Supplier Management Requirements - AS9100 vs. ISO13485

[cutsdean]

We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of ISO13485, but have an issue over supplier management.

We currently have supplier groups for General, Aerospace Production, Stockists, Engineering & Nuclear. It has been suggested that we have another category for medical, but some of the suppliers used for medical product are also Aerospace suppliers. Are there any great differences in the way suppliers should be handled in ISO13485 to that of any other management system?

Any help would be most greatful

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

Stijloor.

 

[MRWardell]

We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of ISO13485, but have an issue over supplier management.

We currently have supplier groups for General, Aerospace Production, Stockists, Engineering & Nuclear. It has been suggested that we have another category for medical, but some of the suppliers used for medical product are also Aerospace suppliers. Are there any great differences in the way suppliers should be handled in ISO13485 to that of any other management system?

Any help would be most greatful

Some quick thoughts. Since you are AS9100 your supplier approval process is probably pretty robust. The FDA/13485 expectation is that you are qualifying your vendors and that the qualification process recognizes the level of criticality of the part or service. Our registrar has the expectation that we do on-site audits of the most critical vendors, at least when we qualify them. Supplier scorecards or some other method of assessing supplier performance is also important. One word of caution - I could not tell from the posting if this is a medical device you designed, or if you are contract manufacturing. Either way, I would suggest you investigate your responsibility to comply with FDA regulations - 21 CFR 820. Here is a link to a great FDA website and document which can provide some guidance. http://www.fda.gov/MedicalDevices/D...MedicalDeviceQualitySystemsManual/default.htm

 

[MIREGMGR]

...your responsibility to comply with FDA regulations

Noting the OP's apparent UK location, this may not apply depending on the customer's location and preferences, of course.

Questions for the OP, which may reveal my lack of knowledge of AS9100 mechanisms: is the organization's certification-oversight with respect to AS9100 and ISO 13485 by the same third party ("notified body" or whatever terminology is appropriate for AS9100), or separate ones? Do some or all of the "medical"-group suppliers have their own ISO 13485 certification?

 

[JJC1979]

I have implemented an AS9100 and ISO 13485 system at the same time in my previous life What you are doing for AS9100 should be sufficient for ISO 13485, however if you have suppliers that are producing a custom part for the product that you are producing; you will want to at least have some type of management in regards to supplier audit or assessment. The first question would really be for me, what are you doing for supplier management in regards to complying with AS9100. Meaning what does your procedure dictate that you will do for supplier management of your suppliers at this point in time?

 

[ssz102]

sorry i have no experice on aerospace and medical products
but i hoping other people can reslove this problem