V
Greetings -
I am the Quality Manager at a small business, we sell medical devices - digital thermometers and blood pressure monitors - our manufacturers are in China and Taiwan. Our company is ISO 13488:1996 and CMDCAS certified.
My boss is going to China next week and I want him to conduct a vendor audit at one of our factories. Our internal audit schedule deems this necessary.
I need some good guidance docs and/or checklists to give him. He has conducted factory audits before but for toys. I need something specific for med devices.
I read a reply which stated one should write their own checklist. I'm okay with doing that but what do I start with?
Thanks for your time,
Van
I am the Quality Manager at a small business, we sell medical devices - digital thermometers and blood pressure monitors - our manufacturers are in China and Taiwan. Our company is ISO 13488:1996 and CMDCAS certified.
My boss is going to China next week and I want him to conduct a vendor audit at one of our factories. Our internal audit schedule deems this necessary.
I need some good guidance docs and/or checklists to give him. He has conducted factory audits before but for toys. I need something specific for med devices.
I read a reply which stated one should write their own checklist. I'm okay with doing that but what do I start with?
Thanks for your time,
Van