QM0023 - Unit 1

Understanding ISO 9001:2008
Unit 1
Unit 1
Quality and Quality Management System
Structure
1.1
Introduction
Objectives
1.2
Definition of Quality
Evolution of the concept of quality
Quality as a noun and an adjective
Two dimensional model of quality
Demings principles of quality
1.3
Quality Management Systems

Quality management and Quality Management Systems (QMS)
Concepts of quality management systems
1.4
ISO and ISO 9000

Evolution of ISO 9000
Product and process standards
ISO 9000 family of standards
Usage and certification of ISO 9000 standards
Constantly evolving standard
TQM and ISO 9000 family of standards
Future plans for ISO 9000
1.5
Summary
1.6
Glossary
1.7
Terminal Questions
1.8
Answers
1.9
Case Study
Sikkim Manipal University
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1.1
Unit 1
Introduction
"Quality is the degree to which a set of inherent characteristics satisfies

customer requirements."
- ISO 9000
The concept of quality has evolved significantly over the last century. In the
1920`s the theories of statistics were effectively applied to quality control.
However its only after the year 1940 the statistical techniques were applied
to the products of manufacturing companies. Then in the year 1950 Japan
introduced the quality control measures in all their products. The approach
towards quality product was so intense, that by 1960 and 1970 Japan was
exporting goods to the USA and Europe, and goods made in Japan became
the definition of quality. The rest of the world soon realised that to compete
in the world market, quality of goods will have to be upgraded. It is only in
1980`s, that the companies in USA and UK, to compete with Japanese
goods, introduced and fully adopted the quality concept.
The concept of quality has moved from mere quality inspection and control
in the early part of the 19th century to quality assurance in mid-1950s to the
current requirement of quality management systems.
The quality management systems of organisations have now become
essential for the success of organisations in the current fiercely competitive
market environment. This is because quality is considered as a strategic
advantage and a viable tool for the organisations across the world as
demonstrated earlier by Japanese in the 1970s.
The ISO 9000 family of standards are standards for quality management
systems for organisations. They provide requirements for establishing and
operating quality management systems in any organisation.
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To understand ISO 9000 standards, it is necessary that you understand the

concepts of quality and quality management systems thoroughly. This unit
will discuss about the concepts of quality and quality management systems
with reference to ISO 9000 standards.
As part of this unit, you will study the concepts of quality and how it has
evolved over the period of time from making defect free products through
quality inspection to ensure customer satisfaction on a continual basis. You
will then study the concepts behind quality management systems and the
central role they play in ISO 9000 standards. Finally, you will study the
evolution of the ISO 9000 family of standards and the brief contents of
various standards of the family.
Objectives
After studying this unit, you should be able to:
define the concept of quality
discuss the evolution of quality
explain the Quality Management Systems (QMS)
discuss the International Standards Organisation (ISO)
discuss the evolution of ISO 9000 family of standards
1.2
Definition of Quality
Defining the word quality is a challenging task as its meaning is different for
different people and industries. For example, for a customer, quality is
associated with a value, that is, how well a product serves its intended
purpose. On the other hand for an organisation, it is related to the
conformance to specifications. Similarly, in the manufacturing industry, the
word quality is associated with producing error-free products while it is
related to customer satisfaction in the service industry.
Thus, various definitions of quality have evolved. Some of these definitions
as given by quality experts are shown in Figure 1.1:
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" The totality of features and characteristics of a product or service that bear on its
ability to satisfy stated and implied needs." - ISO 8402: Quality Vocabulary
" Quality is Conformance to Requirements " - Philip Crosby
" Fitness for Use " - Joseph Juran
" Quality is the losses a product imparts to the society from the time the product is
shipped." - Genichi Taguchi
" Quality should be aimed at the needs of the customer, present and future." Deming
Figure 1.1: Some Important Definitions of Quality
From the above mentioned definitions, it can be said that quality is all about
satisfying the customers by providing them an error-free product while
meeting all the specifications.
In todays highly competitive environment, it becomes necessary for an
organisation to provide quality products to its customers in order to survive
in the market. Providing quality products to customers helps an organisation
to increase its sales and market share and achieve competitive advantage.
On the contrary, if the quality of products and services is not satisfactory, it
may incur huge costs for inspection, testing, scrap, rework, and handling of
complaints. Quality is not only associated with the single aspect of a product
but also with its various dimensions, such as features, reliability, durability,
performance, perceived quality, aesthetics, and serviceability.
1.2.1
Evolution of the concept of quality
The word Quality is derived from the Latin word Qualitas meaning of
what. Its use can be traced as far as back to the Roman Orator and
Politician, Cicero (106 43 B.C.) who used it to mean grade or property.
The word has now undergone a complete transformation to encompass
customer satisfaction and delight that arises out of meeting or exceeding
customer requirements through the product or service offered by an
organisation. This transformation of the concept of quality has made it an
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essential strategic weapon of organisations in todays hyper competitive

environment.
Quality has evolved over a period of time and it is still evolving to new
forms. The evolution of quality and its concepts can be categorised into four
phases, which are shown in Figure 1.2:
Emphasis is on Defect Free Products
After Production
Quality
Inspection
Function delinked from manufacturing

Separate Department
Defect Free Products to be ensured during Production rather than inspecting

for defects after production
Quality
Control
Emphasis is on Controlling Production Process through "in-process

inspections"
Focuses o n defect identification
Separate Department /Function
Emphasis on process control through sampling techqniues
Efforts to ensure quality even before production starts through concepts of
"process compliance"
Quality
Assurance
Focusses on defect prevention

Statistical Quality and Process Control Techniques (SPC/SQC)
Emphasis on prevention of defects even before production starts and through

integrated efforts of process compliance, quality control and inspection
Quality
Management
Quality Management through involvement of top management, functional

areas and employees with customer focus
Requires managing quality on a continuous basis
Figure 1.2: Four Phases of Concepts of Quality
The four phases of evolution of quality are discussed as follows:

Quality Inspection: In the year 1910, the term quality was associated with
inspection, a method of ensuring quality. The inspection process involved
ensuring whether the product is as per the specifications prescribed by an
organisation. The products were inspected for defects after they were
manufactured and defective products were sent for rework. This resulted in
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good quality products but often at great costs due to the costs involved in
inspection and rework. Thus, though quality as a separate function
increased efficiency, it amounted to quality being considered as a cost
escalating concept rather than a cost reducing concept. During this period,
though the importance of quality was recognised, the emphasis was mostly
on mass inspection rather than prevention of defects. For example, in 1928,
the Western Electric Company had employed 40,000 people, out of which
5,200 people were appointed in the Inspection Department in order to
ensure the quality of products.
Quality Control: The enormous costs involved in inspection and rework to
maintain quality led to the evolution of concepts of controlling the production
process itself for ensuring quality rather than inspecting the products after
they were manufactured. During this period, the concept of in-process
inspection came into being and the objective was to control the occurrence
of defects during the production process itself. The idea is to look for early
signs that the units will be defective so that the necessary corrections can
be made to avoid producing defective products. This phase of the quality
movement can be termed as Quality Control.
Quality Assurance: It is the phase of the quality movement that focused on
going a step further in preventing defects, by eliminating the occurrence of
defects during pre-production. It involves measuring, comparing with the
pre-defined standards, monitoring the production process and feedback
associated that confers error prevention in a product. This phase can be
termed as Quality Assurance.
The concept of quality assurance as a separate department that ensured
quality as a built-in concept evolved during 1950s when Bell System created
a separate function of quality assurance using statistical quality and process
control (SPC/SQC) techniques. The pioneers of this concept were Dr.
Walter Shewart and Dr. W. Edwards Deming among others.
Quality Management: Later, Dr Joesph Juran and Dr W. Edwards Deming
introduced statistical quality control techniques to the Japanese who were
very receptive to their ideas as the Japanese were involved in the massive
efforts towards rebuilding the Japanese Economy, post-World War II
destruction. In this effort, Deming went beyond quality assurance to
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inculcate quality culture that starts from the top management. This phase
can be termed as Quality Management phase. It is during this phase the
concepts of customer satisfaction, top management involvement, employee
involvement, continuous improvements etc. were pioneered by Deming.
This phase ultimately led to the Total Quality Management (TQM)
movement which encompassed all the activities of the organisation towards
a quality culture.
1.2.2
Quality as a noun and an adjective
As discussed in the previous section, the term quality has evolved over the
period and is no longer used just as an adjective to describe an attribute of
the product like good quality product.
The term quality is now used widely as a noun where the characteristic of
quality is in-built into the product. For example, when the term quality comes
next to a noun, say sound quality, it denotes the essential characteristics of
a product itself rather than as a feature. This way the quality is no more an
additional advantage of a product but a mandatory attribute/quality that is
inherent in the product. Here the product itself stands for the quality.
By using quality as a noun, we describe it in concrete terms, allowing us to
market it as a product in its own right rather than using the term quality as
an adjective to indicate superiority of the product or service we are offering.
This evolution of the quality concept is in tune with the quality movement
where the term quality has come to encompass all the functions and the
value chain of the organisation.
1.2.3
Two dimensional model of quality
The term customer satisfaction was incorporated in the definition of quality.

The quality movement focused more on identifying and exceeding customer
requirements. Generally, the relationship between customer satisfaction and
quality was considered one dimensional. This implies that an increase in
quality of a product will lead to an increase in the level of customer
satisfaction and vice-versa. This is also termed as the linear function or one
dimensional model of quality wherein a higher perceived quality always
results in higher customer satisfaction.
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However, a Japanese professor, Noriaki Kano, suggested that the customer

satisfaction may be a non-linear function with respect to perceived quality. A
non-linear function implies that higher perceived quality need not always
result in higher customer satisfaction. This concept of quality as a non-linear
function is also called a two dimensional models of quality. According to a
two dimensional models of quality, customer satisfaction not only depends
on perceived quality alone but on the specific customer requirements.
These requirements can be categorised in the following types by Kano:
Expected Requirements / Dis-satisfiers/ Must-be Requirements
These pertain to the mandatory requirements, not stated by customers but

assumed as given for the product. The absence of the features pertaining to
these requirements in a product would create dissatisfaction in the minds of
the customers. However, their presence does not improve customer
satisfaction. For example, tool kit is provided to the customers with the
purchase of a car or bike. Getting the toolkit along with the car or bike will
not increase the level of satisfaction of customers as it is mandatory and
provided by every organisation. However, if toolkit is not provided with the
car, then the customer will get dissatisfied.
Normal Requirements / Satisfiers/ One-Dimensional
These requirements are expected by the customers. These are one

dimensional requirement the degree of customer satisfaction increases
with the increase in the degree of fulfilment of the requirements. For
example, a manufacturing organisation that is receiving 10% defective
products from its supplier will be more satisfied if it gets only 7% defective
products. The level of satisfaction of the organisation will increase with the
increase in the quality of the product (or reduction in the number of defective
products) provided by the supplier.
Attractive Requirements / Exciters
These are the requirements that are not expected by the customers.
Fulfilling these requirements lead to high levels of customer satisfaction.
However, there will be no dissatisfaction if they are not met. For instance, if
along with the car the automobile organisations start providing two spare
tyres instead of one tyre, it will delight the customer.
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Indifferent Requirements
These are the requirements whose presence or absence would not affect
the customer satisfaction. For example, getting a free subscription coupon
in a text book.
Reverse Requirements
These are the requirements whose presence will lead to customer

dissatisfaction and vice-versa. For example, a bank offers a zero per cent
loan for electronic goods. However, there are 5% administrative charges for
processing the loan.
The two-dimensional model of Kano allows analysing the customer
requirements for the purpose of improving customer satisfaction that moves
the quality concept of satisfying customer requirements to ascertain
customer requirements that would improve customer satisfaction. Thus, the
concept of quality with this model would require the manufacturer to move
beyond how to make to what to make.
According to the two-dimensional model, when a new feature is introduced
in the market, it may lead to customer delight as they are unexpected or not
demanded by the customers. But over the product life cycle, they tend to
become mandatory as every product carries such a feature. For example,
remote control features of Television sets which were features of delight
when introduced in 1983 but has become a mandatory requirement by
1990s.
Figure 1.3 shows the Kanos two- dimensional models of quality:
Figure 1.3: Kanos Two-Dimensional Models of Quality
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The concepts like House of Quality, Quality Function Deployment (QFD),

Failure Modes and Effect Analysis (FMEA) etc. thus focus on studying the
customer requirements and building them into the product as an overall and
in-built characteristics towards meeting and exceeding the customer
requirements.
The organisation wide quality initiatives like quality management systems
that start from customer requirements as mandated by ISO 9000 family of
quality standards thus tries to capture the customer requirements and
create customer focused process approach that tries to build-in customer
delight.
1.2.4
Demings principles of quality
Dr Edward Deming was of the opinion that if an organisation practices

quality management, it would be able to reduce its costs and increase its
productivity and market share. His ideas were implemented by many
Japanese organisations. Dr Edward Deming devised 14 points related to
quality management in an organisation. These points are as follows:
Create constancy of purpose toward improvement of product and
service: Implies that there should be consistent improvement in the quality
of products and services.
Adopt the new philosophy: Implies that an organisation should have a
clear quality vision. Moreover, an organisation should be more focused on
meeting the needs of customers than reacting to competitive pressure.
Cease dependence on mass inspection: Refers to another important
point related to quality management as given by Deming. According to him,
an organisation should prefer to prevent errors or defects by improving its
processes rather than detecting defects by inspecting the final product.
End the practice of awarding business on the basis of a price tag
alone: Implies that an organisation should stick to a single supplier.
According to Deming, an organisation should not change its suppliers only
on the basis of price at which they offer the resources. This is because
frequent switching between different suppliers may lead to inconsistency in
the quality of the output. On the other hand, suppliers should be pressed to
follow the specified quality standards.
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Improve constantly and forever the system of production and service:

Refers to a view of Deming according to which there should be continuous
improvement in the production system and processes of an organisation.
According to Deming, an organisation can bring continuous improvement in
its production system by making its employees aware of the quality aspect
and providing a proper training to them. This helps employees to perform
their jobs effectively. The concept of continuous improvement is now known
as Kaizen, which had been suggested by Deming more than 40 years ago.
Institute training: Refers to a Demings viewpoint according to which
proper training should be imparted to the new as well as existing employees
so that they perform well on the job and achieve better quality control.
Proper training also helps in reducing variations in the quality of products.
Adopt and institute leadership: Indicates that according to Deming, The
job of management is not supervision but leadership. Quality and
productivity cannot come about in leadership vacuum. This implies that
simple supervision alone cannot suffice. Therefore, the management should
provide support and adequate resources to employees to lift their morale
and improve productivity.
Drive out fear: Refers to a Demings view that if an organisation desires to
maintain quality and increase productivity, it is vital that employees should
drive out the fear and feel secured. According to Deming, an employee can
have different types of fears, such as the fear to express ideas, fear of the
top management, and fear of less productivity. If these fears areremoved, it
would lead to a significant improvement in the performance of employees.
Break down barriers between staff members: Indicates that to achieve
the set quality goals, all the departments of an organisation should work in
coordination with each other. This ultimately leads to the achievement of
organisational goals.
Eliminate unclear slogans and exhortations: Implies that an organisation
should clearly mention its expectations from employees and measure their
performance from time to time.
Eliminate numerical quotas for the workforce and numerical goals for
management: Refers to one of the important points as given by Dr Deming.
According to him, an organisation should not adopt those work standards
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that recommend numerical quotas and goals for employees. This is

because numerical goals may hamper the productivity and work quality of
employees.
Remove barriers that rob people of pride of workmanship: Implies that
an organisation should allow every employee to take pride in his/her work
without making any comparisons.
Encourage education and self-improvement for everyone: Signifies that
an organisation should conduct continuous training programs to improve the
skills of employees. This helps employees to adapt to changes that take
place in the work environment.
Put everybody in the organisation to work to accomplish
transformation: Refers to another important point given by Deming.
According to him, every individual employee should be able to improve
his/her quality of work. This would lead to the accomplishment of overall
quality goals of the organisation.
Self Assessment Questions:
1.
Four phases of evolution of quality are

____________, _________, and ____________
2.
The Concept of Quality Management differs from Quality Control as it

pertains to managing quality during production. (True/False)
3.
The definition of quality by Philip Crosby is Fitness for Use.

(True/False)
4.
ISO 9000 defines quality as __________________
5.
The concept of quality has gained importance as the term now is

used as an adjective rather than as a noun. (True/False)
6.
As per Kanos two-dimensional Model of quality, the increase in

degree of fulfilment of requirements necessarily increases customer
satisfaction. (True/False)
7.
Kanos two dimensional models necessitate ___________________

as quality philosophy as the emphasis shifts from satisfying
requirements of customers to proactively identifying new
requirements.
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____________,
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Activity 1:
Identify and list some examples wherein attractive requirements have
become mandatory requirements for products in the manufacturing
industry.
1.3
Quality Management Systems
As discussed in previous section, the concept of quality moved from quality

inspection (after production) to quality control (during production) to quality
assurance (before production) and finally to Quality Management systems
(managing for quality and continuous improvement).
Quality management systems involve the entire spectrum of quality
management activities in an organisation that aims at not just production of
quality products that meet customer requirements but a process based
approach that ensures continuous improvement on an on-going basis.
A quality management system is implemented by an organisation for:
Achieving greater consistency and efficiency in the activities involved in

producing and delivering the products or services
Utilising the available resources like time, labour, capital, etc. efficiently
Improving customer satisfaction
Improving the performance of employees, products, and processes by

setting up standards for their evaluation
Improves compliance to standards
In the following subsections, we shall study the relationship between quality

management and quality management systems. In addition, the concepts of
quality management systems has also been explained in the subsequent
sections, which is required for getting an in-depth knowledge of ISO 9000 as
it is all about quality management systems.
1.3.1
Quality management and Quality Management Systems (QMS)
The methodology of achieving, sustaining and improving quality of products

and services towards customer satisfaction by quality control, quality
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assurance and through continual improvement is known as quality

management. This includes quality methodologies and techniques like
quality planning, kaizen, Just-in-time, statistical process control etc. We
shall now see some standard definitions of Quality Management and Quality
Management Systems (QMS):
American Society for Quality (ASQ) defines Quality Management as the
application of a quality management system in managing a process to
achieve maximum customer satisfaction at the lowest overall cost to the
organisation while continuing to improve a process.
The ISO 8402 defines Quality System as the organisation structure,
procedures and resources needed to implement quality management.
The term Quality Management System (QMS) is defined by ASQ as a
formalised system that documents the structure, responsibilities and
procedures required to achieve effective quality management.
The ISO 9000:2005 defines QMS as a management system to direct and
control an organisation with regard to quality.
The Quality Management Principle is defined by ISO / TC 176 (ISO
Technical Committee) as a comprehensive and fundamental rule or belief,
for leading and operating an organisation, aimed at continually improving
performance over the long term by focusing on customers while addressing
the needs of all other interested parties.
Note that all the above definitions of quality management system go beyond
just documenting and following operating procedures but setting up
formalised organisational system to manage quality systematically.
QMS enables the organisation to manage the quality of its products and
processes through:
Providing focus on customer requirements and customer service
Providing access to markets and bids
Motivating employees to become responsible towards customer

requirements
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Providing a universal/holistic approach to quality and business
Facilitating the establishment of operational baselines and aligning them

to the organisations objective
Controlling processes and systems by establishing operational controls
Making internal operations efficient and effective
Encouraging operational problem solving
Establishing the basis for a common parameters of quality between

supplier and producer
Facilitating in monitoring performance of suppliers
1.3.2
Concepts of quality management systems
The objectives of the quality management system are expected to be

integrated with the other objectives of the organisation like growth, funding,
profitability and social responsibility etc. This requires that all the other
management systems of an organisation be properly integrated with quality
management system to form a single coherent management system with
unifying elements ensuring that quality management remains as an
organisation wide philosophy. For this purpose, various concepts are
developed that enables an organisation to implement a quality management
system successfully and derive benefits from it.
Concept of Quality Management

System
Some of these concepts are shown in Figure 1.4:
System Approach
Process Based Approach
PDSA Concept
Eight Quality Management Priciples
Figure 1.4: Concepts of QMS

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The concepts required for implementing QMS successfully in an

organisation are discussed as follows:
System Approach: Quality Management Systems are meant to assist
organisations in enhancing customer satisfaction. The customer satisfaction
can be ensured by meeting the product specifications and customer
requirements. These requirements may be stated by the customers or may
be determined by the organisations. However, the customer needs and
expectations keep changing making the organisations effort to meet
customer requirements a challenge. This is further compounded by
competitive pressures and advances in technology that makes the customer
requirements and hence customer satisfaction a fluid concept. This situation
warrants the organisations to be proactive in ascertaining customer
requirements and designing processes and systems that can meet this
challenge over a period of time. Thus continual improvement becomes a
necessity for the organisations.
The quality management system approach encourages organisations to
analyse customer requirements, define the processes that contribute to the
achievement of a product which is acceptable to the customer, and keep
these processes under control. Systems approach suggests that an
organisation's effectiveness and efficiency in achieving its quality objectives
are contributed by identifying, understanding and managing all interrelated
processes as a system. Quality Control involves checking transformed and
transforming resources in all stages of production process. As per ISO 9000
standards, a quality management system (QMS) can provide the framework
for continual improvement to increase the chances of enhancing customer
satisfaction. The presence of such formal systems gives confidence to the
customers and other stakeholders that the organisation is able to provide
products that consistently fulfil the requirements.
Process Based Approach: A set of inter-related activities that transform
inputs to outputs can be termed as a process. There are numerous such
processes that exist in any organisation. In order to function effectively, the
organisations should identify and manage the interrelated and interacting
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processes. As the output of one process often affects that of another

process.
A system thinking of managing processes is required as managers cannot
manage effectively by managing the parts in isolation. An understanding of
processes that cross functional boundaries and alignment of these
processes towards a common vision or goal and their optimisation is
required.
Quality Guru, W Edwards Deming, insisted on systems thinking and the
need for the quality systems to be focused on specific purpose or objective.
He advocated the process improvement methodology called Plan-DoCheck-Act (PDCA) cycle where the importance of planning quality
management activities prior hand and the necessary feedback systems
were stressed upon.
PDSA Concept: The concept of Plan-Do-Check-Act (PDCA) cycle
advocated by Deming (also called Deming cycle) requires systematic
approach to process improvement towards quality management objectives.
The concept was revised by Deming in 1990 to Plan-Do-Study-Act (PDSA)
cycle where study stage involves detailed analysis.
The plan stage consists of
studying the current processes and
documenting/describing it to enable understanding of all the factors involved

like inputs, outputs, customers, suppliers, customer expectations etc. It also
involves gathering data pertaining to inherent problems, identifying cause of
problems, testing theories of causes, and developing solutions and action
plans. In the do stage, the plan is implemented on a trial basis to evaluate a
proposed solution and provide objective data. The study stage determines
whether the trial plan is working correctly by evaluating the results. The final
stage of Act, a final plan is standardised and implemented as current best
practice and communicated throughout the organisation. Figure 1.5 shows
the PDSA cycle:
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Figure 1.5: PDSA cycle
Eight Quality Management Principles: The ISO 9000 standards advocate

eight quality management principles that shall be used by top management
in order to lead the organisation towards improved performance as listed
below:
a.
Customer focus
b.
Leadership
c.
Involvement of people
d.
Process approach
e.
System approach to management
f.
Continual improvement
g.
Factual approach to decision making
h.
Mutually beneficial supplier relationships
These eight quality management principles form the basis for the quality
management system standards within the ISO 9000 family. These are
elaborated along with all other terminologies involved in the standard in ISO
9000:2005. You will study each of these principles in detail in Unit 2 of this
course material.
8.
Quality management system directly or indirectly helps in increasing

the sales of an organisation. (True/False)
9.
Improving the quality of products and services through quality control,

assurance, and continual improvement is called _____________.
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10. Which of the following is not a concept of quality management

system?
A. System Approach
B. Process Based Approach
C. PDSA Concept
D. Communication
11. ISO 9000 recommends Demings PDCA cycle as a process
improvement methodology (True/False)
12. Leadership is one of the eight principles of quality management
system advocated by ISO 9000 standards (True/False)
1.4
ISO and ISO 9000
A standard is a document that provides requirements, specifications,

guidelines or characteristics that can be used consistently to ensure that
materials, products, processes and services are fit for their purpose.
-- International Organisation for Standardization (ISO)
Before 1947, similar type of products and technologies were evaluated
based on different criteria in different countries or region. In such a case, it
became difficult for the producers of these products or technology to sell
their products around the world, which directly affected the international
trading process. Moreover, no industry can function independently, it needs
to be linked with other industries directly or indirectly. For example, aviation
industry requires bolts for manufacturing airplanes and other equipment that
are used in this sector. Similarly, welding is used in nuclear engineering and
electronic data processing has penetrated in almost all the industries. This
increasing penetration of industries among themselves, globalisation, and
rapid development of new technologies has led to the requirement of
establishing standards that can be accepted worldwide.
ISO is a worldwide federation of national standards bodies of different
countries, with its headquarters in Geneva. It is a non-governmental
organisation established in 1947. The mission of ISO is to promote the
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development of standardisation and related activities in the world with a

view to facilitating the international exchange of goods and services, and in
developing cooperation in the spheres of intellectual, scientific,
technological and economic activity. The results of ISO technical work are
published as International Standards.
The individual countries utilise the ISO standards to formulate the standards
for their own countries. Some 70 countries have adopted and published ISO
9000 standards as their own national standards. The national standards
usually have a different name, but they contain exactly the same text as the
original ISO 9000 standards.
In the United States, the ISO 9000 standards have been adopted and
published by ANSI and ASQC and are known as ANSI/ISO/ASQC Q9000
series. In India, the Indian body for National Standards, Bureau of Indian
Standards (BIS) have issued IS/ISO 9000 family of standards on the basis
of ISO 9000 standards.
1.4.1
Evolution of ISO 9000
The need for quality standards can be traced to the middle of eighteenth
century when a French gunsmith, Honore Le Blanc, developed a system for
manufacturing muskets to a standard pattern using interchangeable parts.
In 1798, the US government awarded Eli Whitney a contract to supply
muskets to armed forces. The use of interchangeable parts necessitated
careful control of quality according to a designed standard. This required
consideration of natural and artificial variations in production processes.
Later with the advent of scientific management and specialisation of
management functions requiring quality inspection as separate department,
the need for quality standards became important. During World War II, the
Unites States military began using statistical sampling procedures and
imposed stringent standards on suppliers. The concept of statistical quality
control became widely known during this period and was adopted
throughout the manufacturing industry.
The first set of standards for quality was issued when US Department of
Defense introduced the US Military Standards for defense procurement
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MIL-Q-9858 in 1959. These standards subsequently were revised as BS

5179 series and then to BS 5750.
The ISO 9000 standards were issued in 1987 based on BS 5750 standards.
These standards have since undergone revisions into 1994 version followed
by 2000 version and then finally to its current form as ISO 9001:2008
standards.
1.4.2
Product and process standards
As we have seen in the earlier sections, the concept of quality has moved
from product quality to process quality. The quality standards have also now
moved beyond product standards to quality management system standards.
The concept of quality encompasses all the areas of management that
contribute directly or indirectly to quality and customer satisfaction. The term
quality from denoting manufacturing of defect free products now signifies
quality of management practices. The term Big Q was used to contrast the
difference between managing for quality in all organisational processes as
opposed to focusing solely on manufacturing quality, dented by the term
Little Q. Thus apart from quality standards required for product acceptance
criteria, there was need for quality standards meant for quality management
systems in organisations.
The ISO 9000 family of standards specify requirements and
recommendations for the design and assessment of quality management
systems. ISO 9000 is not a product standard and there are no product
acceptance criteria in ISO 9000. The purpose of these standards is to help
organisations to implement and operate effective quality management
systems. These standards also serve as a medium for communicating
concepts in the field of quality management that have been approved by an
international committee of representatives from national standard bodies.
They serve the organisations that act either as customers and suppliers.
The ISO 9001: 2008 standards enable organisations to demonstrate that
they have the capability to consistently provide products that meets the
customer requirements.
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As per International Standards Organisation (ISO),

ISO 9001:2008 specifies requirements for a quality management system
where an organisation
Needs to demonstrate its ability to consistently provide product that

meets customer and applicable statutory and regulatory requirements
Aims to enhance customer satisfaction through the effective application

of the system, including processes for continual improvement of the
system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be

applicable to all organisations, regardless of type, size and product
provided.
1.4.3
ISO 9000 family of standards
There are four standards in ISO 9000 family - ISO 9000, ISO 9001, ISO
9004 and ISO 19011. Each of these standards fulfills a different purpose.
Though the ISO 9001:2008 is the actual standard for certification purpose,
the other standards provide further information and are more elaborate and
complimentary in nature. They are listed in the table below:
ISO 9001:2008 - sets out the requirements of a quality management
system
ISO 9000:2005 - covers the basic concept and language
ISO 9004:2009 - focuses on how to make a quality management system
more efficient and effective
ISO19011:2011 - sets out guidance on internal and external audits of
quality management systems
(Source: http://www.iso.org/iso/iso_9000)
These standards put together form a coherent set of quality management
system standards facilitating mutual understanding in national and
international trade.
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1.4.4
Unit 1
Usage and certification of ISO 9000 standards
The ISO 9000 contains requirements for quality management systems in

organisations. The certification is not actually a requirement of ISO 9000
standards but customers started demanding it and made it part of their
contract requirements.
The ISO 9000 standards are originally meant to be used in contractual
situations where suppliers need to demonstrate their capability to meet the
requirements. The idea is that if suppliers can show that they adhere to the
requirements of ISO 9001, then only conforming products would be shipped
to customers which would, in theory, reduce the need for customers to verify
the product on receipt. Customers or Third parties can use the standard to
assess the capability of organisations to provide product that meets
customer and regulatory requirements.
The associated certifications schemes are not actually the requirement of
the ISO 9000 family of standards but they were meant to reduce the costs of
customer sponsored audits performed to verify the capability of the
suppliers. This allows the customers to trade with organisations who
otherwise have no credentials in market place.
However, the ISO 9000 standards have evolved beyond the above functions
(though they are primary) and now serve as a concrete basis for developing
and implementing quality management systems towards Total Quality
Management (TQM). You will see more on this on subsequent units as you
study in details the ISO 9000 standards.
1.4.5
Constantly evolving Standard
The earlier versions of the ISO 9000 family of standards was characterised
by its focus on procedures. This gave rise to the impression that ISO 9000
was simply a matter of documenting what you do and doing what you
document. Consequently, it was felt that ISO 9000 only leads to further
bureaucracy of procedures, records and forms that have little to do with
enhancing quality. The main purpose of ISO 9000 standards seemed to be
to assure customers that product meets requirements making it primarily a
quality assurance standard.
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The ISO 9000:2000 version focuses more on quality management systems

that are based on process based approach. The standard introduced the
eight quality management principles, which, if applied effectively, shall lead
to the satisfaction of all interested parties.
In 2008, the ISO 9001: 2000 standard is revised and a new version ISO
9001:2008 has evolved. In ISO 9001:2008, the existing requirements of ISO
9001:2000 are clarified to strengthen its links with other management
standards, such as ISO 14001:2004 (Environmental Management Systems)
and no additional requirement is added. This version is currently applicable
in organisations.
ISO standards are constantly revised after every four years. This revision is
made based on the experiences, feedback from member countries, etc.
1.4.6
TQM and ISO 9000 family of standards
Total Quality Management (TQM) also has the emphasis on establishing

processes for managing quality. The British Standard BS 7850 defines TQM
as management philosophy and company practices that aim to harness the
human and material resources of an organisation in the most effective way
to achieve the objectives of the organisation
TQM strives for long term organisational success by continuous
improvement that involves both top management and employees towards
meeting and exceeding customer requirements on an on-going basis. It is a
management philosophy or management model that requires a quality
culture to be imbibed in all parts of the organisation.
As can be seen from the above definition, the ISO 9000 family of standards
also have similar focus towards achieving total quality though they pertain
only to the requirement of minimal quality management systems expected
and their integration to other management systems. The eight management
principles that form the basis of requirements for quality management
systems in ISO 9000 standards are closely related to the principles of TQM.
The companies that embark on TQM culture can consider implementing and
certifying on ISO 9001 as a right stepping stone towards subsequent
implementation of TQM in their organisation. This is because the
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implementation and certification of ISO 9000 also requires a shift in culture

of the organisation towards total quality.
A company that has successfully implemented TQM philosophy would have
far exceeded the requirements of ISO 9000 family of standards as these
standards only give basic requirements or minimal standards.
1.4.7
Future plans for ISO 9000
ISO has already started its work on revising the current version of ISO 9000
family of standards. The ISO technical committee ISO/TC 176, Quality
management and quality assurance, subcommittee SC 2, Quality systems,
is currently involved in laying the groundwork for the next generation of
quality management standards. These revised ISO 9000 family of standards
are expected to be released in 2015 (ISO 9000: 2015).
13. List the standards that comprise ISO 9000 family of quality
management standards.
14. The ISO 9001:2008 is primarily same in content as that of ISO
9001:1994. (True / False)
15. The purpose of ISO 9000: 2005 is to ___________
1.5
Summary
Let us summarise the key learnings of this unit.
Quality refers to the extent to which a product or service is able to satisfy

the needs of a customer while meeting their specifications.
The origin of quality can be traced as far back as 106-43 B.C. Quality
has evolved over a period of time and is continuously evolving to new
forms.
The evolution of quality involves four phase, namely quality inspection,

quality control, quality assurance, and quality management.
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The term quality is no longer used just as an adjective, but also as a

noun where the characteristics of quality is in-built into the product.
According to Noriaki Kano, it is not necessary that increase in product

quality will increase the customer satisfaction as it is mostly dependent
on the fulfilment of their requirements. He has given a two-dimensional
model for quality in which he categorises the requirements of customers
into three types, namely expected requirements, normal requirements,
and attractive requirements.
Dr Edward Deming devised 14 points related to quality management in

an organisation such as create constancy of purpose, adopt a
philosophy, create dependence, end the practice, improve constantly
and so on.
1.6
QMS is a system employed for the efficient management of quality in an

organisation. This system helps in improving the business processes
and customer satisfaction. There are certain concepts that are required
for the effective implementation of QMS in an organisation. These
concepts are system approach, process based approach, PDSA cycle,
and eight quality management principles.
Glossary
Quality: The extent to which the characteristics of a product, service or

process is able to meet the customer requirements.
Quality Control: It is a part of quality management that focuses on the
fulfilment of quality requirements of a product, service, or process.
Quality Assurance: It is the part of quality management, which ensures
that the quality requirements will be fulfilled.
Quality Improvement: It is the part of quality management that focuses on
increasing the ability of a product, service, or process to meet its quality
requirements.
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Quality Management: The set of activities required for improving a

business process in order to achieve maximum customer satisfaction at the
lowest cost of the organisation.
1.7
Terminal Questions
1.
Explain the four phases of evolution of concept of quality.
2.
What do you understand by the term quality management system

(QMS)?
3.
Write brief note on the following:

a. Process based approach
b. PDSA cycle
4.
Write brief note on the three ISO 9000 family of standards.
5.
How does ISO 9001: 1994 differ from ISO 9001: 2008?
6.
Differentiate between TQM and ISO 9000.
1.8
Answers
Self Assessment Questions

1.
quality inspection, quality control, quality assurance, quality

management
2.
False
3.
False
4.
Set of inherent characteristics that satisfies the requirements
False
6.
False
7.
customer satisfaction and delight
8.
True
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9.
Unit 1
quality management
10. D
11. True
12. True
13. The standards comprise ISO family are ISO 9000: 2005, ISO 9001:
2008, and ISO 9004: 2009.
14. False
15. describe the fundamentals of quality management systems and
specifies the terminology for quality management systems
Terminal Questions
1.
The four phases of evolution of concept of quality are quality inspection,

quality control, quality assurance, and quality management. Refer to
Section 1.2 Definition of Quality.
2.
Quality Management System is a system used for managing the

different activities involved in quality management effectively. Refer to
Section 1.3 Quality Management Systems.
3.
Process based approach involves the management of different process

should be done collectively and not in isolation in order to achieve a
common goal. On the other hand, PDSA cycle is the process that
involves various stages, such as plan, do, study, and act, required for
improving a business process. Refer to Section 1.3 Quality
Management Systems.
4.
The three standards of ISO family are ISO 9000: 2005, ISO 9001: 2008,
and ISO 9004: 2000. Refer to Section 1.4 ISO and ISO 9000.
5.
ISO 9001: 2000 is a revised version of ISO 9001: 1994 standards.

Refer to Section 1.4 ISO and ISO 9000.
6.
The organisations want to implement TQM culture can implement ISO

9000 family of standards before it; however, implementing ISO 9000
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after implementing TQM is not beneficial as these standards only give

basic requirements or minimal standards. Refer to Section 1.4 ISO and
ISO 9000.
1.9
Case Study
TQM at ABC Pvt. Ltd.

ABC Pvt. Ltd. is one of the biggest ready mix concrete producers in India. It
has 400 employees who are working in seven different locations. The
organisation has been facing a number of problems, such as increase in
costs, decrease in sales volume, and dissatisfied customers, for the past
three months. Therefore, the management of ABC has decided to
implement a culture of quality, customer service, and continuous
improvement. For implementing such culture, the organisation has
conducted TQM readiness assessment program. This program has helped
the organisation in determining the areas of customer service improvement
and cost reduction. Moreover, on the basis of this program, the organisation
has provided training on TQM to all its employees. In addition, the CEO of
ABC has conducted a meeting with employees to make them aware about
the benefits of TQM.
With the implementation of TQM, ABC is able to save $2 million to $3 million
every year. In addition, it gets a 25:1 payback on its investment in TQM.
Now, ABC is able to achieve a high level of customer satisfaction.
Questions
1.
What would be the difference if ABC implements ISO 9000 standards

instead of TQM to solve its existing problems?
2.
What benefits did ABC derived by implementing TQM?
References
Gitlow, H.S. (2000), Quality Management Systems: A Practical Guide.

Boca Raton, Florida: CRC Press LLC.
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Hoyle D.(2009) , The ISO 9000 Quality Systems Handbook, Burlington,

USA: Elsevier Ltd.
E-References
About ISO. Retrieved from http://www.iso.org/iso/home/about.htm.
Quality Management Systems. Retrieved from

http://www.abahe.co.uk/business-administration/Quality-ManagementSystems.pdf.
ISO 9000, 9001, and 9004. Retrieved from http://www.praxiom.com/isodefinition.htm#Quality management system (QMS).
B1930
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Understanding ISO 9001:2008

Quality and Quality Management System

Quality Management Systems

ISO and ISO 9000

Sikkim Manipal University

Understanding ISO 9001:2008

"Quality is the degree to which a set of inherent characteristics satisfies

Sikkim Manipal University

Understanding ISO 9001:2008

To understand ISO 9000 standards, it is necessary that you understand the

define the concept of quality

discuss the evolution of quality

explain the Quality Management Systems (QMS)

discuss the International Standards Organisation (ISO)

discuss the evolution of ISO 9000 family of standards

Sikkim Manipal University

Understanding ISO 9001:2008

" Quality is Conformance to Requirements " - Philip Crosby

" Fitness for Use " - Joseph Juran

Figure 1.1: Some Important Definitions of Quality

Evolution of the concept of quality

Understanding ISO 9001:2008

essential strategic weapon of organisations in todays hyper competitive

Function delinked from manufacturing

Defect Free Products to be ensured during Production rather than inspecting

Emphasis is on Controlling Production Process through "in-process

Focusses on defect prevention

Emphasis on prevention of defects even before production starts and through

Quality Management through involvement of top management, functional

Figure 1.2: Four Phases of Concepts of Quality

The four phases of evolution of quality are discussed as follows:

Understanding ISO 9001:2008

Understanding ISO 9001:2008

Quality as a noun and an adjective

Two dimensional model of quality

The term customer satisfaction was incorporated in the definition of quality.

Sikkim Manipal University

Understanding ISO 9001:2008

However, a Japanese professor, Noriaki Kano, suggested that the customer

Expected Requirements / Dis-satisfiers/ Must-be Requirements

These pertain to the mandatory requirements, not stated by customers but

Normal Requirements / Satisfiers/ One-Dimensional

These requirements are expected by the customers. These are one

Attractive Requirements / Exciters

Understanding ISO 9001:2008

These are the requirements whose presence will lead to customer

Figure 1.3: Kanos Two-Dimensional Models of Quality

Sikkim Manipal University

Understanding ISO 9001:2008

The concepts like House of Quality, Quality Function Deployment (QFD),

Demings principles of quality

Dr Edward Deming was of the opinion that if an organisation practices

Understanding ISO 9001:2008

Improve constantly and forever the system of production and service:

Understanding ISO 9001:2008

that recommend numerical quotas and goals for employees. This is

Four phases of evolution of quality are

The Concept of Quality Management differs from Quality Control as it

The definition of quality by Philip Crosby is Fitness for Use.

ISO 9000 defines quality as __________________

The concept of quality has gained importance as the term now is

As per Kanos two-dimensional Model of quality, the increase in

Kanos two dimensional models necessitate ___________________