sandra2014
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Hello,
I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and directed it to be changed to an opportunity for improvement. This was noted and signed on the final report by the GM/VP. I searched all the applicable AS9100D, ISO 13485:2016, ISO 9001:2015 stds, but the requirements do not specifically state that this is a violation. Please direct me to the specific clause that would deem this unacceptable? Any advice is greatly appreciated!
I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and directed it to be changed to an opportunity for improvement. This was noted and signed on the final report by the GM/VP. I searched all the applicable AS9100D, ISO 13485:2016, ISO 9001:2015 stds, but the requirements do not specifically state that this is a violation. Please direct me to the specific clause that would deem this unacceptable? Any advice is greatly appreciated!