Tag Archives: product development

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: Product Development and Customer Satisfaction

Q: Does a company certified to ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements that produces raw materials for a customer according to their written specification also, as a raw material supplier, have a responsibility under ISO 9001 to meet the … Continue reading

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Quality in Radical Innovation

Q: Design for Six Sigma (DFSS) involves the discovery, development, and understanding of critical to quality areas and fosters innovation. However, studies have shown that using focus groups, interviews, and etc., based on current users only bring forth ideas relative … Continue reading

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Calibration of AutoCAD Software

Q: To what extent must an engineering firm, specializing in railway infrastructure and transportation, have its AutoCAD software “calibrated” or verified? Also, what about software designed to calculate earthwork quantities for railway alignments laid out on topographic mapping for all … Continue reading

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Does ISO 9001 clause 7 apply to processes?

Q: Does clause 7 Product Realization in ISO 9001:2008 Quality management systems–Requirements apply to the design and development of manufacturing processes? We have four facilities that are ISO 9001 certified under one certificate. One location designs the product, and the … Continue reading

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