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Welcome to Today’s Session
3 Reasons Your Organization Needs to
Know the New ISO 9000:2015
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Agenda Today
The history and differences of the new ISO 9000 standard. Why this new standard is important to your industry and your
company. How you should think about using the new standard in your
industry.
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A Bit of History
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Outputs
Why ISO? A Typical Business
4
ProcessorsInputs
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A Typical Business
Quality Management Systems
RESU
LT$
Stakeholders
Culture
QP QI QCManage Improvement & Change
STRATEG
IC PLA
ND
evelop Vision
Technology
Stakeholders
Regulation
Competition
Customers
Develop & Manage Human Capital
Supply Chain & Logistics
Order Fulfillment Process
Development Process
5
Operational Processes
Selling Process
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EstablishBaseline
Performance
IdentifyCTQs
Monitor ActualPerformance
Compare to CTQ Targets
Take Action
Assuring Repeatable & Compliant Processes
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An Effective Business Model Assessment
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Time
Inspection,Compliance
,CAPA
ControlQbD
Plan AssureAuditLean, SS,
6S
Improve
What goes up is bad!!!
Share lessons learned
Waste & COPQ
How to Think About ISO
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EnterpriseFocus
ProcessFocus
ProductFocus
1980 – Present
Improved Results
ISO 9000
Baldrige
ISO is not a Total System
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ISO 9000: 2015 v. 2008
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Why ISO 9000:2015?
2. ISO 9000:2015 is a good model to assure this. It is a global standard and it has improved considerably.
3. The new revision includes a new emphasis on Risk Management which will make it more valuable to the
organization.
1. Every organization needs to prove to its customers the services and products it delivers meets their
requirements.
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Destined for Disaster: Why ISO 9001: 2015 Isn’t a Business Model
By John J. Guzik
Here is a cold, hard fact: Individuals who support this notion have obviously never run a business. They may have been involved in one and perhaps served in the higher echelons of management,
but they’ve probably never held the reins of an entire organization.
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