Category Archives: ISO 9001 – Quality Management Systems

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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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

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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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Approved Supplier List 17025 or 9001?

Question Every once and while our company will need to find a rare or hard to find item on the web. Due to the rarity of the item we sometimes need to look at sites that are not a typical … 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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