Slide 161 of 262

Specification Interpretations

One of the biggest complaints with ISO9001 is interpretation of the standard. Each auditor has his/her own paradigm and thus expectations. This is one of the reasons why having the same auditors is preferred. This is also the reason why I prefer the pre-assessment be limited to an on-site document review where the auditors set up in offices or a conference room. There they review the Quality Manual against the level 2’s in interviews. Level 3 documents are reviewed and objective evidence provided as requested - however, this is all done in the conference room, NOT on the floor. In short - Are our systems acceptable. - This type of audit is a Verification Audit as opposed to a Validation Audit which is where they actually hit the floor. Now - the 2 big questions:

1) How are disputes with an audit finding handled? Ask them to explain their system. (Request a copy of their procedure!)

2) How does the registrar ensure consistency of interpretations within their company? Some companies have weekly in-house meetings, some have conference calls, some do nothing. THIS IS IMPORTANT!!!

	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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