The definitions presented here are based on ISO 8402: Quality management and quality assuranceVocabulary. 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. For your convenience, our definitions are presented in alphabetical order (for quick access, please click a letter).
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Conformity
ISO 9001, ISO
9002, and ISO 9003 list many quality system requirements. If your
organization meets these requirements, you can say that it conforms
to these requirements. You can say that it is behaving in conformity
with these requirements. You can say that it is in conformance.
Contract
review
A contract review is a
set of activities that you must carry out to ensure that all
customer orders or contracts specify all the quality requirements
you must meet and to ensure that you can meet these requirements.
A quality requirement is a characteristic that an entity must have. For example, a customer may require that a product (entity) achieve a specific dependability score (characteristic).
Corrective
actions
Corrective actions are
steps that are taken to remove the causes of an existing
nonconformity or to make quality improvements.
Customers
A customer is anyone
who receives products or services from a supplier.
A customer can be either external or internal to the supplier
organization.
You are a supplier organization if you provide products or services to customers.
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.
A quality requirement is a property or characteristic (quality) that a product or service must have.
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.
Elements
Elements include
responsibilities, authorities, relationships, functions,
policies, procedures, practices, processes, and resources.
Quality system elements combine to form a quality system.
Entity
An entity could be a
product, process, person, activity, machine, service, system,
department, company, institution, or organization.
Internal quality audit
Internal audits are
carried out by your personnel. Internal quality audits examine
the elements of a quality system in order to evaluate how well
these elements comply with quality system requirements.
Nonconforming products
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, ISO 9002, and ISO 9003 list quality 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, or 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 actions
Preventive actions are
steps that are taken to remove the causes of potential
nonconformities or to make quality improvements.
Procedures
Quality procedures
control activities. A well defined procedure controls a logically
distinct set of activities. Such a procedure precisely 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
procedures may be documented or undocumented, ISO usually expects
them to be documented.
Process
A process uses
resources to transform inputs into outputs. Processes can be
social, industrial, agricultural, governmental, chemical,
mechanical, electrical, and so on. In every case, inputs are
turned into outputs because some kind of work, activity, or
function is carried out.
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 conforms to these requirements.
Product
nonconformity
When one or more characteristics of a product fail to meet
specified requirements, they are referred to as product
nonconformities.
Quality
An entity has characteristics. Some of these characteristics are
derived from stated or implied needs. The set of these special
need-oriented characteristics make up the quality of an entity.
In short, a quality is a characteristic.
For example, the need for dependability is met by designing a dependable product. Dependability then becomes a quality (characteristic) of the product (entity).
An entity is a product, process, person, activity, machine, service, system, department, company, institution, or organization.
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
audits
Quality audits examine
the elements of a quality system in order to evaluate how well
these elements comply with quality system requirements.
Elements include responsibilities, authorities, relationships, functions, procedures, processes, and resources. Elements combine to form a quality system.
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 a set of activities whose purpose is to enhance the
efficiency and effectiveness of the organization for the benefit
of both the organization and its customers.
We believe that quality improvement ought to focus on quality, not on efficiency. Let's leave that to the "efficiency experts".
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 is a
document which states your quality policy and describes your
quality system. It describes the roles, relationships, functions,
processes, procedures, systems, and resources that affect
quality. 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.
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 your 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 system element is
performing.
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
system
A quality system is a
network of processes made up of elements. Elements
include responsibilities, authorities, relationships, functions,
plans, policies, procedures, practices, processes, and resources.
The purpose of a quality system is to satisfy quality management
requirements and to assure that customers receive quality
products and services.
Quality
system element
Quality system elements
include responsibilities, authorities, relationships, functions,
plans, policies, procedures, practices, processes, and resources.
Quality system elements combine to form a quality system.
Quality
system requirement
A quality is a
characteristic. A system
is a set of interrelated elements. And a requirement
is an obligation. Therefore, a quality
system requirement is a characteristic that
a systemic element 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.
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 suppliers perform activities that
are oriented towards meeting customer needs.
Service
delivery
Service delivery is a
customer-oriented activity.
Service delivery activities are carried out by suppliers and are
oriented towards meeting customer needs.
Standard
Surprisingly, ISO does not seem to define the term standard
(or at least not in ISO 8402). Since they call every chapter or
publication a standard,
it may just mean that all their publications are standards,
by definition. However, we believe that ISO also uses the term standard
to suggest the concept of an expectation, obligation,
requirement, or norm that they want organizations to accept. In
addition, ISO seems to use the term standard
to refer to a way of being or doing things as in the phrase:
"this is the standard way we do this".
Subcontractor
According to ISO, a subcontractor
is an organization that provides you the contractor (supplier)
with a product. According to ISO, you are the supplier
(contractor) because you, in turn, supply products to your
customers. This may not be the way you use these terms.
Supplier
A supplier is an
organization that provides products 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.
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This web page was first published on May 25, 1997 |
This web page was updated on May 10, 1999 |
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Our website translates the ISO 9000, ISO 9001, ISO 9002, ISO 9003, ISO 9004, ISO 10011, and ISO 10013 standards into plain English. It also presents three ISO 9000 internal audit programs, and a quality system development plan.