Tag Archives: ISO 9001

Relocation Requires Audit?

Question One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 … Continue reading

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Customer ISO Status In Jeopardy?

Question My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection … Continue reading

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EHS Procedures and ISO 14001

Question Do EHS procedure have to be managed under ISO 9001:2008 if the company is not ISO 14001 certified? Answer It depends – are the EHS procedures part of the QMS of the organization. If so, yes. Otherwise no. Charles Cianfrani … Continue reading

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Special Process NCRs During Audit

Question Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process. One of the NCRs was “Some welders are not qualified prior to … Continue reading

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Clauses 8.4.1 and 8.4.2 in 9001

Question The insurance company I am temporarily helping on quality is limiting its ISO 9001 certified perimeter to the administration of contracts and claims. With regard to clauses 8.4.1 and particularly 8.4.2 of ISO 9001:2015, should the other internal entities … Continue reading

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“Shall Be Determined” in 9001

Question Many of the Quality Management Systems requirements in the ISO 9001: 2015 manual include the verbiage “shall be determined.”  I need to be sure that I understand exactly what this means in this context.  For example, “4.4  QMS and … 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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