Awareness and Use of

ISO 9000:2015
Quality Management
Systems
Fundamentals and
Vocabulary
Normative Reference for ISO
9001:2015
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Purpose and Scope

The purpose of this presentation is to stress the
importance of using ISO 9000:2015 for the
auditing and implementation of ISO 9001:2015
The presentation is intended to be used for
training by the public

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Normative References
As quoted directly from ISO 9001:2015

The following referenced

documents are indispensable
for the application of this
document:.
ISO 9000:2015, Quality
management systems
Fundamentals and vocabulary
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indispensable

Definition of indispensable from the Merriam-Webster Dictionary

adjectiveindispensable\in-di-spen(t)-s-bl\
o extremely important and necessary
1: not subject to being set aside or neglected
o <anindispensableobligation>
2: absolutely necessary:Essential
o <anindispensablemember of the staff>

Definition of indispensable from the Oxford Dictionary

/ndspnsbl/
too important to be without
SYNONYMessential Cars have become an indispensable part
of our lives.
indispensableto somebody/somethingShe made herself
indispensable to the department
.indispensablefor something/for doing somethingA good
dictionary
for learning a foreign
language.
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of US TAG tois
ISOindispensable
TC 176
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ISO 9000 Series

ISO 9000 - Quality management systems
Fundamentals and vocabulary
o ISO 9000 provides an essential background for the
proper understanding and implementation of the ISO
9001 International Standard.

ISO 9001 Quality Management Systems Requirement

o ISO 9001 specifies requirements aimed primarily at
giving confidence in the products and services provided
by an organization and thereby improving customer
satisfaction.

ISO 9004 - Managing for the sustained

success of an organization - A quality
management approach
o ISO 9004, Provides guidance for organizations that
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of US TAG to
TC 176
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choose
toISOprogress
beyond the requirements
of the ISO

Common Ground
Standards which Normative reference
ISO 9001 also require the use of ISO
9000,
Some prime examples are shown here:
SAE AS 9100C:2009 Aerospace Requirements
ISO TS 16949:2009 - AutomotiveRequirements
ISO 13485:2003 Medical devicesRequirements
QUEST TL9000 The Telecom Quality
Management System Requirements
ISO 19600:2014 Compliance
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ISO 9000 Table of

Contents
Foreword & Introduction
1 Scope
2 Fundamental concepts and quality
management principles
2.1 General
2.2 Fundamental concepts
2.2.1 Quality
2.2.2 Quality management system
Descriptive
2.2.3 Context of an organization language with
no
2.2.4 Interested parties
requirements
2.2.5 Support
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ISO 9000 Table of

Contents Continued
2.3 Quality management
principles
2.3.1
2.3.2
2.3.3
2.3.4
2.3.5
2.3.6
2.3.7

Customer focus
No
Leadership
requirements;
Engagement of people
ideas useful
in guiding
Process approach
organizations
Improvement
actions. Used
as a basis for
Evidence-based decision making
developing
Relationship management ISO 9001.

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ISO 9000 Table of

Contents Continued
2.4 Developing the QMS using
fundamental concepts and
principles
2.4.1 QMS model
2.4.2 Development of a QMS
2.4.3 QMS standards, other
management systems and excellence
models

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Continued
3 Terms and definitions - Terms related
to
3.1
3.2
3.3
3.4
3.5
3.6
3.7

person or people
organization
activity
process
system
requirement
result

3.8 data, information

and document
3.9 customer
3.10 characteristic
3.11 determination
3.12 action
3.13 audit

Required definitions of terms used

in requirements standards such as
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ISO 9000 Table of

Contents Continued
Annex A
Concept diagrams
in understanding
Concept relationships andaid
of interrelationships
among terms and
their graphical representation
concepts.

Bibliography, Alphabetical index of

terms

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Method of Properly Using ISO

9000
Taking ISO 9001:2015 clause 10.2.1d; for example:
The Organization shall review the
effectiveness of any corrective action taken
By substituting effectiveness and corrective
action with their definitions from ISO 9000 this
statement becomes:
The Organization shall review the extent to
which planned activities are realized and
planned results are achieved for any action
taken to eliminate the cause of a
nonconformity and to prevent recurrence

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Understanding the definitions and

fundamental concepts in ISO
9001:2015
The Following are examples of some of the
Interested
New, Revised or Removed Terms of ISO
party
9001
New
Competence Revised
Risk
Output Revised
Risk-based New
thinking New
Information Revised
Revised
Provider
Information
New
Revised
Documented
system
Revised
New
information
Verification
Effectiveness Revis
Validation
ed
Corrective
action
Preventive
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Revised

Removed

New Terms in the first 6 Clauses of ISO

9001:2015
1. Scope of standard
2. Normative references
3. Terms and definitions
4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of
interested parties
4.3 Determining the scope of the quality management
system - b) the requirements of relevant interested
parties
4.4 Quality management system and its processes - f)
address the risks
5. Leadership
6. Planning
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Understanding Context
Context of an organization
Understanding the context of the organization is a
process. This process determines factors which
influence the organizations purpose, objectives and
sustainability.

Context of the organization

Combination of internal & external issues that can
have an effect on an organizations approach to
developing and achieving its objectives.

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Understanding Interested Parties

When determining the scope of the organization, we shall
consider the expectations of relevant interested parties

All of the following can be "interested parties"

person having an interest in the success of an organization

person that can affect an activity
organization that perceives itself to be affected by a decision
stakeholder
person having an interest in the performance of an
organization
providers regulators
competitors
opposing pressure group
There are more!!!
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Understanding Risk
The term Risk has been added to ISO 9001:2015
and is noted in many places throughout the
standard.
Risk - effect of uncertainty positive or negative.
consequence, or likelihood reference to
potential events the consequences of an event
This may apply, for example, to; a product,
service, process, provider, customer, consumer,
environment, employee, & the competition.
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Assisting Organizations
The Price of ISO 9000 is 1/3 the cost of
other ISO standards of similar size
ISO 9000 terms are broken down by
category to promote international
understanding and increase confidence in
the global market
The electronic Adobe version of ISO 9000
includes click-on numerical links for defined
terms.
ASQ offers standard bundle packages to
promote the use of Normative Reference
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Documents.
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Reference links for additional

Information
Paul Palmes article Whats Normative
Anyway
o http://www.insidestandards.com/iso-90002015-whats-normativeanyway/

ASQ.org Standards Connection

o http://asq.org/standardsconnection/

ASQ.org Standards Central

o http://asq.org/knowledge-center/standards-iso-9001-2015.html

ASQ Standards Channel

o http://videos.asq.org/asq-standards-channel

ISO/FDIS 9000:2015 NOTE Guidance on some

additional frequently-used words in the QMS standards
developed by ISO/TC 176, and which have an
identified dictionary meaning, is provided in a glossary
available at:
o http://www.iso.org/iso/03_terminology_used_in_iso_9000_family.p
8/26/2015
df

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