Implementing ISO 9001 in a customised product environment - We make artificial teeth

[vinisanthosh]

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

 

[Marc]

Dental Product - We make artificial teeth specific to the patient

Start with a Gap Analysis. Do you have a copy of ISO 9001?

 

[Al Rosen]

Re: Implementing ISO 9001 in a customised product environment - We make artificial te

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

Artificial teeth are medical devices. Use ISO 13485 as a Quality Standard. There is an ISO 13485 Gap Analysis posted here.

 

[vinisanthosh]

Re: Dental Product - We make artificial teeth specific to the patient

Start with a 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

 

[Al Rosen]

Re: Dental Product - We make artificial teeth specific to the patient

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

Get ISO 13485!

 

[Sidney Vianna]

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....

Sorry, I couldn't resist....

 

[Marc]

Re: Dental Product - We make artificial teeth specific to the patient

Get ISO 13485!

Al's right. You really need the appropriate standards to read and reference.

 

[apestate]

is any of the denture sent to the US?

 

[vinisanthosh]

I will get a copy.

Yes, we send to US

 

[Al Rosen]

Re: Implementing ISO 9001 in a customised product environment - We make artificial te

I will get a copy.

Yes, we send to US

You also need to meet the FDA regulations including the QSR.