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lnterctatrronalstandard - ISO 9OOO
Qualrty fitnnagement systelns- EfirdaffLentals and
vocabubry
Fourth edition - 201 5-09-15
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Contents
Foreword
Introduction
Quality management systems -
Funda mentals and vocabulary
Scope
Fundamental concepts and quality
management principles
General
Fundamentaf concepts
Quality
Qua lity ma nagement system
Context of an organization
Interested parties
Support
Qua lity ma nagement principles
Customer focus
Leadership
Engagement of people
Process approach
lmprovement
Evidence-based decision making
Relationship ma nagement
Developing the QMS using fundamental
concepts and principles
QMS model
Development of a QMS
qMS standards, other management
systems and excellence models
Terms and definitions
Terms related to person or people
Terms related to organization
Terms related to activity
Terms related to process
Terms related to system
Terms related to requirement
Terms related to result
Terms related to data, information and
document
3.9 Terms related to customer
3.L0 Terms related to characteristic
3.L1 Terms retated to determination
3.LZ Terms related to action
3.13 Terms related to audit
- Annex A (infor.mative) Concept relationships and
their gra phica I representation
- Bibliography
- Alphabetical index of terms
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2.2
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2.2.2
2.2.3
2.2.4
2.2.5
2.3
2.3.L
2.3.2
2.3.3
2.3.4
2.3.5
2.3.6
2.3.7
2,4
2.4.L
2.4.2
2.4.3
3
3.L
3.2
3.3
3.4
3.5
3.6
3.7
3.8
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Foreword
ISO (the International Organization for
Standardization) is a worldwide federation of
national standards bodies (lSO member bodies).
The work of preparing International Standards is
normally carried out through ISO technical
committees. Each member body interested in a
subject for which a technical committee has been
established has the right to be represented on that
committee. International organizations,
governmental and non-governmental, in liaison
with lSO, also take part in the work.
ISO collaborates closely with the International
Electrotechnical Commission (lEC) on all matters of
electrotechnical standardization. The procedures
used to develop this document and those intended
for its further maintenance are described in the
ISO/IEC Directives, Part L. In particular the different
approval criteria needed for the different types of
ISO documents should be noted. This document
was drafted in accordance with the editorial rules
of the lso/lEc Directives Part 2 (see
www. iso. orgld i rectives )
Attention is drawn to the possibility that some of
the elements of this document may be the subject
of patent rights. ISO shall not be held responsible
for identifying any or all such patent rights. Details
of any patent rights identified during the
development of the document will be in the
Introduction and/or on the ISO list of patent
declarations received (see www.iso.org /patents).
Any trade name used in this document is
information given for the convenience of users and
does not constitute an endorsement.
For an explanation on the meaning of ISO specific
terms and expressions related to conformity
assessment, as well as information about ISO's
adherence to World Trade Organization (WTO)
principles in the Technical Barriers to Trade (TBT)
see the following U RL:
www. iso.orgliso'"eword. htm l.
The committee responsible for this document is
Technical Committee ISO/TC L76, Quality
management and quality assurance, Subcommittee
SC L, Concepts and terminology.
This fourth edition cancels and replaces the third
edition (lSO 9000:2005), which has been technically
revised.
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lntroduction
This International Standard provides the
fundamental concepts, principles and vocabulary
for quality management systems (aUS1 and
provides the foundation for other QMS standards.
This lnternational Standard is intended to help the
user to understand the fundamental concepts,
principles and vocabulary of quality management,
in order to be able to effectively and efficiently
implement a QMS and realize value from other
QMS standards.
This International Standard proposes a well-defined
QMS, based on a framework that integrates
established fundamental concepts, principles,
processes and resources related to quality, in order
to help organizations realize their objectives. lt is
applicable to all organizations, regardless of size,
complexity or business model. lts aim is to increase
an organization's awareness of its duties and
commitment in fulfilling the needs and
expectations of its customers and interested
parties, and in achieving satisfaction with its
products and services.
This lnternational Standard contains seven quality
management principles supporting the
fundamental concepts described in 2.2. In 2'3, for
each quality management principle, there is a
"statement" describing each principle, a "rationale"
explaining why the organization would address the
principle, "key benefits" that are attributed to the
principle, and "possible actions" that an
organization can take in applying the principle'
This International Standard contains the terms and
definitions that apply to all quality management
and QMS standards developed by ISO/[ C L76, and
other sector-specific QMS standards based on
those standards, at the time of publication. The
terms and definitions are arranged in conceptual
order, with an alphabetical index provided at the
end of the document. Annex A includes a set of
diagrams of the concept sYstems that form the
concept ordering.
NOTE Guidance on some additional frequently-
used words in the QMS standards developed by
ISO/IC L76, and which have an identified dictionary
meaning, is provided in a glossary available at:
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Quality management systems - Fundamentals and
1 Scope
This International Standard describes the
fundamental concepts and principles of quality
management which are universally applicable to the
following:
- organizations seeking sustained success through the
implementation of a quality management system;
- customers seeking confidence in an organization's
ability to consistently provide products and services
conforming to their requirements;
- organizations seeking confidence in their supply
chain that product and service requirements will be
met;
- organizations and interested parties seeking to
improve communication through a common
understanding of the vocabulary used in quality
management;
- organizations performing conformity assessments
against the requirements of ISO 9@1;
- providers of training, assessment or advice in
quality management;
- developers of related standards.
is International Standard specifies the terms and
definitions that appfy to all quality management and
quality management system standards developed by
rso/rc fi6.
2 Fundamental concepts and quality management
principles
2. L General
e quality management concepts and principles
described in this International Standard give the
organization the capacity to meet challenges
presented by an environment that is profoundly
different from recent decades. The context in which
an organization works today is characterized by
accelerated change, globalization of markets and the
emergence of knowledge as a principal resource. The
impact of quality extends beyond customer
satisfaction: it can also have a direct impact on the
organization's reputation.
Society has become better educated and more
demanding, making interested parties increasingly
more influential. By providing fundamental concepts
and principles to be used in the development of a
quality management system (QfUS1, this International
Standard provides a way of thinking about the
organization more broadly.
All concepts, principles and their interrelationships
should be seen as a whole and not in isolation of
each other.
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No individual concept or principle is more important
than another. At any one time, finding the right
balance in application is critical.
2.7 Funda menta I concepts
2.2.L Quality
An organization focused on quality promotes a
culture that results in the behavior, attitudes,
activities and processes that deliver value through
lfilling the needs and expectations of customers
and other relevant interested parties.
The quality of an organization's products and services
is determined by the ability to satisfy customers and
intended and unintended impact on relevant
interested parties.
quality of products and services includes not only
ir intended function and performance, but also
their perceived value and benefit to the customer.
ZI.Z Quality management system
A QMS comprises activities by which the organization
identifies its objectives and determines the processes
and resources required to achieve desired results.
The QMS manages the interacting processes and
resources required to provide value and realize
results for relevant interested parties,
The QMS enables top management to optimize the
use of resources considering the long and short-term
conseguences of their decision.
A QMS provides the means to identify actions to
address intended and unintended consequences in
providing products and services.
2.3 Context of an organization
Understanding the context of the organization is a
process. This process determines factors which
influence the organization's purpose, objectives and
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legal, technological, competitive, market, cultural,
social and economic environments.
Examples of the ways in which an organization's
purpose can be expressed include its vision, mission,
policies and objectives.
2.2.4 | nterested pa rties
The concept of interested parties extends beyond a
focus solely on the customer. lt is important to
consider all relevant interested parties.
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Part of the process for understanding the context of
the organization is to identify its interested parties.
The relevant interested parties are those that provide
significant risk to organizational sustainability if their
needs and expectations are not met.
Organizations define what results are necessary to
deliver to those relevant interested parties to reduce
that risk.
Organizations attract, capture and retain the support
of the relevant interested parties they depend upon
their success.
2.2.5 Support
2.2.5.L General
Top management support of the QMS and
engagement of people enables:
- provision of adequate human and other resources;
- monitoring processes and results;
-determining and evaluating of risks and
opportunities;
- i mplementing appropriate actions.
Responsible acquisition, deployment, maintenance,
enhancement and disposal of resources support the
rganization in achieving its obiectives.
2.2.5.2 People
People are essential resources within the
organization. The performance of the organization is
dependent upon how people behave within the
system in which they work. Within an organization,
people becorne engaged and aligned through a
common understanding of the quality policy and the
or ganization's desi red results.
2.2.5.3 Competence
A QMS is most effective when all employees
understand and apply the skills, training, education
and experience needed to perform their roles and
responsibilities. lt is the responsibility of top
management to provide opportunities for people to
develop these necessary competencies.
2.2.5.4 Awareness
Awareness is attained when people understand their
responsibilities and how their actions contribute to
achi evement of the orga n ization's objectives.
2.2.5.5 Communication
Planned and effective internal (i.e. throughout the
organization) and external (i.e. with relevant
interested parties) communication enhances people's
engagement and increased understanding of:
- the context of the organization;
- the needs and expectations of customers and other
relevant interested parties;
- the QMS.
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2.3 Quality management principles
2.3.L Customer focus
2.3.L.1 Statement
e primary focus of quality management is to meet
customer requirements and to strive to exceed
c ustomer expectati on s.
2.3.L.2 Rationale
Sustained success is achieved when an organization
attracts and retains the confidence of customers and
other interested parties. Every aspect of customer
interaction provides an opportunity to create more
value for the customer. Understanding current and
future needs of customers and other interested
parties contributes to the sustained success of the
organization.
2.3.L.3 Key benefits
Some potential key benefits are:
- increased customer value;
- i ncreased customer satisfaction;
- improved customer loyalty;
- enhanced repeat business;
- enhanced reputation of the organization;
- expanded customer base;
- increased revenue and market share.
2.3.L.4 Possi b le actions
Possible actions include:
- recognize direct and indirect customers as those
who receive value from the organization;
understand customers' current and future needs
nd expectations;
- link the organization's objectives to customer needs
and expectations;
communicate customer needs and expectations
roughout the organization;
- plan, design, develop, produce, deliver and support
products and services to meet customer needs and
expectations;
- measure and monitor customer satisfaction and
take appropriate actions;
- determine and take actions on interested parties'
needs and expectations that can affect customer
satisfaction;
- actively manage relationships with customers to
achieve sustained success.
2.3.2 Leadership
2.3.2.L Statement
Leaders at all levels establish unity of purpose and
direction and create conditions in which people are
engaged in achieving the organization's quality
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2.3.2.2 Rationale
Creation of unity of purpose and the direction and
engagement of people enable an organization to
align its strategies, policies, processes and resources
o achieve its objectives.
2.3.2.3 Key benefits
- increased effectiveness and efficiency in meeting
the organization's quality objectives;
better coordination of the organization's processes;
improved communication between levels and
functions of the organization;
development and improvement of the capability of
the organization and its people to deliver desired
results.
2.3.2.4 Possible actions
- eommunicate the organization's mission, vision,
strategy, policies and processes throughout the
organization;
- create and sustain shared values, fairness and
ethical models for behavior at all levels of the
organization;
- establish a culture of trust and integrity;
-encourage an organization-wide comrnitment to
quality;
- ensure that leaders at alf levels are positive
examples to people in the organization;
- provide people with the required resources, training
and authority to act with accountability;
- inspire, encourage and recognize the contribution of
people.
2.3.3 Engagement of people
2.3.3.1 Statement
Competent, empowered and engaged people at all
levels throughout the organization are essential to
enhance the organization's capability to create and
deliver value.
2.3.3.2 Rationale
In order to manage an organization effectively and
efficiently, it is important to respect and involve all
people at all levels. Recognition, empowerment and
enhancement of competence facilitate the
engagement of people in achieving the organization's
quality objectives.
- improved understanding of the organization's
quality objectives by people in the organization and
increased motivation to achieve them;
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- enhanced involvement of people in improvement
activities;
- enhanced personal development, initiatives and
creativity;
- enhanced people satisfaction;
- enhanced trust and collaboration throughout the
organization;
- increased attention to shared values and culture
throughout the organization.
2.3.3.4 Possi ble actions
-communicate with people to promote
understanding of the importance of their individual
contribution;
- promote collaboration throughout the organization;
- facilitate open discussion and sharing of knowledge
and experience;
-empower people to determine constraints to
performance and to take initiatives without fear;
-recognize and acknowledge people's contribution,
learning and improvement;
-enable self-evaluation of performance against
personal objectives;
- conduct surveys to assess people's satisfaction,
communicate the results and take appropriate
actions.
2.3.4 Process approach
2.3.4.L Statement
Consistent and predictable results are achieved more
effectively and efficiently when activities are
understood and managed as interrelated processes
that function as a coherent system.
2.3.4.2 Rationale
The QMS consists of interrelated processes.
Understanding how results are produced by this
system enables an organization to optimize the
system and its performance.
- enhanced ability to focus effort on key processes
and opportunities for improvement;
- consistent and predictable outcomes through a
system of aligned processes;
- optimized performance through effective process
managernent, efficient use of resources and reduced
cross-fu nctional ba rriers;
- enabling the organization to
interested parties related
effectiveness and efficiency,
confidence to
consistency,
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- define objectives of the system and processes
necessary to achieve them;
- estabfish authority, responsibirity and accountability
for managing processes;
the system as a whole;
- manage processes and their interrelations as a
system to achieve the organization's quality
objectives effectively and efficiently;
- ensure the necessary information is available to
operate and improve the processes and to monitor,
analyse and evaluate the performance of the overall
system;
- manage risks which can affect outputs of the
processes and overall outcomes of the eMS.
2.3.5 lmprovement
2.3.5.L Statement
successful organizations have an ongoing focus on
improvement.
2.3.5.2 Rationale
lmprovement is essential for an organization to
maintain current levels of performance, to react to
changes in its internal and external conditions and to
create new opportunities.
- improved process performance, organizational
capa bility and customer satisfaction;
- enhanced focus on root cause investigation and
determination, followed by prevention and-corrective
actions;
- enhanced ability to anticipate and react to internal
and external risks and opportunities;
- enhanced consideration of both incremental and
b rea khrough im p rovement;
- improved use of learning for improvement;
- enhanced drive for innovation.
- promote establishment of improvement objectives
at all levels of the organization;
- educate and train people at all levels on how to
apply basic tools and methodologies to achieve
i m provement objectives;
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-ensure people are competent to successfully
promote and complete improvement projects;
-develop and deploy processes to implement
i mprovement projects th roughout the orga n ization;
-track, review and audit the planning,
implementation, completion and results of
improvement projects;
-integrate improvement consideration into
development of new or modified products and
services and processes;
- recognize and acknowledge improvement.
2.3.6 Evidence-based decision making
2.3.6.1 Statement
Decisions based on the analysis and evaluation of
data and information are more likely to produce
desired resufts.
2.3.6.2 Rationale
Decision-making can be a complex process and it
always involves some uncertainty. lt often involves
multiple types and sources of inputs, as well as their
interpretation, which can be subjective. lt is
important to understand cause and effect
relationships and potential unintended
consequences. Facts, evidence and data analysis lead
to greater objectivity and confidence in decision
making.
Some potentiat key benefits are:
- irnproved decision-making processes;
- improved assessment of process performance and
ability to achieve objectives;
- improved operational effectiveness and efficiency;
- increased ability to review, challenge and change
opinions and decisions;
- increased ability to demonstrate the effectiveness
of past decisions.
- determine, measure and monitor key indicators to
demonstrate the organization's performance;
- make all data needed available to the relevant
people;
- ensure that data and information are sufficiently
accurate, reliable and secure;
- analyse and evaluate data and information using
suitable methods;
- ensure people are competent to analyse and
evaluate data as needed;
- make decisions and take actions based on evidence,
balanced with experience and intuition.
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2.3.7 Relationshi p management
2.3.7.L Statement
For sustained success, organizations manage their
relationships with interested parties, such as
providers.
2.3.7.2 Rationale
Relevant interested parties influence the
performance of an organization.
Sustained success is more likely to be achieved when
the organization manages relationships with all of its
interested parties to optimize their impact on its
performance. Relationship management with its
provider and partner networks is of particular
importance.
- enhanced performance of the organization and its
interested parties through responding to the
opportunities and constraints related to each
interested party;
- common understanding of objectives and values
among interested parties;
- increased capability to create value for interested
parties by sharing resources and competence and
managing quality related risks;
- a well-managed supply chain that provides a stable
ow of products and services.
2.3.7 .4 Possible actions
- determine relevant interested parties (such as
providers, partners, customers, investors, employees
or society as a whole) and their relationship with the
organization;
- determine and prioritize interested party
relationships that need to be managed;
- establish relationships that balance short-term gains
with long-term considerations;
- gather and share information, expertise and
resources with relevant interested parties;
- measure performance and provide performance
feedback to interested parties, as appropriate, to
enhance improvement initiatives;
- establish collaborative development and
improvernent activities with providers, partners and
other interested parties;
- encourage and recognize improvements and
achievements by providers and partners.
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2.4.L QMS model
2.4.L.L General
Organizations share many characteristics with
humans as a living and learning social organism. Each
is adaptive and comprises interacting systems,
processes and activities. In order to adapt to their
ing context, each needs the ability to change.
Organizations often innovate to achieve
breakthrough improvements. An organization's QMS
model recognizes that not all systernt processes and
activities can be predetermined; therefore, it needs
to be flexible and adaptable within the complexities
of the organizational context.
.4.L.2 System
Organizations seek to understand the internal and
external context to identifo the needs and
expectations of refevant interested parties. This
information is used in the development of the QMS
achieve organizational sustainability. The outputs
one process can be the inputs into other
processes and are interlinked into the overall
network. Although often appearing to be comprised
of similar processes, each organization and its QMS is
unique.
2.4.L.3 Processes
The organization has processes that can be defined,
measured and improved. These processes interact to
deliver results consistent with the organization's
objectives and cross functional boundaries. Some
processes can be critical while others are not.
Processes have interrelated activities with inputs to
deliver outputs.
2.4.L.4 Activity
People collaborate within a process to carry out their
daily activities. Some activities are prescribed and
depend on an understanding of the objectives of the
organization, while others are not and react to
ernal stimuli to determine their nature and
on.
2.4.2 Development of a QMS
A QMS is a dynamic system that evolves over time
through periods of improvement. Every organization
has quality management activities, whether they
have been formally planned or not.
s International Standard provides guidance on
how to develop a formal system to manage these
activities. lt is necessary to determine activities which
already exist in the organization and their suitability
regarding the context of the organization.
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This International Standard, along with ISO 9004 and
ISO 900L, can then be used to assist the organization
to develop a cohesive QMS.
A formal QMS provides a framework for planning,
executing, monitoring and improving the
performance of quality management activities. The
QMS does not need to be complicated; rather it
needs to accurately reflect the needs of the
organization. ln developing the QMS, the
fundamental concepts and principles given in this
International Standard can provide valuable
guidance.
QMS planning is not a singular event, rather it is an
ongoing process. Plans evolve as the organization
learns and circumstances change. A plan takes into
account all quality activities of the organization and
ensures that it covers all guidance of this
International Standard and requirements of ISO 900L.
T.lre plan is implemented upon approval.
It is important for an organization to regularly
monitor and evaluate both the implementation of
e plan and the performance of the QMS. Carefully
considered indicators facilitate these monitoring and
evaf uation activiti es.
Auditing is a means of evaluating the effectiveness of
the QMS, in order to identify risks and to determine
the fulfilment of requirements. In order for audits to
be effective, tangible and intangible evidence needs
o be collected. Actions are taken for correction and
improvement based upon analysis of the evidence
ered. The knowledge gained could lead to
innovation, taking QMS performance to higher levels.
2.4.3 QMS standards, other management systems
d excellence models
standards developed by ISO/TC L76, in other
management system standards and in organizational
excellence models are based on common principles.
all enable an organization to identify risks and
opportunities and contain guidance for improvement.
In the current context, many issues such as
innovation, ethics, trust and reputation could be
regarded as parameters within the QMS. Standards
related to quality management (e.g. ISO 9001),
environmental management {e.g. ISO 1,4001) and
energy management (e.g. ISO 50001), as well as
other management standards and organizationaf
excellence models, have addressed this.
The QMS standards developed by ISO/TC 175 provide
a comprehensive set of requirements and guidelines
for a QMS.
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ISO 9001 specifies requirements for a QMS. ISO 9004
provides guidance on a wide range of objectives of a
QMS for sustainable success and improved
performance.
Guidelines for components of a QMS include ISO
1.0001, tso L0002, tso 10003, tso 10004, tso 10009,
ISO 100L2 and ISO L90L1.
Guidelines for technicaf subjects in support of a QMS
include ISO 10005, ISO 10006, ISO 1@07, ISO L0014,
ISO 10015, ISO 10018 and ISO 10019.
Technical reports in support of a QMS include lSOffR
10013 and ISO/IR 1m17. Requirements for a QMS
are also provided in sector-specific standards, such as
rso/Ts r.6949.
various parts of an organization's management
system, including its QMS, can be integrated as a
single management system. The objectives, processes
and resources related to quality, growth, funding,
profitability, environment, occupational health and
safety, energy, security and other aspects of the
organization can be more effectively and efficiently
achieved and used when the QMS is integrated with
other management systems.
The organization can perform an integrated audit of
its management system against the requirements of
multiple lnternational Standards, such as ISO 9m1,
ISO 14001, ISO/IEC 27001 and ISO 5m01.
NOTE the ISO handbook 'The integrated use of
management system standards" can provide useful
guidance.
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3 Terms and definitions
3.1Terms related to person or people
3.L.1 Top management
person or group of people who directs and controls
an organization (3.2.L) at the highest level
Note 1 to entry: Top management has the power to
delegate authority and provide resources within the
organization.
Note 2 to entry: lf the scope of the management
system (3.5.3) covers only part of an organization,
then top management refers to those who direct and
control that part of the organization.
Note 3 to entry: This constitutes one of the common
terms and core definitions for ISO management
system standards given in Annex SL of the
Gonsolidated ISO Supplement to the ISO/IEC
Directives, Part 1.
3.L.2 Quality management system consultant
person who assists the organization (3.2.1) on quality
management system realization (3.4.3), giving advice
or information (3.S.2)
Note 1 to entry: The quafity management system
consultant can also assist in realizing parts of a
quality management system (3.5.4).
Note 2 to entry: ISO 1.0019:2005 provides guidance
on how to distinguish a competent quality
management system consultant from one who is not
competent.
[SOURCE: l5O 10019:2005, 3.2, modified]
3.1.3 Involvement
taking part in an activity, event or situation
3.L.4 Engagement
lnvolvement (3.1.3) in, and contribution to, activities
to achieve shared objectives (3.7.1)
3. 1.5 Configuration authority
Configuration control board
d isposition i ng a uthority
person or a group of persons with assigned
responsibility and authority to make decisions on the
configuration (3. L0.6 )
Note 1 to entry: Relevant interested parties (3.2.3)
within and outside the organization (3.2.1) should be
represented on the configuration authority.
ISOU RCE : ISO 10007 :2OO3, 3.8, modified]
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3.1.6 dispute resolver
<Customer satisfaction> individual person assigned by
a DRP-provider (3.2.71to assist the parties in resolving
a dispute (3.9.6)
EXAMPLE Staff, volunteer, contra ct (3.4.7) personnel.
[SOURCE: ISO 10003:2OO7, 3.7, modified]
3.2 Terms related to organization
3.2.I Organization
Person or group of people that has its own functions
with responsibilities, authorities and relationships to
achieve its objectives (3.7.1)
Note L to entry: The concept of organization
includes, but is not limited to, sofe-trader, company,
corporation, firm, enterprise, authority, partnership,
association (3.2.8li, charity or institution, or part or
c,ombination thereof, whether incorporated or not,
pUplic or private.
Consolidated ISO Supplement to the ISO/IEC
Directives, Part 1. The original definition has been
modified by modifying Note 1to entry.
3.2.2 context of the organization
combination of internal and external issues that can
have an effect on an organization's (3.2.L) approach
to developing and achieving its objectives (3.7.L|
Note 1 to entry: The organization's objectives can be
related to its products (3.7.6) and services (3.7.7),
investments and behavior towards its interested
parties (3.2.3).
Note 2 to entry: The concept of context of the
organization is equafly applicable to not-for-profit or
public service organizations as it is to those seeking
profits.
Note 3 to entry: In English, this concept is often
referred to by other terms such as "business
environmenf', "organizational environment'' or
"ecosystem of an organization".
Note 4 to entry: Understanding the infrastructure
(3.5.2) can help to define the context of the
organization.
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3.2.3lnterested party
Stakeholder
Person or organization (3.2.1) that can affect, be
affected by, or perceive itself to be affected by a
decision or activity
EXAMPLE Customers (3.2.41, owners, people in an
organization, providers (3.2.5), bankers, regulators,
unions, partners or society that can include
competitors or opposing pressure groups.
Note t to entry: This constitutes one of the common
modified by adding the Example.
3.2.4 Customer
Rerson or organization (3.2.1) that could or does
reeeive a product (3.7.6) or a service (3.7.71 that is
intended for or required by this person or
organization
EXAMPLE Consumer, client, end-user, retailer,
receiver of product or service from an internal
process (3.4.1), beneficiary and purchaser.
Note L to entry: A customer can be internal or
external to the organization.
3.2.5 Provider
Supplier
Organization (3.2.L) that provides a product (3.7.6) or
a service (3.7.71
EXAMPLE Producer, distributor, retailer or vendor of a
product or a service.
Note 1 to entry: A provider can be internal or external
to the organization.
Note 2 to entry: ln a contractual situation, a provider
is sometimes called "contractof .
3.2.6 Externa I provider
External supplier
Provider (3.2.5) that is not part of the organization
(3.2.1)
EXAMPLE Producer, distributor, retailer or vendor of a
product (3.7.6) or a service (3.7.71
3.2.7 DRP-provider
Dispute resol ution process provider
person or organization (3.2.1-) that supplies and
operates an external dispute (3.9.6) resolution
ocess 8.4.L
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Note 1 to entry: Generally, a DRP-provider is a legal
entity, separate from the organization or person as an
individual and the complainant. In this wov, the
attributes of independence and fairness are
emphasized.
In some situations, a separate unit is established
within the organization to handle unresolved
complaints (3.9.3).
Note 2 to entry: The DRP-provider contracts (3.4.7)
with the parties to provide dispute resolution, and is
accountable for performance (3.7.8). The DRP-
provider supplies dispute resolvers (3.1.6). The DRP-
provider also utilizes support, executive and other
managerial staff to supply financiaf resources, clericaf
support, scheduling assistance, training, meeting
rooms, supervision and similar functions.
Note 3 to entry: DRP-providers can take many forms
including not-for-profit, for-profit and public entities.
An association (3.2.8) can also be a DRP-provider.
Note 4 to entry: In l5O 10003:2ffi7 instead of the
term DRP-provider, the term "provider" is used.
[SOURCE: l5O 10003:2AA7, 3.9, modified]
3.2.8 Association
<Customer satisfaction> organization (3.2.t1
consisting of member organizations or persons
ISOURCE: ISO 100O3:2m7, 3.1J
3.2.9 Metrologica I fu nction
Functional unit with administrative and technical
responsibility for defining and implementing the
measurement management system (3.5.7)
[SOURCE: ISO LOOL2:2003, 3.6, modified]
3.3 Terms related to activity
3.3.1 improvement
activity to enhance performance (3.7.8)
Note L to entry: The activity can be recurring or
singular.
3.3.2 continua I i m provement
recurring activity to enhance performance (3.7.8)
Note 1 to entry: The process (3.4.1) of establishing
objectives (3.7.1) and finding opportunities for
improvement (3.3.1) is a continual process through
the use of audit findings (3.1-3.9) and audit
conclusions (3.L3.10), analysis of data (3.8.1),
management (3.3.3) reviews (3.tL.21 or other means
and generally leads to corrective action (3.L2.21 or
preventive action (3. 12. 1).
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3.3.3 management
coordinated activities to direct and controf an
organization (3.2.1)
Note L to entry: Management can include
estabf ishing policies (3.5.8) and objectives (3.7.L,
and processes (3.4.1)to achieve these objectives.
Note 2 to entry: The word "management" sometimes
refers to people, i.e. a person or group of people
with
authority and responsibility for the conduct and
control of an organization. When "management" is
Uqgd in this sense, it should always be used with
soine form of qualifier to avoid confusion with the
concept of "management'' as a set of activities
defined above. For example, "management shall..." is
deprecated whereas "top management (3.1.1)
shall..." is acceptable. Otherwise different words
should be adopted to convey the concept when
related to people, e.g. managerial or managers.
3.3.4 qua lity ma nagement
management (3.3.3) with regard to quality (3.6.2)
Note L to entry: Quality management can include
establishing quality policies (3.5.9) and quality
objectives (3.7.2), and processes (3.4.1) to achieve
these quality objectives through quality planning
(3.3.5), quality assurance (3.3.6), quality control
(3.3.7l1, and quality improvement (3.3.S).
3.3.5 quality planning
part of quality management (3.3.4) focused on
setting quality objectives (3.7.21 and specifying
necessary operational processes (3.4.L), and related
resources to achieve the quality objectives
Note 1to entry: Establishing quality plans (3.8.9) can
be part of quality planning.
3.3.6 quality assurance
part o-f quality management (3.3.4) focused on
providing confidence that quality requirements
(3.6.s) will be fulfilled
3.3.7 quality control
fulfi lling quality requirements (3. 6.5 )
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3.3.8 quality improvement
increasing the ability to fulfil quality requirements
(3.6.s)
Note L to entry: The quality requirements can be
ref ated to any aspect such as effectiveness (3.7.L1,1,
efficiency 8.7.10) or traceability (3.6.13).
3.3.9 configuration management
coordinated activities to direct and control
configuration (3. L0.6)
Note L to entry: Configuration management generally
concentrates on technical and organizational activities
that establish and maintain controf of a product
(3.7.61or service (3.7.7l,and its product configuration
information (3.6.8) throughout the life cycle of the
product.
ISOURCE: ISO 10007:2003, 3.6, modified - Note 1 to
entry has been modifiedl
3.3.10 change control
<configuration management> activities for control of
the output (3.7.5) after formal approval of its product
configuration information (3.6.8 )
ISOURCE: ISO 10007:2003, 3.1, modifiedJ
3.3.1.1 activity
<project management> smallest identified object of
work in a project (3.4.2)
ISOU RCE: ISO 10006:20O3, 3. 1, modifiedl
3.3.L2 project ma nagement
planning, organizing, monitoring (3.11.3), controlling
and reporting of all aspects of a project (3.4.21, and
the motivation of all those involved in it to achieve
the project objectives
ISOURCE: ISO 10005:2003, 3.61
3.3.13 configuration object
object (3.6.1) within a configuration (3.10.6) that
satisfies an end-use function
[SOURCE: ISO 10007:2003, 3.5, modified]
3.4 Terms related to process
3.4.L Process
Set of interrelated or interacting activities that use
inputs to deliver an intended result
Note 1 to entry: Whether the "intended result" of a
process is called output (3.7.5), product (3.7.6) or
service (3.7.71 depends on the context of the
reference
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Note 2 to entry: Inputs to a process are generally the
outputs of other processes and outputs or a process
are generally the inputs to other processes.
Note 3 to entry: Two or more interrelated and
interacting processes in series can also be referred to
as a process.
Note 4 to entry: processes in an organization ( )
are generally planned and carried out r
controlled conditions to add value.
3.4.2 Project
Unique process (3.4.L), consisting of a set of
coordinated and controrted activitiel with start and
dates, undertaken
conforming to spe
ng the constraints of
Note 1 to entry: An individual project can form part of
a farger Rloject structure and generalfy has a defined
start and finish date.
Note 2 to entry: In some projects the obiectives and
Note 3 to entry: The output (3. ) of a project can be
one or several units of product service.
Note 4 to entry: The project,s organization ( ) is
normally temporary and establishld for the me
of the project.
Note 5 to entry: The complexity of the interactions
a.mong project activities is not necessarify related to
the project size.
ISOURCE: ISO 10006:2003, 3.5, modified - Notes 1 to
3 have been modifiedl
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(ot-tlrtgu'.-!t-rtJF f fbtptil) t.te 1r.r jj+f e*#ilff..l{itf ?.ilabl,l
3.4.3 Quality management system realization
Process (3.4.L) of establishing, documenting,
implementing, maintaining and continually improving
a quality management system (3.5.a)
[SOURCE: ISO 10019:2005, 3.L, modified - Notes have
been deletedl
3.4.4 Competence acquisition
Process (3.4.L) of attaining competence (3.10.4)
[SOURCE: ISO 10018:2OLz, 3.2, modified]
3.4.5 Procedure
Specified way to carry out an activity or a process
(3.4.1)
Note 1 to entry: Procedures can be documented or
not.
3.4.6 Outsource (verb)
Nlake an arrangement where an external organization
(3.2.L) performs part of an organization's function or
process (3.4.1)
Note L to entry: An external organization is outside
the scope of the management system (3.5.3),
although the outsourced function or process is within
the scope.
Directives, Part 1.
3.4.7 Contract
Binding agreement
3.4.8 Design and development
Set of processes (3.4.1) that transform requirements
(3.6.4) for an object (3.6.1) into more detailed
requirements for that object
Note 1 to entry: The requirements forming input to
design and development are often the result of
research and can be expressed in a broader, more
general sense than the requirements forming the
output (3.7.5) of design and development. The
requirements are generally defined in terms of
characteristics (3.L0.1). In a project (3.4.21 there can
be several design and development stages.
Note 2 to entry: In English the words "design" and
"development" and the term "design and
development" are sometimes used synonymously and
sometimes used to define different stages of the
overall design and development.
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In French the words "conception" and
"development" and the term "conception et
development" are sometimes used synonymously and
sometimes used to define different stages of the
overal[ design and development.
Note 3 to entry: A qualifier can be applied to indicate
the nature of what is being designed and developed
(e.9. product (3.7.5) design and development, service
(3.7.7l,design and development or process design and
development).
3.5 Terms related to system
3.5.1 system
set of interrelated or interacting elements
3.5.2Infrastructure
<organization> system (3.5.1) of facilities, equipment
and services (3.7.71 needed for the operation of an
olganization (3.2.1)
3.5.3 Management system
Set of interrelated or interacting elements of an
organization (3.2.1) to establish policies (3.5.S) and
objectives (3.7.1), and processes (3.4.1) to achieve
those objectives
Note 1to entry: A management system can address a
single discipline or several disciplines, e.g. quality
management (3.3.4), financial management or
environmental management.
Note 2 to entry: The management system elements
establish the organization's structure, roles and
responsibilities, planning, operation, policies,
practices, rules, beliefs, objectives and processes to
achieve those objectives.
Note 3 to entry: The scope of a management system
can include the whole of the organization, specific
and identified functions of the organization, specific
and identified sections of the organization, or one or
more functions across a group of organizations.
modified by modifying Notes 1to 3 to entry.
3.5.4 Quality management system
part of a management system (3.5.3) with regard to
quality (3.6.2)
3.5.5 Work environment
set of conditions under which work is performed
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Note t to entry: Conditions can include physical,
social, psychological and environmental factors (such
as temperature, lighting, recognition schemes,
occupational stress, ergonomics and atmospheric
composition).
3.5.6 Metrological confirmation
set of operations required to ensure that measuring
equipment (3.11.6) conforms to the requirements
(3.6.4) for its intended use
Note 1 to entry: Metrological confirmation generally
includes calibration or verification (3.8.12), any
necessary adjustment or repair (3.L2.9l1, and
subsequent recalibration, comparison with the
metrological requirements for the intended use of the
equipment, as well as any required sealing and
labelling.
Note 2 to entry: Metrological confirmation is not
achieved until and unless the fitness of the measuring
equipment for the intended use has been
demonstrated and documented.
Note 3 to entry: The requirements for intended use
include such considerations as range, resolution and
maximum permissible errors.
Note 4 to entry: Metrological requirements are
usually distinct from, and are not specified in, product
(3.7 .6) requirements.
[SOURCE: ISO LOOL2:2003, 3.5, modified - Note 1 to
entry has been modifiedl
3.5.7 Measurement management system
set of interrelated or interacting elements necessary
to achieve metrological confirmation (3.5.6) and
control of measurement processes (3.11.5)
[SOURCE: ISO L0Ot2:2003, 3,1, modified]
3.5.8 Policy
<Organization> intentions and direction of an
organization (3.2.1) as formally expressed by its top
management (3.1.1)
Note L to entry: This constitutes one of the common
Directives, Part L.
3.5.9 Quality policy
policy (3.5.8) related to quality (3.5.2)
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Note L to entry: Generally, the quality policy is
consistent with the overall policy of the organization
(3.2.1-), can be aligned with the organization's vision
(3.5.10) and mission (3.5.11) and provides a
framework for the setting of quality objectives (3.7.2).
Note 2 to entry: Quality management (3.3.4)
principles presented in this International Standard can
form a basis for the establishment of a quality poticy.
3.5.L0 Vision
<Organization> aspiration of what an organization
(3.2.1) would like to become as expressed by top
management (3.1.1)
3.5.11 Mission
<Organization> organization's (3.2.1) purpose for
existing as expressed by top management (3.1.1)
3.5.12 Strategy
plan to achieve a long-term or overall objective (3.7.1)
3.5 Terms related to requirement
3.6.1 Object
Entity
Item
anything perceivable or conceivable
EXAMPLE Product (3.7.61, service (3.7.71, process
(3.4.1l1, person, organization (3.2.1), system (3.5.1),
resource.
Note L to entry: Objects can be material (e.g. an
engine, a sheet of paper, a diamond), immaterial
(e.g. conversion ratio, a project plan) or imagined
(e.g. the future state of the organization).
[SOURCE: ISO L087 - 1:2000, 3.t.t, modified]
3.6.2 Quality
degree to which a set of inherent characteristics
(3.10.1) of an object (3.6.1) fulfils requirements
(3.6.4)
Note 1 to entry: The term "quality" can be used with
adjectives such as poor, good or excellent.
Note 2 to entry: "lnherent", as opposed to
"assigned", means existing in the object (3.6.1).
3.6.3 Grade
category or rank given to different requirements
(3.6.4) for an object (3.6.1) having the same
functional use
EXAMPLE Class of airline ticket and category of hotel
in a hotel brochure.
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Note L to entry: When establishing a quality
requirement (3.6.5), the grade is generally specified.
3.6.4 Requirement
need or expectation that is stated, generally implied
or obligatory
Note 1 to entry: "Generally implied" means that it is
custom or common practice for the organization
(3.2.1) and interested parties (3.2.3) that the need or
expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that
is stated, for example in documented information
(3.8.6).
Note 3 to entry: A qualifier can be used to denote a
specific type of requirement, e.g. product (3.7.6)
requirement, quality management (3.3.4)
requirement, customer 13.2.41 requirement, quality
rbquirement (3.6.5).
Note 4 to entry: Requirements can be generated by
different interested parties or by the organization
itself.
Note 5 to entry: lt can be necessary for achieving
high customer satisfaction (3.9.2) to fulfil an
expectation of a customer even if it is neither stated
nor generally implied or obligatory.
Directives, Part L. The original definition has been
modified by adding Notes 3 to 5 to entry.
3.5.5 Quality requirement
requirement (3.6.4) related to quality (3.6.2)
3.5.5 Statutory requirement
obligatory requirement (3.6.4) specified by a
legislative body
3.6.7 Regulatory requirement
obligatory requirement (3.6.4) specified by an
authority mandated by a legislative body
3.5.8 Product configuratlon information
requirement (3.6.4) or other information for product
(3.7.6) design, realization, verification (3.8.12),
operation and support
[SOURCE: ISO LOOOT:2003, 3.9, modified]
3.6.9 Nonconformity
non-fulfilment of a requirement (3.6.4)
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Directives, Part 1.
3.6.10 Defect
nonconformity (3.6.9) related to an intended or
specified use
Note L to entry: The distinction between the
concepts defect and nonconformity is important as it
has legal connotations, particularly those associated
with product (3.7.61 and service (3.7.71 liability
issues.
Note 2 to entry: The intended use as intended by the
customer (3.2.a1can be affected by the nature of the
information (3.8.21, such as operating or
maintenance instructions, provided by the provider
(3.2.s).
g.6),rr Conformity
fulfilment of a requirement (3.6.4)
Note 1 to entry: In English the word "conformance"
is synonymous but deprecated. In French the word
"compliance" is synonymous but deprecated.
modified by adding Note 1. to entry.
3.6.L2 Capability
ability of an object (3.6.1) to realize an output (3.7.5)
that will fulfil the requirements (3.6.4) for that
output
Note 1 to entry: Process (3.4.L) capability terms in
the fiefd of statistics are defined in ISO 3534-2.
3.6.L3 Traceability
ability to trace the history, application or location of
an object (3.6.1)
Note 1 to entry: When considering a product (3.7.6)
or a service (3.7.7 ), traceability can relate to:
- the origin of materials and parts;
- the processing history;
- the distribution and location of the product or
service after delivery.
Note 2 to entry: In the field of metrology, the
definition in ISO/IEC Guide 99 is the accepted
deflnition.
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