Tag Archives: Aura Stewart

Relocation Requires Audit?

Question One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 … Continue reading

Posted in Auditing, ISO 9001 - Quality Management Systems, Other | Tagged , , | 1 Comment

Cleanrooms, Classes, and Control Charts

Question My question has to do with cleanroom monitoring, specifically particle counts. Using ISO 14644-1: 1999, (we are still transitioning to the new standard). We have 27 test sites in our cleanroom. Our Particle Counter takes 10 readings per minute … Continue reading

Posted in Other, Quality Tools | Tagged ,