Monthly Archives: October 2012

Rescheduling an ISO 9001 Surveillance Audit

Q: Our organization had its last external (third party) audit in December 2011 for ISO 9001:2008 — Quality management systems — Requirements. We planned to have our next audit the week of November 26, 2012, but the auditor has become … Continue reading

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ISO 9001 Statutory and Regulatory Requirements

Q: I manage the quality managent program at my company according to ISO 9001:2008 — Quality management systems –Requirements.  I was hoping to find some assistance in the area of statutory and regulatory requirements.  Can you provide me with some … Continue reading

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Z1.4 and Z1.9 in micro testing and API chemical analysis

Q: I work at a cosmetics manufacturing company that produces sunscreen in bulk amounts. When we make 3,000 kg of sunscreen, we will use that in 10,000 units of final sunscreen products which will weigh 300 g each. How many … Continue reading

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ISO 9001, Control of Monitoring and Measuring Equipment

Q: In ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6,  there is a requirement which states: “When used in the monitoring and measurement of specified measurements, the ability of computer software to satisfy the intended application shall be confirmed.” … Continue reading

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Z1.4:2008 inspection levels

Q: I am reading ANSI/ASQ Z1.4-2008: Sampling procedures and tables for inspection by attributes, and there is a small section regarding inspection level (clause 9.2). Can I get further explanation of how one would justify that less discrimination is needed? … Continue reading

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Capability Analysis

Q: Why is a standard capability analysis determined to be best represented by 30 pieces? I have answered this question by explaining it best represents a normal distribution. But I wonder if this is traceable to an industry standard? A: … Continue reading

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