Slide 59 of 262

As you can see, most of the documents in the above listing are parallels to the 20 ‘old’ ISO elements. It may be that the new standard does not specifically require a document to cover each of these, however it will most often be the case that your company will have to document these systems at least minimally.

As I have stated before, the level of documentation your company will need cannot be determined by a book or reference. Your company may have relatively simple systems and on-the-job training may be utilized more than at another company. You may be a facility which is part of a corporation where there are flow-downs you will have to comply with (some of which will probably be documentation requirements). Or, your company may only consist of 8 souls who provide a service - your documentation will probably be minimal.

You have to review, within your company, what you are doing now and making some common sense determinations of where documentation is relevant and ‘necessary’.

Some Other Expected Process Maps

Planning (5.4, 7.1, 8.1, 8.5.1)

• Management Review (5.6)

• Resource Management (6)

• Training (6.2.2)

• Customer Processes (7.2)

• Customer Communication (7.2.3)

• Design and Development (7.3)

• Purchasing (7.4)

• Operations Control (7.5.1)

• Product ID / Traceability ( 7.5.2)

• Customer Property (7.5.4)

• Preservation of Product (7.5.5)

• Validation of Processes (7.5.2)

• Process Measurement / Monitoring (8.2.3)

• Product Measurement / Monitoring (8.2.4)

• Analysis / Improvement (8.4, 8.5)

  Note: Some of these may not be relevant to your company. An example is Product Identification and Traceability. If you are a service company, Product Preservation will probably not apply to your situation. Remember, however, that exclusions are limited to requirements within Element 7 - Product Realization.

	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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