6.1 Planning: NC on External Audit

We have received the Nonconformity on our external Audit

While planning QMS quality objectives do not take into account clause 4.1 (Issue/risks and opportunities). How to close it?

 

Good day @Ptbabu;
Consider this...
* Think of 4.1 and 4.2 as the identification of who cares and what do they care about (relative to your organization's "purpose" and "...organization’s ability to consistently provide products
and services that meet customer and applicable statutory and regulatory requirements").

* Once you have identified who cares and what do they care about, then consider risks and opportunities associated with them and address with plans those "...that need to be
addressed...." [6.1].

Food for thought....
Many times long standing and well run organizations already meet the intent of the standard. If this describes your organization, then maybe your organization's existing goals and objectives (and associated plans) ALREADY address the risks and opportunities associated with what was identified via 4.1 and 4.2? Maybe the gap is simply the need to "tie" the current goals and objectives (and associated plans) with the risks and opportunities relative to the "who" and "what" identified via 4.1 and 4.2?

Hope this helps.
Be well.

 

How did the auditor know that you failed to consider 4.1 and 4.2? I’d like to see also the statement of the nc.

 

I think it may be a typo which should be 6.1.

 

Yes, I am also anxious to see the actual citing Andy.