Afeter a recent audit performed by a customer, my company was issued a finding that we did not solicit feedback from them on a regular basis. This was a finding against ISO 13485 7.2.3 & 8.2.1.
Is my company required to ask for performance data?
Several years ago, an employee at that company used to send my company performance data (on-time delivery, quality / escapes). He left the company and a new guy took over, the same guy who issued this finding. To me it appears the ball was dropped at that company. Nothing was probably written down as to what was being done and when the new guy started - no more data was presented.
The "problem" was found during the audit when management review records were reviewed. There was performance data from other companies in there, data which was provide by but never solicited from them, but there wasn't any in there for his company.
Is there an actual nonconformance here?
Is my company required to ask for performance data?
Several years ago, an employee at that company used to send my company performance data (on-time delivery, quality / escapes). He left the company and a new guy took over, the same guy who issued this finding. To me it appears the ball was dropped at that company. Nothing was probably written down as to what was being done and when the new guy started - no more data was presented.
The "problem" was found during the audit when management review records were reviewed. There was performance data from other companies in there, data which was provide by but never solicited from them, but there wasn't any in there for his company.
Is there an actual nonconformance here?