ISO 9001 certification with limited scope

[nickie]

Hi, we are a small company, primarily a distributor of medical devices but we do some small scale contract development and manufacture work in this field. We operate an ISO 13485:2016 QMS and have recently submitted a tender bid to supply products as a distributor to a big organisation that requires us to be certified to ISO 9001:2015. For speed and simplicity, we have decided to limit the scope of this certification to sales and distribution, as this is all that is required for this organisation. We have a third party 9001 audit next month.

I have identified and addressed the requirements that differ from those of ISO 13485 and put together a simple top level manual, as a separate document to our ISO 13485 manual. However, I'm not sure whether in this I should just include the processes that are directly related to sales and distribution, or include the other processes that the company performs in a flow chart but maybe indicate somehow they are not relevant to the scope?

Thank you.

 

[ScottK]

Hi, we are a small company, primarily a distributor of medical devices but we do some small scale contract development and manufacture work in this field. We operate an ISO 13485:2016 QMS and have recently submitted a tender bid to supply products as a distributor to a big organisation that requires us to be certified to ISO 9001:2015. For speed and simplicity, we have decided to limit the scope of this certification to sales and distribution, as this is all that is required for this organisation. We have a third party 9001 audit next month.

I have identified and addressed the requirements that differ from those of ISO 13485 and put together a simple top level manual, as a separate document to our ISO 13485 manual. However, I'm not sure whether in this I should just include the processes that are directly related to sales and distribution, or include the other processes that the company performs in a flow chart but maybe indicate somehow they are not relevant to the scope?

Thank you.

Have you questioned the customer on this?
I've never run across a situation where a customer would insist on ISO 9001 registration if I already had ISO 13485.

 

[nickie]

Thanks for your reply. Yes, we did question the customer, and they do not recognise 13485 despite the products they are buying being medical devices! Despite telling them 13485 was actually more relevant to the products they insist on 9001 which is frustrating, but winning the tender would mean a lot of business for us so unfortunately they call the shots!

 

[ScottK]

Thanks for your reply. Yes, we did question the customer, and they do not recognise 13485 despite the products they are buying being medical devices! Despite telling them 13485 was actually more relevant to the products they insist on 9001 which is frustrating, but winning the tender would mean a lot of business for us so unfortunately they call the shots!

I think you're best bet is taking this up with your registrar to get their expectations and how they see 9001 and 13485 integrated. They're not as similar as they used to be and it may be that you may as well not limit the scope because you'll be doing close to the same amount of work, particularly in regard to the context of the organization and continual improvement.