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Indian Standard
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Quality Management Systems —

Fundamentals and Vocabulary
( Fourth Revision )
ICS 03.120.10
© BIS 2016
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BUREAU OF INDIAN STANDARDS
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MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI-110002
www.bis.org.in www.standardsbis.in
January 2016 Price Group 14

Quality Management Sectional Committee, MSD 02
NATIONAL FOREWORD
This Indian Standard (Fourth Revision) which is identical with ISO 9000 : 2015 ‘Quality management
systems — Fundamentals and vocabulary’ issued by the International Organization for Standardization
(ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Quality Management
Sectional Committee and approval of the Management and Systems Division Council.
This standard was first published in 1988 and subsequently revised in 1994, 2000 and 2005. This
standard is being revised again for adoption of ISO 9000 : 2015 version.
The text of ISO Standard has been approved as suitable for publication as an Indian Standard without
deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention
is particularly drawn to the following:
Wherever the words ‘International Standard’ appear referring to this standard, they should be read as
‘Indian Standard’.
Annex A of this standard is for information only.
IS/ISO 9000 : 2015
Indian Standard
QUALITY MANAGEMENT SYSTEMS —
FUNDAMENTALS AND VOCABULARY
( Fourth Revision )
1 Scope

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— organizations and interested parties seeking to improve communication through a common

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2 Fundamental concepts and quality management principles
2.1 General

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accelerated change, globalization of markets and the emergence of knowledge as a principal resource.

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organization’s reputation.

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All concepts, principles and their interrelationships should be seen as a whole and not in isolation of

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the right balance in application is critical.
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2.2 Fundamental concepts
2.2.1 Quality
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relevant interested parties.

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and the intended and unintended impact on relevant interested parties.

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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
consequences of their decision.
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providing products and services.
2.2.3 Context of an organization
Understanding the context of the organization is a process. This process determines factors which
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values, culture, knowledge and performance of the organization. It also considers external factors such
as legal, technological, competitive, market, cultural, social and economic environments.
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those relevant interested parties to reduce that risk.
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upon for their success.
2.2.5 Support
2.2.5.1 General
Top management support of the QMS and engagement of people enables:

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— implementing appropriate actions.
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People are essential resources within the organization. The performance of the organization is

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Within an organization, people become engaged and aligned through a common understanding of the

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Awareness is attained when people understand their responsibilities and how their actions contribute

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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:

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— the QMS.
2.3 Quality management principles
2.3.1 Customer focus
2.3.1.1 Statement

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customer expectations.
2.3.1.2 Rationale

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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.

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— increased revenue and market share.
2.3.1.4 Possible actions
Possible actions include:

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— plan, design, develop, produce, deliver and support products and services to meet customer needs

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2.3.2.1 Statement
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— create and sustain shared values, fairness and ethical models for behaviour at all levels of the

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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

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all people at all levels. Recognition, empowerment and enhancement of competence facilitate the

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— communicate with people to promote understanding of the importance of their individual

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2.3.4.1 Statement
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— manage risks which can affect outputs of the processes and overall outcomes of the QMS.
2.3.5 Improvement
2.3.5.1 Statement
Successful organizations have an ongoing focus on improvement.
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2.3.5.2 Rationale
Improvement 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.

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2.3.6 Evidence-based decision making
2.3.6.1 Statement
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2.3.6.2 Rationale
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— make decisions and take actions based on evidence, balanced with experience and intuition.
2.3.7 Relationship management
2.3.7.1 Statement
For sustained success, organizations manage their relationships with relevant interested parties, such
as providers.
2.3.7.2 Rationale
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to optimize their impact on its performance. Relationship management with its provider and partner
networks is of particular importance.

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— measure performance and provide performance feedback to interested parties, as appropriate, to

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2.4.1 QMS model
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2.4.1.2 System
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expectations of relevant interested parties. This information is used in the development of the QMS

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processes and are interlinked into the overall network. Although often appearing to be comprised of
similar processes, each organization and its QMS is unique.
2.4.1.3 Processes

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processes can be critical while others are not. Processes have interrelated activities with inputs to
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external stimuli to determine their nature and execution.
2.4.2 Development of a QMS
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the context of the organization. This International Standard, along with ISO 9004 and ISO 9001, 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

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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

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ensures that it covers all guidance of this International Standard and requirements of ISO 9001. The
plan is implemented upon approval.

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evaluation activities.
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of the evidence gathered. The knowledge gained could lead to innovation, taking QMS performance to
higher levels.
2.4.3 QMS standards, other management systems and excellence models

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standards and organizational excellence models, have addressed this.

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3.1.1
top management
person or group of people who directs and controls an organization (3.2.1) at the highest level
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quality management system consultant
person who assists the organization (3.2.1) on quality management system realization (3.4.3), giving
advice or information (3.8.2)
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organization
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context of the organization
combination of internal and external issues that can have an effect on an organization’s (3.2.1) approach
to developing and achieving its objectives (3.7.1)
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supplier
organization (3.2.1) that provides a product (3.7.6) or a service (3.7.7)
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external supplier
provider (3.2.5) that is not part of the organization (3.2.1)
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3.2.7
DRP-provider
dispute resolution process provider
person or organization (3.2.1) that supplies and operates an external dispute (3.9.6) resolution
process (3.4.1)
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improvement

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management (3.3.3) with regard to quality (3.6.2)
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quality planning
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project management
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process
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quality management system realization
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make an arrangement where an external organization (3.2.1) performs part of an organization’s
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3.5.1
system
set of interrelated or interacting elements
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3.5.2
infrastructure
<organization> system (3.5.1) of facilities, equipment and services (3.7.7) needed for the operation of an
organization (3.2.1)
3.5.3
management system
set of interrelated or interacting elements of an organization (3.2.1) to establish policies (3.5.8) and
objectives (3.7.1), and processes (3.4.15

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quality management system
part of a management system (3.5.3) with regard to quality (3.6.2)
3.5.5
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set of conditions under which work is performed
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set of operations required to ensure that measuring equipment (3.11.6) conforms to the requirements
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3.5.8
policy
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policy (3.5.8) related to quality (3.6.2)
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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).
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mission
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3.5.12
strategy
plan to achieve a long-term or overall objective (3.7.1)
3.6 Terms related to requirement

3.6.1
object

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requirement

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interested parties (3.2.3) that the need or expectation under consideration is implied.
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quality requirement
requirement (3.6.4) related to quality (3.6.2)
3.6.6
statutory requirement
requirement (3.6.45
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3.6.7
regulatory requirement
requirement (3.6.45
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3.6.8
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requirement (3.6.4) or other information for product (3.7.6) design, realization,
(3.8.12),
operation and support
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nonconformity
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defect
nonconformity (3.6.95

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product (3.7.6) and service (3.7.75
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information (3.8.25(

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3.6.11
conformity
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IS/ISO 9000 : 2015
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capability
object (3.6.1) to realize an output (3.7.55 !
requirements (3.6.4) for that output
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traceability

( object (3.6.1)
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dependability

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innovation
new or changed object (3.6.1) realizing or redistributing value
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3.7.1
objective
result to be achieved
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(organization (3.2.1)-wide, project
(3.4.2), product (3.7.6) and process (3.4.1)).
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operational criterion, as a quality objective (3.7.25

2
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goal, or target).
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organization (3.2.1), consistent with the quality policy (3.5.95(

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IS/ISO 9000 : 2015
3.7.2
quality objective
objective (3.7.1) related to quality (3.6.2)
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organization’s (3.2.1) quality policy (3.5.9).
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processes (3.4.1) in
the organization (3.2.1).
3.7.3
success
<organization> achievement of an objective (3.7.1)
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!

interested parties (3.2.3), such as customers (3.2.4), users,

investors/shareholders (owners), people in the organization, providers (3.2.5), partners, interest groups and
communities.
3.7.4
sustained success
<organization> success (3.7.3) over a period of time
6
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organization (3.2.1) and those of the social and ecological environment.
6
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(3.2.4), owners, people in an organization, providers (3.2.55(
( (

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output
result of a process (3.4.1)
6
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organization (3.2.1) is a product (3.7.6) or a service (3.7.7) depends
on the preponderance of the characteristics (3.10.15
(
--

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receiving an order and serving a hamburger ordered in a restaurant is part of a service.
3.7.6
product
output (3.7.5) of an organization (3.2.15

between the organization and the customer (3.2.4)
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provider (3.2.5) and customer, but can often involve this service (3.7.75

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characteristic (3.10.152
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materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware
and processed materials are often referred to as goods. Software consists of information (3.8.2) regardless of

2
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service
output (3.7.5) of an organization (3.2.15

organization and the customer (3.2.4)
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requirements (3.6.45

banks, accountancies or public organizations, e.g. schools or hospitals.
21
IS/ISO 9000 : 2015
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product (3.7.652
--

5

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information (3.8.2) in the context of knowledge
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performance
measurable result
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management (3.3.3) of activities (3.3.11), processes (3.4.1), products
(3.7.6), services (3.7.7), systems (3.5.1) or organizations (3.2.1).
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risk

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information (3.8.2) related to, understanding
or knowledge of, an event, its consequence, or likelihood.
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relationship between the result achieved and the resources used
3.7.11
effectiveness
extent to which planned activities are realized and planned results are achieved
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IS/ISO 9000 : 2015
3.8 Terms related to data, information and document

3.8.1
data
facts about an object (3.6.1)
3.8.2
information
meaningful data (3.8.1)
3.8.3
objective evidence
data (3.8.15

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records (3.8.10),
statements of fact or other information (3.8.2) which are relevant to the audit criteria (3.13.75
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information system

organization (3.2.1)
3.8.5
document
information (3.8.2) and the medium on which it is contained
EXAMPLE Record (3.8.10),
(3.8.7), procedure document, drawing, report, standard.
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sample, or combination thereof.
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and for records (e.g. the requirement to be retrievable).
3.8.6
documented information
information (3.8.25

organization (3.2.1) and the medium
on which it is contained
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— the management system (3.5.3), including related processes (3.4.15

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document (3.8.5) stating requirements (3.6.4)
EXAMPLE Quality manual (3.8.8), quality plan (3.8.9), technical drawing, procedure document, work
instruction.
23
IS/ISO 9000 : 2015
6
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2
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(process (3.4.15
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and test (3.11.85
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3.8.8
quality manual

(3.8.7) for the quality management system (3.5.4) of an organization (3.2.1)
6
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organization (3.2.1).
3.8.9
quality plan

(3.8.7) of the procedures (3.4.55

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(3.4.1) and to product (3.7.6) and service (3.7.7) realization processes.
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quality manual (3.8.8) or to procedure
documents (3.8.5).
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quality planning (3.3.5).
3.8.10
record
document (3.8.5) stating results achieved or providing evidence of activities performed
6
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traceability (3.6.13) and to provide evidence of

(3.8.12), preventive action (3.12.1) and corrective action (3.12.2).
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project management plan
document (3.8.55

objective(s) (3.7.1) of the project (3.4.2)
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objective evidence (3.8.35(
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inspection (3.11.7) or of
other forms of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
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IS/ISO 9000 : 2015
3.8.13
validation
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objective evidence (3.8.3), that the requirements (3.6.4) for a

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test (3.11.8) or other form of
determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
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formalized recording and reporting of

(3.6.8), the status of proposed
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3.9.1
feedback
<customer satisfaction> opinions, comments and expressions of interest in a product (3.7.6), a service
(3.7.7) or a complaints-handling process (3.4.1)
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customer satisfaction
customer’s (3.2.45

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customer in question, until the product (3.7.6) or service (3.7.75

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complaint
<customer satisfaction> expression of dissatisfaction made to an organization (3.2.1), related to its
product (3.7.6) or service (3.7.7), or the complaints-handling process (3.4.1) itself, where a response or

/
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25
IS/ISO 9000 : 2015
3.9.4
customer service
interaction of the organization (3.2.1) with the customer (3.2.45

product
(3.7.6) or a service (3.7.7)
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customer satisfaction code of conduct
promises, made to customers (3.2.45organization (3.2.1) concerning its behaviour, that are aimed
at enhanced customer satisfaction (3.9.2) and related provisions
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(3.8.2), and complaints (3.9.3) handling procedures (3.4.5).
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<customer satisfaction> disagreement, arising from a complaint (3.9.3), submitted to a DRP-provider
(3.2.7)
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3.10.1
characteristic
distinguishing feature
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5
f) functional (e.g. maximum speed of an aircraft).
3.10.2
quality characteristic
inherent characteristic (3.10.1) of an object (3.6.1) related to a requirement (3.6.4)
6
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26
IS/ISO 9000 : 2015
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human factor
characteristic (3.10.1) of a person having an impact on an object (3.6.1) under consideration
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3.10.4
competence

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characteristic (3.10.15!

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characteristics (3.10.1) of a product (3.7.6) or service (3.7.75
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approved

(3.6.8) that establishes the characteristics (3.10.1) of a
product (3.7.6) or service (3.7.7) at a point in time that serves as reference for activities throughout the

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3.11.1
determination
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characteristics (3.10.1) and their characteristic values
3.11.2
review
determination (3.11.15
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ffectiveness (3.7.11) of an object (3.6.1) to achieve
established objectives (3.7.1)
EXAMPLE Management review, design and development (3.4.8) review, review of customer (3.2.4)
requirements (3.6.4), review of corrective action (3.12.2) and peer review.
6
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(3.7.10).
27
IS/ISO 9000 : 2015
3.11.3
monitoring
determining (3.11.1) the status of a system (3.5.1), a process (3.4.1), a product (3.7.6), a service (3.7.7),

6
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measurement
process (3.4.1) to determine a value
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measurement process

3.11.6
measuring equipment

(
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measurement process (3.11.5)
3.11.7
inspection
determination (3.11.1) of conformity (3.6.115
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(3.8.12).
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test
determination (3.11.1) according to requirements (3.6.45
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conformity (3.6.11), it can be used for purposes of validation (3.8.13).
3.11.9
progress evaluation
<

project (3.4.2) objectives
(3.7.1)
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processes (3.4.15(

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product (3.7.6) or service (3.7.7).
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project management plan (3.8.11).
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28
IS/ISO 9000 : 2015
3.12 Terms related to action

3.12.1
preventive action
action to eliminate the cause of a potential nonconformity (3.6.9) or other potential undesirable situation
6
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prevent recurrence.
3.12.2
corrective action
action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence
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correction
action to eliminate a detected nonconformity (3.6.9)
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corrective action (3.12.2).
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3.12.4
regrade
alteration of the grade (3.6.3) of a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) in order to
make it conform to requirements (3.6.4) differing from the initial requirements
3.12.5
concession
permission to use or release (3.12.7) a product (3.7.6) or service (3.7.75

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(3.6.9) characteristics (3.10.15
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deviation permit

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requirements (3.6.4) of a product (3.7.6) or service
(3.7.7) prior to its realization
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release
permission to proceed to the next stage of a process (3.4.1) or the next process
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29
IS/ISO 9000 : 2015
3.12.8
rework
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it conform to the
6
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repair
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it acceptable for the intended
use
6
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product or service conform to the requirements (3.6.45-
<
concession
(3.12.5) is required.
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for use, for example as part of maintenance.
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scrap
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.75

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3.13.1
audit

(

process (3.4.1) for obtaining objective evidence (3.8.3) and
<

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audit criteria (3.13.75
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(3.6.11) of an object (3.6.1) according to a procedure (3.4.55

<

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and it can be a combined audit (3.13.2) or a joint audit (3.13.3).
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organization (3.2.1) itself for management (3.3.3) review (3.11.2) and other internal purposes, and can form the
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IS/ISO 9000 : 2015
3.13.2
combined audit
audit (3.13.1) carried out together at a single auditee (3.13.12) on two or more management systems (3.5.3)
6
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organization (3.2.1).
3.13.3
joint audit
audit (3.13.1) carried out at a single auditee (3.13.125
organizations (3.2.1)
3.13.4
audit programme
set of one or more audits (3.13.15

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audit scope
extent and boundaries of an audit (3.13.1)
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audit plan
description of the activities and arrangements for an audit (3.13.1)
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audit criteria
set of policies (3.5.8), procedures (3.4.5) or requirements (3.6.4) used as a reference against which
objective evidence (3.8.3) is compared
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audit evidence
records, statements of fact or other information, which are relevant to the audit criteria (3.13.7)

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results of the evaluation of the collected audit evidence (3.13.8) against audit criteria (3.13.7)
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improvement (3.3.1) or recording
good practices.
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audit criteria (3.13.7) are selected from statutory requirements (3.6.6) or
regulatory requirements (3.6.75(
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31
IS/ISO 9000 : 2015
3.13.10
audit conclusion
outcome of an audit (3.13.15(

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(3.13.9)
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audit client
organization (3.2.1) or person requesting an audit (3.13.1)
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auditee
organization (3.2.1) being audited
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auditee (3.13.12) to assist the audit team (3.13.14)
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audit team
one or more persons conducting an audit (3.13.15(

technical experts (3.13.16)
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auditor
person who conducts an audit (3.13.1)
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technical expert

!

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audit team (3.13.14)
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to be audited, or language or culture.
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auditor (3.13.15) in the audit team (3.13.14).
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observer
<audit> person who accompanies the audit team (3.13.14) but does not act as an auditor (3.13.15)
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who witnesses the audit (3.13.1).
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32
IS/ISO 9000 : 2015
Annex A
(informative)
Concept relationships and their graphical representation
A.1 General

(

species and describing the characteristics that distinguish it from its parent or sibling concepts.

/

2
Clause A.2),
partitive (see Clause A.3) and associative (see Clause A.4).
A.2 Generic relation

and contain descriptions of these characteristics which distinguish them from the superordinate (parent)
and coordinate (sibling) concepts, e.g. the relation of spring, summer, autumn and winter to season.
X

2
Figure A.1).
Example adapted from ISO 704:2009, (5.5.2.2.1)
Figure A.1 — Graphical representation of a generic relation
A.3 Partitive relation

(
--
(
(

!

- (

!

2

5
-
>

2
Figure A.2).
Example adapted from ISO 704:2009, (5.5.2.3.1)
Figure A.2 — Graphical representation of a partitive relation
A.4 Associative relation

Associative relations cannot provide the economies in description that are present in generic and

33
IS/ISO 9000 : 2015

(
--

( (
(
function, material and product.
7

2
Figure A.3).
Example adapted from ISO 704:2009, (5.6.2)
Figure A.3 — Graphical representation of an associative relation
A.5 Concept diagrams

Figures A.4 to A.16 show the concept diagrams on which the thematic groupings of Clause 3 are based.

!

(

Clause 3
-
Figure A.4 — 3.1 Concepts of the class “person or people” and related concepts
34
IS/ISO 9000 : 2015
Figure A.5 — 3.2 Concepts of the class “organization” and related concepts
35
IS/ISO 9000 : 2015
Figure A.6 — 3.3 Concepts of the class “activity” and related concepts
36
IS/ISO 9000 : 2015
Figure A.7 — 3.4 Concepts of the class “process” and related concepts
37
IS/ISO 9000 : 2015
Figure A.8 — 3.5 Concepts of the class “system” and related concepts
38
IS/ISO 9000 : 2015
Figure A.9 — 3.6 Concepts of the class “requirement” and related concepts
39
IS/ISO 9000 : 2015
Figure A.10 — 3.7 Concepts of the class “result” and related concepts
40
IS/ISO 9000 : 2015
Figure A.11 — 3.8 Concepts of the class “data, information and document” and related concepts
41
IS/ISO 9000 : 2015
Figure A.12 — 3.9 Concepts of the class “customer” and related concepts
42
IS/ISO 9000 : 2015
Figure A.13 — 3.10 Concepts of the class “characteristic” and related concepts
43
IS/ISO 9000 : 2015
Figure A.14 — 3.11 Concepts of the class “determination” and related concepts
44
IS/ISO 9000 : 2015
Figure A.15 — 3.12 Concepts of the class “action” and related concepts
45
IS/ISO 9000 : 2015
Figure A.16 — 3.13 Concepts of the class “audit” and related concepts
46
IS/ISO 9000 : 2015
Bibliography
}'~ $+&Ny&&%(Terminology work — Principles and methods

}y~ $'&+E'y&&&(Terminology work — Vocabulary — Part 1: Theory and application
}\~ $\V\NEy(Statistics — Vocabulary and symbols — Part 2: Applied statistics
}N~ $%&&'(Quality management systems — Requirements
}V~ $%&&N(Managing for the sustained success of an organization — A quality management approach
},~ $'&&&'y&&+(Quality management — Customer satisfaction — Guidelines for codes of conduct
for organizations
}+~ $ '&&&yy&'N( Quality management — Customer satisfaction — Guidelines for complaints
handling in organizations
}~ $'&&&\y&&+(Quality management — Customer satisfaction — Guidelines for dispute resolution
external to organizations
}%~ $ '&&&Ny&'y( Quality management — Customer satisfaction — Guidelines for monitoring
and measuring
}'&~ $'&&&Vy&&V(Quality management systems — Guidelines for quality plans
}''~ $'&&&,y&&\(Quality management systems — Guidelines for quality management in projects
}'y~ $'&&&+y&&\(

}'\~ $'&&&(Quality management — Customer satisfaction — Guidelines for business-to-consumer
electronic commerce transactions
}'N~ $'&&'yy&&\(Measurement management systems — Requirements for measurement processes
and measuring equipment
}'V~ $)@'&&'\(Guidelines for quality management system documentation
}',~ $'&&'N(

}'+~ $'&&'V(Quality management — Guidelines for training
}'~ $)@'&&'+(Guidance on statistical techniques for ISO 9001:2000
}'%~ $'&&'y&'y(Quality management — Guidelines on people involvement and competence
}y&~ $'&&'%y&&V(Guidelines for the selection of quality management system consultants and use of
their services
}y'~ $'&yN'E'(Terminological entries in standards — Part 1: General requirements and examples
of presentation
}yy~ $ '&yN'Ey( Terminological entries in standards — Part 2: Adoption of standardized
terminological entries
}y\~ $'N&&'(Environmental management systems — Requirements with guidance for use
}yN~ $) ',%N%( Quality management systems — Particular requirements for the application of
ISO 9001:2008 for automotive production and relevant service part organizations
}yV~ $)=*'+&&&(Conformity assessment — Vocabulary and general principles
47
IS/ISO 9000 : 2015
}y,~ $'%&''y&''(Guidelines for auditing management systems

}y+~ $)=*y+&&'(Information technology — Security techniques — Information security management
systems — Requirements
}y~ $\'&&&(Risk management — Principles and guidelines
}y%~ $V&&&'(Energy management systems — Requirements with guidance for use
}\&~ =*,&&V&E'%y(International electrotechnical vocabulary — Part 192: Dependability
}\'~ $)=*X
y(Standardization and related activities — General vocabulary
}\y~ $X
+\(Risk management — Vocabulary
}\\~ $)=* X
%%( International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
}\N~ 3

1)
1) Available from website: http://www.iso.org
48
IS/ISO 9000 : 2015
Alphabetical index of terms
3.3.11 context of the organization 3.2.2

association 3.2.8 continual improvement 3.3.2
audit 3.13.1 contract 3.4.7
audit client 3.13.11 correction 3.12.3
audit conclusion 3.13.10 corrective action 3.12.2
audit criteria 3.13.7 customer 3.2.4
auditee 3.13.12 customer satisfaction 3.9.2
audit evidence 3.13.8 customer satisfaction code of conduct 3.9.5
!3.13.9 customer service 3.9.4
auditor 3.13.15 data 3.8.1
audit plan 3.13.6 defect 3.6.10
audit programme 3.13.4

3.6.14
audit scope 3.13.5 design and development 3.4.8
audit team 3.13.14 determination 3.11.1
3.6.12 deviation permit 3.12.6
change control 3.3.10 2

! 53.1.5
characteristic 3.10.1
dispute 3.9.6
combined audit 3.13.2
dispute resolution process provider (admitted
competence 3.10.4 term for DRP-provider) 3.2.7
competence acquisition 3.4.4 dispute resolver 3.1.6
complaint 3.9.3 document 3.8.5
concession 3.12.5 documented information 3.8.6
! 3.10.6 DRP-provider 3.2.7
! 3.1.5 effectiveness 3.7.11
!

3.10.7
!
3.7.10
! 2

engagement 3.1.4
! 53.1.5

2

<
53.6.1
! <
3.3.13
external provider 3.2.6
!

3.3.9
external supplier (admitted term for external
! 3.8.14 provider) 3.2.6
3.6.11 feedback 3.9.1
49
IS/ISO 9000 : 2015
grade 3.6.3 3.5.8

guide 3.13.13 preventive action 3.12.1
human factor 3.10.3 procedure 3.4.5
improvement 3.3.1 process 3.4.1
information 3.8.2 product 3.7.6

3.8.4 ! 3.6.8
infrastructure 3.5.2 progress evaluation 3.11.9
innovation 3.6.15 <
3.4.2
inspection 3.11.7 <

3.3.12

3.2.3 <

3.8.11
involvement 3.1.3 provider 3.2.5

2

<
53.6.1 3.6.2
< 3.13.3
3.3.6
management 3.3.3
3.10.2

3.5.3 3.3.7
measurement 3.11.4

3.3.8

3.5.7

3.3.4
measurement process 3.11.5

3.5.4
measuring equipment 3.11.6

3.1.2
metrological characteristic 3.10.5

3.4.3

! 3.5.6 3.8.8
metrological function 3.2.9 <

3.7.2
mission 3.5.11 3.8.9
monitoring 3.11.3 3.3.5
3.6.9 3.5.9
<
3.6.1

3.6.5
<

3.7.1 record 3.8.10
<

3.8.3 regrade 3.12.4
observer 3.13.17

3.6.7
organization 3.2.1 release 3.12.7
output 3.7.5 repair 3.12.9
outsource (verb) 3.4.6 requirement 3.6.4
performance 3.7.8 review 3.11.2
50
IS/ISO 9000 : 2015
rework 3.12.8 supplier (admitted term for provider) 3.2.5

risk 3.7.9 sustained success 3.7.4
scrap 3.12.10
3.5.1
service 3.7.7 technical expert 3.13.16

!
3.8.15 test 3.11.8

! 3.8.7 top management 3.1.1

2

5
3.6.13
3.2.3
validation 3.8.13

3.6.6

! 3.8.12

3.5.12
vision 3.5.10
success 3.7.3
work environment 3.5.5
51
Bureau of Indian Standards
BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote
harmonious development of the activities of standardization, marking and quality certification of goods
and attending to connected matters in the country.
Copyright
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without the prior permission in writing of BIS. This does not preclude the free use, in the course of
implementing the standard, of necessary details, such as symbols and sizes, type or grade designations.
Enquiries relating to copyright be addressed to the Director (Publications), BIS.
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Users of Indian Standards should ascertain that they are in possession of the latest amendments or
edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards : Monthly Additions’.
This Indian Standard has been developed from Doc No.: MSD 02 (0575).
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What is the scope of this standard?

What is the scope of this standard?

What are the fundamental concepts and quality management principles discussed in this standard?

What are the fundamental concepts and quality management principles discussed in this standard?

Hkkjrh; ekud IS/ISO 9000 : 2015

xq.krk izcaèk i¼fr;k¡ —

Quality Management Systems —

Hkkjrh; ekud C;wjks

January 2016 Price Group 14

2 Fundamental concepts and quality management principles

2.2 Fundamental concepts

7    

2.2.2 Quality management system

2.2.3 Context of an organization

2.2.4 Interested parties

Top management support of the QMS and engagement of people enables:

2.3 Quality management principles

2.3.1 Customer focus

— increased revenue and market share.

2.3.1.4 Possible actions

Possible actions include:

2.3.2.4 Possible actions

Possible actions include:

2.3.3 Engagement of people

2.3.3.4 Possible actions

Possible actions include:

2.3.4 Process approach

2.3.4.4 Possible actions

Possible actions include:

Successful organizations have an ongoing focus on improvement.

Improvement is essential for an organization to maintain current levels of performance, to react to

2.3.5.4 Possible actions

Possible actions include:

2.3.6 Evidence-based decision making

2.3.6.4 Possible actions

Possible actions include:

2.3.7 Relationship management

2.3.7.4 Possible actions

Possible actions include:

2.4 Developing the QMS using fundamental concepts and principles

2.4.1 QMS model

2.4.2 Development of a QMS

734  

2.4.3 QMS standards, other management systems and excellence models

3.1 Terms related to person or people

3.2 Terms related to organization

3.3 Terms related to activity

3.4 Terms related to process

3.5 Terms related to system

3.6 Terms related to requirement

3.7 Terms related to result

    !   

   interested parties (3.2.3), such as customers (3.2.4), users,

    

3.8 Terms related to data, information and document

— the management system (3.5.3), including related processes (3.4.15

— evidence of results achieved (records (3.8.10)).

3.9 Terms related to customer

3.10 Terms related to characteristic

7

734

!

interested parties (3.2.3), such as customers (3.2.4), users,

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}y,~ $'%&''y&''(Guidelines for auditing management systems

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grade 3.6.3 3.5.8