Tag Archives: Aura Stewart

ISO Requirements or Good Documentation Practices?

  Question Are these standard for ISO or just good documentation practices? 1. All entries, except IPQA, should be made with blue ball pen in clear and legible handwriting. 2. IPQA entries shall be done in black ball pen. Answer … Continue reading

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

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

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