Quality Manual for 2nd site

[mgoodman08]

Our company is expanding some of our production to another site. We'll be using all the same procedures etc since it's production we are currently doing now. Was looking for advice/tips about the quality manual. I don't think we need a separate one or do we or do I just add the address to the cover of our current QM?

For context we are a ISO 13485:2016 Medical Device Manufacturer.

 

[Marc]

We'll be using all the same procedures etc since it's production we are currently doing now.

I would think another quality manual wouldn't be necessary as long as it's clear that procedures, etc., from the "mother ship" are to be followed at the satellite site. that said, with regard to various procedures, ensure that you have appropriate procedures specific to that site. Most of the companies I have seen had additional site-specific procedures of one type or another, not always related to production.

 

[indubioush]

Your quality manual needs to state the role of each company site and the applicability of quality system requirements for each site. For example, if one site is responsible for product development and the other is a manufacturing-only site, your quality manual needs to state this.

 

[Marc]

That's true. The "main" quality and/or relevant documents will all have to be appropriately revised.