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This is meant to give you a basic idea of the intention / requirements. A detailed discussion is presented in Clause_Interp_and_Upgrading.doc.

7.3.7 Control of Design and Development Changes
NOTE: There are no new requirements in Design and Development Changes from the 1994 version.

The ISO 9001:2000 standard states that all design and/or development changes must be identified, documented and controlled. This should not be an issue. Any basic design system should address documentation and tracking of changes. In the extreme, there is configuration management.

Potential Audit Questions:

1. Does your company document ALL design/ development changes? If you document some, but not all, what characteristics qualify a change for documentation?

2. If your company does document your changes, are these documents controlled in your QMS document control system? If not, why?

	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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