When a nonconformity occurs, including any arising from complaints, the company will: react to the nonconformity and, as applicable: act to control and correct it; deal with the consequences; evaluate the need for action to eliminate the cause[s] of the nonconformity, in order that it does not recur or occur elsewhere, by: reviewing and analysing the nonconformity; determining the causes of the nonconformity; determining if similar nonconformities exist, or could potentially occur; implement any action noted; review the effectiveness of any corrective action taken; update risks and opportunities determined during planning, if necessary; make changes to the Quality Management System, if necessary. Corrective actions are appropriate to the effects of the nonconformities encountered. The company retains documented information as evidence of the nature of the nonconformities any subsequent actions taken and the results of any corrective action.
What a yawn. The most important clause in the standard and it will put you to sleep. And to kick it all off, the standard uses the wonderful term, nonconformity. I have often wondered if there would be a better word to describe something that is not fit for purpose (previous quality rant), but the old thesaurus doesn’t give us much. At least be thankful they didn’t decide to use any of these… disapprobation, discordance, heterodoxy, recalcitrance, transgression or contumaciousness. Dodged that bullet.
But enough of the words, it is the intent that is the maxim here. Leaving the specificity (noice word huh) of having to highlight the need to include complaints (der), the standard wants us to react, then control, then correct, then deal with consequences both now and possible future impacts. There are no guidelines or notations or examples, just good old find it, fix it, test it and stop it from happening again based on the risk to your business. Super stuff this. The only prescriptive part of the clause is to keep records to show what you have done. No process, no procedure. Just show the evidence and away you go.