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How to deal with a major non-conformity? 
19 March 2021 

How to deal with a major non-conformity? 

During the external audit, the certification body finds a critical deviation with regard to one of the standard requirements. What now? 

First of all: no need to panic! Consider a deviation as a gift and not as criticism; it will certainly not result in the loss of your certificate. It gives you the opportunity to learn where the problem comes from and to remove the weak spot from your system. Such a deviation (a major non-conformity) prevents you from obtaining or renewing a certificate. But this is a temporary problem…you just need to handle it correctly. The non-conformity must be resolved and tested within the timeframe defined by the certification body. Usually this is a period of 3 months. 

Analysis of the cause

Step one is analysis of the cause which will reveal the áctual cause. Make sure that you do not only stick to direct causes but also look for basic causes (errors in procedures, management, method of working etc.). A frequently used method is the 5 x why. 

Corrective action

When the cause is known, step two can be taken: the corrective action. At that moment, the actual deviation is solved (based on direct causes) but also prevented from occurring again in the future (based on basic causes). 

The cause analysis and measures taken must be reported to the auditor before the final step can begin. In the case of a major nonconformity, the effectiveness of the corrective measures must always be verified by the auditor who established the nonconformity. The auditor may wish to return to the site to do this. 

(Re)certification

As soon as the auditor has approved the report, the deviation will be closed and (re)certification can be proceeded to. 

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