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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 we 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 not to be misled by the ISO 9001:2015 cl. 10.2.1.b.3 that 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,

ISO 9001:2015 QMS Transition QnA

CBG Inc. 2016

Supporting the work of Quality

Professionals
www.c-bg.com

training@c-bg.com

9001:2015 version excluded the preventive actions term as being less generic
compared to the new techniques.

Question: Does the ISO 9001:2015 require the Actions to address risks and
opportunities to be the object of analysis and evaluation?

Answer: When studying the Standard requirements do not get misled by the wording.
The organization shall analyze and evaluate appropriate data and information arising from
monitoring and measurement.
The results of analysis shall be used to evaluate the effectiveness of actions taken to address risks
and opportunities;
ISO 9001:2015 cl.9.1.3.e
ISO 9001:2015 Cl.9.1.3.e refers to the analysis and evaluation of the effectiveness of
actions taken to address risks and opportunities
Thus, saying that Actions to address risks and opportunities are the object of analysis
and evaluation is not entirely accurate.
More questions answered in the ISO 9001:2015 QMS Transition Program Workshop

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CBG Inc. 2016