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Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2

tony s

Information Seeker
ISO 9001Ş2015 - 10.2.1e
...maybe a better approach is "every ncf. leads to a risk"....:)
In a cause and effect relationship, I am more inclined to see that risks can cause NCs - and not the other way around. Clause 10.2.1e is intended for determining the risk/s that may have been overlooked previously (i.e. during the planning of the QMS and/or its processes) that led to the occurrence of the NC.

As per ISO/TS 9002 Clause 6.1.1, the purpose of determining risks is to prevent NCs including nonconforming outputs. Thus, risks are causes and NCs are effects.
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