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Risk based quality management system auditing

Quality Management System auditing is not a new concept; however, Risk based quality management system auditing is relatively new. Both auditing and risk based auditing and controls have been there in finance and accounting world for a long time. But now it is getting more and more attention in Management Systems too. All organizations have challenges in their businesses, But these internal and external challenges pose a threat to our goals and risk of their non fulfillment. Risk is compound estimate of the probable frequency, severity or perception of harm & damage. So more chances of something going wrong the more risk, the more severe the consequences the higher the risk. Sure, the worst scenario would be higher probability and severe consequences. But without risk there is no innovation, return, rewards so what should we do, answer to that is that we should manage the risk by establishing processes and controls. Risk management is Analysis, evaluation and assessment of risk and its rational control in helping to promote the objectives and targets of the business.

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We can give more value to our Quality Management System audit by linking audit results with risk. In Risk Based QMS audit we go step beyond NCR identification and do categorization based on risk. It will add value as on the basis of that management can prioritize issues accordingly.

We can make a table for all the clauses and sub clauses of the standard. During audit assign risk of High, Medium & Low as per the probability and severity of the item. We can also assign score to each clause/requirement with reference to audit result.


After audit the score and risk data can be consolidated and analyzed to prioritize the actions to be taken.

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Risk based quality management system  

Risk is compound estimate of the probable frequency, severity or perception of harm & damage. So more chances of something going wrong the m...

Risk based quality management system  

Risk is compound estimate of the probable frequency, severity or perception of harm & damage. So more chances of something going wrong the m...

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