Thursday, April 7, 2016

QMS Transition to the ISO 9001:2015 requirements: questions and answers

A saying 'The devil is in the detail' is 100% applicable to the QMS transition to the new version of ISO 9001:2015.
The requirements wording of the Standard is often confusing while the decisions to be made are very important.

We start publishing Questions that other users encountered in the process of their QMS transition with our Answers.

If you have a QMS related question - please email it to support@c-bg.com  and will do our best to get you an expert opinion.


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

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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