Author Archives: Ask The Experts

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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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  The opinion is that the ANSI/ASQ Z1.4-2003 (R2013) is outdated and no longer an acceptable method of determining a qualification … Continue reading

Posted in FDA regulated industries, Other, Z1.4 & Z1.9 - Sampling | Tagged ,

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

Posted in Other, Sampling, Z1.4 & Z1.9 - Sampling | Tagged , | 1 Comment


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 ,

Verification or Calibration?

Question There is a second part to 7.6 para “a” which reads; “where no such standards exist, the basis used for calibration or verification shall be recorded.” It is clear for shops that are complying to the ISO 9001:2008(E) we … 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

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , | 1 Comment