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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).
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).
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).
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
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).
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.
Bibliography
Answering Questions About ISO 9000:2000. (2010). Retrieved October 23, 2014, from PCI
Magazine:
http://www.pcimag.com/CDA/Archives/bcd09fb6a36a7010VgnVCM100000f932a8c0
Arauz R, S. H. (2004). ISO 9000 performance in Japanese industries. Total Quality Management
and Business Excellence , 3-33.
(2004). How to conceptually harmonize ISO 9000 certification, levels of excellence recognition
and real improvement. In T. Conti, Total Quality Management and Business Excellence (pp.
665-677).
Dwyer, G. (2002). Business excellence versus ISO 9000 in Irish context which delivers?
Managerial Auditing Journal , 404-412.
(2010). Critical factors for effective implementation of ISO 9001 in SME service companies. In
C. V. E L Psomas., Managing Service Quality (pp. 440-457). Almeida, Muniz Jr. and Costa.
Heras, I. C. (2002). ISO 9000 certification and the bottom line: a comparative study of the
profitability of Basque region companies. Managerial Auditing Journal , 72-78.
Jang, W. (2008). Successful ISO 9000 implementation in Taiwan: How can we achieve it, and
what does it mean? International Journal of Productivity and Performance Management , 600622.
(2000). ISO 9000 and performance of small tourism enterprises: a focus on Westons Cider
Company. In J. D. M M Augustyn, Managing Service Quality. 374-388.
7
Magd, H. (2008). ISO 9001:2000 in the Egyptian manufacturing sector: perceptions and
perspectives. International Journal of Quality & Reliability Management , 173-200.
Maranho, M. (2005). ISO Srie 9000 (verso 2000) Manual de Implementao. Rio de
Janeiro: Qualitymark .
(2003). Qualidade Simplesmente Total. In L. R. Moura, Qualitymark Editora, 2 Edio (p. 208).
Position Papers. (2007, December). Retrieved October 24, 2014, from Active Pharmaceutical
Ingredients Committee: http://apic.cefic.org/pub/2qualitymgtsystgmp9712.pdf
U Cebeki, A. B. (2002). An approach to the evaluation of quality performance of the companies
in Turkey. Managerial Auditing Journal , 92-100.