ISO 9000 1994 DefinitionsTranslated into Plain English |
The following definitions are OBSOLETE.
Please see our ISO 9000 2005 DEFINITIONS.
The definitions presented here are loosely based on ISO 8402: 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
ISO 9001, 9002, and 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, 9002, and 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
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, or electrical in nature (this is not an
exhaustive list). 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 manifested in a product that is dependable. Dependability becomes a quality (characteristic) of the product (entity).
An entity could be 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.
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.
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 objectives and requirements, and to
explain how quality system requirements will be applied or
implemented.
Quality
plan
A quality plan explains how you intend to meet quality system
requirements.
Quality
policy
A quality policy statement defines the purpose or intent of your
quality system.
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 defined as 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 can be defined as a set of interrelated elements
whose purpose is to satisfy quality management requirements.
These elements include the responsibilities, authorities,
relationships, functions, processes, procedures, and resources
that are oriented towards quality.
Quality
system element
Quality system elements include responsibilities, authorities,
relationships, functions, policies, procedures, 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, equipment, technologies, and techniques.
Service
Service is a customer oriented result. This result is produced by
suppliers when they carry out 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 long-term corporate success by encouraging
employee participation, satisfying customer needs and
expectations, respecting societal values and beliefs, and obeying
governmental statutes and regulations.
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PRAXIOM RESEARCH GROUP
LIMITED Updated on January 3, 2012 |
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First published on June 5, 1997 at www.connect.ab.ca/~praxiom/defn.htm |
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