for further reading.
5. Summary
The Departments of Radiology, Radiotherapy and
Nuclear Medicine of the University Medical Centre in
219
Utrecht, Netherlands, are combined within one decentra-
lised division. In 1995 this division initiated a strategic
planning process, resulting in a strategic vision and a
mission statement. During the planning process the division
management concluded that development of an integrated
quality system was of great strategic importance to the three
departments, for three reasons. Firstly, the division was
faced with an increasing demand for medical activities
and decreasing budgets, making it essential to control both
quality and costs. Secondly, due to the growing interrelation
between different improvement projects, an integral and
systematic approach was needed. Finally, the Dutch govern-
ment now requires health care organisations to operate a
veri®able quality control system.
In July 1997, the Department of Nuclear Medicine
completed the implementation of its ISO 9000 quality
system and obtained an ISO 9002 certi®cate. Working
according to ISO 9000 standards has had a number of bene-
®ts for the department. For example, a strict document
control procedure makes it possible to create and maintain
relevant procedures and protocols. This is vital for quality
control, especially for technological departments such as
nuclear medicine.
Now Ð two years later Ð we are reaching the limits of
the bene®ts of ISO. This was the primary reason to consider
a new quality management model, preferably one that
complements the ISO 9000 system. The Department of
Nuclear Medicine, as well as the rest of the University
Medical Centre, has chosen to work with the Model for
Business Excellence, developed by the European Founda-
tion for Quality Management.
The EFQM Model consists of nine distinctive areas,
each representing a different aspect of an organisation.
These nine areas are subdivided into areas concerned
with what results have been achieved (Results) and areas
concerned with how these results have been achieved
(Enablers). The model serves as a useful framework to
structure quality improvement efforts because of its inte-
grated cycle for continuous improvement. The cycle begins
by carrying out a self-assessment to see what Results are
achieved at a given moment. Based on these ®ndings orga-
nisations can decide what actions must be taken to
220 H.P.A. Geraedts et al. / Computerized Medical Imaging and Graphics 25 (2001) 217±220
strengthen one or several Enablers, in order to achieve better
results next time.
At present, a special task force is performing a self-
assessment. The outcome of this assessment will be
discussed in several meetings with groups of employees to
determine the present position of the department on the
areas of the EFQM model. The management team will
then decide which areas will be the focal point for the
next two years so that speci®c improvement projects can
be developed. The role of the ISO 9000 system remains
unchanged.
The EFQM model makes it easy to enlarge the quality
management viewpoint and to take an objective look at the
organization and the results it achieves. It helps to relate the
different aspects of the organization to one balanced view-
point. The combination of ISO 9000 and the EFQM-model,
within the framework of Total Quality Management has
proven to be very useful and effective so far.
References
[1] Total Quality Management. The European Model For Self-Appraisal,
Europeen Foundation for Quality Management, 1993.
[2] Foley EC. Winning European Quality, interpreting the requirements
for the European quality award. European Foundation for Quality
Management, 1994.
Harm P.A. Geraedts was born in 1968. He graduated from the Maas-
tricht University in Health Sciences. He currently holds the position of
Junior Managing Director within the Division of Radiology, Radiother-
apy and Nuclear Medicine at the University Medical Centre in Utrecht,
the Netherlands and has an MBA degree. Mr Geraedts has been
involved in the implementation of ISO 9002 since the division ®rst
started working with these standards in 1994.
Richard Montenarie was born in 1971. He graduated in Quality
Management from the University of Lincolnshire and Humberside,
Great Britain. He holds the position of Quality Management Of®cer
within the Division of Radiology, Radiotherapy and Nuclear Medicine
as well as the Heart Lung Institute, both at the University Medical
Centre in Utrecht, the Netherlands. He is specialised in the implementa-
tion of the EFQM Model for Business Excellence.
Peter P. van Rijk was born in 1944. He graduated from Utrecht
University Medical School. Dr van Rijk holds the position of Medical
Director in the Department of Nuclear Medicine of the University
Medical Centre in Utrecht, the Netherlands. He was Chairman of The
Netherlands Society of Nuclear Medicine from 1994 to 1999. Since
1999, he has been President-Elect of the European Association of
Nuclear Medicine in order to organise the Association's congress in
Amsterdam in 2003.