Quality Management System

Quality Management System
1. For more than two decades “quality” and “quality management systems” have been
leading buzzwords in the business world. Quality Management System (QMS) is an
internationally harmonized guidance is intended to assist industrial manufacturers by describing
a model for an effective quality for the industry. In case of pharmaceutical industry QMS is of
great importance as product quality is a major concern here.
A quality management system is a management technique used to communicate to

employees what is required to produce the desired quality of products and services and to
influence employee actions to complete tasks according to the quality specifications
Japan and USA played a great role in the history of development of QMS. The push for
increased quality began in American manufacturing companies in the 1980s, following in the
footsteps of Japanese manufacturers. Japanese companies found themselves with a distinct
competitive advantage over American companies with their ability to produce much higher
quality products with fewer defects.
1.1 QMS in pharmaceutical industry describes a comprehensive model for an effective

pharmaceutical quality system that is based on International Organization for Standardization
(ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations and
other Standard Operating Procedures (SOP).QMS can be implemented throughout the different
stages of a product lifecycle.
2. ISO 9000 is a series of quality management systems (QMS) standards created by the
International Organization for Standardization, a federation of 132 national standards bodies.
The ISO 9000 QMS standards are not specific to products or services, but apply to the processes
that create them. The standards are generic in nature so that they can be used by manufacturing
and service industries anywhere in the world. The Quality management system standards of the
ISO 9000 series are based on eight quality management principles. These principles can be used
by senior management as a framework to guide their organizations towards improved
performance.
2.1. According to ISO 9000 series these eight principles are:
 Customer Focus
 Leadership
| Quality Management System Page no. 1
 Involvement of people
 Process approach
 System approach to the management
 Continual improvement
 Functional approach to decision making
 Mutually beneficial supplier relationships
2.1.1. Customer Focus: Organizations depend on their customers and therefore should
understand current and future customer needs, should meet customer requirements and strive to
exceed customer expectations. Pharmaceutical industries should recognize their customers and
correctly evaluate their current and future needs.
Benefits:
I. Increased revenue and market share obtained through flexible and fast responses to
market opportunities.
II. Increased effectiveness in the use of the organization’s resources to enhance customer
satisfaction
III. Improved customer loyalty leading to repeat business.
2.1.2. Leadership: Leaders establish unity of purpose and direction of the organization. They
should create and maintain the internal environment in which people can become fully involved
in achieving the organization’s objectives. In case of a sensitive industry like pharmaceuticals,
there must be a unique leadership for overall development.
Benefits:
I. People will understand and be motivated towards the organization’s goals and objectives.
II. Activities are evaluated, aligned and implemented in a unified way.
III. Miscommunication between levels of an organization will be minimized.
2.1.3. Involvement of people: People at all levels are the essence of an organization and their
full involvement enables their abilities to be used for the organization’s benefit. To maintain
quality pharmaceuticals should ensure the best desired participation from every employee. Every
person should be considered for his own action.
Benefits:
I. Motivated, committed and involved people within the organization.
II. Innovation and creativity in furthering the organization’s objectives.
III. People being accountable for their own performance.
IV. People eager to participate in and contribute to continual improvement.

2.1.4. Process approach: A desired result is achieved more efficiently when activities and
related resources are managed as a process.
Benefits:
I. Lower costs and shorter cycle times through effective use of resources.
II. Improved, consistent and predictable results.
III. Focused and prioritized improvement opportunities.
2.1.5. System approach to management: Identifying, understanding and managing interrelated

processes as a system contributes to the organization’s effectiveness and efficiency in achieving
its objectives. Rules and regulations should be clear and same for everyone.
Benefits:
I. Integration and alignment of the processes that will best achieve the desired results.
II. Ability to focus effort on the key processes
III. Providing confidence to interested parties as to the consistency, effectiveness and
efficiency of the organization.
2.1.6. Continual improvement: Continual improvement of the organization’s overall

performance should be a permanent objective of the organization. Aiming this objective not only
a pharmaceutical industry but also any industry can achieve its highest position.
Benefits:
I. Performance advantage through improved organizational capabilities

II. Alignment of improvement activities at all levels to an organization’s strategic intent
III. Flexibility to react quickly to opportunities
2.1.7. Factual approach to decision making: Effective decisions are based on the analysis of
data and information. This is why every action taken should be recorded and archived to use
them as a reference and as a statistics.
Benefits:
I. Informed decisions.
II. An increased ability to demonstrate the effectiveness of past decisions through reference
to factual records.
III. Increased ability to review, challenge and change opinions and decisions.

2.1.8. Mutually beneficial supplier relationships: An organization and its suppliers are
interdependent and a mutually beneficial relationship enhances the ability of both to create value.
But the raw materials supplier must be approved and ensured to supply materials with desired
quality by quality assurance so that the product quality is never hampered.
Benefits:
I. Increased ability to create value for both parties

II. Flexibility and speed of joint responses to changing market or customer needs and
expectations.
III. Optimization of costs and resources.
3. Purpose of QMS:
✔ Establishes a vision for the employees.

✔ Sets standards for employees.
✔ Builds motivation within the company.
✔ Sets goals for employees.
✔ Helps fight the resistance to change within organizations.
✔ Helps direct the corporate culture.
4. The quality movement and quality systems have had many different names or terms of
reference in the past few decades, and might look like a short-lived business management trend
at first glance. With ever increasing competition and consumer expectations, professionals and
business managers cannot ignore quality issues and expect to maintain or improve their
competitive position. Quality systems, time and again, have been responsible for substantial
increases in the bottom line of businesses in every industry and have given organizations the
boost they need to meet overall goals and objectives. Organizations that do not accept that
quality improvement is going to be ingrained into every part of their business are not going to be
around to see what the future brings. So QMS has a great part to play in case a pharmaceutical
industry growing into country’s largest one. Hence, they should have a SOP on QMS to strictly
follow and maintain it.

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Quality Management System

A quality management system is a management technique used to communicate to

1.1 QMS in pharmaceutical industry describes a comprehensive model for an effective

2.1. According to ISO 9000 series these eight principles are:

| Quality Management System Page no. 2

2.1.5. System approach to management: Identifying, understanding and managing interrelated

2.1.6. Continual improvement: Continual improvement of the organization’s overall

I. Performance advantage through improved organizational capabilities

| Quality Management System Page no. 3

I. Increased ability to create value for both parties

✔ Establishes a vision for the employees.

| Quality Management System Page no. 4

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