Monthly Archives: March 2012

What is ANSI/ISO/ASQ Q9001:2008?

Q: Is there any difference between ANSI/ISO/ASQ Q9001:2008 and ISO 9001:2008? Is it just semantic, or is it ASQ’s take on ISO 9001:2008 Quality management systems–Requirements? A: They are exactly the same and can be referred to interchangeably. Because of … Continue reading

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Value and Benefits of ISO 9001

Q: My company is struggling with the decision to spend any more money on the ISO 9001:2008 Quality management systems–Requirements registration.  How many of our peers believe that the continuation of this certification is worth the cost? I have been … Continue reading

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Customer satisfaction and loyalty

Q: Can you give me more information about how organizations gain, measure, and retain customer satisfaction and loyalty? A: The Quality Improvement Glossary, by Donald L. Siebels, defines customer loyalty/retention as “the result of an organization’s plans, processes, practice, and … Continue reading

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Lean Six Sigma

Q: Can you explain what Lean Six Sigma is to me?  I’ve heard of both lean and Six Sigma as individual concepts, but I’m not quite sure I understand the term Lean Six Sigma. A: The following concise definition is taken … Continue reading

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ISO Documentation Practices; Difference Between Record and Document

  Q: Is there a published ISO standard for good documentation practices (e.g., crossing out an error with a single line and initialing and dating; striking through a blank space)? Thank you. A: Your question has two parts: 1) Is … Continue reading

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ISO 9001 Implementation Guidance

Q: I am directing a ground floor implementation effort to become certified to the ISO 9001:2008 Quality management systems–Requirements. I work for a small manufacturing company (less than 20 employees). Is there a quality management system (QMS) or ISO template … Continue reading

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ISO 9001:2008 Impact on ISO 13485:2003

Q: Why does Annex B of ISO 13485:2003: Medical devices — Quality management systems — Requirements for regulatory purposes address ISO 9001:2000? Shouldn’t it be ISO 9001:2008 Quality management systems–Requirements? A: ISO 9001 is “controlled” by Technical Committee (TC) 176 while ISO 13485 … Continue reading

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ISO 9001 Quality Manual

Q: My small company is forcing me in the direction of using flowcharts to specify ISO standards. With their many branch statements, they are convoluted and confusing. I prefer plain, simple English. But my question is: is it ok to … Continue reading

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ISO 9001 Procedure Vs. Process

Q: I‘m seeking clarity and advice on a recent incident  I was informed about. An organization I am very familiar with and is fully certified to ISO 9001:2008 Quality management systems–Requirements (with no exemptions) recently had a new external auditor … Continue reading

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What’s the Difference Between ISO 9001 and ISO 19011?

Q: What is the difference between the ISO 9001:2008 and ISO 19011:2011 literature on your web site? Please provide a detailed explanation and their use. A: I can see where the confusion might arise, as the numbers are very similar! … Continue reading

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