Tag Archives: George Hummel

Document Revision Criteria

Question Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485?  Some organization don’t revise the documents for a period of more than 2-3 years.  The reason provided by the organization is that … Continue reading

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Audit Timeline

Question What is the ASQ recommended time frame between an auditee receiving a final audit plan and the audit commencing at the auditee’s site? Answers From Charlie Cianfrani: ASQ does not have a recommendation! From George Hummel: This is not … Continue reading

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Is Certification Revocable?

Question If a company is ISO 9001: 2015 certified, is it revocable? Answers From Jim Werner: A company can indeed have its certification revoked.  Being certified means the company has established a qualify management system that meets the requirements of ISO9001:2015.  … Continue reading

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Clauses vs. Elements in ISO Standards

Question What, if any, is the difference between the words “clause” and “element” in ISO standards? Specifically, “customer shall conduct an internal audit addressing all elements of the management system.”  And, at what level is this in the standard, eg, … 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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ISO 9001 electronic records

Q: I have a few questions about employee training records.  My company is certified to ISO 9001:2008 Quality management systems–Requirements, and we are considering transitioning to electronic records. However, we don’t know what the requirements are from an ISO perspective. Specifically, we want to know: … 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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