ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records

[Diair Marques]

Hello everybody!
I am a newcommer to this site and I am really excited about it. Actuallly, I have read most of the threads under medical devices, and learned a lot.

Help needed!!

We are pursuing ISO 13485 certification.
The scope of the audit is for a Class II product designed under the restrict Desing Control requirements. However, the production kick off is in November. KEMA audit is in December.

Our Quality Manual (complaint to ISO 13485) is in place since July. We have operated under the new QMS for the manufacturing of a fluoride-free toothpaste (cosmetic/no claims) since July to validate the System.
Yes, we chose the same approach for the toothpaste (except for Design Control) to make it consistent.

1- Does somebody knows if KEMA will audit the toothpaste records to assess the existing QMS as the only tool to evaluate records? We will have almost zero records for the Class II product by the time they get here. How it works???

[Aaron Lupo]

Originally Posted by Diair Marques

Hello everybody!
I am a newcommer to this site and I am really excited about it. Actuallly, I have read most of the threads under medical devices, and learned a lot.

Help needed!!

We are pursuing ISO 13485 certification.
The scope of the audit is for a Class II product designed under the restrict Desing Control requirements. However, the production kick off is in November. KEMA audit is in December.

Our Quality Manual (complaint to ISO 13485) is in place since July. We have operated under the new QMS for the manufacturing of a fluoride-free toothpaste (cosmetic/no claims) since July to validate the System.
Yes, we chose the same approach for the toothpaste (except for Design Control) to make it consistent.

1- Does somebody knows if KEMA will audit the toothpaste records to assess the existing QMS as the only tool to evaluate records? We will have almost zero records for the Class II product by the time they get here. How it works???

Are you going for ISO 13485:2003 or 13485:1996? If you want the toothpaste side of your business to be ISO Certified they will audit the records if not then they won't. We use KEMA as our Registrar and they have been very good.