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Process-based
Process-based management management
A structured approach to provide the best
answers to the ISO 9001 requirements
Gionata Carmignani 803
Department of Mechanical, Nuclear and Production Engineering,
University of Pisa, Pisa, Italy

Abstract
Purpose – The purpose of this paper is to provide a structured method to apply process management
approach following ISO 9001:2000 requirements, clause 4.1.
Design/methodology/approach – The content of this paper is focused on the detailed analysis of
the fourth clause of the 2000 edition of norm ISO 9001, and it presents an articulated procedure which
can be undertaken by any organization in order to give the best answers to the requirements therein.
Findings – The method described consists in eight steps, with a top-down approach going from the
definition of the macro-processes of the organization to the definition of the single stages which
constitute the activities. An approach to implement quality objectives deployment is implemented.
In order to better explain the methodology, a case study is used.
Originality/value – Indeed, it is thought that the content of the fourth clause of ISO 9001, and in
particular of paragraph 4.1, represents one of the most important innovations brought in by the new
edition which nevertheless, since this paragraph contains requisites oriented more towards method and
approach mentality to the quality system and less towards detail and strictly operational prescriptions,
has been poorly and erroneously understood, or even deliberately not taken into account. The proposed
methodology represents an original guide line to implement process management approach.
Keywords Process management, ISO 9000 series, Quality standard
Paper type Research paper

Introduction
The processes’ approach in the ISO 9000:2000 is the pivotal element on which ISO
invested in order to re-launch the value of quality as proficiency of an organization’s
management system. The ISO 9000 standard has had a great impact on manufacturing
and service industries by helping to establish the framework required for effective and
efficient quality assurance and quality management systems (Bhuiyan and Alam,
2005). Most contributions have demonstrated that the ISO 9000 series has become the
most prevalent quality initiative among firms in the whole world (Tsiotras and
Gotzamani, 1996; Ismail and Hasmi, 1999; Lee and Palmer, 1999; Beattie and Sohal,
1999). But the implementation of ISO 9000 standards has been difficult due to various
barriers, in particular misunderstanding of the ISO 9000 concepts and methods of
implementation (Chin et al., 2004). Why do managers misunderstand the role of ISO
9000 implementation? One possible explanation is that managers fail to distinguish
between conformance and performance specification (Terziovski and Power, 2007). Business Process Management
Quality management and the implementation of a quality management system Journal
Vol. 14 No. 6, 2008
emphasizes process control and process improvement (Berg et al., 2005). Tsim et al. say pp. 803-812
that the use of process approach management, the process and their interaction of the q Emerald Group Publishing Limited
1463-7154
organization could be visualized and the performance of each process must be DOI 10.1108/14637150810915982
BPMJ measured against the planned and expected results. Process-based approach means,
14,6 first of all, identifying the processes necessary to achieve a product or service, defining
the interactions of such processes among themselves and applying to their
management (control), both at a global and at a single-process level, the Plan-Do-
Check-Act (PDCA) principles. The quality management system is necessary to define
quality policy and objectives, to reach such objectives, to preserve them in time,
804 steadily improving their effectiveness. As a system, it is necessarily a complex of
inter-related processes, that constitute the basic structure, which guides the whole
company system, and in particular the processes and activities giving a fundamental
contribution to the company business, even if they are not directly accountable for
product quality: running actions, strategic planning elements, resource identification
and management, personnel, and supplier management. This vision of the quality
management system is described and prescribed in 9001, through comma 4.1 overall
and in particular with paragraphs: (a), (b), and (c) (the process map). Understanding the
global meaning of the different elements above and putting them in a perspective not to
revolutionize, but to re-interpret the company structure at all levels, would mean
making a decisive quality improvement, in view not simply of a certification, but of a
structural, management and economic soundness arising from the awareness of the
current situation, of the projected goals and of the way to follow to reach them. The aim
of this paper is to proposed a simple but structured approach to implement the process
management methodology in a generic organization according to the requirements of
the comma 4.1 of the ISO 9001:2000. The eight steps approach proposed will be
explained with a case study concerning a public company of train transport services.

The new quality management system

The definitions for the quality management system (SGQ) taken from ISO 9000 are:
System: Set of interrelated or interacting elements
Management system: System to establish policy and objectives and to
achieve those objectives
Quality management system: Management system to direct and control an
organization with regard to quality
According to the 1994 edition (ISO 9001:1004), the quality system was made up of:
.
organizational structure;
.
processes and the procedures describing them; and
.
resources.

The Quality System was documented and implemented through manuals, plans,
procedures and written instructions for an effective carrying out of the activities.
The limit of this interpretation of the concept of quality system is that it does not
make the hierarchical and priority order in the definition of the three elements
mentioned above explicit.
According to the evolved 2000 edition (ISO 9001:2000) (Figure 1), it can be stated that
the starting point for building the system is given, first and foremost, by processes,
 1994 Edition 2000 Edition Process-based
management

Organization Customer Requirements

& Objectives
805
Constrain/
+ Objective
Activities & Input Process
Processes Output
Procedures
Resource

+
Organization &
Resources Resources

Figure 1.
QUALITY SYSTEM
Quality system – 1994
(Manual, Procedures, Instructions, QUALITY SYSTEM
and 2000 edition
Forms)

defined in order to guarantee the customer’s satisfaction, and according to which the
resources and then the organizational structure are fixed.
Finally, as for the documentary description, it becomes a descriptive instrument if it
is deemed necessary in order to reach the quality objectives, and it is not the final goal
of the quality system anymore. Therefore, no more “systems of documents”, but a
documented SQG.

The process “map”

The prescriptions concerning the identification of the necessary processes for the
Quality Management System (SGQ), of their interaction and of the criteria for
controlling them find an effective, clear and ready solution in project mapping.
Maps are an easy instrument to set up and to use, they are direct, completely
cross-function, and extremely useful:
.
they bring the customer’s needs within the company already during the process
and system structuring stage;
.
they enhance the level of understanding of every single process’s complexity and
of process interaction: this leads to greater awareness of one’s own role, in terms
of duties and responsibilities, and therefore to a more productive participation by
the organization members;
.
they favor a consistent break-down (deployment) of the strategic and tactical
objectives at process and single activity level, underlining from the beginning the
most critical and significant aspects; and
.
thanks to the clear definition and precise quantification of the operational
objectives (to which are indicators devised ad hoc are generally associated), they
simplify the monitoring of their degree of attainment.
BPMJ In order to map processes, first of all they must have been properly defined, in
14,6 compliance with a logic which we might term “pull” and which has the customer as the
main reference point.
This means identifying for each process, be it primary or supporting, who is the
customer (internal and/or external), what must be the outcome, what are the resources,
even the non-physical ones, to attain it, what aspects must be object of some sort of
806 control and what are the links and the relations it has with other processes, and how it
is affected by them.
The process flow thus obtained – which is often rendered in the form of block
diagrams and flow charts – must be made substantial with quantitative indications
and measurements, making it a real, essential instrument for managing and controlling
activities, whose concrete usefulness can be exploited at all levels during every
working day, as well as, of course, during system verifications and re-examinations.
These latter characteristics, necessary for a good process map, also answer to the
other paragraphs of comma 4.1 of ISO 9001:2000, in which resource and information
availability is required for the activities, as well as process monitoring and
measurement and the implementation of actions to attain the planned results.
Working with the firms where the proposed technique is implanted, it has been
preferred to concentrate the work of the managers to keep attention on objectives,
indicators and resources of the processes. Therefore, a simple mapping technique is
used (like flow or block diagram) with the IDEF0 notation, avoiding more complex
reference model.

The method to implement a process management approach

The setting up of a quality management system usually begins with the definition of
the policy and of the quality objectives defined by the organization. Once policy and
objectives have been defined (in compliance with the requirements of commas 5.3 and
5.4.1 of the norm), the second step is process definition.
The proposed approach to process definition and the production of the relevant
documentation consists in the following steps:
(1) Identifying macro-processes, their mutual relations, inputs, outputs,
constraints, and necessary resources.
(2) Specifying progressively the single macro-processes to the activity level.
(3) Building complete flow charts for priority activities (and successively for all
activities).
(4) Defining the gaps between the activities, the fixed targets and the norm and, if
necessary, re-thinking (re-engineering) the activity.
(5) Checking the effectiveness of the activities and of the process that subsumes
them.
(6) If necessary, drafting a document that describes the activity (instruction) or the
process (procedure).
(7) Repeating steps 3 through 6 for all the processes.
(8) At the end, documenting the SGQ globally, from process map to policies, to
choices and activities (manual, procedures, instructions, indicators, plans, etc.).
As the eight steps show, the process definition approach is top-down (from the general Process-based
to the particular), while the drafting of descriptive documents, if necessary, is management
bottom-up (from the particular to the general, i.e. from instructions and procedures to
the manual), after the actual implementation of the quality system. This is definitely a
reversed approach in comparison with those used according the 1994 edition norm
(manual ! procedures ! instructions).
807
Step 1: identifying the macro-processes
In the early stage of definition of one’s own quality system, the first step consists in
identifying the macro-processes of the organization.
The index of norm 9001, for example, can be used as a guidance, dividing the
processes in priority and supporting. In Figure 2, the zero level (most general) of the
macro-process identified by a public company of train transport services is reported.
The company has chosen two macro-indicators to measure the effectiveness of the
process, the arrival delay time and the service cost.
From the early stages of the mapping process, it is appropriate to identify a possible
range of performance indicators for the processes. An example of such indicators for
the train transport company is reported in Table I.

Step 2: specifying the single macro-processes to the activity level

Once the macro-processes have been identified, it is necessary to go down to the detail
level, to describing the logical flow of the single activities. The detail level to be reached
might be chosen by taking the following indications into account:
.
complexity of the father macro-process;
.
the last level should be represented by a series of activities in which
responsibilities are univocal, it is possible to identify precise and fixed control
modes and performance indicators; and
.
in any case, a number of four or five levels should not be exceeded.

External input
Train trip service
supply
Output

Indicators:
Arrival delay time Figure 2.
Input from other Service cost Processes map: zero level
processes

Process Train trip service supply

Indicator Objectives (value and/or range)

Arrival delay time Max. delay ¼ 7 percent of the scheduled trip time Table I.
Service cost 0.05 e/km Performance indicators
BPMJ It is desirable, from the identification of processes at the highest level, to trace all the
14,6 inputs, the resources, the constraints and the outputs of all of them. Such objects must
then be distributed during the specification of the details on sub-processes and activities.
Figure 3 contains the first two levels of the mapping of the process of service of
transportation for the train trip service company.
For each phase the value of the suitable indicator is calculated (i.e. the activity cost
808 and/or the lead time). In this way, the whole indicators can be calculated through a
suitable defined function. The evaluation of the indicators has been made on the
detailed activities and through the mathematic functions (bottom-up) we can obtain the
macro-indicators following the process functional tree (Figure 4).

Step 3: building complete flow charts for the activities

Once the macro-processes to the most suitable detail level have “exploded”, the next step
consists in the description of the activities that constitute the process, for example through
a “complete” flow chart, i.e. one that illustrates the stages that make up the activity:
. the sequence;
.
inputs and outputs;
.
resource allocation;
.
documents to be used or to be produced; and
.
control indicators.

Besides, flow charts, also tables, matrixes, Gantt diagrams, tree diagrams, graphs, etc.
can be used.

Step 4: defining the gaps between the activities, the norm and the fixed targets
The drafting of an SGQ should be an important opportunity for the organization, also to
tackle an evaluation of its own processes, and therefore pick the opportunity to re-plan
any activity in order to overcome, from its first implementation, the inefficiencies.
To this purpose, after describing the single activities constituting a process, it is
desirable to measure the real effectiveness and efficiency of single processes in
reaching the fixed objectives of customer’s satisfaction and of performance. The
procedure for the prospective re-engineering of the process or of part of it might follow
the stages below:
.
data collection from the project description or a current activity (performance
modalities, responsibilities, resources, and indicator results);
.
identification of the customer’s needs after the process;
.
translation into process objectives;
.
process re-planning in order to optimize the fixed indicators; and
.
identification of the elements for process control (monitoring system, direct
measures on the process, and indirect measures on the outputs).

Step 5: checking the effectiveness of the activity and of the process

Once the activities constituting the process have been wholly or partly re-engineered,
their effectiveness must be evaluated against the fixed control elements and the
attainment of performance objectives.
 Process-based
External input Train trip service management
supply Output
LEVEL ZERO
Indicator:
Arrival delay time
Input from other Service cost
processes 809

External input
Time card design

Indicator:
Activity cost (B1) External input
Input from other
processes

External input Trip

Crew design
LEVEL ONE
Indicator:
Indicator: Activity cost (B4)
Input from other Activity cost (B2) Lead time (A4)
processes

External input Ready train on truck

Indicator:
Activity cost (B3)
Lead time (A3)
Input from other
processes

Train composition
planning
LEVEL TWO
Indicator: Constrains/Objectives
Activity cost (B31)

Train composition
operations Ready train to start

Indicator: Indicator:
Activity cost (B32) Activity cost (B33)
Lead time (A32) Lead time (A33)

Arrival delay time = f (A3, A4) = g (A32, A33, …) Figure 3.

Processes map: first and
Service cost = h (B1, B2, B3, B4) = q (B31, B32, B33, …)
second level
BPMJ
14,6 Step 1-2-3
Macro-Process
Step 4

Processes, activity and indicators defintion

Performance and indicator evaluation

810 Process A Process B

Process A.1 Process A.2

Figure 4.
Activity A.1.1 Activity A.1.2
Function process tree and
objectives deployment

Step 6: if necessary, drafting a document that describes the activity or the process
Once the effectiveness of the process has been assessed and verified, the latter can be
described with a document (procedure or instruction or directly in the manual, based
on the detail level), usually structured as follows:
.
Aim and application field.
.
Terms, documents, and reference norms.
.
Sequence of activities and responsibilities.
.
Annexes (schedules, modules, flow charts, etc.).

Step 7: repeating steps 3 through 6 for all the processes

The analysis proposed for the single process must be extended to all the processes with
the same methodology.

Step 8: drafting the document that describes the process map (manual)
Once the processes have been described, it is clear that drafting a quality manual may
represent a synthesis of the work performed with the previous steps, as well as a
description of an SGQ which has been actually implemented and whose effectiveness
has been verified.

Conclusions
The requirements contained in comma 4.1 of ISO 9001:2000 provide a relevant guideline
for single organizations to be able to define their own processes and activities as a function
of customers’ satisfaction and, more in general, of the attainment of quality objectives.
A broad mapping of the processes appears to be insufficient and it does not allow to
set the modalities of activity management and control. The actual problems can be the
following:
 .
in order for the process mapping to be functional to effectiveness and efficiency, Process-based
there is the need for appropriate instruments to represent and manage management
“sequences and interactions”;
.
the issue of objective planning and of the capability to guarantee that, for the
relevant organization levels and functions, quality objectives are fixed, including
those necessary to answer to product and process requirements (indicators),
i.e. the capability of representing and managing in a simple way the “objective 811
deployment”; and
.
at the operational level, as far as process monitoring and control are concerned,
difficulty in retrieving past data and information on the trend of the activity.

Therefore, mapping must be followed by a punctual definition of activities, resources

employed, inputs and outputs, when appropriate performance indicators are reached.
The results can be the following:
.
a simple, actual, user-friendly process mapping would allow to analyze, visualize
and know the course of the processes of an organization and to identify the
interaction among the different processes, to know their aims and to learn about
their requirements and level of satisfaction; and
.
objective planning results clear and easy through objective deployment within
the identified processes and through the fixed indicators.

The most interesting perspective is that in a competitive market, the need to satisfy
customers drags all the processes towards common objectives, in particular
traditionally independent and often priority processes. The method proposed can
represent a simple way to build or adjust a quality management system effectively
oriented towards process-based management.

References
Beattie, K.R. and Sohal, A.S. (1999), “Implementing ISO 9000: a study of its benefits among
Australian organizations?”, Total Quality Management, Vol. 10, pp. 95-106.
Berg, M., van den Heuvel, J., Koning, L., Bogers, Ad.J.J.C. and van Dijen, M.E.M. (2005), “An ISO
9001 quality management system in a hospital: bureaucracy or just benefits?”,
International Journal of Health Care Quality Assurance, Vol. 18 No. 5, pp. 361-9.
Bhuiyan, N. and Alam, N. (2005), “A case study of a quality system implementation in a small
manufacturing firm”, International Journal of Productivity and Performance Management,
Vol. 54 No. 3, pp. 172-86.
Chin, S., Kim, K. and Kim, Y.S. (2004), “A process-based quality management information
system”, Automation in Construction, Vol. 13, pp. 241-59.
Ismail, M.Y. and Hasmi, M.S. (1999), “The state of quality management in the Irish
manufacturing industry”, Total Quality Management, Vol. 10, pp. 853-62.
ISO 9001:2000 (2000), Quality Management Systems – Requirements Specifies, ISO, Geneva.
Lee, K.S. and Palmer, E. (1999), “An empirical examination of ISO 9000-registered companies in
New Zealand”, Total Quality Management, Vol. 10, pp. 887-99.
Terziovski, M. and Power, D. (2007), “Increasing ISO 9000 certification benefits: a continuous
improvement approach”, International Journal of Quality Reliability & Management, Vol. 24
No. 2, pp. 141-63.
BPMJ Tsiotras, G. and Gotzamani, K. (1996), “ISO 9000 as an entry key to TQM: the case of Greek
industry”, International Journal of Quality & Reliability Management, Vol. 13, pp. 64-76.
14,6
Further reading
ISO 9001:1994 (1994), Quality systems – Model for Quality Assurance in Design, Development,
Production, Installation and Servicing, ISO, Geneva.
812 Tsim, Y.C., Yeung, V.W.S. and Leung, E.T.C. (2002), “An adaptation to ISO 9001:2000 for
certified organisations”, Managerial Auditing Journal, Vol. 17/5, pp. 245-50.

About the author

Gionata Carmignani is a researcher at the University of Pisa (Italy). He obtained PhD in 2007 for
quality management and supply chain management studies. In 2000, he worked as program
manager at Nuovo Pignone General Electric Company. In 2001, he worked as quality systems
consultant and in the same year he has began research activities mainly concern quality system
implementation. Some results of his research activities have been published in international
(International Journal of Quality & Reliability Management, Quality & Reliability Engineering
International, International Journal of Production Research, International Journal of Project
Management) and national journals (and he is co-author of two books on “Quality Management
and ISO 9000”.) Since 2006 he is referee for the International Journal of Project Management.
Gionata Carmignani can be contacted at: gionata.carmignani@ing.unipi.it

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