Search the Elsmar Cove!
**Search ALL of** with DuckDuckGo including content not in the forum - Search results with No ads.

Quality Agreement with supplier covering medical devices and consumer requirements

Ajit Basrur

Staff member
My question is specifically on how do organizations maintain the quality agreement requirements with their contract manufacturer - in my example, an organization who manufactures medical devices and consumer electronics have a contract manufacturer. The organization proposed two different quality agreements but the contract manufacturer is suggesting a single agreement with two sets of requirements.

I was leaning two different quality agreements but was also thinking of a single agreement based on the ISO 13485 standard, where they had the text from ISO 9001 in black and specific medical device requirements in blue text.

I would love to hear from you all if you have encountered this situation and what approach did you take?



Involved In Discussions
My organization had a single quality agreement with our CM. The CM had a process where they performed a regulatory assessment to tailor their internal QMS controls to the needs of the specific product to be manufactured. As the customer, we signed off on this assessment. In our case, products ranged from a class III life sustaining device as well as telecom product.


Starting to get Involved
It may be smart, depending on the legal ins and outs, to contractually agree to the implementation of a separate quality plan document which is more able to grow and change to reflect the needs of your business and which you can issue on an ongoing basis (subject to their acceptance and sign-off on the changes).

It could be thought of as similar to maintaining up to date part specifications, only for your quality requirements. This might help you separate the regular legal wordiness from more specific quality requirements.
Top Bottom