Hello!

My company deals with patients in dentistry. We make artificial teeth with specifications that are unique to each patient. The work order comes from dentists along with cast / model of the teeth of each patient. We complete the work and send it back to the dentist.

Can anyone help me? How should I start with the implementation process? Is there anybody from a related company or with product that is customer specific?

Vini

Start with a Gap Analysis (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=gap+analysis). Do you have a copy of ISO 9001?

Hello!

My company deals with patients in dentistry. We make artificial teeth with specifications that are unique to each patient. The work order comes from dentists along with cast / model of the teeth of each patient. We complete the work and send it back to the dentist.

Can anyone help me? How should I start with the implementation process? Is there anybody from a related company or with product that is customer specific?

ViniArtificial teeth are medical devices. Use ISO 13485 as a Quality Standard. There is an ISO 13485 Gap Analysis posted here (http://elsmar.com/Forums/attachment.php?attachmentid=1922).

Start with a Gap Analysis (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=gap+analysis). Do you have a copy of ISO 9001?

Hello Marc, I dont have a copy of ISO 9001,

I have been going thru GAP analysis. It puts some sense. Thanks, marc & Al Rosen

Vini

Hello Marc, I dont have a copy of ISO 9001,

I have been going thru GAP analysis. It puts some sense. Thanks, marc & Al Rosen

ViniGet ISO 13485!

My company deals with patients in dentistry. We make artificial teeth with specifications that are unique to each patient. Finally! A quality system that will have some teeth to it....:lmao:

Sorry, I couldn't resist....:tg:

Get ISO 13485!
Al's right. You really need the appropriate standards to read :read: and reference.

is any of the denture sent to the US?

I will get a copy.

Yes, we send to US

I will get a copy.

Yes, we send to USYou also need to meet the FDA regulations including the QSR. (http://www.fda.gov/cdrh/devadvice/)

The QSR is exhaustive :thanx:

The QSR is exhaustive :thanx:How so??

How so??

I'm not sure whether he meant "exhaustive" (comprehensive) or "exhausting" (very tiring). Maybe both (exhaustiving?) :D

I'm not sure whether he meant "exhaustive" (comprehensive) or "exhausting" (very tiring). Maybe both (exhaustiving?) :DI think both, but I interpreted it as the latter.

"This manual is arranged as if the reader were starting a new business. That is, as if an entrepreneur were sequentially:
1. obtaining information on GMP requirements;
2. determining the appropriate quality system needed to control the design, production and distribution of the proposed device;
3. designing products and processes;
4. training employees;
5. acquiring adequate facilities;
6. purchasing and installing processing equipment;
7. drafting the device master record;
8. noting how to change the device master records;
9. procuring components and materials;
10. producing devices;
11. labeling devices;
12. evaluating finished devices;
13. packaging devices;
14. distributing devices;
15. processing complaints and analyzing service and repair data;
16. servicing devices;
17. auditing and correcting deficiencies in the quality system; and,
18. preparing for an FDA inspection."

The above is from the Quality System regulation. I am new to ISO Quality System and wanted help to start from scratch. I meant exhaustive as the manual deals with all departments and also contains samples of flow charts, forms, & other basic informations that I need. I am not going for a FDA inspection, but can use most of the informations given.

I am not a 'he', I am a 'she':)

Hi There,

The need for ISO 13485 is for medical device manufacturer's and if you are exporting to either Canada or the USA this requirement is critical. In addition there are other governmental requirements as well.

Based on your post, my recommendation would be to define your scope of registration, it seems that you are manufacturing (teeth or dentures) based on data submitted by dentists.

The best course of action is to proceed to ISO 9001:2000 certification in which you would define your scope of registration as such. The ISO 13485 requirements are clear, perhaps you would be better off achieving ISO 9001:2000 certification and allow yourself to appeal to a broader customer base.

Thanks and good luck.