G
gretzles
I am working with a company that has several manufacturing locations, but other support processes are localized in a single location.
One manufacturing site manufactures medical devices and requires ISO 13485. So I'm trying to work out how to deal with the support processes that affect this site, but aren't specific for this site and aren't located at this site. Eg Purchasing is done centrally for all sites.
Does anyone have any suggestions of things I need to consider when deciding whether these processes are being outsourced or whether they are just remotely located internal processes.
Either way they need to understand their requirements and how it impacts on the other quality system processes and the risks will determine the monitoring requirements.
Will external auditors want to visit the other sites to audit if they are not listed as outsourced, or would it be enough to have the records available?
One manufacturing site manufactures medical devices and requires ISO 13485. So I'm trying to work out how to deal with the support processes that affect this site, but aren't specific for this site and aren't located at this site. Eg Purchasing is done centrally for all sites.
Does anyone have any suggestions of things I need to consider when deciding whether these processes are being outsourced or whether they are just remotely located internal processes.
Either way they need to understand their requirements and how it impacts on the other quality system processes and the risks will determine the monitoring requirements.
Will external auditors want to visit the other sites to audit if they are not listed as outsourced, or would it be enough to have the records available?