ISO 9000 2000 Definitions
Translated into Plain English

These definitions are OBSOLETE. See our NEW ISO 9000 2015 Definitions.

The definitions presented here are based on ISO 8402:1994 Quality 
management and quality assurance—Vocabulary
. However, in order
to present you with the following plain English definitions, we've also
 had to study all of the other ISO 9000 publications. We felt this was 
necessary in order to figure out how ISO actually uses these terms. 

 

Conformity

Conformity is all about meeting requirements. ISO 9001 2000
lists many quality system requirements. If your organization
meets these requirements, you can say that it
conforms to
these requirements. 

Continual
improvement

Continual improvement is a set of activities that an
organization routinely carries out in order to enhance its ability
to meet requirements. Continual improvement can be achieved
by carrying out internal audits, performing management
reviews, analyzing data, and implementing corrective
and preventive actions.

Contract 
review

Contract review is a set of activities that an organization
carries out in order to make sure that customer orders and
contracts specify all the requirements that must be met, and
in order to establish that the organization can actually meet
these requirements.

Corrective 
action

Corrective actions are steps that are taken to remove the
causes of an existing nonconformity or to make quality
improvements. Corrective actions address actual problems.
In general, the corrective action process can be thought of
as a problem solving process.

Customer

A customer is anyone who receives products or services
from a supplier. A customer can be either external or internal
to the supplier organization.

Customer
satisfaction

Customer satisfaction is a perception. It is also a question of
degree.  It can vary from high satisfaction to low satisfaction.
If customers believe that you've met their requirements, they
experience high satisfaction. If they believe that you've not
met their requirements, they experience low satisfaction.

Design 
review

A design review is a set of activities whose purpose is to
evaluate how well a potential product (a design) meets all
quality requirements. During the course of this review,
problems must be identified and solutions must be
developed.

Design 
validation

Design validation is a process whose purpose is to examine 
products and to use objective evidence to confirm that these 
products meet user needs.

Design 
verification

Design verification is a process whose purpose is to examine 
design outputs and to use objective evidence to confirm that 
outputs meet input requirements.

Entity

An entity could be a product, process, person, activity,
machine, service, system, department, company, institution,
or organization.

Infrastructure

The term infrastructure includes buildings, workspaces,
equipment, hardware, software, utilities, and support
services such as transportation and communication.

Internal 
quality 
audit

Internal audits are carried out by your personnel. Internal
quality audits examine the elements of a quality management
system in order to evaluate how well these elements comply
with quality system requirements.

Management
review

The purpose of a management review is to evaluate the overall
performance of an organization's quality management system
and to identify improvement opportunities.  These reviews are
carried out by the organization's top managers and are done
on a regular basis.

Nonconforming
product

When one or more characteristics of a product fail to meet
specified requirements, it is referred to as a
nonconforming
product
. When a product deviates from quality requirements,
it fails to conform.

Nonconformity

ISO 9001 2000 lists quality management system requirements.
When your organization deviates from these requirements, a
nonconformity occurs. When a product, process, procedure,
system, or structure deviates from ISO requirements, a formal
nonconformity exists.

Organization

An organization is a company, corporation, firm, or institution
that has its own functions and administration. It can be either
incorporated or unincorporated, privately or publicly owned.

Organizational
structure

The structure of an organization is the pattern of
responsibilities, authorities, and relationships that control
how people perform their functions and govern how they
interact with one another.

Preventive 
action

Preventive actions are steps that are taken to remove the
causes  of potential nonconformities or to make quality
improvements. Preventive actions address potential
problems, ones that haven't yet occurred. In general,
the preventive action process can be thought of as
a risk analysis process.

Procedure

Quality procedures control processes or activities. A well
defined procedure controls a logically distinct process or
activity, including the associated inputs and outputs. Such
a procedure defines the work that should be done, and
explains how it should be done, who should do it, and under
what circumstances. In addition, it explains what authority and
what responsibility has been allocated, which supplies and
materials should be used, and which documents and records
must be used to carry out the work. While quality procedures
may be documented or undocumented, ISO usually expects
them to be documented.

Process

In general, a process uses resources to transform inputs
into outputs. In every case, inputs are turned into outputs
because some kind of work, activity, or function is carried
out. Processes can be administrative, industrial, agricultural,
governmental, chemical, mechanical, electrical, and so on. 
An ISO 9001 Quality Management System is made up of the
following processes:

  • Purchasing process.

  • Production process.

  • Product design process.

  • Product protection process.

  • Service provision process.

  • Document control process.

  • Record keeping process.

  • Internal audit process.

  • Planning process.

  • Training process.

  • Monitoring process.

  • Measurement process.

  • Market research process.

  • Regulatory research process.

  • Continual improvement process.

  • Internal Communications process.

  • Customer Communications process.

  • Customer needs assessment process.

  • Nonconformance management process.

Process 
approach

The process approach is a management strategy. When
managers use a process approach, it means that they control
the processes that make up a Quality Management System,
the interaction between these processes, and the inputs
and outputs that glue these processes together. It means
that they manage by focusing on processes.

Product

A product is an output that results from a process. Products
can be tangible or intangible, a thing or an idea, hardware or
software, information or knowledge, a process or procedure,
a service or function, or a concept or creation. Please note
that when ISO uses the term
product they also mean service.

Product 
inspection

Product inspection is an activity that compares product
characteristics with product requirements in order to establish
conformity. More precisely, product inspection is an activity
that compares one or more characteristics of a product with
specified requirements in order to determine if the product
meets these requirements.

Product
nonconformity

When one or more characteristics of a product fail to meet
specified requirements, they are referred to as
product
nonconformities
.

Product 
realization

A product starts out as an idea. The idea is realized or
actualized by following a set of product realization processes.
So product realization refers to all the processes that are used
to bring products into being. 

Quality

A quality is a characteristic that a product or service must
have. For example, products must be reliable, useable, and
repairable. These are some of the characteristics that a good
quality product must have. Similarly, service should be
courteous, efficient, and effective. These are some of the
characteristics that a good quality service must have.
In short, a quality is a desirable characteristic.

However, not all qualities are equal. Some are more important
than others. The most important qualities are the ones that
customers want. These are the qualities that products and
services must have. 

So providing quality products and services is all about
meeting customer requirements. It's all about meeting the
needs and expectations of customers.
So a quality product
or service
is one that meets the needs and expectations
of customers.

Quality 
assurance

Quality assurance (Q.A.) is defined as a set of activities
whose purpose is to demonstrate that an entity meets all
quality requirements. Q.A. activities are carried out in order
to inspire the confidence of both customers and managers,
confidence that all quality requirements are being met.

Quality 
audit

Quality audits examine the elements of a quality management
system in order to evaluate how well these elements comply
with quality system requirements.

Quality 
control

Quality control is defined as a set of activities or techniques
whose purpose is to ensure that all quality requirements are
being met. In order to achieve this purpose, processes are
monitored and performance problems are solved.

Quality
improvement

Quality improvement refers to anything that enhances
an organization's ability to meet quality requirements.

Quality
management

Quality management includes all the activities that managers
carry out in an effort to implement their quality policy. These
activities include quality planning, quality control, quality
assurance, and quality improvement.

Quality 
manual

A quality manual documents an organization's Quality
Management System. It can be a paper manual or an
electronic manual.

Quality 
planning

Quality planning is defined as a set of activities whose
purpose is to define quality system policies, objectives,
and requirements, and to explain how these policies will
be applied, how these objectives will be achieved, and
how these requirements will be met. It is always future
oriented.

Quality
plan

A quality plan explains how you intend to apply your quality 
policies, achieve your quality objectives, and meet your
quality system requirements.

Quality 
policy

A quality policy statement defines or describes
an organization's commitment to quality.

Quality 
record

A quality record contains objective evidence which shows
how well a quality requirement is being met or how well a
quality process is performing. It always documents what
has happened in the past.

Quality
requirement

A quality requirement is a characteristic that an entity must
have. For example, a customer may require that a particular
product (entity) achieve a specific dependability score
(characteristic).

Quality
surveillance

Quality surveillance is a set of activities whose purpose
is to monitor an entity and review its records to prove
that quality requirements are being met.

Quality
management
system

A quality management system is a web of interconnected
processes. Each process uses resources to turn inputs into
outputs. And all of these processes are interconnected by
means of many input-output relationships. Every process
generates at least one output, and this output becomes an
input for another process. These input-output relationships
glue all of these processes together - that's what makes
it a system.

Quality system
requirement

A quality is a characteristic. A system is a set of interrelated
processes, and a
 requirement is an obligation.  Therefore, a
quality system requirement is a characteristic that a process
must have.

Record

A record is a document that contains objective evidence
which shows how well activities are being performed or
what kind of results are being achieved. It always
documents what has happened in the past.

Requirement

A requirement is a need, expectation, or obligation. It can be
stated or implied by an organization, its customers, or other
interested parties. There are many types of requirements.
Some of these include quality requirements, customer
requirements, management requirements, and product
requirements.

Resources

Resources include people, money, information, knowledge,
skill, energy, facilities, machines, tools, equipment,
technologies, and techniques.

Service

Service is a customer-oriented result. This result is produced 
when an organization performs activities that are oriented
towards meeting customer needs and expectations.

Service 
delivery

Service delivery is a customer-oriented activity. Service
delivery activities are carried out by organizations and are
oriented towards meeting customer needs and expectations.

Special
process

A special process is any production or service delivery
process that generates outputs that cannot be measured,
monitored, or verified until it's too late. It's often too late
because deficiencies may not be obvious until after the
resulting products have been used or services have been
delivered. In order to prevent output deficiencies, these
special processes must be validated in order to prove
that they can generate planned results.

Standard

A standard is a document. It is a set of rules that control how
people develop and manage materials, products, services,
technologies, processes, and systems.

ISO's standards are agreements. ISO refers to them as
agreements because its members must agree on content
and give formal approval  before they are published.

ISO standards are developed by technical committees.
Members of  these technical committees come from many
countries. Therefore, ISO  standards tend to have very
broad support.

Supplier

A supplier is an organization that provides products or
services to customers. Customers can be either internal
or external to the supplier organization.

Total quality
management

Total quality management is defined as a management
approach that tries to achieve and sustain long-term
organizational success by encouraging employee
feedback and participation, satisfying customer needs 
and expectations, respecting societal values and beliefs, 
and obeying governmental statutes and regulations.

Work 
environment

The term work environment refers to all the factors that
influence work. In general, these include social, cultural,
psychological, physical, and environmental conditions.
The term work environment includes lighting, temperature,
and noise factors, as well as the whole range of ergonomic
influences. It also includes things like supervisory practices
as well as reward and recognition programs. All of these
things influence how work is performed.

 

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Updated on November 30, 2014

First published on January 10, 2001 at www.praxiom.com/iso-definition.htm

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