|
|
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.
|
|
|
