Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same. Mid-2018 we recertified our medical device manufacturing facility to ISO 13485 under the MDSAP certification plan. We completed the audit with a few minor NC's and were recommended for re-certification. To this date, we still have not received our certificate due to a 'backlog' with our auditing body. We have pressed them repeatedly on this and have mostly been given the runaround for the past 7 months or so.
Is anyone else experiencing this issue with their auditing body? Is it worth investigating other auditing bodies to see if we can get better service elsewhere? From what I'm reading, it looks like this might be a problem with multiple firms now. This has gone on long enough to potentially be a breach of contract on the auditor's part and is beginning to impact our business operations.
I'm curious if others are having the same issue and how you plan to handle it!
Is anyone else experiencing this issue with their auditing body? Is it worth investigating other auditing bodies to see if we can get better service elsewhere? From what I'm reading, it looks like this might be a problem with multiple firms now. This has gone on long enough to potentially be a breach of contract on the auditor's part and is beginning to impact our business operations.
I'm curious if others are having the same issue and how you plan to handle it!