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ISO-9000-Awareness-Presentation-8-27-15.pptx
1. 1
Awareness and Use of
ISO 9000:2015
“Quality Management
Systems — Fundamentals and
Vocabulary”
Normative Reference for ISO 9001:2015
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2. 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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3. 3
“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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4. 4
“indispensable”
• adjective in·dis·pens·able ˌin-di-ˈspen(t)-sə-bəl
o extremely important and necessary
• 1: not subject to being set aside or neglected
o <an indispensable obligation>
• 2: absolutely necessary : Essential
o <an indispensable member of the staff>
• /ˌɪndɪˈspɛnsəbl/
• too important to be without
• SYNONYM essential Cars have become an indispensable part of our lives.
• indispensable to somebody/something She made herself indispensable to the
department
• .indispensable for something/for doing something A good dictionary is
indispensable for learning a foreign language.
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Definition of indispensable from the “Merriam-Webster Dictionary”
Definition of indispensable from the “Oxford Dictionary”
5. 5
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 choose to progress
beyond the requirements of the ISO 9001 International Standard to
address a broader range of topics that can lead to continual
improvement of the organization's overall performance.
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6. ISO 9001 Provides 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 - Automotive- Requirements
• ISO 13485:2003 Medical devices-Requirements
• QUEST TL9000 The Telecom Quality Management
System – Requirements
• ISO 19600:2014 “Compliance management
systems – Guidelines
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6
7. 7
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
2.2.3 Context of an organization
2.2.4 Interested parties
2.2.5 Support
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Descriptive
language with no
requirements
8. 8
ISO 9000 Table of Contents Continued
2.3 Quality management principles
2.3.1 Customer focus
2.3.2 Leadership
2.3.3 Engagement of people
2.3.4 Process approach
2.3.5 Improvement
2.3.6 Evidence-based decision making
2.3.7 Relationship management
Compliments of US TAG to ISO TC 176 8/26/2015
No requirements;
ideas useful in
guiding
organizations’
actions. Used as a
basis for
developing ISO
9001.
9. 9
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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ISO 9000 Table of Contents Continued
10. ISO 9000 Table of Contents Continued
3 Terms and definitions - Terms related to …
3.8 data, information and
document
3.9 customer
3.10 characteristic
3.11 determination
3.12 action
3.13 audit
3.1 person or people
3.2 organization
3.3 activity
3.4 process
3.5 system
3.6 requirement
3.7 result
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Required definitions of terms used in
requirements standards such as ISO 9001
11. ISO 9000 Table of Contents Continued
Annex A
Concept relationships and
their graphical representation
Bibliography, Alphabetical index of terms
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Concept diagrams aid in
understanding of
interrelationships among
terms and concepts.
12. 12
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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13. 13
Understanding the definitions and fundamental
concepts in ISO 9001:2015
• Interested party
• Risk
• Risk-based
thinking
• Provider
• Documented
information
• Effectiveness
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• Competence
• Output
• Information
• Information system
• Verification
• Validation
• Corrective action
• Preventive action
The Following are examples of some of the
New, Revised or Removed Terms of ISO 9001
New
New
New
New
New
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Revised
Removed
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14. 14
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”
6.4 Actions to address “risks and opportunities”.
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15. 15
Understanding “Context”
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 sustainability.
Context of the organization
• Combination of internal & external issues that can have an effect
on an organization’s approach to developing and achieving its
objectives.
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16. 16
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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17. 17
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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18. 18
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 Documents.
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19. 19
Reference links for additional Information
• Paul Palmes article – “What’s Normative Anyway”
o http://www.insidestandards.com/iso-90002015-whats-normative-anyway/
• 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.pdf
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Editor's Notes
The differences between ISO 9001:2008 and ISO 9001:2015 are so significant that using ISO 9000:2015 is the best way to implement the revised standard correctly.
Stress the importance of using ISO 9000:2015 in understanding ISO 9001:2015
Shown here is the wording used in all standards to define “Normative References” and that ISO 9000:2015 is the only Normative reference to ISO 9001:2015. Be sure to point out the word “Indispensable” when viewing this slide as it is defined in the next slide.
“Extremely Important & Necessary” – “Too Important to be Without” Pretty much says it all!
These three are the ISO 9000 Series Standards. Both ISO 9000 and ISO 9001’s new revisions are being released together. ISO 9004 is currently under revision.
ISO 9001 has been used to form the basis of Quality Management Systems in many major industries and is therefore stated as their Normative Reference document. As ISO 9001 is the Normative reference in many other standards. The need to understand the guidelines outlined in ISO 9000 to benefit an organization applying the requirements of standards is critical.
ISO 9000 is far more useful than you may have been aware. The Fundamental Concepts are explained within ISO 9000 without burdening the reader with additional requirements. The better we all understand these Fundamental concepts the easier it is to create and maintain a truly beneficial Quality management system.
Quality Management Principles apply to every clause in a Quality Management Standard. These are the guidelines that keep the entire system moving in the right direction.
ISO 9000 provides the framework needed to build a Quality Management System and have it work toward the success of the organization.
There are 13 different groupings of terms in the ISO standard. An alphabetical index is also provided.
This slide demonstrates the proper use of ISO 9000. All terms defined in ISO 9000 should be second nature to all organizations who are certifying. The importance of global understanding of the intent of these terms ensures the true value of being certified.
(This slide has two slide in sections which show which terms are New, Revised, and Removed.) On the first click state that “These examples are either New, Revised, and Removed.” (Give the group a slight pause to review the list then click in the two blocks showing them which are which. Terms are grouped showing new first, then revised, and the only shown removed term is at the end.) “All new and revised terms are defined in ISO 9000:2015.”
Not all of these new terms can possibly be covered in this presentation alone but we will go over a few of them.
An organizations purpose, objectives and sustainability are truly influenced by specific factors such as who the customer is or what the competition is doing. But not all factors apply to every organization. Defining your organization’s context gives you the focus needed to address only the factors which are truly important to your organization.
ISO 9000 helps you identify interested parties, your organization will define which ones it needs to react to.
Risk based thinking will be a new concept for many organizations. The degree at which Risk is addressed in each organization will depend on the context of the organization.