AuditAn audit is a systematic evidence
gathering process. Audits must be Organizations use first party audits to audit
themselves. First party Second party audits are external audits.
They’re usually done by ISO also distinguishes between combined
audits and joint audits. |
Audit criteriaAudit criteria
are used as a reference point and include policies, |
Audit evidenceAudit evidence includes records,
factual statements, and other verifiable |
Audit findingsAudit findings result from a process
that evaluates audit evidence |
Audit programAn audit program (or programme)
refers to a set of one or more |
CharacteristicA characteristic is a distinctive
feature or property of something. |
CompetenceCompetence means being able to apply
knowledge and skill to |
ComplaintIn the context of ISO 9001, a complaint
refers to an expression of |
ConcessionA concession is a special approval that is
granted to release a |
ConformityConformity is the "fulfillment of a
requirement". To conform means |
Context of the organizationAn organization’s context is its
business environment. It includes An organization’s external context
includes all of the needs and ISO 9001 2015 expects you to consider your
organization’s |
Continual improvementContinual improvement is a set of
recurring activities that are carried |
ContractA contract is a binding agreement between two or more parties. |
CorrectionA correction is any action that is
taken to eliminate a nonconformity. |
Corrective actionCorrective actions are
steps that are taken to eliminate |
Counterfeit partA counterfeit part is
an unauthorized copy, imitation, substitute, or |
Critical itemItems are critical if
they have a major impact on the provision and |
CustomerA customer is anyone who receives
products or services (outputs) |
Customer satisfactionCustomer satisfaction is a
perception. It's also a question of degree. Since satisfaction is a perception, customers
may not be satisfied There are many ways to monitor and measure
customer satisfaction. |
DataThe term data is defined as any facts about an object. |
DefectA defect is a type of
nonconformity. It occurs when a product |
Design and developmentDesign and development is a process
(or a set of processes) that uses An object is any entity that is
either conceivable or perceivable. Objects
|
DeterminationTo determine means to find or to identify the value of a characteristic. |
Documented informationThe term documented
information refers to information
that Documented information includes
information about the management |
EffectivenessEffectiveness refers to the degree
to which a planned effect is achieved. |
FeedbackThe term feedback is used to refer
to a comment or an opinion |
FunctionA function is a role that is performed by a unit of an organization. |
ImprovementImprovement is a set of activities
that organizations carry out in |
InformationInformation is “meaningful data”.
While it's not entirely clear what the |
Information systemIn the context of this ISO 9001 standard, an
information system is |
InfrastructureThe term infrastructure refers to
the entire system of facilities, |
InnovationInnovation is a process that results
in a new or substantially changed |
Interested partyAn interested party
is anyone who can affect, be affected by, or |
Key characteristicA key characteristic is a feature
or an attribute that has a significant |
KnowledgeKnowledge is a collection of
information and a justified belief |
ManagementThe term management
refers to all the activities
that are used to |
Management systemA management system is a set of
interrelated or interacting elements There are many types of management
systems. Some of these include The scope or focus of a management
system could be restricted to |
MeasurementMeasurement is a process that is
used to determine |
Measuring equipmentMeasuring equipment
includes all the things needed to carry |
MonitoringTo monitor means to determine the
status of an activity, process, |
NonconformityNonconformity is a nonfulfillment or
failure to meet a requirement. |
ObjectAn object is any entity that is
either conceivable or
perceivable. |
ObjectiveAn objective is a result you intend
to achieve. Objectives can be Quality objectives are generally
based on or derived from an |
Objective audit evidenceObjective audit evidence is
information that is verifiable and |
Objective evidenceObjective evidence is data that
shows or proves that something |
OrganizationAn organization can be a single
person or a group that achieves its |
OutputAn output is the result of a
process. Outputs can be either tangible ISO 9001 lists four generic output
categories: services, software, |
OutsourceWhen an organization makes an arrangement with an outside |
PerformanceAccording to ISO, the term performance
refers to a measurable result. |
Performance indicatorA performance indicator (metric) is
a characteristic that is used to |
PolicyA policy
is a general commitment,
direction, or intention
and is |
ProcessA process is a set of activities
that are interrelated or that interact While processes usually transform
inputs into outputs, this Organizational
processes should be planned and
carried |
Process approachThe process approach is a
management strategy. When managers |
Process-based quality management systemA process-based quality management
system uses a process approach Each process uses
resources to transform inputs into outputs. |
ProductA product
is a tangible or intangible output that is the
result of a Products
can be tangible or intangible. According to a
note to |
Product safetyA product is safe
if it is able to perform to its designed or
intended |
ProviderA provider is a person or an
organization that supplies or provides |
QualityThe adjective quality applies to
objects and refers to the degree to The quality of an object can be
determined by comparing a set |
Quality managementQuality management
includes all the activities that organizations
|
Quality management systemA quality management system (QMS)
is a set of interrelated or |
Quality objectiveA quality objective is a quality
result that you intend to achieve. The adjective quality applies to
objects and refers to the degree to |
Quality policyA quality policy should express top
management's commitment to the ISO's quality management principles ask
you to focus on customers |
Regulatory requirementA regulatory requirement is an
obligation that is specified by |
ReleaseTo release means to grant permission
to proceed to the next stage |
RequirementA requirement is a need,
expectation, or obligation. It can be stated or There are many types of requirements. Some of
these include customer |
ReviewA review
is an activity. Its purpose is to figure out how
well the thing There are many kinds of reviews. Some of
these include management |
RiskAccording to ISO 9000, risk is the
“effect of uncertainty on an expected This definition recognizes that all of us
operate in an uncertain world. Uncertainty (or lack of certainty)
is a state or condition that involves While this definition argues that risk can be
positive as well as |
Risk-based thinkingRisk-based thinking
refers to a coordinated set of activities and While risk-based thinking is now an essential
part of the new |
ServiceA service
is an intangible output
and is the result of a process Service provision can take many
forms. Service can be provided |
Special requirementA special
requirement is a requirement that may be
especially Since there is
a risk that your organization may not be able to
meet a |
Statutory requirementA statutory requirement is defined by a legislative body and is obligatory. |
StrategyA strategy is a plan for achieving an objective. |
SupplierA supplier
is a person or an organization that provides products or Examples of suppliers include
organizations and people who produce, |
SystemA system
is defined as a set of interrelated or interacting elements. |
Top managementThe term top management normally
refers to the people at the top However, if the scope of a management system
covers only part |
TraceabilityTraceability is the ability to
identify and trace the history, distribution, |
ValidationValidation is a process. It uses
objective evidence to confirm that the There are several ways to confirm that the
requirements which define |
VerificationVerification is a process. It uses
objective evidence to confirm There are many ways to verify that
requirements have been met. |
* We've translated ISO and AS9100
quality management definitions into
plain English in order to make them easier to understand. Our plain definitions are primarily based on the formal definitions found in the ISO 9000 2015 standard and on the definitions added by AS9100D. But we also consider how AS9100D actually uses these terms. We’ve also defined several important terms that ISO 9001 2015 uses but doesn't formally define, terms that are, nevertheless, essential to a proper understanding of the new ISO 9001 standard. For example, ISO 9001 2015 uses the terms risk-based thinking, process approach, and process-based quality management system, but doesn’t formally define what these terms mean. We’ve addressed this shortcoming by considering how the standard uses these terms and by using other definitions to construct a new definition. |
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Updated on April 15, 2021. First published on August 15, 2017. |
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