My customer have requested to follow new procedure for uploading certain documents into their portal. how do i control it internally making sure the

[Maddy1992]

My customer have requested to follow new procedure for uploading certain documents into their portal. how do i control it internally making sure the necessary personnel is trained and aware of the changes. is there a certain format or template to suggest?

 

[Ed Panek]

Create a controlled training document. We use REF or reference for the naming. It could just be a power point with the instructions on it. That's the least burdensome. If the customer has problems with your compliance you can escalate in your QMS to be more formal.

Assuming this is ISO 13485 a risk-based approach is acceptable. For example, what is the result if the process isn't followed correctly? If the result is quite serious then tight controls may be needed

 

[Miner]

Do you have an existing format? Using something already in place is the least disruptive way to go.

Alternatively, you could use a simple job aid format (see example) or one with screenshots (example).

 

[ScottK]

I would have a work instruction for the people doing the upload that they can pull up and reference every time.

We ask this of some of our suppliers and, as a customer, we provide them with instructions on what needs to be in the files, in what format, and the address to upload them... it's up to the supplier to document how they are going get the file to that location with their systems.