ISO13485 Section 7.5.1.1 and 7.5.2.1 for a Distributor

Q

QAtemp

I am with a company that is a distributor that distributes a product that is specified as medical grade material. We do not manufacture the material. We receive the material in and pretty much ship it out. Sometimes we re-package the material into smaller packages when requested by a customer.

I am currently writing the Quality Manual and I am not sure how applicable Sections "7.5.1.1 Control of production and service provision" and "7.5.2.1 Validation of processes for production and service provision" are to our business. We do not perform any value added processes.

When we do re-package, we QC sample test some of the material. It involves some analytical equipment that utilizes software. So, another question is "Should that software be validated?"

Thanks!
 
A

Aliasanonymous

The service you provide in this case is distribution and re-packaging.
The control is hence on the incoming and outgoing of the product, as well as packaging. How you ensure goods are in acceptable conditions when coming in or going out.. How do you re-package your product and make sure they are correctly done.. identification and traceability and all the other requirements that falls under control of production and service provision.

Your software is used to verify the conformance of your products and hence need to be validated.

:2cents:
 
Top Bottom