Category Archives: ISO 9001 – Quality Management Systems

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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Quality Progress’ Standard Issues Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about ISO 9001: 2015 and top management. You must be logged in to view the column. And at this link, ASQ members may find additional articles published in Quality … 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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Work Instructions and Audits

Question Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by … Continue reading

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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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