The requirements wording of the Standard is often confusing while the decisions to be made are very important.
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Question: I disagree that ISO 9001:2015 'Corrective Actions' Procedure does not includes preventive actions functions. The verbiage ‘preventative’ was removed, but the functions of preventative actions are still required, right?
Answer: ‘Corrective actions’ Procedure regulates the response to the
occurred nonconformity,
including correction, identification and elimination of the causes of this nonconformity.
When a nonconformity occurs, including any arising from complaints,
the organization shall …
…evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere, by … determining
if similar nonconformities exist, or could potentially occur;
ISO 9001:2015 Cl. 10.2.1.b.3
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It is important to note that ISO 9001:2015 cl. 10.2.1.b.3 also refers to the nonconformities that are similar to the occurred identified
nonconformity.
With regard to Preventive actions in 9001:2008 version,
their main purpose was to identify, analyze and eliminate the causes of potential nonconformities. The
main technique to identify potential nonconformities was negative trends
of processes identification and analysis.
In 9001:2015 Version, the requirements for monitoring,
measuring, analysis and evaluation were enhanced, which, among other things,
provide negative trends analysis. In addition, a very effective tool for prevention
of potential issues, including nonconformities, was added – Actions to address
risks and opportunities. In this regard, 9001:2015 version excluded the ‘preventive
actions’ term as being less generic compared to the new techniques.
More questions answered in the ISO 9001:2015 QMS Transition Program Workshop
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