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Examples of iso 9000 documents4/7/2024 Try to keep in mind the big picture of (complying with) the standard: ensure you are operating your business to consistently produce quality products or services. Your SWOT analysis might identify this as a threat (or opportunity) and you may drive some knowledge-sharing activities (training). ![]() For example, you might have a group of highly skilled individuals who each have "tribal knowledge" that only they possess. The outputs from your SWOT analysis can feed into the identification of interested parties (4.2), can help refine the scope of the QMS (4.3), can certainly drive risk-based planning and actions (6), and may compliment pretty much everything else downstream. That said, I believe the intent is just to get you considering the full scope of your operation. I heard one auditor say they would start at the Management Review and try to unravel things from there. 4.1 doesn't have any requirement for documented information so about all an auditor could do would be to see if you have an understanding of the organization and its context. This is apparently going to be one of those weird areas.
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