Monthly Archives: November 2015

ISO 9001:2015 Documented Information Requirements

Question I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document? Answer Thank you for the … Continue reading

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Value Stream Mapping

Question We produce plastic fittings and pipes. We only have one process: only one machine is needed to produce a product.  Can we still benefit from Value Stream Mapping? If yes, could you please explain how? Answer Thank you for … Continue reading

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ISO 9001: 2015 Deliverables and Processes

Question Under the revised ISO 9001 2015 standard, what do you see as the key deliverables and processes owned by the Quality manager or QA department? Answer A project or process is made up of primary components aimed toward successful … Continue reading

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ISO 9001: 2015 Design and Development Clause

Question We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001-2015. Answer There are two ways to approach this: One is to use the process developed … Continue reading

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Inspection Sample Size

Question The customer expects certain levels of inspection: pull 157 bottles for visual testing, but then they also want 20 pulled for dimensional testing. Can’t the 20 additional bottles be a subset of the original testing sample? When calculating the … Continue reading

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Sampling and Daylight Savings Time

Question We are wondering if there is any generally accepted procedure to account for seemingly duplicate sample times when operating over the time period when clocks ‘fall back’ one hour for the end of daylight savings time? Our standard practice … Continue reading

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