Can ISO 13485 be implemented in just one section of a business?

[lenwelshlass]

Good Afternoon

We are a small manufacturing company who predominantly specialise in the production of wipes and paper.

We have however, recently started to pack a class IIb wound dressings on behalf of the manufacturer.

We are already accredited to ISO 9001:2008 and have a class 8 clean room where the dressings are packed and of course have passed audit by the manufacturers notified body.

We now want to implement ISO 13485 within our own organisation and quite quickly. My colleagues have requested that perhaps we now segment out business to have a "medical" division and only implement the system in that section of the business. There are shared resources though, sales, accounts and warehousing and I am not sure if this can work!!

Does any fellow members have any experience of this or perhaps some advice?

Really appreciate your help.

kind Regards
Helen:

 

[MIREGMGR]

If you use the same NB for the two certificates, I'm sure they can help you to sort out how to document which activities "belong" to which certificate, or to both.

You do however have to do that formal documentation of activities, and it will be referenced constantly in regulatory audits.

No need for two separate businesses or divisions. Lots of businesses have activities subject to more than one type of regulation.

 

[DannyK]

Good Afternoon

We are a small manufacturing company who predominantly specialise in the production of wipes and paper.

We have however, recently started to pack a class IIb wound dressings on behalf of the manufacturer.

We are already accredited to ISO 9001:2008 and have a class 8 clean room where the dressings are packed and of course have passed audit by the manufacturers notified body.

We now want to implement ISO 13485 within our own organisation and quite quickly. My colleagues have requested that perhaps we now segment out business to have a "medical" division and only implement the system in that section of the business. There are shared resources though, sales, accounts and warehousing and I am not sure if this can work!!

Does any fellow members have any experience of this or perhaps some advice?

Really appreciate your help.

kind Regards
Helen:

I have been involved with many companies that have successfully implemented ISO 13485 in a portion of their business. The key point is to identify the scope of activities within the quality manual. You should also ensure that the auditor understands what applies and what does not.

 

[mdurivage]

I have performed audits at companies where one part was 9001 and another part was 13485. Each had an independent quality manual but shared a common core of procedures. However there were procedures and processes that were different.

 

[b9ofus]

There is no reason why you cannot separate a specific process/product for ISO 13485. You may have to have two audits though, one for each registration.