How to cover another manufacturing "site" or warehouse into current ISO 13485 cert

[ganglai]

Hi all,

We are a small class I medical device manufacturer. Because of increase in volume/orders, we have to look into moving one or two manufacturing processes, e.g melding or assembly or warehouse into another site close by.

The team will still be the same team, e.g. GM, QA, PM. We just need more spaces to allow everything to happen.

The QMS system will be the same. Is it just as simply as to adding the other "site" onto the manual? Thanks.

 

[somashekar]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

The words 'Close by' is very important.

Also of importance is the need to have the another site mentioned on the certificate.

This certainly will be a significant change, and you have to address all the process links and changes that are foreseen ... {Remember to understand what is required per the 5.4.2 b) of the ISO 13485}
The next is to threadbare discuss your plan with your CB.

 

[ganglai]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

Thanks for your reply.

Just a following up question. Finish product will only be off from one "site" and the other "site" will only produce WIP. Will the site which produces WIP be required in the certificate? Many thanks.

 

[somashekar]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

Not necessary. But if you so desire, you can have it on the certificate. This again is a part of your big plan, that you must discuss with your CB as soon as you firm up the plan.

 

[MIREGMGR]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

Our major CB's stance is that inclusion on the certificate of a second building, which itself does not create finished devices, is mandatory.

 

[Ajit Basrur]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

My understanding is also on the same lines as MIREGMGR.

 

[ganglai]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

Big thanks to all.

We will discuss this with the CB.

Again thanks to all.

 

[ElizaAnderson]

Re: How to cover another manufacturing "site" or warehouse into current ISO 13485 cer

Not necessary. But if you so desire, you can have it on the certificate. This again is a part of your big plan, that you must discuss with your CB as soon as you firm up the plan.

You are saying right, it is not necessary, but totally depends on company desire and plan.