Chapter 3: Literature Review

Quality Management System (QMS) is defined as a group of resources and rules properly
implemented with the objective to guide each part of the company to execute standardly their
tasks in harmony with the others, where the purpose is to achieve a good level of quality and
productivity (Maranho, 2005). The QMS is concerned not only with the organizational structure
of the business, which defines the responsibility of the people, but also, with the establishment of
mechanisms for process management, defining what to do for the results to be obtained (Moura,
2003).

The implementation of a QMS is a strategic decision seeking to standardize

organizational processes and their better management (E L Psomas., 2010). A QMS is based on
standards that look for common elements, such as continuous improvement, alignment between
the process goals with the customer goals and the process management. The success is not
related to the choice of a particular standard, but rather to how the certification is conducted.
Among the existing standards, the ISO 9001 deserves a special insofar that is used globally by
most organizations, facilitating public recognition in business relation, especially in initial phases
of the business, where parts do not know each other (Conti, 2004). The ISO 9001 was based on a
process model that can be applied in any business, such as manufacturing or services. They argue
that the standard requisites are written in generic terns which make it more attractive to business
operation (Answering Questions About ISO 9000:2000, 2010).

An increasing number of organizations have developed and adopted such systems, in

order to increase efficiency, competitiveness and customer satisfaction. In the early years most of
the certification was issued to manufacturing industries (Magd, 2008), (E L Psomas., 2010). C. I.
Lin and W. Y. Jang argue that the nature and scope of ISO 9001 are well perceived by the
organizations, other items, however, remain unsolved, for example acceptance of the new system
by employees (Jang, 2008). If implemented properly, its benefits must exceed the costs due to
the improved performance and building a sustainable competitive advantage (M M Augustyn,
2000). Such benefits include: improved awareness of the importance of quality and customer
satisfaction (U Cebeki, 2002); cost reduction and customer complaints (Dwyer, 2002); the
standardization of work procedures and improved communication (Heras, 2002); as well as
increased market share (Arauz R, 2004). However, it should be noted that the introduction of a
QMS in an organization will not produce the adequate results if the same is performed
inefficiently (E L Psomas., 2010).

Because the pharmaceutical industry has traditionally focused upon the application of
Good Manufacturing Practice (GMP), it has been slow to consider the potential benefits to be
gained by implementing an EN ISO 9001 Quality Management System (QMS) (Position Papers,
2007).

Over the last few years the global pharmaceutical market has undergone significant
change, forcing pharmaceutical companies, more than ever before, to focus on customer needs
and upon their own internal efficiency in order to continue to compete effectively.

With this in mind CEFIC commissioned a working group of experts drawn from several
major Active Pharmaceutical Ingredients (API) producers to prepare a practical, user-friendly
guidance document integrating current GMP requirements into the EN-ISO 9001 QMS
framework. To achieve this, the working group have taken relevant features from the
August1996 CEFIC/EFPIA publication Good Manufacturing Practice for Active Ingredients
Manufacturers and combined these with the relevant complementary requirements of EN-ISO
9001 Quality Systems: Model for quality assurance in design, development, production,
installation and servicing. It is intended that these Guidelines are applicable to all APIs
(Position Papers, 2007).

According to E L Psomas, the critical factors are the crucial elements that require
evaluation and categorization to ensure effective management and implementation of a single
system, so the effective implementation of the ISO 9001:2008 depends on the approach of the
organizations on the critical success factors identified (E L Psomas., 2010).

The top Management Commitment is cited by several authors. In accordance with E L

Psomas, it is related to the support given by the leadership in the process of implementation. In
terms of quality, leadership involve efforts of top management as an example to integrate quality
improvement within strategic planning and through the entire organization, in addition they
promote the values of quality in the working practices (M M Augustyn, 2000).

Research indicates that leadership is critical to the success of any effort related to changes
in the operating philosophy of an organization. Without the leadership of top management, the
behavior of people in an organization tends to be reluctant to change (Conti, 2004). Competent
leaders understand the importance of their commitment to the quality efforts and allocate
resources for the improvement of quality programs.

Success depends on the team commitment and the development of a schedule for
implementation, and then maintenance activities that must be performed after certification to
ensure the system's sustainability. The authors state that quality professionals should be at the
forefront of organizations promoting increased competitiveness, but will be heard only if
statement which may be offered in clear terms where managers and employees can identify
themselves. Improve the performance through good planning; better processes and complete
involvement of people should be the focus of quality professionals nowadays (Heras, 2002).

In addition to the commitment of top management, team commitment and resource

allocation, quality oriented culture in the organization is fundamental. It is defined as the shared
belief, values, norms and behaviors of the organization that may contribute to the wide
implementation of the quality (Heras, 2002).

E L Psomas., C V Fotopoulos, and P K Dimitrios say that the top management should
pay attention to culture and organizational infrastructure, as both represent the most critical areas
to ensure that a robust internal environment is created as a basis for effective implementation of a
QMS. They indicate that it is necessary to concentrate efforts to provide facilities, equipment and

technology to the organization.

The organization structure, related to the resource allocation, is also seen as a factor of
influence. Studies performed by M M Augustine and J D Pheby measured the association
between structure and property of the organization with the implementation stage of the QMS
and the QMS approach. As a QMS is considered as an approach to quality management, a set of
specific tools and methods to suit the activities and quality improvement programs, it is
necessary resources to conduct that, for example, a department dedicated to full support the QMS
and resource allocation budget for QMS (M M Augustyn, 2000).

As the organizational structure for quality, expertise was also noted as a supporting factor
for the implementation of the quality management approach. This reveals the organizational
ability to use quality tools that is guaranteed with training to the team involved. Organizational
technical factors found in the literature were: education and training with respect to the quality
paradigms and methods, the scientific approach to problem solving, the information system, as
well as a system for data analysis and reporting. According to empirical research was established
a positive relationship between technical factors and implementation of the QMS. The most
important factors identified were an organizational information system, capacity for data analysis
and abilities of employees to perform the scientific approach to solve problems (Magd, 2008).

As a technology management, the implementation of a QMS requires support or change

in organizational infrastructure. It is important to have defined the responsibilities and authorities
between the team involved with a clear description of the tasks related to the QMS activities for

each employee. Due to the paradigm of the QMS is based on data; its implementation needs to be
supported by installation of appropriate performance measurements. Magd (2008) also
comments that the failure to define responsibilities and authorities for personnel is an important
factor for the implementation.

E L Psomas., C V Fotopoulos, and P K Dimitrios say that the lack of management

support and training for employees are directly linked to poor perception of quality by the
organization, in other words, the absence of a culture focused on quality or lack of awareness of
the people about the importance of ISO 9001. Additionally, it was observed that the shortage of
resources, the very resistance to change and failure definition of responsibilities and authorities
are other factors that contribute also to inefficiency in the implementation of the ISO process (E
L Psomas., 2010).

In general, E L Psomas., C V Fotopoulos, and P K Dimitrios conclude that management

should firstly ensure that the motivation for the implementation is originated from an inner
necessity rather than an external pressure. Therefore, the focus is on changing the culture of the
entire organization, from top management to the operators, with a transformational vision for a
quality oriented culture.

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