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QMS History of Quality Evolution Lec-1

Qms , MLT

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34 views24 pages

QMS History of Quality Evolution Lec-1

Qms , MLT

Uploaded by

sumit kumar jha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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What is Quality?

It is an extent to which the inherent or innate characteristics of any product


or service fulfils the requirements

Quality in the traditional sense pertains to examine whether a product or


service meets its expected characteristics and satisfies the consumer
Quality control in the medical sector is focused on the needs of the
patients as the industry is meant for the fulfillment of their
requirements

For healthcare industry, the Institute of Medicine (IOM) has defined


quality as “the degree to which health care services for individuals
and populations increase the likelihood of desired outcomes and are
consistent with current professional knowledge.”

Quality in healthcare assures that programs and services are


implemented at the highest standards and patients receive the
highest level of care.
History of Quality Evolution
• The concept of quality has been evolving since ancient times

• The modern history of quality can be traced back to the Industrial


Revolution of the 18th century, where quality became an important
concern in manufacturing processes.

• Manufacturers started to realize the importance of producing high-quality


products in order to meet customer demands and compete in the market.
Principal innovators and their contributions

One of the earliest concepts of the quality management movement was that of quality
control of the product based on inspection

In the early 20th century, quality became a more formalized discipline with the introduction
of statistical quality control methods in manufacturing by Walter Shewhart, an American
physicist and engineer, which paved the way for the work of other quality pioneers such as
W. Edwards Deming, Joseph Juran, and Arman Feigenbaum.

Quality control methods were not applied in the laboratory until the 1940s. Other critical
thinkers and innovators, Kaoru Ishikawa and Genichi Taguchi, added to the concepts.

The most recent quality control method is of importance to the laboratory is Galvin’s work
on micro-scale error reduction.
Shewhart Contribution

•Shewhart developed a method for statistical process control forming the basis for
quality control procedures in the laboratory.

• SQC is a set of statistical techniques and methodologies used to


monitor, control, and improve the quality of products or
processes in various industries.
• SQC uses statistical tools and techniques to measure, analyze, and
manage the variability inherent in manufacturing and service
processes.
• The goal of SQC is to ensure that products or services consistently
meet or exceed predefined quality standards.
Edwards Deming Contribution
• Deming was an American statistician, professor, author, lecturer, and
consultant.
• He is best known for his work in Japan after World War II, where he helped
Japanese companies transform their manufacturing processes and improve
product quality. Deming emphasized the importance of statistical methods
in managing and improving quality.
• He introduced his famous "Deming Cycle" or "PDCA Cycle" (Plan-Do-
Check-Act), which is a continuous improvement framework widely used
today.
• He also introduced the "14 Points for Management," which are principles for
achieving quality and productivity improvement in organizations.
Joseph Juran Contribution
• Juran was a Romanian-born American engineer and management
consultant.
• He is known for his contributions to the development of quality
management and for coining the concept of "Total Quality
Management" (TQM)
• Juran emphasized the importance of top management commitment to
quality, as well as the need to involve all employees in the quality
improvement process.
• He introduced the concept of the "Juran Trilogy," which consists of
Quality Planning, Quality Control, and Quality Improvement.
• Juran's focus was on management's role in establishing the right
quality policies and strategies.
Armand Feigenbaum contribution
• Feigenbaum was an American quality control expert and author.
• He is known for introducing the concept of "Total Quality Control"
(TQC), which laid the foundation for later developments in Total
Quality Management.
• Feigenbaum emphasized that quality control should be an integral part
of every aspect of an organization, from design and production to
marketing and customer service.
• His work stressed the importance of a holistic approach to quality
improvement and the involvement of all employees in the quality
process.
• Collectively, these individuals played pivotal roles in shaping the
quality management philosophies and practices that are still influential
in modern business and management.
• Their ideas have been instrumental in helping organizations achieve
• In the mid-20th century, the focus of quality management shifted from a purely statistical
approach to a more holistic approach that included aspects such as customer satisfaction,
employee involvement, and continuous improvement.

• This led to the development of quality management systems such as Total Quality
Management (TQM), Six Sigma, and Lean Manufacturing.

• In recent years, the evolution of quality has been influenced by new technologies such as
the Internet of Things (IoT), Big Data, and Artificial Intelligence (AI). These technologies are
being used to develop new approaches to quality management and to improve quality across
different industries.

• Overall, the history of quality has been marked by a continuous evolution towards a more
customer-focused, holistic, and data-driven approach.
"7 Tools of Quality Control"

• These "Seven Basic Tools," are a set of fundamental


statistical and graphical techniques that are used to analyze
and solve quality-related problems in various processes.
• These tools were popularized by Kaoru Ishikawa, a Japanese
quality management expert.
• Quality circles, on the other hand, are a concept related to
employee involvement and participatory management in
quality improvement initiatives.
Important laboratory standards organizations

An important aspect of quality management is assessment, measuring performance


against a standard or benchmark.

The concept of quality management requires that standards be set

Various standards organization sets international laboratory standards for standards for
industrial manufacturing; we know these standards as ISO standards.
International laboratory standards organization

ISO
The ISO 9000 documents provide guidance for quality in manufacturing and service
industries, and can be broadly applied to many other kinds of organizations.

ISO 9001:2000 addresses general quality management system requirements and applies
to laboratories.

There are two ISO standards that are specific to laboratories:

y ISO/IEC 17025:2005. General requirements for the competence of testing and calibration
laboratories. Geneva: International Organization for Standardization, 2005.

y ISO 15189:2007. Medical laboratories—particular requirements for quality and


competence. Geneva: International Organization for Standardization, 2007.
International laboratory standards organization

CLSI
Another important international standards organization for laboratories is the Clinical and Laboratory
Standards Institute, or CLSI, formerly known as the National Committee for Clinical Laboratory Standards
(NCCLS).

CLSI uses a consensus process involving many stakeholders for developing standards.

CLSI developed the quality management system model based on 12 quality system essentials, and is fully
compatible with ISO laboratory standards.

CLSI has two documents that are very important in the clinical laboratory:
y A quality management system model for health care; approved guideline—second edition. CLSI/NCCLS
document HS1-A2. Wayne, PA, NCCLS, 2004.

y Application of a quality management system model for laboratory services; approved guideline—third
edition. CLSI/NCCLS document GP26-A3. Wayne, PA, NCCLS, 2004.
ISO 9001 is the internationally recognized standard for Quality Management Systems (QMS)
It is the most widely used QMS standard in the world
Summary
Quality management is not new; it grew from the work of innovators who
defined quality over a span of 80 years.

Quality management is as applicable for the medical laboratory as it is for


manufacturing and industry.

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