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ISO Quality Systems Overview

The document discusses quality systems and ISO standards. It provides an overview of the history and evolution of quality systems from medieval times to modern approaches like Total Quality Management. Key concepts discussed include defining quality, categories of quality like quality of design and conformance, and costs of poor quality like internal failure costs. The objectives are to identify concepts of quality systems, classify ISO 9000 principles, understand QS 9000, learn about ISO 14000, and plan school-based ISO procedures.

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0% found this document useful (0 votes)
181 views19 pages

ISO Quality Systems Overview

The document discusses quality systems and ISO standards. It provides an overview of the history and evolution of quality systems from medieval times to modern approaches like Total Quality Management. Key concepts discussed include defining quality, categories of quality like quality of design and conformance, and costs of poor quality like internal failure costs. The objectives are to identify concepts of quality systems, classify ISO 9000 principles, understand QS 9000, learn about ISO 14000, and plan school-based ISO procedures.

Uploaded by

jein_am
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

MODULE 13: QUALITY SYSTEMS

LESSON 1: Introduction to the Basic Concepts of Quality Systems

LESSON 2: The Eight Principles: ISO 9000’sBasis

LESSON 3:ISO QS 9000

LESSON 4:ISO 14000

OVERVIEW OF THE TOPIC

In every organization, both management and the general workforce


tend to resist change, whether it be in systems, culture or environment. That
is natural – people are usually happy to continue with what they have always
done. There are various reasons for implementing a quality system that
conforms to an ISO standard. The primary reason is that customers or
marketing are suggesting or demanding compliance to a quality system. Other
reasons are needed improvements in processes or systems and a desire for
global deployment of products and services. As more and more organizations
become registered, they are requiring their subcontractors or suppliers to be
registered, creating a snowball effect.

Establishing a quality management system is not rocket science. The


intent of any QMS is simply to provide a system for developing or improving
processes through a structured approach, effective deployment and better
control. The quality management system not only provides a structure and
framework, it also ensures the rigor of an audit mechanism that enforces
corrective action. Continuous improvement happens within all processes in a
systematic manner.

ISO or International Organization for Standardization that promotes


worldwide, standards for the improvement of quality, productivity and
operating efficiency through a series of standards and guidelines.

OBJECTIVES:

At the end of session, the learners must:


1. identify basic concepts of quality systems,
2. classify the principles of ISO 9000,
3. acquire comprehensive input on QS 9000,
4. identify basic concepts about ISO 14000 and
5. plan for a school-based ISO procedures.

SESSION PROPER:

LESSON 1: Introduction to the Basic Concepts of Quality Systems

Video Presentation : (The Houses Made by the Three Little Pigs)


If video not available, read the story here!

1|Page
THE THREE LITTLE PIGS
Once upon a time there were three little pigs and the time came for them to
leave home and seek their fortunes. Before they left, their mother told them "
Whatever you do , do it the best that you can because that's the way to get
along in the world.

The first little pig built his house out of straw because it was the easiest thing
to do. The second little pig built his house out of sticks. This was a little bit
stronger than a straw house. The third little pig built his house out of bricks.

One night the big bad wolf, who dearly loved to eat fat little piggies, came along
and saw the first little pig in his house of straw. He said "Let me in, Let me in,
little pig or I'll huff and I'll puff and I'll blow your house in!" "Not by the hair of
my chinny chin chin", said the little pig. But of course the wolf did blow the
house in and ate the first little pig.

The wolf then came to the house of sticks. "Let me in ,Let me in little pig or I'll
huff and I'll puff and I'll blow your house in" "Not by the hair of my chinny chin
chin", said the little pig. But the wolf blew that house in too, and ate the second
little pig.

The wolf then came to the house of bricks. " Let me in , let me in" cried the wolf
"Or I'll huff and I'll puff till I blow your house in" "Not by the hair of my chinny
chin chin" said the pigs. Well, the wolf huffed and puffed but he could not blow
down that brick house.

But the wolf was a sly old wolf and he climbed up on the roof to look for a way
into the brick house.

The little pig saw the wolf climb up on the roof and lit a roaring fire in the
fireplace and placed on it a large kettle of water.

When the wolf finally found the hole in the chimney he crawled down and
KERSPLASH right into that kettle of water and that was the end of his troubles
with the big bad wolf.

The next day the little pig invited his mother over . She said "You see it is just
as I told you. The way to get along in the world is to do things as well as you
can." Fortunately for that little pig, he learned that lesson. And he just lived
happily ever after!

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From the story of the Three Little Pigs, let us answer the following questions:

1.What are the things to be consider in attaining a goal?

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2.Which is more important, attain the goal or attain a quality goal?

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Basic Concepts of Quality Systems

The quality movement can trace its roots back to medieval Europe,
where craftsmen began organizing into unions called guilds in the late 13th
century.

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Until the early 19th century, manufacturing in the industrialized world
tended to follow this craftsmanship model. The factory system, with its
emphasis on product inspection, started in Great Britain in the mid-1750s and
grew into the Industrial Revolution in the early 1800s.

In the early 20th century, manufacturers began to include quality


processes in quality practices.

After the United States entered World War II, quality became a critical
component of the war effort: Bullets manufactured in one state, for example,
had to work consistently in rifles made in another. The armed forces initially
inspected virtually every unit of product; then to simplify and speed up this
process without compromising safety, the military began to use sampling
techniques for inspection, aided by the publication of military-specification
standards and training courses in Walter Shewhart’s statistical process control
techniques.

The birth of total quality in the United States came as a direct response
to the quality revolution in Japan following World War II. The Japanese
welcomed the input of Americans Joseph M. Juran and W. Edwards Deming
and rather than concentrating on inspection, focused on improving all
organizational processes through the people who used them.

By the 1970s, U.S. industrial sectors such as automobiles and


electronics had been broadsided by Japan’s high-quality competition. The
U.S. response, emphasizing not only statistics but approaches that embraced
the entire organization, became known as total quality management (TQM).

By the last decade of the 20th century, TQM was considered a fad by
many business leaders. But while the use of the term TQM has faded
somewhat, particularly in the United States, its practices continue.

In the few years since the turn of the century, the quality movement
seems to have matured beyond Total Quality. New quality systems have
evolved from the foundations of Deming, Juran and the early Japanese
practitioners of quality, and quality has moved beyond manufacturing into
service, healthcare, education and government sectors.

The word quality is often used indiscriminately for many different


meanings. Quality can be defined as “fitness for use,” “customer satisfaction,”
“doing things right the first time,” or “zero defects.” These definitions are
acceptable because quality can refer to degrees of excellence. Webster’s
dictionary defines quality as “an inherent characteristic, property or attribute.”
Quality Review will define quality as a characteristic of a product or process
that can be measured. Quality control is the science of keeping these
characteristics or qualities within certain bounds.

In a manufacturing or service environment, there are two major


categories of quality: quality of design and quality of conformance. A poorly
designed product will not function properly regardless of how well it meets its

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specifications. Conversely, a product that does not conform to excellent
design specifications will not properly perform its intended function.

The costs associated with providing poor quality products or services.


There are four categories: internal failure costs (costs associated with defects
found before the customer receives the product or service), external failure
costs (costs associated with defects found after the customer receives the
product or service), appraisal costs (costs incurred to determine the degree of
conformance to quality requirements) and prevention costs (costs incurred to
keep failure and appraisal costs to a minimum).

Cost of quality is a methodology that allows an organization to


determine the extent to which its resources are used for activities that prevent
poor quality, that appraise the quality of the organization’s products or
services, and that result from internal and external failures. Having such
information allows an organization to determine the potential savings to be
gained by implementing process improvements. Quality-related activities that
incur costs may be divided into prevention costs, appraisal costs, and internal
and external failure costs.

LESSON 2: The Eight Principles: ISO 9000’s Basis

Applying the Principles in our Real Life.

Do the “Plan-Do-Check-Act“ in the following situation.(at least one )then share


to the class.

1. to become a more ethical person


2. to get better grades
3. be more loving to your partner
4. to lose weight
5. to be an innovative teacher

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Situation: ________________________________________________

Plan-Do-Check- Act

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The Eight Principles: ISO 9000’s Basis

What is ISO 9000?

ISO 9000 is a set of international standards on quality management


and quality assurance developed to help companies effectively document the
quality system elements to be implemented 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. However, it should be
considered to be a first step, the base level of a quality system, not a
complete guarantee of quality.

The thrust of ISO 9000 is for organizations to implement a QMS


conforming to the standard’s requirements and, through the consistent,
rigorous employment of the QMS, to

 Improve customer satisfaction by fulfilling customer


requirements;

6|Page
 Achieve continual improvement of organizational performance
and competitiveness;
 Continually improve its process, products, and services; and
 Comply with regulatory requirements.

ISO 9000’S OBJECTIVE

The original aim of ISO 900 was to ensure that the products or services
provided by registered organization were consistently fit for their intended
purpose. The ISO 9000 raised the standard’s aim to a new level. Customer
focus and continual improvement, along with the other six principles that have
been incorporated into the standard, are intended to make registered
organizations more competitive.

20 ELEMENTS OF ISO 9000 SERIES STANDARDS

 Management Responsibilities
 Quality system
 Contract review
 Design control
 Document and data control
 Purchasing
 Control of customer supplied product
 Product identification and traceability
 Process control
 Inspection and testing
 Control of inspection, measuring, and test equipment
 Inspection and test status
 Control of non conforming product
 Corrective and preventive actions
 Handling, storage, packaging, preservation and delivery
 Control of quality records
 Internal quality audits
 Training
 Servicing
 Statistical techniques

HOW TO GET CERTIFICATION

 Get top management commitment


 Train personnel
 Prepare Quality Policy Manual
 Prepare Operating Procedures
 Hold internal audit
 Select registrar
 Go through registration process
 Obtain ISO 9000 registration

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The Eight Principles: ISO 9000’s Basis

The ISO 9000 QMS is based on the eight principles from total quality
management (TQM):

1.Customer Focus.

Understand the costumer’s needs, meet the customer’s requirements,


and strive to exceed the costumer’s expectations.

2.Leadership.

Establish unity of purpose and organizational direction and provide an


environment that promotes employee involvement and achievement of
objectives.

3.Involvement of People.

Take advantage of fully involved employee, using all their abilities for
the benefit of the organization.

4.Process Approach.

Recognize that things accomplished are the results of processes and


that processes along with related activities and resources must be managed.

5.System Approach to Management

The multiple interrelated processes that contribute to the organization’s


effectiveness are a system and should be managed as a system.

6.Contunual Improvement

Continual improvement should be a permanent objective applied to the


organization and to its people, processes, systems and products.

7.Factual Approach to Decision Making.

Decisions must be based on the analysis of accurate, relevant, and


reliable data and information.

8.Mutually Beneficial Supplier Relationships.

Both the organization and the supplier benefiting from one another’s
resources and knowledge results in value for all.

8|Page
ADVANTAGES OF ISO 9000

 Create a more efficient, effective operation


 Increase customer satisfaction and retention
 Reduce audits
 Enhance marketing
 Improve employee
 motivation, awareness, and morale
 Promote international trade
 Increase profit
 Reduce waste and increase productivity.

DISADVANTAGES OF ISO 9000

 The amount of money, time and paperwork required for


registration
 Company can intend to produce a poor quality product and providing
it does so consistently and with the proper documentation can put
an ISO 9001 stamp on it
 The standard is seen as especially prone to failure when a company
is interested in certification before quality
 Certifications are in fact often based on customer contractual
requirements rather than a desire to actually improve quality
 Competition among the numerous certifying
 bodies, leading to a softer approach to the defects noticed in the
operation of the Quality System of a firm

LESSON 3: ISO QS 9000

Read the comparison of two products and answer the following question
below.
A Ferrari and a Ford Escort are compared. Both cars will perform the
same basic function of getting from point A to point B. Each will
generally conform to its design specification. The owners in both cases
may be satisfied with the way their cars are put together. However, that
is where the similarity ends. The Escort owner does not expect his car
to go 150 mph, have leather seats and have twelve coats of paint, or
be highly responsive. The Ferrari owner expects these characteristics
or qualities.

1.What do you think the best quality product, the Ferrari or Ford Escort?why?

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ISO QS 9000

What is QS 9000
QS 9000 is the name given to the Quality System Requirements of the
automotive industry which were developed by Chrysler, Ford, General Motors
and major truck manufacturers and issued in late 1994. QS-9000 replaces
such quality system requirements as Ford Q-101, Chrysler's Supplier Quality
Assurance Manual, GM's NAO Targets for Excellence and the Truck
Manufacturer's quality system manuals. The influence of QS-9000 is being
seen throughout the automotive industry as it has virtually eliminated varying
demands and waste associated with redundant systems.
Proof of conformance to QS-9000 is certification/registration by an
accredited third party such as Underwriter's Laboratories (UL) or the American
Bureau of Shipping (ABS). Companies that become registered under QS-
9000 will be considered to have higher standards and better quality products.
This paper will describe the steps a company needs to take to achieve this
goal.

WHY QS-9000?
QS-9000 will help companies to stay ahead of their competition. It will
do this by filling gaps in the business and quality systems that can cause
problems. QS-9000 eliminates redundant and unnecessary work practices.
QS-9000 tells current and potential customers that the product has consistent
quality and is manufactured under controlled conditions. This system is
globally accepted as proof of quality in the automotive industry and is also a
major customer requirement. Surprisingly, it was not a Chrysler, Ford or
General Motors idea. Actually the automotive suppliers suggested it, and

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while automotive standardization work began in 1988, the problem appeared
much earlier.
Years ago, customers were closer to their suppliers. Think back to the
rural general store. The customer could go to the proprietor to purchase or
barter for goods. If the quality of the goods was found to be poor, the
customer could return to the store and deal directly with the proprietor to get
satisfaction.
With the advent of the Industrial Age, the distance between customers
and suppliers increased. As the population grew, new companies were
formed and fitted into material supply chains. It became difficult for companies
to obtain what is called the "voice of the customer."
As an interim step, suppliers worked to a specification. As
specifications multiplied, terminology became difficult to understand. There
were multiple terms with the same meaning and terms that had multiple
meanings. Over time, multiple specifications led to standards development.
By the mid-1980s, suppliers were subject to numerous military, national
and customer standards. Some companies dedicated full-time employees to
each customer account just to understand the varying quality requirements

How Does QS-9000 Differ From ISO-9000?


QS-9000 is sometimes seen as being identical to ISO 9000, but this is
not true. Even though each element of ISO 9000 is an element of QS-9000,
QS-9000 adds clauses to the majority of the ISO 9000 elements. For
example, QS-9000 adds requirements for a business plan, tracking customer
satisfaction and bench marking to element 4.1 of ISO 9000, Management
Responsibility. QS-9000 also uses sector-specific requirements. The following
requirements are not based on ISO 9000:
 production part approval process
 the requirements for gaining approval from the customer to run a
new or altered part or process
 continuous improvement
 automotive suppliers are required to have systems in place to
ensure that organized, measurable improvement activities take
place for a variety for business aspects
 manufacturing capabilities
 requirements for planning and effectiveness for equipment,
facilities and processes
 requirements for mistake proofing, and tooling management.

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LESSON 4: ISO 14000

The Coca-Cola Company is committed to protecting the environment.


Coca Cola Aims:
Our commitments are focused where we have the most opportunity to
make a difference -- water stewardship, sustainable packaging, energy
management and climate protection.
Our community water programs are designed to support healthy
watersheds and sustainable programs to balance the water used throughout
our production process. Learn about our wide range of locally relevant
initiatives and download our community water partnership reports.
Our commitment to responsible citizenship also includes conservation
of natural resources and protection of the soil, water and climate required to
sustain life on earth. We global supply chain to develop and encourage more
sustainable practices to benefit suppliers, customers and consumers.

1.What do you think the connection of the Coca Cola program practices in the
ISO?
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ISO 14000

What is ISO 14000?

is a series of international, voluntary environmental management


standards, guides, and technical reports. The standards specify requirements
for establishing an environmental policy, determining environmental impacts
of products or services, planning environmental objectives, implementing
programs to meet objectives, and conducting correctiveaction and
management review.

The primary objective of the ISO 14000 series of standards is to


promote effective environmental management systems in organizations. The
standards seek to provide cost-effective tools that make use of best practices
for organizing and applying information about environmental management.

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The ISO 14000 family was developed in response to a recognized
industry need for standardization. With different organizational approaches to
environmental management, comparisons of systems and collaboration had
proved difficult.

The ISO 14000 standards are voluntary environmental management


system standards being created under the auspices of the International
Organization for Standardization. ISO has 111 member countries represented
mainly by industry and government standards groups. The American National
Standards Institute represents the United States.

The standards can be classified according to their focus:

 Organization and process evaluation standards-Environmental


management system (ISO 14001, 14004), environmental auditing (ISO
14010, 14011/1, 14012) and environmental performance evaluation
(ISO 14031).
 Product-oriented standards-Life-cycle assessment (ISO 14040, 14041,
14042, 14043), environmental labeling (ISO 14021, 14024, 14025) and
environmental aspects in product standards (ISO 14060).
 Definition standard - A terms-and-definitions standard (ISO 14050)
harmonizes the language among the others.

ISO 14001, the environmental management system specification, is


intended as the only standard establishing requirements against which
companies will be audited for certification. It is the backbone of the series and
was marked by heated debate over how prescriptive it should be.

What are the major requirements?

The standard's first requirement is that your company have a publicly


available environmental policy articulated by top management. It should be
appropriate to the nature of the organization and include commitments toward
pollution prevention and continual improvement of the EMS.

Along with the policy, you shall establish and maintain procedures to
identify significant environmental aspects and their associated impacts.
Procedures to ensure compliance should be consistent with the environmental
policy and include legal and other requirements. Objectives and targets will
also be documented and must be consistent with the goals of the
environmental policy, including continual improvement and pollution
prevention.

Each employee's role and position must be clearly defined, and all
employees must be aware of the impact of their work on the environment.
Your company is responsible for ensuring that all employees are adequately
trained.

The EMS should be set up to facilitate internal communication. To that


end, all relevant documentation should be easily available and usable, in
either print or electronic form.

13 | P a g e
Organizations must continually monitor and document their
environmental effects and periodically review them to ensure continual
improvement and the effectiveness of the EMS. Management is responsible
for an internal review of the EMS on a regular basis.

How does ISO 14001 relate to other environmental standards?

ISO 14001 is the heart of the series while the other standards provide
guidance on specific aspects of environmental management. The ISO 14004
EMS guidance document explains how to implement ISO 14001. You will find
auditing guidance for both internal and external audits in the ISO 14010
standard on auditing principles, ISO 14011/1 on procedures and ISO 14012
on auditor qualifications.

Experts speculate that companies will look to the ISO 14031


environmental performance evaluation standard to help them measure the
environmental impacts of their processes and performance improvement.
Environmental labeling (ISO 14020) covers everything from labeling principles
and practices to standards for practitioner programs. These are the standards
most likely to affect your corporate presence in the retail market because they
deal with product marks and their meanings, and attempt to harmonize the 25
existing labeling standards. ISO 14020 doesn't relate directly to the other
standards.

Life-cycle assessment standards (ISO 14040) will help you evaluate


the make-up of products themselves and the totality of their individual effects
on the environment, from cradle to grave.

ISO requires that every family of standards include a dictionary of


common terms and phrases, and ISO 14050 fulfills this need. TC 207
delegates are seeking to ensure that as much language as possible coincides
with that in the ISO 9000 quality standards.

Delegates also decided to create a guide for other ISO standards


writers called environmental aspects of product standards (ISO 14060).

The European Union has developed the Eco-Management and Audit


Scheme, which explicitly ties the concept of performance directly to
environment management, unlike ISO 14001. The EU probably will adopt ISO
14001 as meeting EMAS requirements, along with a document bridging the
few remaining gaps.

The Chemical Manufacturers Association and the American Petroleum


Institute are both looking at revising their management system standards,
such as Responsible Care, to be more in step with ISO 14001.

How does ISO 14000 relate to ISO 9000?

The ISO 9000 quality management system standards are like the ISO
14000 series because they apply to all sizes and types of companies and

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operations. They both require companies to state what they do, do what they
state and then evaluate their system.

Tentative plans for the ISO 14000 and ISO 9000 series call for
integrating the two series into one management standard that will also include
health and safety. To spare the expense of a separate audit, several
companies have expressed interest in having joint audits performed for both
ISO 14001 and ISO 9001.

Most agree that the ISO 14000 series will impact companies more than
ISO 9000 will. Unlike ISO 9000, the ISO 14000 standards will have significant
legal implications and a broader stakeholder base. According to David J.
Freeman, a lawyer with Battle Fowler and co-leader of a U.S. TAG legal
forum, issues that arise include:

 Confidentiality of audits and application under audit privilege laws.


 The possibility that ISO 14001 and other standards will become the
new "standards of care."
 The practical and legal effects of ISO 14000 use in government
regulatory, enforcement and purchasing activities.
 The possibility that the standards will pose barriers to trade.
 The way that environmental claims and labeling work with the Federal
Trade Commission's guidelines.

ANALYSIS:
Base on the comprehensive input about ISO 9000, can we combined it to
other certification standards?
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ABSTRACTION:
Mind Map: A mind map generator activity will be developed to highlight the
concepts discussed. Create mind mapping through the following concepts.
Choose one and share to the class.

 Quality Systems
 Principles of ISO 9000
 QS 9000
 ISO 14000

MIND MAP

16 | P a g e
APPLICATION:
1.Accomplish an individual plan for ISO journey based on the Eight Principles
of ISO 9000 utilizing the sample learning grid .

PRINCIPLE SCHEME (Plan of Action)

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to Decision


Making

Mutually Beneficial Supplier


Relationships

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“Quality is never an accident; it is always the result of high intention,
sincere effort, intelligent direction; it represents the wise choice of many
alternatives”

William A. Foster

REFERENCES:

Besterfield, Dale 1999 ( Total Quality Management) Prentice Hal International


Inc.

Evans, James R/ Lindsay William 2014 (Total Quality Management) Ninth


Edition, Cengage Learning Asia Pte.Ltd

Goetsch David L/ Davis Stanley (Quality Management for Organizational


Excellence) 7th Edition, Copy write 2014

Stevenson, William J. and Chuong, Sum Chee. Operations Management: An


Asian Perspective. McGraw-Hill,(2007).

Randall, Richard C. Randall’s practical guide to

ISO 9000: implementation, registration, and beyond. Reading, Mass. Addison-


Wesley, (1995).

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www.mastercontrol.com/iso14000/ISO_14000_Certification.html

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