1 awareness and use of iso 9000:2015 “quality management systems — fundamentals and...

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Awareness and Use of ISO 9000:2015

“Quality Management Systems — Fundamentals and

Vocabulary”

Normative Reference for ISO 9001:20151Compliments of US TAG to ISO TC 176 8/26/2015

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

8/26/2015Compliments of US TAG to ISO TC 176 2

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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”

3Compliments of US TAG to ISO TC 176 8/26/2015

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“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.

48/26/2015Compliments of US TAG to ISO TC 176

Definition of indispensable from the “Merriam-Webster Dictionary”

Definition of indispensable from the “Oxford Dictionary”

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ISO 9000 Series• ISO 9000 - � Quality management systems — Fundamentals

and vocabularyo ISO 9000 provides an essential background for the proper

understanding and implementation of the ISO 9001 International Standard.

• ISO 9001 – Quality Management Systems - Requiremento 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 approacho 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.


ISO 9001 Provides Common GroundStandards 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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ISO 9000 Table of ContentsForeword & Introduction1 Scope2 Fundamental concepts and quality management principles

2.1 General2.2 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

Compliments of US TAG to ISO TC 176 8/26/2015

Descriptive language with no requirements

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ISO 9000 Table of Contents Continued

2.3 Quality management principles2.3.1 Customer focus2.3.2 Leadership2.3.3 Engagement of people2.3.4 Process approach2.3.5 Improvement2.3.6 Evidence-based decision making2.3.7 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.

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2.4 Developing the QMS using fundamental concepts and principles2.4.1 QMS model

2.4.2 Development of a QMS

2.4.3 QMS standards, other management systems and excellence models




3 Terms and definitions - Terms related to …3.8 data, information and document3.9 customer3.10 characteristic3.11 determination3.12 action3.13 audit

3.1 person or people3.2 organization3.3 activity3.4 process3.5 system3.6 requirement3.7 result


Required definitions of terms used in requirements standards such as ISO 9001


Annex A Concept relationships and their graphical representation

Bibliography, Alphabetical index of terms


Concept diagrams aid in understanding of interrelationships among terms and concepts.

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Method of Properly Using ISO 9000Taking 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

• 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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New “Terms” in the first 6 Clauses of ISO 9001:20151. Scope of standard2. 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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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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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 Documents.


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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 Connectiono http://asq.org/standardsconnection/

• ASQ.org Standards Centralo http://asq.org/knowledge-center/standards-iso-9001-2015.html

• ASQ Standards Channelo 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
