Reapplying for ISO 13485 certification after certificate revocation

[blmuskrat]

We lost our ISO 13485:2003 with CMDCAS certificate 18 months ago and I wanted to go to ISO 13485:2016 but Canada will not recognize the 2016 version for sale of product. I am reverting to a revised corrected company QMS to the 2003 standard and want to use a new 3rd party registrar company. Do I need to devulge that I had a prior certificate to this new registrar and lost it due the QA Manager not getting the CAPA's resolved in time? The previous registrar decided not to renew certificate due to this reason, the QA person is no longer and nothing transpired for 18 months, plus their expense was exhoribatant. I've since revised the old QMS and corrected prior CAPA's to compliance to the 2003 and await the new registrar but want to know the correct process I should undertake before the new audit, thanks.

 

[Sidney Vianna]

No, you don't need to divulge the fact that the organization had been previously certified, if you starting from scratch again.

Good luck.

 

[blmuskrat]

Thanks, Sidney.

Curious to see if anyone else has comments.

 

[blmuskrat]

Sidney:
Just for clarification, although we lost the ISO and CMDCAS certificates 18 months go, I've been requested to revise and correct what was of the old QMS system that was in place to compliance, which I've done. Would your answer still be the same?

After we have a successful stage I and Stage II audit to ISO 13485:2003, I will implement ISO 13485:2016 later on in mid 2017.

Thanks.