Slide 9 of 262

The original thrust was to provide for compliance to new EC safety directives for Regulated Products. The goal is to allow for meeting product regulations in all EC countries by providing a route to gaining approval for use of the CE (Communaute Europeene) mark. The CE mark is becoming the passport for selling regulated products in Europe.

A. Unregulated Products Examples
• Paper
• Furniture

B. Regulated Products Examples
• Machinery
• Toys
• Personal Protection Equipment
• Medical Devices
• Telecommunications Equipment

Quality Systems

No Quality System

World Class Quality System

Meets Product Specifications

Mil-Q-9858

ISO 9001

ISO 9001

ISO 9004

Deming Prize

Beyond Deming

Malcolm Baldrige National Quality Award

USA

"How Much Is It and Do You Have Any In Stock Right Now?"

• Price
• Availability
• Safety
• Quality

Europe

"How Long Will It Last and Is It Safe?"

• Quality
• Safety
• Inter-operability
• Price

Consumer (Customer) Buying Determined By:

	The. Deming PDCA Cycle	QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram. Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation

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