Category Archives: Other

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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Zero Acceptance Number Sampling Plans and the FDA

Question There has been some debate over using the MIL-STD-1916 acceptance sampling plan over the ANSI/ASQ Z1.4-2003 (R2013) sampling plans.  The opinion is that the ANSI/ASQ Z1.4-2003 (R2013) is outdated and no longer an acceptable method of determining a qualification … Continue reading

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AQL Clarifications

Question I am confused about the values used for AQLs. For example in Table II-A the AQL values range from 0.010 to 1000. Where do these values come from and what do they mean? The table states, “AQLs, in Percent … Continue reading

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DPMO

Question My question concerns the process performance metric DPMO (defects per million opportunities). I want to use this to quantify a particular supplier’s performance. My question is, is the number of defects referred to in the calculation the number of … 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

Posted in ISO 13485 - Medical Devices, ISO 9001 - Quality Management Systems, Other | Tagged ,