Dear Aneela,

  I'm assuming by now you have spoken to Konstantinos Flampouris regarding the current status of the Viamed certificates,

 Is there anything I can do to get things moving, I dont have any other BSI Invoices I can with-hold to force the issue.

The foremost Issue is the ISO 13485:2016 Certificate as our old certificate has now Expired. Aside from the outstanding Technical File Issues, I believe we got a completly clean bill of health regarding the actual 13485:2016 QMS system.

With regard the technical files - I believe it looks worse than it actually is. A bit of content, 

It starts with the Visit from Richard Tully in August 2015, He reviewed / audited our Tom thumb Files (on site in our offices).
Minor Non Conformance 1225836N1 Essential Requirements was raised due to our ER list being Generic and pointing to the location of files.
The ER checklist has subsequently been computerised like the rest of our QMS system, with each ER pointing to digital copies of files required.

The 2017 Reports with all the non conformances, were on the product files :  
Tom thumb (Same files as Richard Tully audited 2 years prior), 
Microstim, 
and CE540537 (an own brand label certificate),

The 2017 Reports had pretty much the same non conformances repeated across them. including I believe a non conformance for us not having a 'Declaration of conformance' in the files. Which is the very first document any auditor asks to see against any product whether being audited from a QMS or a Technical perspective. So something fundemental went wrong between our system on site and the Remote Audit offsite. This should have been obvious if the auditor in 2017 took a look at the previous look at the technical visits to Viamed as the exact same files had been reviewed before (within 2 years).

I believe it comes down to the computerisation of the ER list, while on site its simply a matter of selecting the requirment and then looking at the documents linked, the PDF print of the ER had an issue in it was not listing all the documents it should have done. this was not seen before the remote files  were generated as the PDF is not required to actually utilise the system while on site. 
While the files were supplied I dont think they were looked at, I believe the auditor only looked for files specifically linked to the ER PDF listing.

Unfortunatly, I went away on annual leave July 2017, and came back with a severely broken shoulder requiring full general surgery so I was out of action for quite some time. I attempted to be available for the QMS audit on the 12th/13th/14th September 2017 but lasted 1 day before I had to call a stop to the audit, it was too soon after my operation for me to be able to function. This didnt help in trying to clear up the non conformances. which now seem to be in limbo, and I get no response when trying to get them resolved.

Also for the Record,
CE 540537, BSI have never been supplied Any Files for you to review. Repeatably throughout 2017, as soon as OBL certificates had been stopped and OBL had to become full virtual manufacturer, I told BSI I would be removing the Viamed name and be adding the original manufacturers name as the manufacturer to all the various products. so we would not be requiring the CE 540537 to be reviewed - just a little time to cycle past the stock with the Viamed name on, 
Yet I have a BSI report on CE 540735, full of non conformances, on files you have never recieved (Because they dont exist, we only had files to comply with OBL requirements).








 




















 



 as there were 3 'Remote' Audits done at the same time,
the files were sent to BSI months before the actual audits,
the acutal audits July 2017 were carried out as I left for my annual leave, which I came back with a severely broken shoulder requiring full general surgery