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Module 1 Notes - 18ME734.

Total Quality Management (TQM) is defined as a continuous effort by management and employees to ensure long-term customer loyalty and satisfaction. TQM requires six basic concepts: 1) committed management, 2) focus on customers, 3) effective workforce involvement, 4) continuous improvement, 5) treating suppliers as partners, and 6) establishing performance measures. Historical figures like Deming, Juran, and Shewhart influenced the development of TQM principles like statistical process control, reliability engineering, and the plan-do-study-act cycle. TQM aims to integrate all functions to achieve quality goods and services that exceed customer needs.

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0% found this document useful (1 vote)
222 views17 pages

Module 1 Notes - 18ME734.

Total Quality Management (TQM) is defined as a continuous effort by management and employees to ensure long-term customer loyalty and satisfaction. TQM requires six basic concepts: 1) committed management, 2) focus on customers, 3) effective workforce involvement, 4) continuous improvement, 5) treating suppliers as partners, and 6) establishing performance measures. Historical figures like Deming, Juran, and Shewhart influenced the development of TQM principles like statistical process control, reliability engineering, and the plan-do-study-act cycle. TQM aims to integrate all functions to achieve quality goods and services that exceed customer needs.

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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

Module 1

Principles and Practices


Total Quality Management (TQM) is an enhancement to the traditional way of doing business.
Total - Made up of the whole.
Quality - Degree of excellence a product or service provides.
Management - Act, art, or manner of handling, controlling, directing, etc.

Therefore, TQM is the art of managing the whole to achieve excellence.


It is the application of quantitative methods and human resources to improve all the processes within an
organization and exceed customer needs now and in the future.

TQM is the integration of all functions and processes within an organization in order to achieve
continuous improvement of quality of goods / services with a goal of customer satisfaction.

The purpose of TQM is to provide a quality product and/or service to customers, which will, in turn,
increase productivity and lower cost. With a higher quality product and lower price, competitive position
in the marketplace will be enhanced

Total Quality management is defined as a continuous effort by the management as well as


employees of a particular organization to ensure long term customer loyalty and customer
satisfaction

TQM requires six basic concepts:

1. A committed and involved management to provide long-term top-to-bottom organizational support.


2. An unwavering focus on the customer, both internally and externally.
3. Effective involvement and utilization of the entire work force.
4. Continuous improvement of the business and production process.
5. Treating suppliers as partners.
6. Establish performance measures for the processes

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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

1. A committed management

Management involvement and commitment is very much necessary in quality program. A quality
council must be established to develop a clear vision. Quality goals are included in the business plan.
An annual quality improvement program is organized and includes input from the entire work force.

Managers participate in the quality improvement teams and also act as advisers to other teams. TQM
is a continual activity that must be inculcated in the organizational culture – it is not just a one-shot
program. TQM must be known and communicated to all workers.

2. A rigid focus on customer

The first of the Total Quality Management principles puts the focus back on the people buying your
product or service.

Your customers determine the quality of your product. If your product fulfills a need and lasts as long
or longer than expected, customers know that they have spent their money on a quality product.

To implement this TQM principle:


 Research and understand your customers’ needs and expectations.
 Align your organization’s objectives with customer needs.
 Communicate with customers, measure satisfaction, and use the results to find ways to improve
processes.
 Manage customer relationships.
 Find a balance for satisfying customers and other interested parties (such as owners, employees,
suppliers, and investors).

3. Effective involvement and utilization of the entire work force

You can’t increase productivity, processes, or sales without the total commitment of all employees.
They need to understand the vision and goals that have been communicated.

They must be sufficiently trained and given the proper resources to complete tasks in order to be
committed to reaching goals on time.

To implement this TQM principle:

 Clearly communicate and acknowledge the importance of each individual contribution to the
completed product.
 Stress that each team or individual accepts ownership and give them the responsibility and
opportunity to solve problems when they arise.
 Encourage employees to self-evaluate performance against personal goals and objectives, and
make modifications as necessary to improve workflow.
 Acknowledge successes and optimized performance to build confidence in your employees
and your stakeholders.
 Make responsibilities clear, provide adequate training, and make sure your resources are used
as efficiently as possible.
 Encourage people to continually seek opportunities to learn and move into other roles to
increase their knowledge, competence, and experience.
 Create an environment where employees can openly discuss problems and suggest ways to
solve them.

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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

4. Continual improvement

Optimal efficiency and complete customer satisfaction doesn’t happen in a day - your business should
continually find ways to improve processes and adapt your products and services as customer needs
shift. As previously stated, the other Total Quality Management principles should help your business
keep an eye toward continual improvement.

To implement this TQM principle:

 Implement policies to establish product, process, and system improvements as measurable goals
for individuals, teams, and departments.
 Recognize, acknowledge, and encourage innovation to improve processes and development.
 Encourage employees to participate in available training sessions to learn and take on new and
additional roles.

5. Treating suppliers as partners


About 40% of the products / services in an organization are bought out and hence the supplier
quantity must be outstanding.

A supplier must be treated as partner of the organization and it should be clear to the supplier that his
success / failure depends on the success / failure of the organization which depends on the quality of
product / service supplied by him.

6. Establish performance measures

The five performance measures considered the most appropriate in TQM environment are: 
Overall customer satisfaction, number of complaints, percentage of on‐time delivery, and average
time for complaint resolution and employee satisfaction.

Shewhart, Deming, and Juran are often considered to be the three founders of the quality
improvement movement. Two of Shewhart's contributions continue to influence the daily work of
quality - namely, control charts and the Plan–Do–Study–Act (PDSA) cycle.

Total Quality management originated in the manufacturing sector, but can be applied to almost all
organizations.

Historical Background of TQM


Throughout history, strategies adopted to manage quality have changed. Prior to the 20th
Century, Quality was managed on ancient principles:
(i) Product inspection by customers.
(ii) The craftsmanship concept.

The product manufactured during early period were not complicated, and quality was not
greatly affected. As products become complicated & jobs were specialized, it became necessary
to inspect products after manufacture.

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Later on came the concept and practice in

(1) Quality Engineering: Originated from the application of statistical methods for quality control in
manufacturing, called statistical process control.

(2) Reliability Engineering: Improving reliability during product design by quantifying factors of


safety, reducing the number of components and quality at difference levels.

The Japanese have applied Total Quality Control since World War-II in the name of Company Wide
Quality Control (CWQC)

Main gurus of the quality of administration

1. Edwards Deming

He was considered as the father of total quality, offering novel systems to measure it. His aim was to
satisfy the customer to the maximum, offering products as cheap as possible.

DEMING'S SEVEN DEADLY DISEASES - significantly contributed to the American quality crisis.

• Lack of constancy of purpose to plan and deliver products and services that will help a company
survive in the long term.
• Emphasis on short-term profits caused by short-term thinking (which is just the opposite of
constancy of purpose), fear of takeovers, worry about quarterly dividends, and other types of
reactive management.

• Performance appraisals (i.e., annual reviews, merit ratings) that promote fear and stimulate
unnecessary competition among employees.

• Mobility of management (i.e., job hopping), which promotes short-term thinking.

• Management by use of visible figures without concern about other data, such as the effect of
happy and unhappy customers on sales, and the increase in overall quality and productivity that
comes from quality improvement upstream.

• Excessive medical costs, which now have been acknowledged as excessive by federal and state
governments, as well as industries themselves.

• Excessive costs of liability further increased by lawyers working on contingency fees.

DEMING'S 14 Points

• Continuously improve the system of production and service . Management's job is to continuously
improve the system with input from workers and management
• Institute training on the job. When training is an integral part of the system, operators are better
able to prevent defects. Deming understood that employees are the fundamental asset of every
company, and they must know and buy into a company's goals

• Institute leadership (modern methods of supervision). The best supervisors are leaders and
coaches, not dictators. Deming high-lighted the key role of supervisors who serve as a vital link
between managers and workers

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• Drive out fear. Create a fear-free environment where everyone can contribute and work
effectively. There is an economic loss associated with fear in an organization. Employees try to
please their superiors. Also, because they feel that they might lose their jobs, they are hesitant to
ask questions about their jobs, production methods, and process parameters

• Cease dependence on inspection - Prevent defects instead of trying to detect them

• Management by use of visible figures without concern about other data, such as the effect of
happy and unhappy customers on sales

• Break down barriers between areas. People should work cooperatively with mutual trust, respect,
and appreciation for the needs of others in their work.

• Eliminate slogans aimed solely at the work force. Get rid of unclear slogans. Eliminate
exhortations that are meaningless. Let people know exactly what you want – don’t make them
guess. Don’t let words and nice-sounding phrases replace effective leadership. Outline your
expectations, and then praise people face-to-face for doing good work.

• Eliminate numerical goals, work standards, and quotas. Objectives set for others can force sub-
optimization or defective output in order to achieve them. Instead, learn the capabilities of
processes and how to improve them

• Remove barriers that hinder workers (and hinder pride in workmanship). The direct effect of pride
in workmanship is increased motivation and a greater ability for employees to see themselves as
part of the same team

• Institute a vigorous program of education and self-improvement. Deming's philosophy is based on


long-term, continuous process improvement that cannot be carried out without properly trained
and motivated employees

• Improve constantly and forever. Emphasize training and education so everyone can do their jobs
better

• Eliminate management by objectives Look at how the process is carried out, not just numerical
targets. Deming said that production targets encourage high output and low quality

• Take action to accomplish the transformation. Create a structure in top management that will
promote the previous thirteen points

2. Walter A. Shewhart

Walter Shewhart developed modern statistical concepts and scientific methods to minimize the
human efforts. Shewhart's methods influenced other statisticians like W Edwards Deming and Joseph
Juran.

He developed Statistical Process Control Charts (SPC). The control chart is a graph used to study
how a process changes over time. Data are plotted in time order. A control chart always has a central
line for the average, an upper line for the upper control limit, and a lower line for the lower control
limit.

By comparing current data to these lines, you can draw conclusions about whether the process
variation is consistent (in control) or is unpredictable (out of control, affected by special causes of
variation).

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The original founder of the PDCA cycle is Walter A. Shewhart (1939). William Edwards Deming
further developed the PCDA cycle in the 1950 to help organisations achieve better results.

The PDCA cycle stands for the abbreviation of the four main steps in the cycle: Plan, Do, Check and
(Re) Act
Figure 2: SPC Charts

Total Quality management can be divided into four categories:

 Plan
 Do
 Check
 Act

Also referred to as PDCA cycle.

Planning Phase

Planning is the most crucial phase of total quality management. In this phase employees have to come
up with their problems and queries which need to be addressed. They need to come up with the
various challenges they face in their day to day operations and also analyze the problem’s root cause.
Employees are required to do necessary research and collect relevant data which would help them find
solutions to all the problems.

Doing Phase

In the doing phase, employees develop a solution for the problems defined in planning phase.
Strategies are devised and implemented to overcome the challenges faced by employees. The
effectiveness of solutions and strategies is also measured in this stage.

Checking Phase

Checking phase is the stage where people actually do a comparison analysis of before and after data to
confirm the effectiveness of the processes and measure the results.

Acting Phase

In this phase employees document their results and prepare themselves to address other problems.

3. Joseph Juran

Juran is widely acknowledged for the addition of the human dimension to quality management. He
advocated the training and education of managers. Juran proposed that human relations problems

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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

are supposed to be isolated and that the fundamental cause of quality issues was resistance to
change.

Juran has been called the father of quality, a quality guru, and the man who taught quality to the
Japanese. One of his stellar contributions is the Juran trilogy of the three quality processes: quality
control, quality planning, and quality improvement.

• The role of quality planning is to design a process that will be able to


meet established goals under operating conditions
• The role of quality control is to operate and when necessary correct the
process so that it performs with optimal effectiveness.
• The role of quality improvement is to devise ways to take the process
to unprecedented levels of performance.

4. Kaoru Ishikawa

Ishikawa believed that increased internal cooperation and coordination positively affects a


customer's needs and ultimately leads to process efficiency and better quality of products and
services

Ishikawa diagrams are sometimes referred to as fish bone diagrams. An Ishikawa diagram is a
diagram that shows the causes of an event and is often used in manufacturing and product
development to outline the different steps in a process, demonstrate where quality control issues might
arise, and determine which resources are required at specific times.

They resemble a fish skeleton, with the "ribs" representing the causes of an event and the final
outcome appearing at the head of the skeleton. The purpose of the Ishikawa diagram is to allow
management to determine which issues have to be addressed in order to gain or avoid a particular
event.

5. Phillip Crosby

Crosby's approach revolves around Zero Defects. Doing things right the first time is always cheaper
than trying to fix defects, after they have been created. Thus, quality is free. According to Crosby,
costs of poor quality are higher than organizations realize

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Philip Crosby is best known for his books:


Quality is Free - His first book that made him famous.
Zero Defects - One of his four absolutes of quality.
The Four Absolutes of Quality - See the details below.
The Crosby Vaccine - for management to prevent poor quality

Crosby's principle, Doing It Right the First Time, was his answer to the quality crisis. He defined
quality as full and perfect conformance to the customers' requirements.  The essence of his philosophy
is expressed in what he called the Absolutes of Quality Management and the Basic Elements of
Improvement.

The Absolutes of Quality Management


Crosby defined Four Absolutes of Quality Management, which are

The First Absolute: The definition of quality is conformance to requirements


The Next Absolute: The system of quality is prevention
The Third Absolute: The performance standard is zero defects
The Final Absolute: The measurement of quality is the price of non-conformance
Quality

Juran defines quality as fitness for use in terms of design, conformance, availability, safety, and field
use.

Q = P / E where Q = quality, P = performance, E = expectations

If Q is greater than 1.0, then the customer has a good feeling about the product or service. Of course,
the determination of P and E will most likely be based on perception with the organization
determining performance and the customer determining expectations.

A more definitive definition of quality is given in ISO 9000: 2000. It is defined as the degree to which
a set of inherent characteristics fulfills requirements. Degree means that quality can be used with
adjectives such as poor, good, and excellent. Inherent is defined as existing in something, especially
as a permanent characteristic.

Characteristics can be quantitative or qualitative. Requirement is a need or expectation that is stated;


generally implied by the organization, its customers, and other interested parties; or obligatory.

Q - Quality first L - Long-term vision


U - User is the king I - Innovation error proofing
A - Avoid defects T - Training for all

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Y - Yearning for facts T - Team work


R - Respect humanity
C - Cost consciousness O - Operator in state of self-
O - Optimal tolerance control
N - Nip the vital few L - Leadership from top
The Quality Vaccine
Crosby explained that this vaccination was the medicine for organizations to prevent poor quality.
 Integrity: Quality must be taken seriously throughout the entire organization, from the
highest levels to the lowest. The company's future will be judged by the quality it delivers.
 Systems: The right measures and systems are necessary for quality costs, performance,
education, improvement, review, and customer satisfaction.
 Communication: Communication is a very important factor in an organization. It is
required to communicate the specifications, requirements, and improvement opportunities
of the organization. Listening to customers and operatives intently and incorporating
feedback will give the organization an edge over the competition.
 Operations: a culture of improvement should be the norm in any organization, and the
process should be solid.
 Policies: policies that are implemented should be consistent and clear throughout the
organization.

Obstacles in implementing TQM

Many organizations, especially small ones with a niche, are comfortable with their current state.
They are satisfied with the amount of work being performed, the profits realized, and the
perception that the customers are satisfied. Organizations with this culture will see little need for
TQM until they begin to lose market share.

Once an organization embarks on TQM, there will be obstacles to its successful implementation.
The applications of solar energy are:

1. Lack of Management Commitment


In order for any organizational effort to succeed, there must be a substantial management
commitment of management time and organizational resources. The purpose must be clearly and
continuously communicated to all personnel. Management must consistently apply the principles
of TQM.

Robert Galvin of Motorola said that only the CEO can ensure, even in times of great pressure, that
quality and customer satisfaction are preserved. In a survey of 188 quality professionals, 66%
reported that management’s compensation is not linked to quality goals such as failure costs,
customer complaints, and cycle time reduction.

2. Inability to Change Organizational Culture


Changing an organization’s culture is difficult and will require as much as five years. Individuals
resist change - they become accustomed to doing a particular process and it becomes the preferred
way. Management must understand and utilize the basic concepts of change.

They are:

1. People change when they want to and to meet their own needs.
2. Never expect anyone to engage in behavior that serves the organization’s values unless adequate
reason (why) has been given.

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3. For change to be accepted, people must be moved from a state of fear to trust. It is difficult for
individuals to change their way of doing things; it is much more difficult for an organization to
make a cultural change.

3. Improper Planning
All constituents of the organization must be involved in the development of the implementation
plan and any modifications that occur as the plan evolves.

Of particular importance is the two-way communication of ideas by all personnel during the
development of the plan and its implementation.

Customer satisfaction should be the goal rather than financial or sales goals. Peterson Products, a
metal stamping firm near Chicago, improved on-time delivery, which resulted in a 25% increase in
sales. Focus on quality and the other goals will follow.

4. Lack of Continuous Training and Education


Training and education is an ongoing process for everyone in the organization. Needs must be
determined and a plan developed to achieve those needs.
Training and education are most effective when senior management conducts the training on the
principles of TQM. Informal training occurs by communicating the TQM effort to all personnel on
a continual basis

5. Incompatible Organizational Structure and Isolated Individuals and Departments


Differences between departments and individuals can create implementation problems. The use of
multifunctional teams will help to break down long-standing barriers.

Restructuring to make the organization more responsive to customer needs may be needed.
Individuals who do not embrace the new philosophy can be required to leave the organization.
Adherence to the six basic concepts will minimize the problems over time.

6. Ineffective Measurement Techniques and Lack of Access to Data and Results


Key characteristics of the organization should be measured so that effective decisions can be
made. In order to improve a process you need to measure the effect of improvement ideas. Access
to data and quick retrieval is necessary for effective processes.

7. Paying Inadequate Attention to Internal and External Customers


Organizations need to understand the changing needs and expectations of their customers.
Effective feedback mechanisms that provide data for decision making are necessary for this
understanding. One way to overcome this obstacle is to give the right people direct access to the
customers. Maruti Suzuki, the leading car manufacturing company in India, takes significant
efforts in training their service technicians and dealers’ sales staff in order to ensure that their
actions and interactions are in synchronization with the changes in customer profiles and
expectations. When an organization fails to empower individuals and teams, it cannot hold them
responsible for producing results.

8. Inadequate Use of Empowerment and Teamwork

Teams need to have the proper training and, at least in the beginning, a facilitator. Whenever
possible, the team’s recommendations should be followed. Individuals should be empowered to
make decisions that affect the efficiency of their process or the satisfaction of their customers.
Solar Turbines, Inc. flattened its organization by restructuring into work teams and delegating
authority to the point of customer contact or to the work performed.

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9. Failure to Continually Improve


It is tempting to sit back and rest on your laurels. However, a lack of continuous improvement of
the processes, product, and/or service will even leave the leader of the pack in the dust. Will
Rogers said it best, “Even if you’re on the right track, you’ll get run over if you just sit there.”
Even though Champion Mortgage’s 1998 business volume increased 59%, it continues to address
culture, staff, and service issues.

Quality Management System (QMS)


If we look at QMS in reverse, we can develop a better understanding of its definition. QMS is a
System for Managing the Quality of a product or process. Furthermore, QMS is a system for
documenting the structure, procedures, responsibilities and processes needed for effective quality
management.  The QMS outlines how an organization will produce, document, control and deliver
a product or service possessing customer perceived value.

Why Implement a Quality Management System (QMS)


Multiple benefits result from development and implementation of a robust Quality Management
System.  Some of the most obvious benefits to implementing QMS are as follows:

 Managing product and process quality enables an organization to consistently meet the
needs and wants of their customers through Voice of the Customer (VOC). Increased customer
satisfaction results in more sales, increased market share and a loyal customer base.
 Ensuring that all government regulations and requirements are met with every new product
introduction allows marketing products worldwide.
 Reduction of costly rework and / or scrap is realized through implementation and
monitoring of process controls.
 Management is able to make decisions based on data not conjecture. The data collected
through the implementation of Statistical Process Control (SPC) and other methods allows
management to make decisions based on evidence. Valuable resources are utilized where they
will have the most impact on improving process efficiency and reducing quality issues.
 Engagement of the associates in the process and product improvement efforts helps to
create a continuous improvement culture within the organization. Through the introduction
of Kaizen, 5S and other quality tools, the associates gradually take mental ownership of the
process.  Associates invested in the processes they perform are best at identifying opportunities
for improvements that will result in better quality, efficiency and safety.

Developing and implementing a Quality Management System enables organizations of all types
be more efficient and effective. Some have the false impression that the quality system only
involves actions performed by personnel within the quality department. The Quality
Management System affects multiple processes and departments within an organization from
sales, design, development, production and delivery of the product or service to the customer.
The QMS promotes cross-functional communication and interaction throughout the
organizational structure, which can result in a more unified and stronger organization.

ISO Registration

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The International Organization for Standardization (ISO) was founded in 1946 in Geneva,
Switzerland, where it is still based. Its mandate is to promote the development of international
standards to facilitate the exchange of goods and services worldwide. ISO is composed of more
than 90 member countries. The United States representative is the American National Standards
Institute (ANSI).

 Suitable for both small and large organizations.


 Better internal management.
 Less wastage.
 Increase in efficiency, productivity and profit.
 Improved customer retention and acquisition.
 Consistent outcomes, measured and monitored.
 Globally recognised standard.

ISO 9000 series of standards

ISO 9000 is defined as a set of international standards on quality management and quality
assurance developed to help companies effectively document the quality system elements needed
to maintain an efficient quality system. They are not specific to any one industry and can be
applied to organizations of any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve
continual improvement. It should be considered to be a first step or the base level of a quality
system.

ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO),
a specialized international agency for standardization composed of the national standards bodies
of more than 160 countries. The standards underwent revisions in 2000 and 2008. The most recent
versions of the standard, ISO 9000:2015 and ISO 9001:2015, were published in September 2015.

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1. Customer focus
o Understand the needs of existing and future customers
o Align organizational objectives with customer needs and expectations
o Meet customer requirements
o Measure customer satisfaction
o Manage customer relationships
o Aim to exceed customer expectations
o Learn more about the customer experience and customer satisfaction

2. Leadership
o Establish a vision and direction for the organization
o Set challenging goals
o Model organizational values
o Establish trust
o Equip and empower employees
o Recognize employee contributions
o Learn more about leadership

3. Engagement of people
o Ensure that people’s abilities are used and valued
o Make people accountable
o Enable participation in continual improvement
o Evaluate individual performance
o Enable learning and knowledge sharing
o Enable open discussion of problems and constraints
o Learn more about employee involvement

4. Process approach
o Manage activities as processes
o Measure the capability of activities
o Identify linkages between activities
o Prioritize improvement opportunities
o Deploy resources effectively
o Learn more about a process view of work and see process analysis tools

5. Improvement
o Improve organizational performance and capabilities
o Align improvement activities
o Empower people to make improvements

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o Measure improvement consistently


o Celebrate improvements
o Learn more about approaches to continual improvement

6. Evidence-based decision making


o Ensure the accessibility of accurate and reliable data
o Use appropriate methods to analyze data
o Make decisions based on analysis
o Balance data analysis with practical experience
o See tools for decision making

7. Relationship management
o Identify and select suppliers to manage costs, optimize resources, and create value
o Establish relationships considering both the short and long term
o Share expertise, resources, information, and plans with partners
o Collaborate on improvement and development activities
o Recognize supplier successes
o Learn more about supplier quality and see resources related to managing the supply chain

ISO 9001 Requirements

The standard has eight clauses: Scope, Normative References, Definitions, Quality Management
Systems, Management Responsibility, Resource Management, Product and/or Service Realization,
and Measurement, Analysis, and Improvement. The first three clauses are for information while
the last five are requirements that an organization must meet. The numbering system used in the
standard is followed in this section.

The application of a system of processes within an organization, together with their identification
and interactions and the managing of these processes, is referred to as the process approach.

This approach emphasizes the importance of:

 Understanding and fulfilling the requirements.


 The need to consider processes in terms of value added.
 Obtaining results of process performance and effectiveness.
 Continual improvement of processes based on objective measure.

For the five required clauses, the system is shown in Figure

1. Scope
The purpose of the standard is for the organization to demonstrate its ability to provide a product
that meets customer and regulatory requirements and to enhance customer satisfaction. This
purpose is accomplished by evaluating and continually improving the system, rather than the
product. The requirements of the standard are intended to be applicable to all types and sizes of
organizations.

2. Normative Reference

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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

ISO 9000:2005 Quality Management Systems - Fundamentals and vocabulary are a normative
reference that provides applicable concepts and definitions.

3. Terms and Definitions - For the purposes of this standard, the terms and definitions given in ISO
9000:2000 apply. Throughout the text of this standard, the term “Product” also means “Service.”

Clauses 0 to 3: Introduction, Scope, References, Terms and Definitions


Clause 0 mentions the benefits of implementing a QMS and the quality management principles,
and presents the process approach, the Plan-Do-Check-Act cycle

Clause 4: Context of the organization


An organization is not a closed system, isolated from the outside; it is inserted in a particular
context and cannot be independent of what customers are looking for, or what regulators define

Clause 5: Leadership and commitment


Top management must demonstrate leadership and commitment, establish and communicate a
quality policy, and ensure responsibilities and authorities are assigned, communicated and
understood

Clause 6: Planning for the QMS.


It covers Organizational Quality Management System planning to address organizational risks,
opportunities, changes and quality objectives.

Clause 7: Support & Resource management.


This covers: providing resources, ensures employees are competent and aware, and includes
documented information to support your quality management system.

Clause 8: Operational planning and control.


It covers the plan and control processes needed to meet the requirements for products and services

Clause 9: Performance evaluation.


ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and evaluate your
quality management system

Clause 10: Improvement actions.

Prepared by: Yogananda B.S. Sri Sairam College of Engineering Anekal. Page |
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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

Select opportunities for improvement, take action against nonconformities, implement corrective
actions as necessary, and continually improve your quality management system

Implementation of ISO 9000

Steps involved
1. Top management commitment
It is not possible to implement the standard without top management knowledge and support
2. Appointment of Management Representative (MR)
M.R. is responsible for coordinating the implementation of quality system and contact person
for all involved in the process, both internal and external
3. Awareness
Everyone in the organization should made aware of the implementation of the system and
understand the same, since the process is going to affect and require their inputs
4. Appointment of implementation team
The team shall consisting of employees from all levels and areas of organization as
representative
5. Training
Training should be imparted to the team, supervisors and internal auditors.
6. Time schedule
A time frame should be made for implementation and registration of the system
7. Selection of element owners
The team selects owners for each of the system elements
8. Review of present system
The performance of present system is reviewed by collecting quality manuals, procedures, and
work instructions.
9. Writing the documents & install the system
Prepare written quality policy and procedure manuals – they can be combined into one
document

Prepared by: Yogananda B.S. Sri Sairam College of Engineering Anekal. Page |
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Regulation – 2018 (CBCS Scheme) Total Quality Management – 18ME734

10. Internal audit


Carry out internal audit of the quality system with the help of cross section of people who have
been trained to audit
11. Management review
Carry out management review to determine the progress and effectiveness of the system in
achieving the stated quality goals
12. Pre-assessment
This activity is to assess where exactly the orgsnization stands in the implementation of quality
system
13. Registration
It is a certification procedure to certify the correct implementation of the quality system by an
organization.

Prepared by: Yogananda B.S. Sri Sairam College of Engineering Anekal. Page |
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