DAYANANDA SAGAR ACADEMY OF TECHNOLOGY &

MANAGEMENT
DEPARTMENT OF MECHANICAL ENGINEERING

TOTAL QUALITY MANAGEMENT

Presented to:
Presented By:
Abhishek – 1DT2ME001 Dr. Mallikarjun Sir
Chethan – 1DT22ME002 Associate Professor
Darshan.V – 1DT22ME003 Dept of Mechanical Engineering
Likith Gopal – 1DT22ME004 DSATM.
 CONTENTS

Benefits of
I ISO
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t
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o ISO 9000
dISO 9001 series of
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requirements.
c standards
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 Quality Management System (QMS)
• A Quality Management System (QMS) is a framework that helps an organization meet
customer needs and improve quality. It includes policies, procedures, and responsibilities that
are documented and followed throughout the organization.
• 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).
 Benefits of ISO registration
• There are various reasons for implementing a quality system that conforms to an ISO standard.
• The primary reason is that customers are suggesting, or market is demanding, compliance to a quality
system. Other reasons include required improvements in processes or systems and a desire for global
deployment of products and services.
• As more and more organizations become registered, they require their subcontractors or suppliers to be
registered, creating a snowball effect.
• Consequently, in order to maintain or increase market share, many organizations are finding that they
should be in conformance with an ISO standard.
• Internal benefits that can be received from developing and implementing a well-documented quality
system can far outweigh the external pressures.
 Benefits of ISO registration
On the negative side, prevention and appraisal costs increased. Additional examples of benefits after registration are as
follows:
1. The American Institute of Certified Public Accountants (AICPA) now has a quality system that works. Also, there was a 4%
improvement in gross margins which was the largest improvement in their history.
2. North town Ford automobile dealership in Toronto, Ontario, raised customer satisfaction and loyalty by 20%. It experienced
a 55% increase in customers who would recommend the dealership.
3. United Airlines reduced the average engine overhaul cycle time from 120 days to 60 days.
4. Cleveland Center for Joint Reconstruction has experienced lower costs and more control and consistency in the care it
provides.
A study of 100 Italian manufacturing firms was undertaken to determine if there was any improvement in performance after
registration. Significant improvement was noted in the following areas:
• Internal quality as measured by the percent of scrap, rework and nonconformities at final inspection
• Production reliability as measured by the number of breakdowns per month, percent of time dedicated to emergencies and
percent of downtime per shift.
• External quality as measured by product accepted by customers without inspection, claims of nonconforming product and
returned product
• Time performance as measured by time to market, on-time delivery and throughput time
• Cost of poor quality as measured by external nonconformities, scrap and rework
 Journal Papers
Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New
Medical Device Regulations in Europe
• Purpose: The new Medical Device Regulations (MDR) in Europe represent unprecedented
challenges for researchers in academic environments. Adherence to regulatory frameworks, like
the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization.
• Methods: We have systematically engineered and implemented a Quality Management System
(QMS) tailored to meet the distinct needs of academic institutions. Our objective was to establish a
comprehensive framework that enable our research group to comply with MDR without hindering
innovation and discovery. Specifically, we engineered a traditional commercial QMS aligned with
ISO13485 to fulfill academic needs. We ensured the QMS focused on requirements relevant to pre-
market clinical investigations and considered appropriate roles for an academic setting.
• Results: We present an optimized QMS implementation to satisfy the urgent need for research
institutions to align with the MDR. Notably, our efforts yielded demonstrable results, culminating in
the successful approval of research projects by the Swedish Medical Product Agency (MPA).
• Conclusion: Here, we share the insights and challenges we encountered during the implementation
of an appropriate and efficient QMS for academic research, which we believe can serve as a
guiding example for other academic research groups. By presenting our QMS implementation
validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal
importance of MDR compliance among researchers in Europe.
 Journal Papers
Quality Management System and Practices
Ng Kim-Soon University Tun Hussein Onn Malaysia Malaysia
1. Introduction Quality is a perceptual, conditional and somewhat subjective attribute of a product or
service. Its meaning in business has developed over time. It has been understood differently and
interpreted differently by different people. A business will benefit most through focusing on the key
processes that provide their customers with products and services.
2. What is quality and TQM? The business meanings of quality have developed over time. Among the
interpretations of quality stated by Wikipedia from the various sources is tabled as below:
 Journal Papers
3. Cost of quality Good quality product or service enables an organization to attract and retain customers. Poor quality leads to
dissatisfaction to customers. As such, the costs of poor quality are not just those of immediate waste or rework and rectification,
it is also the loss of future sales and subsequently the organization performance. The concept of quality costs was first described
by Feigenbaum (1956) as a mean to quantify the total cost of quality-related efforts and deficiencies.
4. Linking quality management system to organizational performance Sila (2005) reviewed that research works have often
link TQM practices with multidimensional measures organizational performance of both financial and non-financial measures.
Kaynak (2003) reported that TQM practices can directly affect financial performance, it also affect indirectly on increasing
market competitiveness (Chong and Rundus, 2004), innovation (Singh and Smith, 2004), and productivity (Rahman and
Bullock, 2005).
• 5. Approaches of implementing TQM: Implementing TQM can be a tedious journey in an organization.
Empirical evidence supports the argument that by focusing on quality, a business can substantially
improve its performance
• The Guru Approach.
• The TQM Element Approach.
• The Company Model Approach.
• The Japanese Total Quality Approach.
• The Prize Criteria Approach.
• 6. The quality journey The journey of quality management never ends. Quality management is evolving and tomorrow will
present a different scenario through adding and discarding practices. Whether it is a big organization or a small one,
producing products or services, it is quality that matters to the customers.
 ISO 9000
1. ISO 9000:2000
• Quality Management Systems (QMS) fundamentals and vocabulary discusses the fundamental concepts related to the QMS and provides
the terminology used in the other two standards.
2. ISO 9001:2000
• QMS requirements is the standard used for registration by demonstrating conformity of the
• QMS to customers, regulator and the organization's own requirements.
3. ISO 9004:2000
• QMS guidelines for performance improvement provide guidelines that an organization can use to establish a QMS focused on improving
performance
4. ISO 9001 Requirements
The standard has following eight clauses:
1. Scope
2. Normative references
3. Definitions
4. Quality management systems
5. Management responsibility
6. Resource management
7. Product and/or service realization
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