Unit 3

ISO 9000
Introduction to quality systems
To provide good quality products
As per definition of ISO, “The quality system is the organizational structure, responsibilities,
procedures, processes and resources for implementing quality management.”
It involves phases from initial identification to final satisfaction of requirements and customers’
expectations.

Quality system ensures that:

1.The system is well understood and effective
2. Products and services satisfy customers requirements
3. Emphasis to problem prevention, rather than detection after occurrence.

Need for ISO 9000 and other quality system

To provide good quality products and services
To assure quality one has to ensure the quality
And for effective quality assurance system requires a well-defined quality system standard.
Quality and standardization are two important pre-requisites for organization to establish in
this competitive market.
Thus, quality will begin with standards.
So, every increasing demand of providing better quality led to development of quality standards
like ISO 9000.

Objectives of ISO 9000 quality system

1. Achieve, maintain and seek to continuously improve quality of products and services
2. Improve quality of operations to meet customers as well as stake holders stated and
expected needs
3. Provide confidence to management that quality requirements are fulfilled
4. Provide confidence to stake holders
5. Provide confidence to overall organization quality system requirements are fulfilled.

Benefits of ISO certification

Companies going for ISO certification because of following benefits:
1. Solid foundation for improvement, consistency and profitability
2. Good platform for continuous quality improvement
3. Status symbol for company
4. Increases potential market share.
5. Improves employee’s morale and ensures total involvement
6. Ensures customer satisfaction
7. Ensures confidence within all stake holders in company including suppliers, investors and
shareholders etc.
8. Fulfills the mandatory requirements of entry as a supplier to export products overseas.
9. Improves documentation, operating standards and house keeping
 10. Reduce wastage and reduction in cost of production.

What is ISO?
ISO i.e. "International Organization for Standardization” is an association of National standard
bodies of more than 180 countries.
ISO was formed in 1987 and at Geneva, Switzerland.
It is an specialized international agency for standardization with objective of co-ordination and
unification of international standards.
ISO promotes the development of standardization and related activities in the world with a view
to facilitate international trade of goods and services, and developing cooperation within nations
regarding intellectual, scientific, technological and economic activities.
By 2015, ISO had published over 15,000 standards.

Introduction to IS0 9000

ISO 9000 family of standards is related to quality management systems.
It is designed to help organizations ensure that they meet the customer needs and other statutory
and regulatory requirements of QMS.
ISO 9000 is applicable in public as well as private sector

Family of ISO 9000 standards

ISO Quality Management systems: Provides information about concepts and
9000: Fundamentals and Vocabulary vocabulary used in other two standards.
2005 Serves as reference for ISO 9001: 2008
ISO Quality Management systems: Provides requirements to achieve
9001: requirements certification.
2008 Used for registration and certification of
standards
ISO Quality Management systems: Provides guidelines to companies
9004: Guidelines for performance applying beyond ISO 9001: 2008.
2009 improvement Helps to meet customer requirements as
well as checks performance
improvement

Introduction to ISO-9001
It insures manufacturing products according to the standards.
Improve the performance of process
Increase the satisfaction of customers.
Implementation of statutory and regulatory requirements related to products or services.
ISO standards are revised continually by standing technical committees and advisory groups.

Quality Management Principles

These 8 principles are set of comprehensive and fundamental rules for leading and operating an
organization.
1. Customer Focus
2. Leadership
 3. Involvement of people
4. Process Approach
5. System Approach
6. Continual improvement
7. Fact-based decision making
8. Mutually beneficial supplier relationships

Principle 1- Customer Focus

Organizations should understand current and future customer needs, meet customer requirements
& strive to exceed customer expectations.
Provide better service and take care of customer satisfaction.
Steps in Application of Principle are:
Researching and understanding customer needs and expectations.
Communicating customer needs & expectations within organization.
Measuring customer satisfaction level and acting on the results
Systematically managing customer relationships.
Key Benefits:
Increased revenue and market share
Resources used effectively to enhance customer satisfaction
Improved customer trust leading to repeat business.

Principle 2- Leadership
Leaders establish unity and give direction of the organization.
Role models for implementation of policies and value.
Characteristics of Successful Leaders:
Give attention to external and internal customers
Provide training, and create healthy work environment
Emphasize improvement rather than maintenance.
Emphasize defect prevention.
Encourage collaboration rather than competition.
Continually try to improve communications
Choose suppliers on the basis of quality, not price.
Key Benefits:
Sub ordinates motivated towards organization's goals and objectives
Miss-communication will be minimized.

Principle 3 - Involvement of People

Quality is achieved by involving people across all levels of the organization as well as giving
then responsibility for quality.
Steps in Application of this Principle are:
Accept ownership and responsibility to solve problems.
Actively seek opportunities to make improvements, and enhance competencies, knowledge and
experience.
Freely share knowledge & experience in teams.
Focus on the creation of value for customers.
Be innovative in furthering the organization's objectives.
Make people enthusiastic & proud to be part of organization.
Key Benefits:
Motivated, committed and involved people in organization.
Innovation and creativity in furthering the organization's objectives.

Principle 4- Process Approach

A desired result is achieved more efficiently when activities and related resources are managed
as a process.
System of interrelated processes has to be identified, properly understood and managed to
enhance effectiveness and ensure efficient effectiveness of the organization.
To apply a process approach you have to decide what the tasks are, how and where they relate,
what resources and inputs you need, and how to do things in order to arrive at the result you
want.
Key Benefits:
Lowers the costs and shorten the cycle times
Improved, consistent and predictable results.

Principle 5-System Approach to Management

Identifying, understanding and managing the multiple processes together as a system leads to
greater efficiency.
Helps in understanding the interrelation of business elements.
Steps in Application of this Principle are:
Define the system by identifying the processes that affect a given objective.
Structure the system to achieve the objective in efficient way.
Understand the interdependencies among the processes
Evaluate & estimate the resource requirements, establish resource constraints prior to action.
Key Benefits:
Integration and alignment of the processes will achieve the desired results
Ability to focus effort on the key processes

Principle 6-Continual Improvement

Continual improvement of the organization's overall performance should be a permanent
objective.
There is increased ability to embrace new opportunities, organizational flexibility and improved
performance.
Steps in Application of this Principle are:
Use basic improvement concepts for incremental improvement.
Use periodic assessments
Continually improve the efficiency & effectiveness of all processes.
Promote Prevention Based Activities
Provide training using tools of continual improvement such as the PDCA cycle, problem solving,
and process innovation.
Key Benefits:
Improvement in organizational capabilities
Flexibility to react quickly to opportunities

Principle 7 - Factual Approach to Decision Making or Fact Based Decision Making

Effective decisions are based on the analysis of data and information and not on personal or
situational thinking
TQM requires that an organization continually collect and analyze data in order to improve
decision making accuracy, and allow prediction based on past history.
Steps in Application of this Principle are:
Take measurements and collect relevant information.
Check data is accurate, reliable and accessible.
Analyze the data and information using valid methods.
Make decisions and take action based on the results of logical analysis
Key Benefits:
Informed decisions.
An increased ability to demonstrate the effectiveness of past decisions

Principle 8- Mutually Beneficial Supplier Relationships

Strong relationship between the supplier and organization will enhance productivity and
encourage seamless working practices.
It will benefit as optimization of costs and resources
Steps in Application of this Principle are:
Identify and select key suppliers.
Establish supplier relationships.
Create clear and open communications.
Initiate joint development and improvement of processes.
Jointly establish a clear understanding of customers' needs.
Share information and future plans
Key Benefits:
Increased ability to create value for both parties
Optimization of costs and resources.