Tag Archives: ISO 9001

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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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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Transitioning to ISO 9001: 2015

Question ISO 2015 has a 3 year implementation period. I recertified in 2014 and need to recertify in 2017. At this point I have a little under one year to transition instead of the 3 years identified. What alternatives are … Continue reading

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ISO 9001:2015 Documented Information Requirements

Question I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document? Answer Thank you for the … Continue reading

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ISO 9001: 2015 Tools for Auditors and Risk Based Thinking

Question In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper  understanding for auditors ?  I understand that … Continue reading

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Risk Based Thinking in ISO FDIS 9001:2015

Question In 0.3.3 Clause of the standard – it is said that “A positive deviation of the risk can provide an opportunity, but not all positive effects of risk result in opportunities.”  Can you please clarify this statement? Answer Thanks … Continue reading

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