ISO 9000 Overview 110
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Class Outline
Class Outline
Objectives
What Is ISO 9000?
ISO 9000 Background
ISO 9000 Contents
Quality Management Principles
ISO 9001:2008 Components
Quality Management System
The Importance of Documentation
Management Responsibility
Resource Management
Product Realization
The Importance of Process
Measurement, Analysis, and Improvement
Types of ISO 9000 Companies
Advantages of ISO Registration
ISO Registration Steps
The Audit Process
Continual Improvement
Summary
Lesson: 1/19
Objectives
l Define ISO 9000.
l Describe the role of the International Organization for Standardization.
l Identify the documents comprising the ISO 9000 series.
l Describe the eight Quality Management Principles.
l Identify key components of ISO 9001:2008.
l Define the Quality Management System.
l Identify key documents of a QMS.
l Explain the role of management in a quality management system.
l Define resource management in a quality management system.
l Define product realization for a quality management system.
l Describe process design.
l Define process analysis and improvement for a quality management system.
l Identify industries suitable for ISO 9000 certification.
l Identify advantages of ISO 9000 certification and registration.
l Describe the steps required to obtain ISO 9001:2008 certification and registration.
l Describe the auditing process.
l Define continual improvement.
Figure 1. ISO 9001:2008 is divided into eight
sections.
Copyright © 2015 Tooling U, LLC. All Rights Reserved.
Lesson: 1/19
Objectives
l Define ISO 9000.
l Describe the role of the International Organization for Standardization.
l Identify the documents comprising the ISO 9000 series.
l Describe the eight Quality Management Principles.
l Identify key components of ISO 9001:2008.
l Define the Quality Management System.
l Identify key documents of a QMS.
l Explain the role of management in a quality management system.
l Define resource management in a quality management system.
l Define product realization for a quality management system.
l Describe process design.
l Define process analysis and improvement for a quality management system.
l Identify industries suitable for ISO 9000 certification.
l Identify advantages of ISO 9000 certification and registration.
l Describe the steps required to obtain ISO 9001:2008 certification and registration.
l Describe the auditing process.
l Define continual improvement.
Figure 1. ISO 9001:2008 is divided into eight
sections.
Figure 2. Audits are a central part of becoming,
and remaining, registered.
Lesson: 2/19
What Is ISO 9000?
One of the most important activities for today’s businesses is the development of a quality system.
Many organizations choose to demonstrate that they have an effective quality system by becoming
certified and registered to ISO 9001:2008, which is the latest standard in the ISO 9000 series.
ISO 9000 is a series of standards that organizations follow to implement and continually improve a
Quality Management System (QMS). In essence, ISO 9001 is a tool that helps an organization
ensure it is striving to improve and is meeting the needs of its customers. It attempts to reassure
customers that the organization is working to fulfill its promises and consistently deliver a quality
product or service.
ISO 9001 is not meant for any specific industry or a particular type of product or service. It outlines
the content of a QMS, but not instructions regarding how to construct it. It seeks to outline a
simple,
but
thorough,
QMS
structure.
The
QMS models outlined are internationally recognized and
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© 2015
Tooling
U, LLC.
All Rights
Reserved.
are designed to replace multiple QMSs that may be currently in place.
Lesson: 2/19
What Is ISO 9000?
One of the most important activities for today’s businesses is the development of a quality system.
Many organizations choose to demonstrate that they have an effective quality system by becoming
certified and registered to ISO 9001:2008, which is the latest standard in the ISO 9000 series.
ISO 9000 is a series of standards that organizations follow to implement and continually improve a
Quality Management System (QMS). In essence, ISO 9001 is a tool that helps an organization
ensure it is striving to improve and is meeting the needs of its customers. It attempts to reassure
customers that the organization is working to fulfill its promises and consistently deliver a quality
product or service.
ISO 9001 is not meant for any specific industry or a particular type of product or service. It outlines
the content of a QMS, but not instructions regarding how to construct it. It seeks to outline a
simple, but thorough, QMS structure. The QMS models outlined are internationally recognized and
are designed to replace multiple QMSs that may be currently in place.
Though a wide range of organizations are ISO 9001 registered, each company implements an
effective quality management system in its own unique way. This class will teach you the contents
of ISO 9001:2008 and help you understand how this ISO standard applies to your own
organization.
Figure 1. ISO 9000 is a series of standards
that organizations follow to implement and
continually improve a Quality Management
System.
Figure 2. Quality management is a strategy for
improving customer satisfaction.
Lesson: 3/19
ISO 9000 Background
The ISO 9000 series of standards are published by the International Organization for
Standardization, which is commonly called ISO. The organization adopted "ISO" as its short-form
name based on the Greek word isos, which means "equal."
The International Organization for Standardization was founded in 1947 and is based in Geneva,
Switzerland. It is an organization that develops and publishes standards, which are then adopted
by its 162 nation members. Currently, ISO has over 19,000 documented standards. ISO 9000
contains only a small group of these standards, but it is widely recognized and increasingly
influential in the realm of quality. The ISO 9000 series of standards is now in its fourth version.
The ISO 9000 series of standards can be applied to any type and size of organization. ISO 9000
Copyright ©the
2015
Tooling U, LLC.
Rights Reserved.
addresses
processes
of anAll
organization,
not the specific product or service that the
organization offers. This emphasis necessitates the generic nature of the contents. Each
organization is, therefore, responsible for determining the best way to apply the standard to its
Figure 1. The organization adopted "ISO" as
its short-form name based on the Greek word
isos, which means "equal."
Lesson: 3/19
ISO 9000 Background
The ISO 9000 series of standards are published by the International Organization for
Standardization, which is commonly called ISO. The organization adopted "ISO" as its short-form
name based on the Greek word isos, which means "equal."
The International Organization for Standardization was founded in 1947 and is based in Geneva,
Switzerland. It is an organization that develops and publishes standards, which are then adopted
by its 162 nation members. Currently, ISO has over 19,000 documented standards. ISO 9000
contains only a small group of these standards, but it is widely recognized and increasingly
influential in the realm of quality. The ISO 9000 series of standards is now in its fourth version.
The ISO 9000 series of standards can be applied to any type and size of organization. ISO 9000
addresses the processes of an organization, not the specific product or service that the
organization offers. This emphasis necessitates the generic nature of the contents. Each
organization is, therefore, responsible for determining the best way to apply the standard to its
particular products or services.
Figure 1. The organization adopted "ISO" as
its short-form name based on the Greek word
isos, which means "equal."
Figure 2. ISO 9000:2005 is the most current
version of the quality standard.
Lesson: 4/19
ISO 9000 Contents
ISO 9000 is a series of documents that contains requirements for a generic quality management
system. There are three standards in the ISO 9000 series:
l
l
l
ISO 9000:2005 is titled "Quality Management Systems Fundamentals and Vocabulary." This
publication describes the basics, defines vocabulary, and presents an introduction to the
standard.
ISO 9001:2008 is titled "Quality Management Systems Requirements" and contains the
actual requirements an auditor uses to verify conformity of the quality management system of
a company. This publication is the specification standard, and presents the actual material to
which a company is certified.
ISO 9004:2009 is titled "Quality Management Systems Guidelines for Performance
Improvement" and is a guidance document that describes additional recommendations a
company can apply to improve their QMS. This publication is a supplemental document that
focuses on continual improvement.
In general, ISO 9000 refers to the entire collection of these documents. Organizations distinguish
between different versions of documents according to the year designation. For example, ISO
9000:2000 is the precursor to ISO 9000:2005, which is the most recent version. Organizations
that are seeking certification for the first time should begin by studying ISO 9000:2005 to
understand
the concepts
ISO 9001:2008.
Copyright © 2015
Tooling U,and
LLC.language
All Rightswithin
Reserved.
Figure 1. ISO 9001:2008 is the specification
standard, which presents the actual material to
which a company is certified.
Lesson: 4/19
ISO 9000 Contents
ISO 9000 is a series of documents that contains requirements for a generic quality management
system. There are three standards in the ISO 9000 series:
l
l
l
ISO 9000:2005 is titled "Quality Management Systems Fundamentals and Vocabulary." This
publication describes the basics, defines vocabulary, and presents an introduction to the
standard.
ISO 9001:2008 is titled "Quality Management Systems Requirements" and contains the
actual requirements an auditor uses to verify conformity of the quality management system of
a company. This publication is the specification standard, and presents the actual material to
which a company is certified.
ISO 9004:2009 is titled "Quality Management Systems Guidelines for Performance
Improvement" and is a guidance document that describes additional recommendations a
company can apply to improve their QMS. This publication is a supplemental document that
focuses on continual improvement.
In general, ISO 9000 refers to the entire collection of these documents. Organizations distinguish
between different versions of documents according to the year designation. For example, ISO
9000:2000 is the precursor to ISO 9000:2005, which is the most recent version. Organizations
that are seeking certification for the first time should begin by studying ISO 9000:2005 to
understand the concepts and language within ISO 9001:2008.
Figure 1. ISO 9001:2008 is the specification
standard, which presents the actual material to
which a company is certified.
Lesson: 5/19
Quality Management Principles
The foundations of ISO 9000 are the Eight Quality Management Principles, listed in Figure 1. These
principles, defined in ISO 9000:2005 and ISO 9004:2009, are intended to guide the organization in
its quest for improvement:
l
l
l
l
l
l
l
l
The success of an organization depends on its customers. Understanding and meeting the
needs of customers can lead to better revenue and market share, better operational
efficiency, and customer loyalty.
Leaders control the mission and vision of an organization and should fully engage workers in
executing that mission. Good leadership ensures that workers are motivated to achieve goals
and that operations are designed to that end.
An organization is only as good as its people, and thus fully engaging its people is crucial to
an organization's success. The involvement of people leads to an exceptional workforce, one
that is creative, accountable, committed, and eager to improve.
Managing resources and activities as a process leads to benefits like improved performance,
better results, and lower costs.
Managing processes as a system increases effectiveness and helps achieve goals. A systems
Figure 1. The Eight Quality Management
approach can lead to better alignment of processes, better focus, and increased confidence in Principles are intended to guide the
organization in its quest for improvement.
the organization's ability.
Striving to improve performance should be ongoing and permanent. Commitment to
continual improvement leads to the ability to respond to events and opportunities and
unity of purpose regarding improvement throughout the organization.
Decisions should be made based on facts and objective information. In short, a factual
approach leads to good decisions.
Mutually beneficial relationships encourage an organization and its suppliers to create value.
This leads to quick response times, lower costs, and the optimal use of resources.
Copyright © to
2015
Tooling
U, LLC.can
All Rights
Reserved.
Adherence
these
principles
lead to
better organizational processes and customer
satisfaction.
Lesson: 5/19
Quality Management Principles
The foundations of ISO 9000 are the Eight Quality Management Principles, listed in Figure 1. These
principles, defined in ISO 9000:2005 and ISO 9004:2009, are intended to guide the organization in
its quest for improvement:
l
l
l
l
l
l
l
l
The success of an organization depends on its customers. Understanding and meeting the
needs of customers can lead to better revenue and market share, better operational
efficiency, and customer loyalty.
Leaders control the mission and vision of an organization and should fully engage workers in
executing that mission. Good leadership ensures that workers are motivated to achieve goals
and that operations are designed to that end.
An organization is only as good as its people, and thus fully engaging its people is crucial to
an organization's success. The involvement of people leads to an exceptional workforce, one
that is creative, accountable, committed, and eager to improve.
Managing resources and activities as a process leads to benefits like improved performance,
better results, and lower costs.
Managing processes as a system increases effectiveness and helps achieve goals. A systems
Figure 1. The Eight Quality Management
approach can lead to better alignment of processes, better focus, and increased confidence in Principles are intended to guide the
organization in its quest for improvement.
the organization's ability.
Striving to improve performance should be ongoing and permanent. Commitment to
continual improvement leads to the ability to respond to events and opportunities and
unity of purpose regarding improvement throughout the organization.
Decisions should be made based on facts and objective information. In short, a factual
approach leads to good decisions.
Mutually beneficial relationships encourage an organization and its suppliers to create value.
This leads to quick response times, lower costs, and the optimal use of resources.
Adherence to these principles can lead to better organizational processes and customer
satisfaction.
Figure 2. Good leadership ensures that
workers are motivated to achieve goals and
that operations are designed to that end.
Lesson: 6/19
ISO 9001:2008 Components
ISO 9001:2008 contains the actual requirements that the quality management system of an
organization must meet. These requirements are divided into eight sections. The first three
sections are devoted to the scope of the standard, reference materials related to the fundamentals
and vocabulary of the standard, and terms and definitions specifically related to ISO 9001. The
other sections include the following:
Section Four, "Quality Management System," describes the goals and overall structure of an
organization's quality management system.
l Section Five, "Management Responsibility," addresses the roles of management and the
importance of its commitment to quality.
l Section Six, "Resource Management," emphasizes the necessity of the appropriate buildings
and ©
equipment,
asU,
well
asAll
financial,
informational, and human resources.
Copyright
2015 Tooling
LLC.
Rights Reserved.
l Section Seven, "Product Realization," outlines the processes necessary to create a consistent
product that meets requirements and satisfies customer needs.
l Section Eight, "Measurement, Analysis, and Improvement," identifies processes for gathering
l
Lesson: 6/19
ISO 9001:2008 Components
ISO 9001:2008 contains the actual requirements that the quality management system of an
organization must meet. These requirements are divided into eight sections. The first three
sections are devoted to the scope of the standard, reference materials related to the fundamentals
and vocabulary of the standard, and terms and definitions specifically related to ISO 9001. The
other sections include the following:
l
l
l
l
l
Section Four, "Quality Management System," describes the goals and overall structure of an
organization's quality management system.
Section Five, "Management Responsibility," addresses the roles of management and the
importance of its commitment to quality.
Section Six, "Resource Management," emphasizes the necessity of the appropriate buildings
and equipment, as well as financial, informational, and human resources.
Section Seven, "Product Realization," outlines the processes necessary to create a consistent
product that meets requirements and satisfies customer needs.
Section Eight, "Measurement, Analysis, and Improvement," identifies processes for gathering
information and testing the effectiveness of the quality management system.
Each section of the standard is designed to create linked processes that interact within the
company. The end result is a continual improvement program that consistently meets the
customer’s requirements.
Figure 1. ISO 9001:2008 is divided into eight
sections.
Lesson: 7/19
Quality Management System
The heart of ISO 9001 is the Quality Management System (QMS). The QMS is the core set of
written documents created by an organization that states its quality objectives and defines its
processes. The QMS determines how these processes relate to one another and how they are
measured and continually improved.
In essence, the QMS emphasizes the importance of documentation and record keeping. The
observation "if it is not written down, it did not happen" applies here. Effective documentation
provides useful information and eliminates uncertainty.
To be certified, each QMS must address 136 shall statements required by the ISO 9001:2008
standard. The resulting QMS should be unique to the organization. Some organizations may create
documentation that mirrors the ISO 9001 standard. However, this practice is not required.
Primarily, effective documentation should reflect the unique characteristics and circumstances of the
organization. Organizations can exclude aspects from Section 7 of the standard that do not apply
to them, providing that the exclusion does not affect the organization's ability to provide products
that meet the customers’ requirements. These exclusions and justifications need to be documented
in the quality manual.
1. The QMS is the core set of written
Figure
documents created by an organization that
states its quality objectives and defines its
processes.
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Lesson: 7/19
Quality Management System
The heart of ISO 9001 is the Quality Management System (QMS). The QMS is the core set of
written documents created by an organization that states its quality objectives and defines its
processes. The QMS determines how these processes relate to one another and how they are
measured and continually improved.
In essence, the QMS emphasizes the importance of documentation and record keeping. The
observation "if it is not written down, it did not happen" applies here. Effective documentation
provides useful information and eliminates uncertainty.
To be certified, each QMS must address 136 shall statements required by the ISO 9001:2008
standard. The resulting QMS should be unique to the organization. Some organizations may create
documentation that mirrors the ISO 9001 standard. However, this practice is not required.
Primarily, effective documentation should reflect the unique characteristics and circumstances of the
organization. Organizations can exclude aspects from Section 7 of the standard that do not apply
to them, providing that the exclusion does not affect the organization's ability to provide products
that meet the customers’ requirements. These exclusions and justifications need to be documented
in the quality manual.
1. The QMS is the core set of written
Figure
documents created by an organization that
states its quality objectives and defines its
processes.
Figure 2. Effective documentation provides
useful information and eliminates uncertainty.
Lesson: 8/19
The Importance of Documentation
A QMS requires different kinds of documentation, all of which are outlined in Section Four of ISO
9001:2008. The following documentation must be included in the QMS:
The Quality Policy is a concise statement, unique to each organization, that reflects its
commitment to its QMS and continual improvement. The Quality Policy is disseminated to all
employees, is clearly posted in all facilities, and is periodically reviewed.
l Quality Objectives are measurable outcomes toward which all employees work in order to
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2015
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U, LLC. All Rights Reserved.
fulfill©the
quality
policy.
l The Quality Manual documents all existing practices and describes the interaction between
processes, all of which affect the QMS.
l
Lesson: 8/19
The Importance of Documentation
A QMS requires different kinds of documentation, all of which are outlined in Section Four of ISO
9001:2008. The following documentation must be included in the QMS:
l
l
l
l
l
l
The Quality Policy is a concise statement, unique to each organization, that reflects its
commitment to its QMS and continual improvement. The Quality Policy is disseminated to all
employees, is clearly posted in all facilities, and is periodically reviewed.
Quality Objectives are measurable outcomes toward which all employees work in order to
fulfill the quality policy.
The Quality Manual documents all existing practices and describes the interaction between
processes, all of which affect the QMS.
Procedures for six crucial activities must be documented, including the Control of
Documents, Control of Records, Internal Auditing, the Control of Nonconforming Product,
Corrective Action, and Preventive Action.
Additional documents may be needed to show effective implementation of a QMS. Additional
documents can be process maps, production schedules, and work instructions, among
others.
All required records and other records that can demonstrate proper processes and an
effective QMS.
Figure 1. The Quality Manual documents all
existing practices and describes the interaction
between processes, all of which affect the
QMS.
With documentation, "more" is not always "better." In fact, excess documentation is often
forgotten or ignored, thereby creating a nonconformity during an audit. The goal is to create
documents that are lean, readable, and clear, making their use more attractive. Organizations
should focus on reducing and eliminating documentation that has no clear relationship to product
or service conformity.
Figure 2. Organizations should avoid excess
documentation because it is often forgotten or
ignored, thereby creating a nonconformity
during an audit.
Lesson: 9/19
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Management Responsibility
Lesson: 9/19
Management Responsibility
Section Five of ISO 9001:2008 outlines the responsibilities of top management. In order for a QMS
to succeed, it must have the total commitment, support, and active participation of upper
management. ISO 9001:2008 requires top management to contribute to the quality management
system. The main responsibilities of upper management are to gain the confidence of customers by
understanding their expectations and to target the quality management system toward satisfying
those expectations.
Upper management is also responsible for establishing the Quality Policy, Quality Objectives, and
Quality Manual. These documents represent the beliefs and commitment of management regarding
quality and act as guidance documents for the entire organization.
Top management is also responsible for appointing the management representative. This person
ensures that the processes required for the QMS are established, implemented, and maintained.
The representative reports to top management about the performance of the QMS.
Most importantly, upper management must support the quality management system over time.
This requires periodic review of the system. Management is required to routinely conduct reviews
that focus on the effectiveness of quality processes within the organization. By keeping an eye on
processes, management helps guarantee that the organization stays focused on its quality goals.
Figure 1. In order for a QMS to succeed, it
must have the total commitment, support, and
active participation of upper management.
Figure 2. Upper management is responsible for
establishing the Quality Policy, Quality
Objectives, and Quality Manual.
Lesson: 10/19
Resource Management
Section Six of ISO 9001:2008 requires organizations to provide the resources necessary to keep
the QMS running effectively. These resources include obvious needs such as competent personnel,
buildings, equipment, raw materials, and tools. ISO 9001:2008 also stresses the importance of less
obvious resources such as information, finances, and a quality environment.
First off, organizations are required to maintain the workplace. Work facilities that are clean and
free of pollution, as well as extreme noise and temperatures, are more conducive to making
conforming product. Employees are expected to use safety equipment.
Employees are the most important resource in an organization. Employees are expected to have
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© 2015
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LLC.and
All Rights
Reserved.
the
education,
training,
skills,
experience
to do their work. This requires the company to train
and develop its workers and evaluate the effectiveness of the training. Companies are expected to
focus on cultivating competence, motivating employees, and creating job satisfaction.
Lesson: 10/19
Resource Management
Section Six of ISO 9001:2008 requires organizations to provide the resources necessary to keep
the QMS running effectively. These resources include obvious needs such as competent personnel,
buildings, equipment, raw materials, and tools. ISO 9001:2008 also stresses the importance of less
obvious resources such as information, finances, and a quality environment.
First off, organizations are required to maintain the workplace. Work facilities that are clean and
free of pollution, as well as extreme noise and temperatures, are more conducive to making
conforming product. Employees are expected to use safety equipment.
Employees are the most important resource in an organization. Employees are expected to have
the education, training, skills, and experience to do their work. This requires the company to train
and develop its workers and evaluate the effectiveness of the training. Companies are expected to
focus on cultivating competence, motivating employees, and creating job satisfaction.
Figure 1. ISO 9001:2008 requires
organizations to provide resources like
competent personnel and appropriate
buildings, equipment, raw materials, and tools.
Figure 2. Organizations are required to
provide an environment conducive to meeting
quality objectives.
Lesson: 11/19
Product Realization
Product realization, outlined in Section Seven, addresses the activities an organization must
perform to ensure their processes address customer requirements and lead to products that
consistently meet those requirements. Simply put, the company must make sure everyone is
actually doing what is described in the QMS. This is true for every company process, including sales,
product design, production, and purchasing. The sales department must review customer orders
before processing them. As such, sales must not promise to satisfy an order that it later realizes is
beyond the ability of the company.
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Some companies only produce parts designed by other companies. However, companies that
design their own products or services must ensure that their designs address customer
Lesson: 11/19
Product Realization
Product realization, outlined in Section Seven, addresses the activities an organization must
perform to ensure their processes address customer requirements and lead to products that
consistently meet those requirements. Simply put, the company must make sure everyone is
actually doing what is described in the QMS. This is true for every company process, including sales,
product design, production, and purchasing. The sales department must review customer orders
before processing them. As such, sales must not promise to satisfy an order that it later realizes is
beyond the ability of the company.
Some companies only produce parts designed by other companies. However, companies that
design their own products or services must ensure that their designs address customer
requirements by comparing the final design output to the original requirements. This is done by
having a design plan that is reviewed then verified and validated.
To maintain consistent product, companies are required to carefully monitor their inspection
equipment to ensure that the equipment is calibrated and working properly. Companies must also
be able to identify and trace their products throughout the production process with the help of
internal records, as shown in Figure 2.
Additionally, the organization must evaluate suppliers to make sure that they meet the required
criteria. Purchasing must provide clear information to its suppliers, verify that the purchased
product is what was received, and resolve any unclear purchase orders.
Figure 1. Product realization addresses the
activities an organization must perform to
ensure their processes address customer
requirements and lead to products that
consistently meet those requirements.
Figure 2. Internal records help companies
identify and trace their products throughout
the production process.
Lesson: 12/19
The Importance of Process
Essentially, product realization depends upon effective process design. A process is simply a
collection of recognized standard activities. It is "the way actions are typically accomplished." Every
process also has an input and an output; in other words, something "goes in," and then it "goes
out" reflecting the results of the process.
All too often, processes are the unfortunate result of trial-and-error methods or "rules of thumb"
informally passed on from one employee to another. The risk is that unplanned process
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Tooling
U, LLC. All Rights
Reserved.
development
leads
to inconsistencies
and
wasted effort. ISO 9001:2008 requires an organization to
actively design and plan its processes. Effective process design creates a system of processes that
leads to increased consistency, improved communication, and reduced costs. Process design ties
Lesson: 12/19
The Importance of Process
Essentially, product realization depends upon effective process design. A process is simply a
collection of recognized standard activities. It is "the way actions are typically accomplished." Every
process also has an input and an output; in other words, something "goes in," and then it "goes
out" reflecting the results of the process.
All too often, processes are the unfortunate result of trial-and-error methods or "rules of thumb"
informally passed on from one employee to another. The risk is that unplanned process
development leads to inconsistencies and wasted effort. ISO 9001:2008 requires an organization to
actively design and plan its processes. Effective process design creates a system of processes that
leads to increased consistency, improved communication, and reduced costs. Process design ties
together the various departments of an organization to make sure that everyone is working toward
the same goal.
Figure 1. Processes turn inputs into outputs.
Figure 2. Effective process design creates a
system of processes that leads to increased
consistency, improved communication, and
reduced costs.
Lesson: 13/19
Measurement, Analysis, and Improvement
The Eighth Section of ISO 9001:2008 advises organizations to constantly measure and improve
product characteristics, organization processes, and customer satisfaction. To measure and inspect
products, a company must have already clearly defined the requirements of a quality product.
Companies then inspect products to make sure they adhere to these requirements and keep
records of the activities.
Most often, nonconformities are not people mistakes; they are process mistakes. Consequently, a
company is expected to continually monitor its processes by comparing process inputs and
outputs. A company should consider how process results impact quality, time, and cost variables
and make results known to employees.
Companies must always analyze the satisfaction of the customer. For some companies, it is difficult
to identify customer dissatisfaction, let alone satisfaction. Nevertheless, customer satisfaction holds
the key to business success and it must be monitored and recorded.
Additionally, Section Eight includes four key requirements. An organization must conduct regular
internal audits, control nonconforming products, correct actual nonconformities, and prevent
potential nonconformities.
Copyright © 2015 Tooling U, LLC. All Rights Reserved.
Figure 1. ISO 9001:2008 advises
organizations to constantly measure and
Lesson: 13/19
Measurement, Analysis, and Improvement
The Eighth Section of ISO 9001:2008 advises organizations to constantly measure and improve
product characteristics, organization processes, and customer satisfaction. To measure and inspect
products, a company must have already clearly defined the requirements of a quality product.
Companies then inspect products to make sure they adhere to these requirements and keep
records of the activities.
Most often, nonconformities are not people mistakes; they are process mistakes. Consequently, a
company is expected to continually monitor its processes by comparing process inputs and
outputs. A company should consider how process results impact quality, time, and cost variables
and make results known to employees.
Companies must always analyze the satisfaction of the customer. For some companies, it is difficult
to identify customer dissatisfaction, let alone satisfaction. Nevertheless, customer satisfaction holds
the key to business success and it must be monitored and recorded.
Additionally, Section Eight includes four key requirements. An organization must conduct regular
internal audits, control nonconforming products, correct actual nonconformities, and prevent
potential nonconformities.
Figure 1. ISO 9001:2008 advises
organizations to constantly measure and
improve product characteristics, organization
processes, and customer satisfaction.
Figure 2. Customer satisfaction holds the key
to business success and it must be monitored
and recorded.
Lesson: 14/19
Types of ISO 9000 Companies
Any organization, regardless of its type or size, can apply ISO 9001 to improve its quality system.
Uniquely individual organizations, from small "Mom and Pop" operations to multinational
corporations, have implemented and been certified to ISO 9001. The standard outlines the
requirements, but does not mandate how the requirements should be met.
Certain industries, however, are more inclined to pursue ISO 9001 certification than others.
Manufacturing companies have been most likely to seek this certification. Organizations that provide
services are registering with ISO 9000 as well. This includes law offices, hospitals, universities,
government
agencies,
trading
firms.Reserved.
In many instances, the customers encourage, or
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Toolingand
U, LLC.
All Rights
occasionally demand, these organizations to pursue certification.
Lesson: 14/19
Types of ISO 9000 Companies
Any organization, regardless of its type or size, can apply ISO 9001 to improve its quality system.
Uniquely individual organizations, from small "Mom and Pop" operations to multinational
corporations, have implemented and been certified to ISO 9001. The standard outlines the
requirements, but does not mandate how the requirements should be met.
Certain industries, however, are more inclined to pursue ISO 9001 certification than others.
Manufacturing companies have been most likely to seek this certification. Organizations that provide
services are registering with ISO 9000 as well. This includes law offices, hospitals, universities,
government agencies, and trading firms. In many instances, the customers encourage, or
occasionally demand, these organizations to pursue certification.
Figure 1. Manufacturing companies have been
most likely to seek ISO 9000 certification.
Lesson: 15/19
Advantages of ISO Registration
The effective implementation of an ISO 9001 certified and registered quality management system
demands change within the organization. The results of the changes can be beneficial. ISO 9001 is
designed to solidify company processes and improve focus on the customer.
Companies that have been certified to ISO 9001 discover many benefits, including the following:
l
l
l
l
Increased consistency allows employees to better understand their responsibilities and their
role within the organization.
Strengthened relationships between company departments enables them to share information
and work as a team to a common goal.
Improved decision making by management focuses on the needs of the customer.
Enhanced training within companies works to develop the skills of employees.
Figure 1. ISO registration can lead to better
employee performance.
Most importantly, ISO 9000 can improve the financial performance of a company. Monitoring and
improving processes should highlight opportunities to reduce waste. It is common for product
defects to decrease, delivery times to improve, and profits to grow.
Many companies insist that their suppliers be ISO certified. Certification can be a stipulation of a
contract. Not being certified can lead to a loss of opportunities and ultimately decreased market
share.
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Lesson: 15/19
Advantages of ISO Registration
The effective implementation of an ISO 9001 certified and registered quality management system
demands change within the organization. The results of the changes can be beneficial. ISO 9001 is
designed to solidify company processes and improve focus on the customer.
Companies that have been certified to ISO 9001 discover many benefits, including the following:
l
l
l
l
Increased consistency allows employees to better understand their responsibilities and their
role within the organization.
Strengthened relationships between company departments enables them to share information
and work as a team to a common goal.
Improved decision making by management focuses on the needs of the customer.
Enhanced training within companies works to develop the skills of employees.
Figure 1. ISO registration can lead to better
employee performance.
Most importantly, ISO 9000 can improve the financial performance of a company. Monitoring and
improving processes should highlight opportunities to reduce waste. It is common for product
defects to decrease, delivery times to improve, and profits to grow.
Many companies insist that their suppliers be ISO certified. Certification can be a stipulation of a
contract. Not being certified can lead to a loss of opportunities and ultimately decreased market
share.
Lesson: 16/19
ISO Registration Steps
All of the previous sections help to illustrate the efforts that an organization must make to
successfully implement a QMS. Companies can approach certification and registration two ways:
they can do the bare minimum to get certified and "pass the test," or they can commit themselves
to a sincere business improvement effort. The better the effort that a company puts into the
process, the greater the potential reward.
The time it takes to be ready for certification and registration varies. If a company already has an
effective quality management system and seeks certification and registration, the timeline may be 4 to 6 months. However, companies that have to do more work should anticipate needing 8 to 12
months to prepare for certification and registration. Figure 1 shows the general steps leading to
registration. This time span is required to develop all the necessary documentation, train employees
in the system, actually put the system into practice, audit the system, and close corrective actions
before the certification and registration audit. Because the effective implementation of a QMS
changes company processes, employees will need some time to adjust to the new way of doing
Figure 1. ISO registration involves six general
things.
steps.
Copyright © 2015 Tooling U, LLC. All Rights Reserved.
Lesson: 17/19
Lesson: 16/19
ISO Registration Steps
All of the previous sections help to illustrate the efforts that an organization must make to
successfully implement a QMS. Companies can approach certification and registration two ways:
they can do the bare minimum to get certified and "pass the test," or they can commit themselves
to a sincere business improvement effort. The better the effort that a company puts into the
process, the greater the potential reward.
The time it takes to be ready for certification and registration varies. If a company already has an
effective quality management system and seeks certification and registration, the timeline may be 4 to 6 months. However, companies that have to do more work should anticipate needing 8 to 12
months to prepare for certification and registration. Figure 1 shows the general steps leading to
registration. This time span is required to develop all the necessary documentation, train employees
in the system, actually put the system into practice, audit the system, and close corrective actions
before the certification and registration audit. Because the effective implementation of a QMS
changes company processes, employees will need some time to adjust to the new way of doing
Figure 1. ISO registration involves six general
things.
steps.
Lesson: 17/19
The Audit Process
ISO 9001:2008 certification requires that a certified external auditor evaluate an organization's
QMS by comparing it to the standard. External auditors verify that the quality management system
conforms to the standard. Auditors study company documents and observe its processes, but are
prohibited from offering any consulting or advice.
After the audit, the organization receives a report indicating if any nonconformities were found. The
organization is allotted time to correct the nonconformities. A successful audit leads to ISO
9001:2008 certification. The organization’s name is then placed on a registry, thereby becoming
"registered." Periodic surveillance audits of parts of the QMS are carried out by the external
auditors on a semi-annual or annual basis, while recertification audits requiring a full QMS audit are
conducted every three to five years.
ISO 9001:2008 certified companies are also required to periodically conduct internal audits of their
Figure 1. Audits are a central part of becoming,
QMS. An internal auditing team consists of employees from a range of departments and levels, but
and remaining, registered.
with the understanding that employees cannot audit their own departments. Internal auditing
educates employees on the audit process, provides management with valuable information, and
keeps the company focused on continual improvement.
Figure 2. ISO 9001:2008 certified companies
are required to periodically conduct internal
audits.
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Lesson: 17/19
The Audit Process
ISO 9001:2008 certification requires that a certified external auditor evaluate an organization's
QMS by comparing it to the standard. External auditors verify that the quality management system
conforms to the standard. Auditors study company documents and observe its processes, but are
prohibited from offering any consulting or advice.
After the audit, the organization receives a report indicating if any nonconformities were found. The
organization is allotted time to correct the nonconformities. A successful audit leads to ISO
9001:2008 certification. The organization’s name is then placed on a registry, thereby becoming
"registered." Periodic surveillance audits of parts of the QMS are carried out by the external
auditors on a semi-annual or annual basis, while recertification audits requiring a full QMS audit are
conducted every three to five years.
ISO 9001:2008 certified companies are also required to periodically conduct internal audits of their
Figure 1. Audits are a central part of becoming,
QMS. An internal auditing team consists of employees from a range of departments and levels, but
and remaining, registered.
with the understanding that employees cannot audit their own departments. Internal auditing
educates employees on the audit process, provides management with valuable information, and
keeps the company focused on continual improvement.
Figure 2. ISO 9001:2008 certified companies
are required to periodically conduct internal
audits.
Lesson: 18/19
Continual Improvement
One of the goals of ISO 9001:2008 is to keep companies focused on continual improvement. This is
accomplished with a few key tools:
l
l
l
l
Periodic management reviews require upper management to focus on the results of audits,
customer feedback, process and product conformance, and the status of preventive and
corrective actions. They must also address actions from previous management reviews,
changes that could affect the QMS and recommendations for improvement.
The results of measurement and analysis assess product characteristics, processes, and
customer satisfaction.
Internal audits involve employees in the quality management system.
Surveillance audits conducted by an external auditor, on a semi-annual or annual basis,
assure that improvements made are sustained.
Continual improvement means an organization is never really done with a quality initiative. ISO
9001:2008 certification and registration requires constant effort and monitoring. This continuous
effort leads to customer satisfaction and business success.
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ISO 9001:2008 is only one piece of the puzzle, as companies also must acknowledge regulatory
and legal requirements, along with other business pressures. Nevertheless, ISO 9000 provides a
framework that keeps quality issues central to company processes and emphasized throughout the
Figure 1. The results of measurement and
analysis assess product characteristics,
processes, and customer satisfaction.
Lesson: 18/19
Continual Improvement
One of the goals of ISO 9001:2008 is to keep companies focused on continual improvement. This is
accomplished with a few key tools:
l
l
l
l
Periodic management reviews require upper management to focus on the results of audits,
customer feedback, process and product conformance, and the status of preventive and
corrective actions. They must also address actions from previous management reviews,
changes that could affect the QMS and recommendations for improvement.
The results of measurement and analysis assess product characteristics, processes, and
customer satisfaction.
Internal audits involve employees in the quality management system.
Surveillance audits conducted by an external auditor, on a semi-annual or annual basis,
assure that improvements made are sustained.
Continual improvement means an organization is never really done with a quality initiative. ISO
9001:2008 certification and registration requires constant effort and monitoring. This continuous
effort leads to customer satisfaction and business success.
ISO 9001:2008 is only one piece of the puzzle, as companies also must acknowledge regulatory
and legal requirements, along with other business pressures. Nevertheless, ISO 9000 provides a
framework that keeps quality issues central to company processes and emphasized throughout the
organization.
Figure 1. The results of measurement and
analysis assess product characteristics,
processes, and customer satisfaction.
Figure 2. ISO 9001:2008 certification and
registration requires constant effort and
monitoring, which can lead to customer
satisfaction and business success.
Lesson: 19/19
Summary
Organizations can demonstrate a commitment to quality by becoming certified and registered to
ISO 9001:2008, the latest standard in the ISO 9000 series. ISO 9000 is a series of standards that
guide an organization on the requirements to the implementation and continual improvement of a
quality management system.
The ISO 9000 series of standards are published by the International Organization for
Standardization, commonly called ISO. The organization adopted "ISO" as its short-form name
based on the Greek word isos, which means "equal." There are three standards in the ISO 9000
series:
ISO 9000:2005 describes the basics, defines vocabulary, and presents an introduction to the
standard.
l ISO 9001:2008 contains the actual requirements an auditor uses to verify conformity of the
Copyright © 2015 Tooling U, LLC. All Rights Reserved.
quality management system of a company. This publication is the specification standard that
presents the actual material to which a company is certified.
l ISO 9004:2009 describes additional recommendations a company can apply to improve their
l
Figure 1. ISO 9001:2008 is the specification
Lesson: 19/19
Summary
Organizations can demonstrate a commitment to quality by becoming certified and registered to
ISO 9001:2008, the latest standard in the ISO 9000 series. ISO 9000 is a series of standards that
guide an organization on the requirements to the implementation and continual improvement of a
quality management system.
The ISO 9000 series of standards are published by the International Organization for
Standardization, commonly called ISO. The organization adopted "ISO" as its short-form name
based on the Greek word isos, which means "equal." There are three standards in the ISO 9000
series:
l
l
l
ISO 9000:2005 describes the basics, defines vocabulary, and presents an introduction to the
standard.
ISO 9001:2008 contains the actual requirements an auditor uses to verify conformity of the
quality management system of a company. This publication is the specification standard that
presents the actual material to which a company is certified.
ISO 9004:2009 describes additional recommendations a company can apply to improve their
QMS. This publication is a supplemental document that focuses on continual improvement.
Figure 1. ISO 9001:2008 is the specification
standard that presents the actual material to
which a company is certified.
The foundations of ISO 9000 are the Eight Quality Management Principles.
ISO 9001:2008 is divided into eight sections. The first three sections cover the scope of the
standard, reference materials related to the fundamentals and vocabulary of the standard, and
terms and definitions. The other sections include the following:
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l
l
Section Four describes the goals and overall structure of an organization's quality
management system. It also outlines the required documentation, including the quality policy,
quality objectives, quality manual, and minimum procedures.
Section Five addresses the role of management and the importance of its commitment to
quality.
Section Six emphasizes the necessity of the appropriate buildings and equipment, as well as
financial, informational, and human resources.
Section Seven outlines the processes necessary to create a consistent product that meets
requirements and satisfies customer needs.
Section Eight identifies processes for gathering information and testing the effectiveness of
the quality management system.
Figure 2. ISO registration can lead to better
employee performance.
The results of the changes brought by ISO 9000 certification can be beneficial. Change has been
known to solidify company processes and improve focus on the customer, as well as improve the
financial performance of a company.
Class Vocabulary
Term
Definition
Continual Improvement
Crucial Activities
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External Auditor
The belief that an organization must constantly measure the effectiveness of its
processes and strive to meet more difficult objectives to satisfy customers. Continual
improvement is one of the core quality management principles.
Procedures that must be defined and outlined so an organization is prepared for
continual improvement. The six crucial activities of ISO 9000 include control of
documents, control of records, internal auditing, control of nonconforming product,
corrective action, and preventive action.
An individual outside of the organization that objectively assesses the effectiveness of
the organization's quality system. External auditors are required to register with ISO
Class Vocabulary
Term
Definition
Continual Improvement
The belief that an organization must constantly measure the effectiveness of its
processes and strive to meet more difficult objectives to satisfy customers. Continual
improvement is one of the core quality management principles.
Crucial Activities
Procedures that must be defined and outlined so an organization is prepared for
continual improvement. The six crucial activities of ISO 9000 include control of
documents, control of records, internal auditing, control of nonconforming product,
corrective action, and preventive action.
External Auditor
An individual outside of the organization that objectively assesses the effectiveness of
the organization's quality system. External auditors are required to register with ISO
9000.
Input
International Organization For Standardization
ISO
A step or change that enters and contributes to a process.
ISO. A non-governmental organization based in Switzerland that develops and
establishes standards, rules, and guidelines designed to ensure that products,
processes, and services are fit for their purposes.
International Organization for Standardization. A non-governmental organization based
in Switzerland that develops and establishes standards, rules, and guidelines designed
to ensure that products, processes, and services are fit for their purposes. ISO took
its short-form name from the Greek word isos, which means "equal."
ISO 9000
A series of standards intended to guide an organization on the implementation and
continual improvement of a QMS. Certification and registration to ISO 9000 indicates
an organization is striving to meet the quality requirements of its customers.
ISO 9000:2005
One of the three main publications of the ISO 9000 series that describes the basics,
defines vocabulary, and introduces the ISO quality standard. ISO 9000:2005 is titled
"Quality Management Systems Fundamentals and Vocabulary."
ISO 9001:2008
The core standard of ISO 9000 that contains the requirements an auditor uses to
verify conformity of a QMS. ISO 9001:2008 is titled "Quality Management Systems
Requirements" and presents the actual material to which a company is certified.
ISO 9004:2009
One of the three main publications of the ISO 9000 series that describes additional
recommendations a company can apply to improve their QMS. ISO 9004:2009 is titled
"Quality Management Systems Guidelines for Performance Improvement."
Output
Processes
Product Realization
Quality Management System
The result of a process, such as a finished part.
A set of activities that uses resources to transform inputs into outputs. Essentially, a
process describes the way "things get done."
All phases of the development of a product, including idea, design, prototype, and
production.
The objectives and processes of a company designed to focus the company toward
quality and customer satisfaction. The QMS consists of written documents that
address the ISO 9001:2008 standard.
Quality Manual
A key document of a QMS that outlines all existing practices and describes the
interaction between processes, all of which affect the QMS.
Quality Objectives
A key document of a QMS that outlines measurable outcomes toward which all
employees work in order to fulfill the quality policy.
Quality Policy
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Shall Statement
A key document of a QMS that reflects an organization's commitment to quality and
continual improvement. The quality policy is disseminated to all employees, is clearly
posted in all facilities, and is periodically reviewed.
A requirement, stated in plain language, designed to guide conformance to an ISO
standard. The 136 shall statements within ISO 9000 include required records, required
Quality Policy
A key document of a QMS that reflects an organization's commitment to quality and
continual improvement. The quality policy is disseminated to all employees, is clearly
posted in all facilities, and is periodically reviewed.
Shall Statement
A requirement, stated in plain language, designed to guide conformance to an ISO
standard. The 136 shall statements within ISO 9000 include required records, required
procedures, the quality manual, and other process requirements that must be
established.
Standard
An established policy regarding a particular practice or method. The ISO 9000 family of
standards is concerned with establishing and managing quality systems.
Supplier
An organization that provides a product to another organization. Products are often
passed in a chain, from the supplier to the organization to the customer.
Surveillance Audit
A periodic audit performed by an external auditor to ensure that an organization still
meets ISO 9000 requirements. Surveillance audits are required by ISO 9000.
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