Internal Audit of China factory of Medical devices - need guidance

[VHoneyghan]

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

 

[amjadrana]

The standard ISO 13485/ISO 9001 is a good starting point. The important clauses that are important for the manufacturer in China can be added and some that are not significant can be dropped. There are various checklists posted on the website and also at Elsmar cove

 

[amjadrana]

Try out this correspondance matrix ISO 13485 ISO 9001 FDA for reference and for developing your own checklist:

(broken link removed)

 

[howste]

What is the scope of the audit? Is he going to be auditing to the requirements of the 13485:1996 standard, your specific contract requirements, or something else?

I've attached a generic 13485:1996 checklist that may be useful. It has the 13485 requirements in one column, a blank column to use for specific questions or information you would look for, and a third column for the evidence collected throughout the audit. Of course, being a Word document, you can customize it any way you'd like...

 

[VHoneyghan]

This attachment is very helpful, I appreciate your time.
He will be auditing against the requirements of the standard ISO 13485: 1996. Our contract (Quality Interface Agreement) requirements list each aspect of the standard so he will need to cover the entire QS. I will have him focus on Traceability, Design Control, Inspection and testing, Control of Non-conforming product, and Handling, Storage, Delivery. These are the parts of their QS which most affect our QS and the quality of our products. Also some of these areas have been weak points in communication between us.

Again, thanks for your help. I'm so glad this site exists. I'll be sure to continue reading and utilizing the experience of others!

Van

 

[VHoneyghan]

Thank you! This is helpful to read since the factories themselves are auditing against all of these standards, not just ISO 13485. I'm almost finished with the checklist now.
Van