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15.20

Definitions
The following are definitions of terms that can be useful when interpreting the ISO 9000
standards.

Accreditation - The act whereby a nationally recognized body approves an organization to
operate an audit and registration program.

Audit Standard - An authentic description of essential characteristics of audits, which
reflects current thought and practice.

Auditee - The organization being audited.

Auditing Organization - A unit or function that carries out audits through its employees.
This organization may be a department of the auditee, client or an independent third
party.

Capability - Ability to perform designated activities and to achieve results which
fulfill specified requirements.

Certification - The authoritative act of documenting compliance with agreed
requirements.

Certification Body - An impartial organization possessing the necessary competence to
operate a certification program.

Characteristic - A physical, chemical, visual functional or any other identifiable
property of a product or part or material.

Client - The person or organization requesting the audit. Depending on circumstances, the
client may be the auditing organization, the auditee or a third party.

Company - Term used primarily to refer to a business first party, the purpose of which is
to supply a product or service.

Compliance - A judgment that a product or service meets the requirements of a specific
standard.

Conformity - The fulfillment of specified requirements. Same as compliance.

Contract Review - The systematic activities carried out before signing the contract, to
ensure that requirements for quality are adequately defined, free of ambiguity,
documented and realizable by the supplier.

Contractor - The supplier.

Corrective Action - An action taken to eliminate the causes of an existing nonconformity,
defect, or other undesirable situation, to prevent recurrence.

The distinction between correction such as repair, rework or adjustment and corrective
action is that the former relates to the disposition of an existing nonconformity,
whereas, corrective action relates to the elimination of its causes.

Criticality - A relative measure of the consequences of a failure mode and its frequency
of occurrence.

Customer - Ultimate consumer, user, client, beneficiary or second party.

Defect - The non-fulfillment of intended usage requirements. The departure or absence of
one or more quality characteristics from intended usage requirements.

Degree of Demonstration - The extent to which evidence is produced to provide
confidence that specified requirements are fulfilled.

Dependability - The collective term used to describe the availability of performance and
its influencing factors: reliability, performance, maintainability performance and
maintenance support performance.

Dependability is used only for general descriptions in non-quantitative terms.
Dependability is a time-related aspect of quality.

Design Review - A formal, documented, comprehensive and systematic examination of a
design to evaluate the design requirements and the capability of the design to meet the
requirement for quality and to identify problems and propose solutions.

A design review can be conducted at any stage of the design process.

Design Specifications - A description of the physical and functional requirements for a
product. In its initial form, the design specification is a statement of functional
requirements with only general coverage of physical and test requirements. The design
specification evolves through the research & development phase to reflect progressive
refinements in performance, design, configuration and test requirements.

Design Transfer - The transfer of the design basis or baseline into specifications for
the product, its components, packaging, labeling, and the manufacturing and quality
assurance procedures, methods, specifications, etc., so that the product can be
produced using production methods.

Discrepancy - A failure to meet the specified requirement, supported by evidence (Also
can be called Nonconformance, Deficiency or Finding).

Disposition of Nonconformity - The action to be taken to deal with an existing non-
conforming condition in order to resolve the nonconformity.

Document - Something written or printed that gives information or proof of some fact; any
object used as evidence; to prove or support by means of documents.

Environment - The conditions, circumstances, influences and stresses surrounding and
affecting the product during manufacturing, storage, handling, transportation,
installation and use.

Failure - An event in which a previously acceptable product does not perform one or more
of its required functions within the specified limits under specified conditions.

Failure Analysis - The logical, systematic examination of an item, including its diagrams
or formulas, to identify and analyze the probability, causes and consequences of
potential and real failures.

Failure Cause - The physical or chemical process, design defect, quality defect,
component misapplication, or other processes which are the basic reason for failure or
which initiate the physical process by which deterioration proceeds to failure.

Failure Effect - The consequences a failure has on the operation, function, or status of
a product.

Failure Mode - The manner in which a failure is observed. The way a failure occurs and
its impact on the product performance.

Failure Mode and Effect Analysis - The process of identifying potential design weaknesses
through reviewing schematics, engineering drawings, etc., to identify basic faults at the
part/material level and determine their effect at finished or sub-assembly level on
safety and effectiveness.

Failure Pattern - The occurrence of two or more failures of the same component or feature
in identical or equivalent application, which are caused by the same basic failure
mechanism.

Fault Tree Analysis - The process of identifying potential design weaknesses using a
highly detailed logic diagram depicting basic faults and events that can lead to system
failure and/or safety hazard.

ISO - The International Organization for Standardization.

Lead Auditor - The individual appointed by the registration organization to be
responsible for the quality audit.

Management Review - A formal quality evaluation, by top management, of the status and
adequacy of the quality system in relation to quality policy and new objectives resulting
from changing circumstances.

Non-conformance - A condition of any product or component in which one or more
characteristics do not conform to requirements. Includes failures, deficiencies, defects
and malfunctions.

Organization - A company, corporation, firm, enterprise or institution, or part thereof
(whether incorporated or not, public or private) that has its own function(s) and
administration.

Organizational Structure - The set of formal and informal responsibilities, authorities
and relationships, arranged in a pattern, through which an organization performs its
functions.

Policy - A definite course or method of action to guide and determine present and future
decisions. It is a guide to decision making under a given set of circumstances within the
framework of corporate objectives, goals and management philosophies.

Preventive Action - An action taken to eliminate the causes of a potential nonconformity,
defect or other undesirable situation, to prevent occurrence.

Procedure - A particular way of accomplishing something, an established way of doing
things, a series of steps followed in a definite regular order. It ensures the consistent
and repetitive approach to actions.

Process - A set of interrelated resources and activities that transform inputs into
outputs with the aim of adding value. Resources include personnel, facilities, equipment,
technology, methodology and finances. The aim of adding value if quality related.

Product - The result of activities or processes. A product can be tangible or intangible,
or a combination of both.

Product Liability - A generic term used to describe the responsibility on a producer or
others to make restitution for loss related to personal injury, property damage or other
harm caused by a product or service. Liability is defined by law so that it may vary from
country to country according to national legislation.

Production Permit - A written authorization for a product, prior to its production, to
depart from originally specified requirements; also known as deviation.

Purchaser - The customer.

Qualification - A documented determination that a product (and its associated software),
component, packaging or labeling, meets all prescribed design and performance
requirements.

Quality - The composite of all the characteristics, including performance, of an item,
product or service that bear on its ability to satisfy stated or implied needs.

In a contractual environment, needs are specified, whereas, in other environments,
implied needs should be identified and defined. In many instances, needs can change with
time; this implies periodic revision of requirements for quality. Needs are usually
translated into characteristics with specified criteria.

Quality is sometimes referred to as "fitness for use", "customer satisfaction",
or "conformance to the requirements."

Quality Assurance - A planned and systematic pattern of all actions necessary to provide
adequate confidence that the product, its components, packaging and labeling are
acceptable for their intended use.

Quality Audit - A systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve objectives.

The quality audit typically applies, but is not limited to a quality system or elements
thereof, to processes, to products, or to services. Such audits are often called "quality
system audit", "process quality audit", "product quality audit" or "service quality
audit."

Quality audits are carried out by staff not having direct responsibility in the areas
being audited but preferably, working in cooperation with the relevant personnel.

One purpose of a quality audit is to evaluate the need of improvement or corrective
action. An audit should not be confused with surveillance or inspection activities
performed for the purpose of process control or product acceptance.

Quality audits can be conducted for internal or external purposes.

Quality Audit Observation - A statement of fact made during quality audit and
substantiated by objective evidence.

Quality Auditor - A person who has the qualification status to perform quality audits.

Quality Control - The operational techniques and activities that are used to fulfill
requirements for quality. All that is done to be sure that the product is what it should
be.

Quality control involves operational techniques and activities aimed both at monitoring a
process and at eliminating causes of unsatisfactory performance at all stages of the
organization's operation in order to result in economic effectiveness.

Quality Document - A document that contains either requirements for quality system
elements for products or services. The results of activities such as inspections or
quality audits.

Quality Evaluation - A systematic examination of the extent to which an entity (part,
product, service or organization) is capable of meeting specified requirements. A quality
evaluation may be used to determine supplier quality capability. In this case, the result
of quality evaluation may be used for qualification, approval, and registration or
accreditation purposes.

A quality evaluation examines potential quality capability, whereas, a quality audit
additionally examines effective implementation.

Quality Improvement - The actions taken to increase the value to the customer by
improving the effectiveness and efficiency of processes and activities throughout the
organizational structure.

Quality Losses - The losses caused by not realizing the optimum potential of resources in
processes and activities.

Some examples of quality losses are the loss of customer satisfaction, loss of
opportunity to add customer value, loss to the organization or society, as well as waste
of resources and materials.

Quality Management - All activities of the overall management function that determine
the quality policy, objectives and responsibilities, and implements them by means such
as quality planning, quality control, quality assurance and quality improvement. The
responsibility for quality management belongs to all levels of management but must be
driven by top management. Its implementation involves all members of the organization.

Quality Manual - A document stating the quality policy and describing the quality
system of an organization. A quality manual may relate to the totality of an
organizations activities or only to a part of it.

A quality manual will normally contain, or refer to, the quality policy, the
responsibilities, authorities and interrelationships of personnel who manage, perform,
verify or review work affecting quality, the quality system procedures and instruction,
a statement for reviewing, updating and controlling the manual.

A quality manual can vary in depth and format to suit the needs of an organization. It
may be comprised of more than one document in some instances. When its only purpose is
for demonstration, it may be called a quality assurance manual.

Quality Plan - A document setting out the specific quality practices, resources and
sequence of activities relevant to a particular product, project or contract.

A quality plan pertaining to a specific application usually references the quality
manual.

Quality Policy - The overall quality intentions and direction of an organization
regarding quality, as formally expressed by top management.

Quality Requirements - A translation of customer needs into a set of quantitatively or
qualitatively stated requirements for the characteristics of a product or service to
enable its realization and examination. The requirements for quality should be initially
expressed in functional terms and documented.

Quality System - The organizational structure, responsibilities, procedures, processes
and resources for implementing quality management.

The quality system should only be as comprehensive as needed to meet the quality
objectives. The quality system of an organization is designed primarily to satisfy the
internal requirements of the organization and is not limited to the quality assurance
requirements of a particular customer. For contractual or mandatory quality assessment
purposes, demonstration of the implementation of identified elements of the quality
system may be required.

Record - A document that furnishes objective evidence of activities performed or of
results achieved.

A quality record provides objective evidence of the extent of the fulfillment of the
requirement for quality or the effectiveness of the operation of a quality system
element. Some of the purposes of quality records are demonstration, traceability and
corrective actions. A record can be written or stored on any data medium.

Registration - Formal verification by an accredited body that an organization has been
audited and shown to comply with ISO 9000.

Reliability - The characteristic of a product, or any component thereof, expressed as a
probability that it would perform its required functions under defined conditions for
specified operating periods.

Reliability Assessment - A quantitative assessment of the reliability of a product,
system or portion thereof. Such assessments usually employ mathematical modeling,
directly applicable results of tests on the product, failure data, estimated reliability
figures, and non-statistical engineering estimates.

Self-Inspection - Inspection of the work performed, by the performer of that work,
according to specified rules. Self-inspection is used for process control by the
operator.

Service - The results generated by activities at the interface between the supplier and
the customer and by supplier internal activities, to meet the customer requirements.

Delivery or use of tangible products may form part of the service. A service may be
linked with the manufacture and supply of tangible products.

Severity - The consequences of a failure mode. Severity considers the worst potential
consequences of a failure, determined by the degree of injury.

Specification - Documented detailed requirements with which a product or service has to
comply.

Subcontractor - The organization that provides a product or service to the supplier.
Same as sub-supplier.

System - The principal functioning entities comprising the product, e.g. hardware,
software. Also an organized and disciplined approach to accomplish a task, e.g., a
failure reporting system.

Testing - The determination by technical or scientific means of the properties or
elements of a product or its components, including functional operation, and involving
the application of established scientific principles and procedures.

Traceability - The ability to trace the history, application or location of a product
and, in some cases, service by means of recorded identifications.

Traceability may refer to: a product, a calibration and its relationship to the measuring
equipment and the national or international standards, primary standards, basic physical
constants, properties or references materials. Traceability requirements should be
specified for some stated period of history or to some point of origin.

Validated - The state of being confirmed by examination and provision of objective
evidence that the particular requirements for a specific intended use have been met.

Validation is normally performed on the final product under defined operating
conditions, and when necessary, performed in earlier production stages. Multiple
validations may be carried out if there are different intended uses.

Verification - Confirmation by examination and provision of objective evidence that
specified requirements have been met.

In design and development, verification concerns the process of examining the results of
a given activity to determine conformity with the input requirement for that activity.

Waiver - A written authorization to release a product which does not conform to the
specified requirement. Also called concession.