Supplier / contract testing facility audits - Small start-up - Medical devices

[Wesley - 2007]

I just posted an EM question, now I'm going to hit you for some more assistance.

I have recently become the Quality Manager at a small, start-up medical device company in NC. In this role I will be conducting vendor and contract testing facility audits. I am looking for some guidance on what areas I should focus on and maybe a template of an audit plan to use as a reference tool. If anyone has any information to assist me, or can recommend a reference material, (book, article, etc.) I would be greatly appreciative.

Thank you,

Wes

 

[Al Rosen]

I just posted an EM question, now I'm going to hit you for some more assistance.

I have recently become the Quality Manager at a small, start-up medical device company in NC. In this role I will be conducting vendor and contract testing facility audits. I am looking for some guidance on what areas I should focus on and maybe a template of an audit plan to use as a reference tool. If anyone has any information to assist me, or can recommend a reference material, (book, article, etc.) I would be greatly appreciative.

Thank you,

Wes

Hi Wesley, welcome to the cove.

Try doing a search in the attachments for *supplier*. You will find a number of documents that you may find useful.

 

[Marc]

Also check the Attachments Listing.

 

[Wes Bucey]

Don't hesitate to ask questions about anything you find which might not be clear to you.

 

[Wes Bucey]

Another "bump up" after a slow weekend.

 

[Wes Bucey]

Another bump. I'm stunned there are no answers to this question. I've been bragging up the experts at the Cove and I need my own faith restored.

 

[Wesley - 2007]

I searched the attachments and found many things which will be helpful. Thank you for pointing me in that direction.

Wesley

 

[Pataha]

If you are going the ISO approach, you will have to refer to ISO 19011:2002(e), plus suppliers and contract testing groups will also fall under your risk management plan, which sends you over to ANSI/AAMI/ISO 14971:2000 y 14971/A1:2003. Also, you will need to determine what test will need to be performed for your device. Also depending whether or not you plan to CE Mark Class II or above devices, your testing facility should be recognized to create a CB Scheme. The approved list is on web page (broken link removed). This allows you the freedom of selecting your own notifing body and not get stuck with certain slow ones. Depending on your Medical Device, some of yopur suppliers may already have a CB Scheme on your critical components, this helps control costs with at lest one testing group that I use.

Craig.

 

[VHoneyghan]

Greetings -
I am also looking for a checklist or guidance doc for auditing a med device manufacturer in China. Were you able to find any good docs?
Could you direct me to any?
Thanks