ISO9000-2015

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Welcome to Today’s Session

3 Reasons Your Organization Needs to

Know the New ISO 9000:2015


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.


A Bit of History


Outputs

Why ISO? A Typical Business

4

ProcessorsInputs


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


EstablishBaseline

Performance

IdentifyCTQs

Monitor ActualPerformance

Compare to CTQ Targets

Take Action

Assuring Repeatable & Compliant Processes


An Effective Business Model Assessment


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


EnterpriseFocus

ProcessFocus

ProductFocus

1980 – Present

Improved Results

ISO 9000

Baldrige

ISO is not a Total System


ISO 9000: 2015 v. 2008


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.


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.

ISO9000-2015

Documents

Transcript of ISO9000-2015