Category Archives: ISO 9001 – Quality Management Systems

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

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , , , | Leave a comment

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

Posted in ISO 14001 - Environmental Management Systems, ISO 9001 - Quality Management Systems, Other | Tagged , , , | Leave a comment

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

Posted in Auditing, ISO 9001 - Quality Management Systems, Other | Tagged , , , | Leave a comment

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

Posted in Auditing, ISO 9001 - Quality Management Systems | Tagged ,

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

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

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