Vendor (supplier) for ISO 13485 Medical Devices Co. minimum QA System

[firnum]

Good Day All,

I am a QA Engr. for a Med. Dev. company needing advice on a camera vendor of ours.

We are an ISO 13485 company which makes a non-invasive and non life threatening device having a critical part camera. The vendor is low volume, low budget, product perfect for our rqmts, and has a post it note QA system accept for product drawings.

I am trying to complete a CAPA for a failure from this company and must come up with a min rqmt QA system for them. Are there any templates, flo-charts, or cryptic control plans (efficient), paper or SW, such that our Final Test procedures/Specs are met and they/us can track non-conformities of their own.

I am thinking of simpling writing our Final Test procedures for them for print out and paper control of lots. The CAPA is for a wrong part in their camera which failed our final test of our system.

Thanks in advance!!!

 

[DannyK]

Re: Vendor for 13485 Med Dev. Co. minimum QA

If the supplier is a good fit, an idea would be to create a specification of the minimum requirements and ask to work together with them to meet the requirements.

 

[jkuil]

Re: Vendor for 13485 Med Dev. Co. minimum QA

You can take a number of measures:

• Look for an alternative supplier who can provide the same camera and has a QMS
• Refrain to strict incomming inspections and accept that you have to reject a number of products.
• Support your supplier in implementing a process control system for the camera that meets your requirements and reduces the rejection rate. These procedures can be developed through common design control methods, including risk management

 

[Ajit Basrur]

Danny and Jan have made valid suggestions here - go in for a supplier who has ISO 9001 and then provide him your specifications for consistent supply. Alternatively, if you see the exisiting supplier is a good fit for your product, develop that suppliers to meet up to the minimum requirements of QMS.