Category Archives: ISO 9001 – Quality Management Systems

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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Transition to ISO 9001: 2015

Question We are in the process of reviewing our policies and procedures to be compliant with the ISO 9001: 2015 standard. When converting from ISO 9001: 2008 to ISO 9001: 2015, how should the version control be handled? Should we … Continue reading

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