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IJQRM
25,7

Vectors of innovation to support

quality initiatives in the
framework of ISO 9001:2000

674
Received July 2007
Revised February 2008
Accepted March 2008

Stelian Brad
Department of Production Equipment and Industrial Robotics,
Technical University of Cluj-Napoca, Cluj-Napoca, Romania
Abstract
Purpose The purpose of this paper is to investigate hidden/less tangible dimensions of ISO
9001:2000 standard for better understanding where there are potentials for designing and
implementing highly mature quality management systems (QMSs).
Design/methodology/approach Based on advanced quality tools, 80-20 rule and inventive
problem-solving algorithms, a novel methodology is developed and applied for quantifying the value
weight of ISO 9001:2000 requirements in the equation of business competitiveness, for identifying
critical issues, conflicts and barriers within projects dealing with quality management system (QMS)
design and implementation, as well as for defining in a systematic way innovative solutions to the
challenges arising from these analyses.
Findings A quantitative assessment of the conformity that business processes have relative to ISO
9001:2000 requirements is possible even in the early stage of designing the QMS. A large number of
conflicts and barriers could affect the performance of a QMS. Mature QMSs should consider innovative
vectors of intervention from the early phases of their planning and designing processes.
Research limitations/implications The set of criteria and their ranks that were used to
determine the value weights of the requirements within ISO 9001:2000 have been established only with
a focus group of stakeholders; an extensive survey might reveal slight differences of results.
Practical implications ISO 9001:2000 provides only a generic framework for bringing quality to
life. Both careful performance planning and process innovation are required to elaborate a mature
QMS.
Originality/value The paper reveals a novel tool for quantifying the gap between a given quality
management system and ISO 9001:2000 requirements. A comprehensive set of innovative solutions for
approaching the design and implementation of a QMS in a competitive way are also provided.
Keywords Quality management, Quality function deployment, Quality audit, Innovation,
ISO 9000 series
Paper type Research paper

International Journal of Quality &

Reliability Management
Vol. 25 No. 7, 2008
pp. 674-693
q Emerald Group Publishing Limited
0265-671X
DOI 10.1108/02656710810890872

Introduction
In the present economic environment, more and more companies implement quality
management systems (QMSs) in the attempt of bringing supplementary competitive
advantages to their businesses (e.g. Poksinska et al., 2006; Savaira and Duarte, 2003;
Stone, 2003). Most of the QMSs are based on ISO 9001:2000 standard (ISO, 2000; Arauz
and Suzuki, 2004; Merino-Diaz de Costa, 2003; Paper and Chang, 2005; Savaira and
Duarte, 2003, etc.). Implementation of QMSs involves complex sets of interrelated
Financial support from the Romanian Ministry of Education and Research, within the grant IDEI
856, is acknowledged with gratitude.

activities (e.g. Addey, 2001; Chen and Tsou, 2003; Leonard and McAdam, 2002; Gingele
et al., 2002). This generates constant pressures on companies to change their
organizational culture, attitude and behaviour (both at strategic and operational levels)
(e.g. Arauz and Suzuki, 2004; Chang and Lo, 2005; Claver and Tari, 2003; Conti, 2004;
Martinez-Costa and Martinez-Lorente, 2003; Naveh et al., 2004).
Despite the fact many companies invest significant resources in obtaining
certification of their QMSs according to ISO 9001:2000 standard, they have different
motives to do this, which finally influence the outcomes. There are companies which
use certification mainly for marketing purposes, while some others consider it as a path
for continuous improvement of their organizations (e.g. Naveh et al., 2004; Pivka and
Mulej, 2004; Savaira and Duarte, 2003; Stone, 2003). Park et al. (2007) conclude that
companies which are certified because of internal development reasons performed
compliance with the major requirements of ISO 9001:2000 standard better than those
certified just because of customer request; also, companies with different operating
periods show significant difference in performance for infrastructure, purchasing,
monitoring and measurement.
Studies done by Poksinska et al. (2006) show that ISO 9001:2000 is only a framework
for identifying and managing activities that have an impact on quality; a QMS and its
effects on business performance are not determined by ISO 9001:2000 requirements, but
by the organizational context and the way the system is implemented and operated.
Pivka (2004) has also shown that quality assurance with the formal fulfilment of ISO
9001:2000 standard requirements does not help companies to achieve greater
competitiveness and business success. The quality system compliance with standard
requirements confirms that the company has achieved a maturity level that is capable of
defining processes and performing them according to the definitions; and this not
necessarily means business processes are also efficient. In the same line, Arauz and
Suzuki (2004) found that the activities embraced during the different stages of
preparation for certification influence the performance and the influential factors vary
according to firm size. Keeping the same register, Martinez-Costa and Martinez-Lorente
(2003) highlight that acquisition of ISO 9000 certification by companies does not
necessarily lead to a rise of firms market value. Therefore, Pivka (2004) considers that
quality audits bring value-added in the attempt of increasing process efficiency and
effectiveness. Dereli and Baykasoglu (2006) came to the same conclusion. Their
researches show that ISO 9000 certification process is a cybernetic system where the
feedback part is quality auditing and an effective auditing can therefore improve and
accelerate the certification process. In addition, Lin and Wu (2006) see quality auditing a
point of departure for creating innovation within an organization.
Successful implementation of a QMS requires appropriate project formulation (e.g.
Addey, 2001; Chen and Tsou, 2003). In other words, projects related to QMSs
implementation should consider from the early stages of their lifecycle the right
activities, in the right order and with the right resource involvement, for faster
generation of the expected benefits (e.g. Tsim et al., 2002). In this context, Lin and Wu
(2005) identify the most important activities within ISO 9001:2000 processes which can
facilitate knowledge flow and propose a comprehensive ISO 9000 process-based
knowledge management system architecture which is derived from the in-depth
interview and qualitative analyses. Also, Lewis et al. (2006) made a synthesis of the
literature on TQM implementation in SMEs and identified related critical factors. These

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factors are prioritized according to the frequency in which they appeared. The
compliance requirements of the ISO 9001:2000 standard are mapped to the quality
management principles on which the standard is based. They reveal a need for exploring
various soft and hard factors to enrich practices of TQM implementation. Also, in their
researches, Vouzas and Gotzamani (2005) show that many companies deal with a
number of problematic areas in growing the maturity level of their QMSs following some
excellence models like, for example, EFQM: increased bureaucracy, lack of flexibility in
the design and implementation of the model, low utilization of employees skills and
knowledge. This is because companies usually approach this process in an empiric way.
In this respect, it should be sustained the conclusion of Leonard and McAdam (2002)
about the necessity to align quality programmes with business strategy to ensure that
quality efforts reflect the long-term goals of the organization. But, as Tsim et al. (2002)
highlight, top management is still weak in the adoption of quality management systems,
establishment and implementation of the quality policy and objectives. At the same time,
certified organizations spend a lot of effort for the compliance with the process approach
management. As a conclusion, Tsim et al. (2002) introduce the consideration of
improving quality management systems in areas of effectiveness, efficiency,
productivity, flexibility and adaptability, rather than product.
In the attempt of setting up early mature QMSs, innovation must be considered
during all major steps in designing, implementing and maintaining a QMS based on
ISO 9001:2000. These steps are:
(1) Analysis of the ISO 9001:2000 requirements.
(2) Introduction of interpretive schemes based on experience and technical
background.
(3) Management decision on expand the effort for producing the QMS.
(4) Integration of business strategy with strategic quality management goals.
(5) Integration of strategic organizational policies within a quality manual.
(6) Implementation of the designed QMS.
(7) Demonstration that QMS is effective against quality objectives.
A critical point in this effort is the commitment of the top management to set priorities
in appropriate resource allocation during the design and implementation of QMS. In
most of the cases, managers have a wrong picture of the conformity the business
process has against ISO 9001:2000 requirements (e.g. Chang and Lo, 2005; Claver and
Tari, 2003; Leonard and McAdam, 2002, etc.). This comes from the difficulty to
quantify the level of conformity in the initial phase of the design process (e.g. Conti,
2004). Some of the risks that emerge from this drawback are lower levels of maturity of
the QMSs and/or a longer time and effort to define a mature QMS. Keeping in mind one
of the most important principles in quality management it is better to act
preventively than correctively the idea is to define a tool able to quantify the initial
level of conformity that the business process of the organization has against the set of
requirements stipulated within the ISO 9001:2000 standard.
Under the circumstances mentioned previously, one should conclude that it might
be of real support the use of specific instruments for quantifying business process
conformance with ISO 9001:2000 requirements from the very early moments of QMS
design and implementation. It is one of the purposes of this paper to introduce such a

methodology. As it was already highlighted, in most of the cases the implementation of

QMSs is performed empirically, based on previous experiences of consultants.
However, even if good expertise is brought by consultants, it is of qualitative nature.
Each company is a unique case, so, an optimal implementation of QMSs requires
powerful tools to quantify criticalities, as well as requires robust ways to prioritize
efforts under the framework of many project-related constrains. Lack of such tools
generates sub-optimal solutions in QMSs implementation, which afterwards leads to
negative feedbacks in terms of QMS effectiveness. In order to overcome such
drawbacks, a specific research has been conducted by the author of this paper for
identifying robust approaches of implementing QMSs. Results of this research are
presented in this paper, too.
Research methodology
To obtain a mature QMS even from the early stages of its implementation, a deep and
suitable understanding of ISO 9001:2000 requirements in relation with the specific case
of internal processes and of the business environment where the company runs its
activity is necessary. Handling properly this task is a big challenge considering the
large number of inputs (over 260 inter-correlated requirements of ISO 9001:2000
standard), the relative large set of conflicting problems within the core business
processes, permanent crisis of resources (human, financial, informational, time), crisis
of facilities (e.g. IT infrastructure, production process automation, etc.) and others. To
overpass these barriers, orientation of the research efforts towards better
understanding of the critical, hidden aspects of QMS design and implementation
process according to ISO 9001:2000 standard is required.
The author considers that the process of improving QMS design and
implementation should take into account two key aspects from the perspective of
research and analysis:
(1) How to approach reengineering of current business processes (if necessary)?
(2) How to structure a project dealing with QMS design according to ISO 9001:2000
requirements; that is which should be the type and content of project activities,
how to schedule them and how to monitor them?
To find an answer to these questions, a methodology that uses advanced quality
management tools for handling complexity around the issues under consideration is
step-by-step described in this section:
(1) Define and rank a key set of business competitiveness related criteria. Various
well-known approaches could be used to fulfil this step. A possible way is to
involve a focus group of representatives from industry for criteria definition.
For ranking, the focus group could use the AHP or PMM methods (Cohen, 1995).
There are denoted with CC i ; i 1; . . . ; n the criteria and with Ri ; i 1; . . . ; n
their ranks (degrees of importance).
(2) Elaborate a detailed list of ISO 9001:2000 requirements and organize them on
affinity groups. There are considered m affinity groups AF j ; j 1; . . . ; m, each
having QRkj ; k 1; . . . ; hj ; j 1; . . . ; m ISO 9001:2000 quality requirements.
(3) Determine the value weight of each ISO 9001:2000 quality requirement. QFD
method (Cohen, 1995) could be used to determine the value weight of each

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affinity group (W j ; j 1; . . . ; m) and afterwards to determine the global value

weight
of
each
requirement
inside
the
affinity
groups
(W kj ; k 1; . . . ; hj ; j 1; . . . ; m). Inputs in the weighting process are the
competitiveness criteria and their ranks. There are denoted with
aij ; i 1; :::; n; j 1; . . . ; m; aij [{0, 1, 3, 9, 27} the relationship coefficients
between CC i ; i 1; :::; n and AF j ; j 1; . . . ; m. There are denoted with
aikj ; i 1; :::; n; k 1; . . . ; hj ; j 1; . . . ; m; aikj [{0, 1, 3, 9, 27} the
relationship coefficients between CC i ; i 1; . . . ; n and the set of ISO
9001:2000 quality requirements QRkj ; k 1; . . . ; hj ; j 1; . . ., m within the
affinity group AF j ; j 1; . . . ; m. The significance in linguistic terms of the
numbers within the set {0, 1, 3, 9, 27} is {no relationship, possible/weak
relationship, medium relationship, strong relationship, very strong/critical
relationship}. Value weights are calculated as follows:
n
X
Ri aij
Wj

i1
m X
n
X

Ri aij
j1

n
X

W kj

i1

Ri aikj

i1
hj X
n
X

Ri aikj
k1

100; j 1; m

W j ; k 1; h
j ; j 1; m

i1

(4) Use the results from the previous step as a mechanism for quantifying the gap
of a given business system relative to ISO 9001:2000 requirements. A numerical
scale of integers {Lmin ; Lmin 1; . . . ; Lmax } could be considered to assess the
level of conformity LC kj ; k 1; . . . ; hj ; j 1; . . . ; m against each ISO
9001:2000 quality requirement QRkj ; k 1; . . . ; hj ; j 1; . . . ; m. As a
practical example, the numerical scale could be: 0 no conformance, 1
very poor conformance, 2 poor conformance, 3 close to conformance, 4
conformance with low efficiency, 5 conformance with medium efficiency, 6
conformance with high efficiency, 7 conformance with very high efficiency
(close to ideal). Knowing the value weight W kj ; k 1; . . . ; hj ; j 1; . . . ; m of
each requirement QRkj ; k 1; . . . ; hj ; j 1; . . . ; m (determined with formula
(2)) and the level of conformity of the business system LC kj ; k 1; . . . ; hj ; j
1; . . . ; m against each requirement, a global assessment of the business system
relative to the ideal case can be established. The formula for the global mark in
relative units GM [%] is the following:
hj
m X
X

W kj LC kj

GM %

j1

k1

L max

%

Before starting any process of QMS design, an audit of the current practices
within organization with respect to ISO 9001:2000 quality requirements QRkj ; k
1; . . . ; hj ; j 1; . . . ; m is conducted and the global mark GM [%] can be
calculated. This audit offers to the top management a quantitative
macro-indicator about the state of organization in the starting phase of QMS
design and implementation. Thus, higher commitments and involvements from
the top management, as well as adequate resources could be expected to support
the project related to QMS design and implementation from its early phases.
(5) Define a key set of ISO 9001:2000 quality requirements applying the 80-20 rule
on the set QRkj ; k 1; . . . ; hj ; j 1; . . . ; m with respect to their value weights
W kj ; k 1; . . . ; hj ; j 1; . . . ; m. The new set actually represents the minimal
set of ISO 9001:2000 quality requirements which bring the greatest contribution
to business competitiveness from the perspective of ISO 9001:2000 standard. It
is denoted with QR80220p ; p 1; . . . ; z; z , m the new set of ISO 9001:2000
quality requirements and with W80220p ; p 1; . . . ; z their value weights.
(6) Determine the relative impact that each requirement within the set
QR80220p ; p 1; . . . ; z, has upon the other requirements from the set. In this
respect, the influence coefficients cij ; i j; i; j 1; . . . ; z of requirement
QR80220i upon requirement QR80220j are first determined. A numerical scale
could be used to express the influence levels (e.g. 0 no influence, 1 poor
influence, 3 medium influence, 9 strong influence, 27 very strong influence).
The relative impact IM p ; p 1; ; . . . ; z, is expressed by the following formula:
z
X
Wp
cpj
IM p

z
X
p1

j1;jp
z
X

W p

100; p 1; z

cpj

j1;jp

(7) Define the minimal set of requirements from the set resulted at step 5 by
applying the 80-20 rule with respect to the relative impact calculated with
formula (4). This is a critical set of requirements in terms of QMS success.
Considering technical difficulties in approaching these requirements, a sub-set
of requirements can be even further extracted. For this sub-set, a list of potential
problems must be identified. If these problems are not properly solved, the
effectiveness and efficiency of the QMS is seriously jeopardized.
(8) Elaborate innovative solutions to the problems revealed at step 7. The TRIZ
method could be successfully applied in this respect (e.g. Altshuller, 2000).
However, the application of any other method of innovation and creative
thinking is encouraged at this stage.
(9) Evaluate the relevance and the value weight each solution proposed at step 8
has with respect to business competitiveness. There are denoted with
bij ; i 1; :::; n; j 1; . . . ; g; bij [{0, 1, 3, 9, 27} the relationship coefficients
between CC i ; i 1; :::; n and the innovative solutions IS j ; j 1; . . . ; g, where g
is the number of innovative solutions determined at step 8. The significance of
numbers allocated for bij ; i 1; :::; n; j 1; . . . ; g, is the same like the one in
step 3. The solution IS j ; j 1; . . . ; g, is relevant if and only if at least one

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coefficient bij ; i 1; :::; n; j 1; . . . ; g, has the value 9 or 27. The value weights
V j ; j 1; . . . ; g, of the innovative solutions IS j ; j 1; . . . ; g, are calculated
with the formula:
g
X
Ri bij
Vj

i1
g
n
X
X

Ri bij
j1

100; j 1; g

i1

Value weights V j ; j 1; . . . ; g, give a perspective about the comprehensiveness

of each innovative solution IS j ; j 1; . . . ; g, in the equation of business
competitiveness.
(10) Define and rank performance criteria for the project related to QMS design and
implementation. Similar approaches as in step 1 could be taken into account to
perform this step. There are denoted with PC i ; i 1; :::; x the criteria and with
P i ; i 1; :::; x their ranks (degrees of importance).
(11) Define the major activities in implementing a QMS. For practical purposes,
these activities could be organized on affinity groups. Let us assume there are y
major activities MAj ; j 1; . . . ; y.
(12) Determine the value weights U j ; j 1; . . . ; y, of the major activities
There
are
denoted
with
MAj ; j 1; . . . ; y.
dij ; i 1; :::; x; j 1; . . . ; y; dij [{0, 1, 3, 9, 27} the relationship coefficients
between the criteria PC i ; i 1; :::; x and the activities MAj ; j 1; . . . ; y. The
significance of numbers allocated for dij ; i 1; :::; x; j 1; . . . ; y, is the same as
in step 3. The value weights U j ; j 1; . . . ; y, are calculated with the formula:
x
X
P i dij
Uj

i1
y
x
X
X

P i dij
j1

100; j 1; y

i1

(13) Determine the relative impact that each major activity has upon the other major
activities. In this respect, the influence coefficients f ij ; i j; i; j 1; . . . ; y of
activity MAi upon activity MAj are first determined. A numerical scale could be
used to express the influence levels (e.g. 0 no influence, 1 poor influence, 3
medium influence, 9 strong influence, 27 very strong influence). The
relative impact IP t ; t 1; . . . ; y, is expressed by the following formula:
Ut
IP t

y
X
t1

y
X

f tj

j1;jt
y
X

U t

j1;jt

100; t 1; y

f tj

(14) Define the minimal set of major activities from the set resulted at step 11 by
applying the 80-20 rule with respect to the relative impact IP t ; t 1; . . . ; y.
This is a critical set of activities that strongly influences the success of the
project related to QMS implementation. For this sub-set, a list of potential
barriers and conflicting problems are identified. If these problems are not
properly solved, difficulties in project operation could occur.
(15) Elaborate innovative solutions to the problems identified at step 14. The TRIZ
method could be successfully applied in this respect. However, the application
of any other method of innovation and creative thinking is permitted at this
stage.

Framework of
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681

The methodology in 15 steps makes visible intangible dimensions around the topic of
QMS design and implementation. These dimensions are actually driving vectors in
formulating mature QMSs from the early stages of their lifecycle.
Research results and discussions
This section shows the results from the application of methodology. They represent
useful guidelines for practitioners in improving their approaches of QMS design and
implementation. Table I shows the outputs of the first step of the methodology. A
number of 17 generic criteria of business competitiveness have been defined by a focus
group of 56 representatives from companies operating in various sectors. The process
of criteria definition and ranking has been conducted with the occasion of a training
course.
The analysis of ISO 9001:2000 standard reveals over 260 requirements, organized
into 48 affinity groups. The value weights of the affinity groups come out from the
application of QFD method, having the criteria from Table I and their ranks as inputs.
Results are shown in Table II.

No. Criterion
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

Increase the sales on the external market

Increase the work productivity
Reduce the production costs
Reduce the cycle time
Reduce the delivery time
Increase the return on net assets
Increase the profit rate
Increase the number of orders/contracts in the unit time
Increase the money value of orders/contracts in the unit time
Reduce rework and waste
Increase capability to monitor and track processes
Reduce resistance to change of employees
Increase advantages for employees
Reduce the number of complaints from customers
Reduce the number of internal complaints/failures
Improve cooperation between employees
Robustness to noise factors (e.g. unpredicted orders, market dynamics, staff turnover)

Rank
(%)
6.0
5.8
6.7
5.4
6.5
6.4
6.3
5.0
5.1
6.7
4.6
4.6
4.9
8.4
6.7
4.8
6.1

Table I.
Criteria of business
process competitiveness
and their ranks

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Table II.
Affinity groups and their
relative value weights

No.

Affinity group

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48

General requirements for documentation

Quality manual
Document control
Record control
Management commitment
Orientation towards customer
Quality policy
Planning quality objectives
Planning quality management system
Responsibility and authority
Management representative
Internal communication
General requirements of the top management
Inputs for top management analysis
Outputs of the top management analysis
Resource allocation
Human resource competency
Infrastructure
Working environment
Planning of product realization
Definition of product-related requirements
Analysis of product-related requirements
Communication with customer
Design and development planning
Inputs in design and development
Outputs of design and development
Analysis of design and development
Verification of design and development
Validation of design and development
Control of changes in design and development
Supply process
Information for supply
Verification of supplied product
Production and service control
Validation of production and supply processes
Identification and traceability
Customer property
Product storing
Control of measuring and monitoring devices
Process measuring and monitoring
Customer satisfaction measuring and monitoring
Product measuring and monitoring
Internal audit
Control of non-conforming product
Data analysis
Continuous improvement
Corrective actions
Preventive actions

Value weight
(%)

Importance
index (10 is
the highest)

0.6
1.4
1.5
3.5
2.0
2.3
2.5
2.6
2.9
1.6
1.3
2.9
1.2
1.2
1.4
3.2
1.6
1.6
2.0
3.9
2.8
3.2
2.5
1.8
1.3
1.4
1.6
1.6
1.6
1.1
0.5
1.5
2.1
3.9
1.6
1.9
1.2
0.8
2.1
3.2
4.0
3.2
1.0
2.4
2.4
3.0
1.8
3.3

1.4
3.5
3.8
8.7
5.0
5.8
6.3
6.4
7.2
4.1
3.2
7.3
2.9
3.0
3.5
8.0
3.9
4.1
4.9
9.7
7.0
7.9
6.3
4.4
3.3
3.4
4.0
3.9
3.9
2.8
1.2
3.8
5.3
9.8
4.0
4.7
2.9
2.0
5.1
7.9
10.0
8.1
2.6
6.0
6.0
7.4
4.5
8.1

It should be mentioned that QFD analysis (which is not explicitly shown in this
paper because of space reasons) has also shown that each affinity group plays a key
role in the equation of competitiveness because at least one strong relationship exists
on each raw and each column of the QFD relationship matrix.
The most critical directions of intervention are those having the importance index
higher than 7.0. They are: customer satisfaction measuring and monitoring (10.0);
production and service control (9.9); planning of product realization (9.7); record control
(8.7); product measuring and monitoring (8.1); preventive actions (8.1); resource
allocation (8.0); analysis of product related requirements (7.9); process measuring and
monitoring (7.9); continuous improvement (7.4); Internal communication (7.3); planning
quality management system (7.2); definition of product related requirements (7.0).
The QFD analysis also shows that these 13 directions of intervention are strongly
interdependent. As a consequence, all these directions must be developed in a
well-balanced way relative to each other; in other words, neglecting one of them
automatically leads to inappropriate solving of the others.
Following the methodology, the relative value weight of each ISO 9001:2000
requirement is established. The results lead to a spreadsheet of fourteen A4 pages (over
260 requirements are included). For this reason, in Table III are illustrated only
extracts of this research.

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683

(%)
5.3
Quality policy
5.3.1 The top management takes care that quality policy is adequate for companys mission
5.3.2 The top management takes care that quality policy includes commitments for satisfying
customer requirements
5.3.3 The top management takes care that quality policy includes commitments for continuous
improvement of QMS effectiveness
5.3.4 The top management takes care that quality policy has a well-defined framework for
elaborating and analysing quality objectives
5.3.5 The top management takes care that quality policy was and is permanently
communicated and understood within organization
5.3.6 The top management takes care that quality policy is permanently analysed for being
updated according to companys dynamics
7.1
Planning of product realization
7.1.1 Processes necessary for product development are planned and developed
7.1.2 Planning of product realization is compatible with the requirements for the other
processes of QMS (see 4.1 in ISO 9001:2000)
7.1.3 Quality objectives and product requirements have been determined before planning
product realization
7.1.4 Within product realization planning process, necessary processes for product realization
have been established, specific resources have been allocated and necessary
documentation was defined
7.1.5 Within product realization planning process, required activities for verification,
validation, monitoring, inspection and testing have been determined
7.1.6 Within product realization planning process, product acceptance criteria are defined
7.1.7 Within product realization planning process, necessary records have been established to
show conformity with requirements of both product and related processes
7.1.8 Outputs of the planning process are adequate for organization operation mode

5.12
0.80
1.12
1.12
0.48
1.12
0.48
7.82
1.53
1.19
0.85
0.85
1.19
1.19
0.85
0.17

Table III.
Extracts from the matrix
of quality-related
requirements

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Results from Table III have been experimentally used to assess the level of conformity
of the organizational processes of an enterprise that manufactures low voltage electric
appliances at the starting point of their process of QMS design. Thus, it was possible to
quantify the overall performance of the business system against ISO 9001:2000. For
this case study, the mathematical result was 24.15 per cent conformity with ISO
9001:2000 requirements (that is, in business terms, something around a quarter of the
ideal case). Also, diagnosis revealed weak points with respect to some critical areas
like: continuous improvement, product quality planning, preventive actions, customer
satisfaction monitoring. This incipient audit proved to be extremely motivating for the
top management to allocate adequate resources for QMS design and implementation,
since the interest was to penetrate markets from several EU and Far East countries.
Considering the 80-20 rule, from the set of over 260 requirements, a sub-set of 58 are
essential from the perspective of designing a mature QMS (selection is done based on
the value weights of ISO 9001:2000 requirements; extracts are shown in Table III). This
sub-set requires a deeper analysis. The correlation between the sub-set of 58
requirements shows that 12 of them are critical. They are presented in Table IV.

No.
1
2

3
4
5
6
7
8
9
10
11
Table IV.
Critical requirements
within ISO 9001:2000

12

Affinity group
Customer satisfaction

Critical requirements within ISO 9001:2000

Monitoring of information about customers perception of

how the expressed requirements are satisfied
Continuous improvement Continuous improvement of QMS effectiveness through
effective use of quality policy, quality objectives, audit
outputs, data analysis, corrective actions, preventive
actions and top management analysis
Customer satisfaction
Establish and use methods for gathering and use of
information (related to requirement no. 1 in this Table)
Internal communication Top management takes care that adequate
communication processes are defined and this
communication is targeted on QMS effectiveness
Orientation to customer
Top management takes care that customer requirements
are determined for each order or contract
Orientation to customer
Top management takes care that customer requirements
are satisfied for each order or contract
Record control
Records provide evidences about conformity with
requirements, as well as about effective operation of QMS
Resource allocation
Necessary resources are determined and allocated to
increase customer satisfaction
Record control
Records are stored to provide evidences about conformity
with requirements, as well as about effective operation of
QMS
Planning QMS
Top management takes care that QMS planning is done to
meet article 4.1 from ISO 9001:2000
Communication with
Effective means are determined and implemented for
customer
communication with the customer about feedback and
about complaints
Outputs of the top
The outputs of the analysis done by the top management
management analysis
include decisions and actions about product improvement
with respect to customer requirements

Impact
11.91
9.68

7.32
5.93
4.55
4.41
4.23
3.54
2.88
2.57
2.47
2.11

The first six requirements from Table IV are highly sensitive to noise factors, thus
innovative approaches are required to solve them properly. A brainstorming session
has been conducted to identify potential conflicting problems related to these six
requirements. A set of 14 conflicting problems was worked out.
Table V shows the conflicting problems, the innovative solutions determined with
the support of TRIZ method, as well as the relative impact these solutions have with
respect to the set of criteria from Table I. Impact was determined with the QFD method
and expressed on a scale from 0 to 10. The QFD application shows that all solutions
from Table V have strong relationships with the competitiveness criteria presented in
Table I. This means they have the capability to bring relevant contributions in
improving the framework of QMS design and implementation. The result of QFD
application could be asked directly from the author.
As Table V reveals, from 31 innovative solutions the highest impacts (Id) have the
following:
.
flexible salary structures, direct linked to customer satisfaction (Id 10.0);
.
production to be organized on working cells (Id 7.1);
.
periodical consultancy for data processing and analysis (Id 5.7);
.
solutions to make individual personality working in the benefit of team goals
(Id 4.7);
.
task delegation (individual appreciation) (Id 2.8);
.
employees (from white to blue collars) to establish themselves the performance
goals (Id 2.8); and
.
extended use of the concept mobile factory (Id 2.7).
The performance criteria for the project related to QMS design and implementation are
shown in Table VI. They were proposed and ranked by a group of six consultants and
practitioners in quality management system design and implementation, having over
100 consulting projects in background. With the support of the same group of
consultants and of the Mind-Map method, the author defined a set of main activities
related to QMS design and implementation in accordance with ISO 9001:2000
requirements. They are structured in 12 affinity groups. The main activities are shown
in Table VII, together with their criticality and relative influence.
According to the results in Table VII, 15 activities are critical:
(1) Redesign nonconforming processes.
(2) Design new processes.
(3) Project management monitoring and control quality.
(4) Project management monitoring and control functionality.
(5) Implementation QMS application.
(6) Pre-certification internal audit audit 1.
(7) Diagnosis initial state audit.
(8) Design of documentation system procedures.
(9) Design of documentation working instructions.
(10) Other ISO 9001:2000 requirements organizational issues.

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Requirement
number in Table IV Possible conflicts
Requirement 1

Late reply from customers

Incorrect answer from
customers
High effort for monitoring

686

Impact
index

Keep the customer hot (e.g. various

types of competitions, tombola)
A team for handling answers from
customers
Preliminary actions (clauses in the
contract where the customer engages
to answer in time to well-defined
issues)
Protocols of data transfer between
supplier and customer
A person from the client-company gets
a bonus from us to centralize and
transfer required data (initially
agreed)

1.5
0.9
0.7

1.1
2.3

Requirement 2

Collect incomplete data

Red-blue teams to prepare proposals

0.6

Requirement 3

Collect incorrect data

Superficial analysis done by
management
Superficial audit

Transparent organization
Transparent communication

1.8
2.2

Clear and concise mission statement

and measurable objectives
The team leader will record data and
also will be responsible to meet
deadlines
Workers will themselves define their
goals
Flexible salaries, linked to customer
satisfaction

2.3

Poor or inexistent
deployment tools
Poor gathering models
Poor analysis and synthesis
models
Requirement 4

Inappropriate organizational
culture
Insufficient training to all
levels

Table V.
Conflicting problems and
related innovative
solutions

Solutions

Requirement 5

Requirement 6

Top management does not

allocate enough time because
of time crisis

Dialogue with employees before any

business process reengineering
initiative
All employees to be involved in
formulating communication-related
solutions
Before any meeting, take care and
publish the meeting agenda
Production organized on cells
Minimize bureaucracy
Leadership rotation
Quality circles
Mobile factory concept
Task delegation at individual level
Solutions that individual personality
to be modelled for achieving team
goals

1.7
2.6
10.0
1.8
1.9
0.5
7.1
1.5
1.3
1.3
2.7
2.8
4.7

Periodical consultancy for data

processing and analysis

5.7

Automatic data processing

1.9

No.

Criterion

1
2
3
4
5
6
7
8
9

Meet deadlines
Reduce unexpected activities
Reduce redefinitions within activities
High quality of outputs from each activity
Good planning of human, material and financial resources
Ensure margins of time and money
Achieve objectives at expected parameters
Easy to monitor
Easy and fast reporting

(11)
(12)
(13)
(14)
(15)

Project management
Project management
Project management
Project management
Elaboration of support

Rank (%)
10.5
4.3
2.4
19.7
15.9
10.1
25.1
7.0
5.0

planning activities.
effort estimation.
responsibilities.
risk management.
documentation QMS architecture.

With respect to these critical activities, 86 barriers, conflicts and constrains in

implementing a QMS have been identified by the author; however, this is not
necessarily the exhaustive set of problems. Examples of barriers and constrains related
to QMS implementation are highlighted in Table VIII.
Because of the large number of conflicting problems, barriers and constrains,
process innovation is necessary to master a QMS implementation project. Data from
Table VIII show that problems mainly occur because of incomplete data, inadequate
qualification and training of employees, resistance to change, lack of communication,
lack of responsibilities at process level, poor defined processes, ineffective procedures,
false/incorrect reports and records, inappropriate involvement of personnel, overloaded
staff, insufficient time for analysis, difficulties in estimations. With respect to these
problems, TRIZ method is applied to define innovative vectors of intervention.
A number of 76 innovative solutions have been determined in this respect. Some of
them are shown in Table IX.
For exemplification, it is shown how TRIZ was applied with respect to the problem
incomplete data. According to TRIZ, the first step consists in identifying two
conflicting parameters related to the problem, from a set of 39 predefined generic TRIZ
parameters (Altshuller, 2000). In this example, the conflict is expressed under the form:
increase accuracy of measurement (TRIZ parameter no. 28) without spending the
energy of the dynamic system (TRIZ parameter no. 19). Using a specific TRIZ
contradiction matrix there are revealed three TRIZ inventive principles:
(1) The third TRIZ inventive principle: local quality (transition from a homogeneous
structure of an object or outside environment to a heterogeneous structure;
different parts of an object have to carry out different functions; each part of the
object to be placed under the most favourable conditions of operation).
(2) The sixth TRIZ inventive principle: universality (an object can perform multiple
different functions, therefore there is no need for other elements).

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Table VI.
Criteria to assess project
performance

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Value
weight
(%)

Influence
index
(%)

3.2
3.0
4.8
5.8
2.0
2.8
7.1
5.1
3.7

4.18
4.06
3.98
4.50
1.26
0.90
6.31
1.94
6.11

Diagnosis initial state Study ISO 9001:2000, do audit and analysis

3.2

5.13

Process analysis

Requirements matrix and process flow

Process list

2.6
1.1

1.66
0.54

Bring to minimal
conformity with ISO

Solve conflicts and design new processes

Redesign nonconforming processes

3.0
5.1

6.03
13.65

Cover other ISO

requirements

Organizational issues
Delegate responsibilities
Other management issues

2.2
1.7
1.8

2.68
1.71
0.70

Basic documentation

Quality manual and system procedures

Working instructions and records

2.6
2.2

5.39
2.36

Additional
documentation

Files for procedures

Process matrix
Policy, mission and system architecture
Organizational chart
Job profile
Metrics and information system

1.1
1.3
2.8
1.1
2.2
2.2

1.45
0.87
3.46
0.61
0.71
1.43

QMS implementation Application

Information

4.4
2.0

7.32
1.00

Monitor and adjust

staff training

Update QMS documentation and inform staff

Course content, instruction and testing

2.5
3.1

0.94
0.79

Pre-certification
internal audits

Audit I
Audit II
Audit III
Reports and measures

2.8
2.0
2.9
1.5

3.13
1.69
1.68
0.84

Certification

Preventive training and intermediary audit

Certification audit

3.3
1.5

0.96
0.05

Group

Activity

Project management

Project planning
Responsibilities
Effort estimation
Risk management
Performance indicators/project
Monitoring and control of project
Monitoring and control of project
Monitoring and control of project
Monitoring and control of project

688

Table VII.
Main project activities
and their relevance for
QMS design and
implementation

cost
quality
time
functionality

(3) The 32nd TRIZ inventive principle: changing the colour (change the colour of
an object or its surroundings; change the degree of translucency of an object or
its surroundings; use coloured additives).
Based on the three inventive principles, a set of innovative solutions are proposed:
.
effect on salary;
.
red/blue teams for proposals;

Activity

Barriers/conflicts/constraints

Redesign nonconforming
processes

Some process-related data do not reflect the real picture of the

organization
The algorithm of process redesign does not provide reliable solutions
Acceptance of compromises (because of staff incapacity to implement
the recommendations accordingly)
Resistance to change from some employees
The key persons (process leaders) do not provide data in time to
support reengineering actions
Employees understand and accept with difficulty the redesigned
processes
Top management does not understand the necessity of IT
infrastructure

Design new processes

For some of the new processes, company does not dispose of resources
(competences, equipment, etc.)
Employees accept new processes with difficulty (they often see them
as an extra-effort)

Monitoring and control of

quality

There are no corrective actions emerging from monitoring and control

Poor definition of project quality metrics

QMS implementation

Low maturity level of the QMS: just for responding formally to ISO
requirements
The process flow is too ideal or to rigid and people will not respect
Lack of optimal communication strategy (departments, people)

Risk management

Risk is not estimated

There are no preventive measures for risk control
There are no responsibilities delegated to monitor risk

QMS documentation: system

architecture

Too abstract (non-operational)

Too complex

Responsibilities

Poor definition of responsibilities per task

Noise factors that distract from the scheduled tasks

Effort estimation

Underestimation because of poorly defined tasks

Initial estimation does not take into account the concurrent projects

Activity planning

Not all activities are identified

There are no margins for unexpected aspects
There are omitted tasks for error fixing

Organizational issues

The root causes of some mis-functionalities are not identified

Some people are charged with too many tasks
Poor delegation of responsibilities

QMS documentation: system

procedures

Inefficient procedures
Procedures are defined for ideal cases
Poorly defined records or too complex records

Audit

False reports
Internal auditors with lack of knowledge and skills in doing
appropriate audits

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Table VIII.
Examples of barriers,
conflicts and constraints
in implementing a QMS

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690

Table IX.
Examples of innovative
solutions using TRIZ
method

Problem and its related TRIZ

parameters

Innovative solutions

Incomplete data (TRIZ parameters: Effect on salary

28 vs 19)
Red/blue teams for proposals
Specialist-by-function
Multiple qualification of workforce
Team leaders responsible for both records and data delivery on
the flow
Each person to define and communicate his/her own goals
Data to be communicated in simple forms (signs, colours, etc.)
Transparent organization
Insufficient skilled staff (TRIZ
Training by simulation and use of many case studies
parameters: 39 vs 19)
Virtual prototyping
Provoke the employees give them the chance of property on
change
Customize courses and publish agenda before starting training
Dialogue with employees in advance of any training or change
Bonuses for those that have excellent results in training
Playing-type courses instead of classical ones
Resistance to change (TRIZ
Empowerment and segmentation in decision making
parameters: 35 vs 33)
Periodic re-energizer (continuous improvement in small steps)
Balance tasks/capacity, based on the work contract
Consultancy, lifelong learning programmes and distance learning
Divide the company in autonomous profit centres
Use flexible manufacturing systems (where applicable)
Quality circles and frequent communication
Communication problems (TRIZ
Electronic (invisible) vote
parameters: 24 vs 38)
Special offers to encourage communication
Lack of responsibility (TRIZ
Multiple evaluation tools of employees (including external
parameters: 29 vs 36)
evaluation)
Strategic planning and break barriers between departments
Apply quality-cost management systems
Hoshin planning
Incorrect reports (TRIZ
Clearly defined internal customers
parameters: 24 vs 37)
Robust-to-noise protocols of data transfer
Ineffective procedures (TRIZ
SWOT analysis upon processes
parameters: 27 vs 39)
Creative segmentation and use of innovation tools (e.g. TRIZ,
ASIT)
Quality circles and simulations
Overloaded staff (TRIZ
Improve workplace ergonomics
parameters: 11 vs 26)
Rotation of tasks
Insufficient time for analysis
Force-field analysis and mind-map approaches
(TRIZ parameters: 9 vs 33)
Apply the principle bring the mountain to Mohamed
Difficulty of estimation (TRIZ
Consultancy
parameters: 28 vs 39)
Pre-planning and simulation on multiple scenarios and PERT
Poor implication of personnel
Put the fear of competition as driving force for change
(TRIZ parameters: 13 vs 37)
Statistical process control
Generate periodic inspections from virtual customers
Bonuses for success
Use neutral persons to moderate sensible internal negotiations

.
.
.
.
.
.

specialist-by-function;
multiple qualification of workforce;
team leaders responsible both for records and data delivery on the flow;
each person to define and communicate his/her own goals;
data to be communicated in simple forms (signs, colours, etc.); and
transparent organization.

These innovative solutions are not limited to those mentioned before. Starting from the
three TRIZ inventive principles (3, 6 and 32), the reader could imagine several other
innovative solutions.
Conclusions, limitations and future researches
This paper proposes a novel methodology that brings innovation within projects
referring to QMS design and implementation by following a systematic, scientific
approach. The major goal is to define highly mature QMSs from the early phases of their
lifecycle, because only a mature QMS is able to bring relevant benefits for its users.
By relating ISO 9001:2000 standard to business competitiveness it is possible to
visualize standards requirements in the language of managers. The methodology
exploits advanced methods like AHP and QFD to determine the value weights of ISO
9001:2000 requirements. In this paper, the inputs of analysis have been determined by
a focus group. It might be possible that another configuration of the focus group to
generate slightly different criteria and to rank them somehow different than in the case
study here presented. It could be expected that a more extensive research around the
set of criteria that characterizes business competitiveness would bring new valences in
the value weights of ISO 9001:2000 requirements. However, not the strict mathematical
result is relevant in this discussion; the idea is to figure out a level of achievement
within some acceptable tolerances relative to the ideal state.
The methodology also focuses innovation only on the critical issues of ISO
9001:2000, as they are revealed by some indicators determined on mathematical basis.
The 80-20 rule is the master philosophy here. However, this does not mean at all that
the omitted aspects of the standard are not relevant. In theory, as well as in practice, it
makes sense to explore innovation in all aspects of ISO 9001:2000. Without an
exhaustive consideration of innovation, the maturity of a QMS cannot exceed level 3.5
on a scale from 0 to 5 in the authors opinion. Also, the application of TRIZ method
helps very much in working out innovative solutions; however, innovative solutions
could be elaborated in many other ways and by using several other tools (e.g. ASIT,
USIT, Brainstorming, Mind-Map, 6-3-5, etc.).
In the paper, several problems for QMS design and implementation are revealed and
several solutions to solve these problems without compromises are also proposed. They
come up from the relative limited experience of the author. It is very probable that readers
will generate supplementary (and even more ingenious) solutions; from this perspective,
this paper is an invitation to process innovation in the area of quality management.
The merit of the methodology introduced in this paper is to show a new perspective
in analysing various standards that companies confront with (e.g. ISO 14000, OHSAS
18000, etc.); a perspective, which encourages companies to implement mature
management systems based on these standards.

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Following a similar methodology, researches could be continued to elaborate

scientifically based algorithms for designing the documentation related to a QMS
(quality manual, procedures, working instructions, templates for records, visual tools,
etc.), as well as for approaching the design process of this documentation. This might
faster the whole process around QMS certification.

692
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Corresponding author
Stelian Brad is the corresponding author and can be contacted at: stelian.brad@staff.utcluj.ro

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