ISO 9001:2015 Software Validation Query

Starting to get Involved
Hi All,

We are a dental distribution company based in the UK and hold ISO 9001:2015, we ship products from the EU to a third party distributor in the UK, the office primarily performs order processing, marketing, accounts and other admin activities.

Primarily we use a SAGE software to process orders and help monitor stock levels (working with our third party distributor). Other than the basic microsoft office software, this is the only software we utilise.

We have a software validation process in place, which only covers the SAGE software. I'm wondering that if we can show the SAGE software functions as expected, through the party that provides it, can we essentially remove this process? As I personally don't see the value it adds to our business


Super Moderator
What requirement in ISO 9001 are you addressing with this? I may be getting confused, but I don't recall 9001 mentioning software validation particularly. If you have an internal requirement, may be a different story.


Not out of the crisis
Super Moderator
ISO 9001 doesn't specifically require software validation. The only place validation is mentioned outside of the design and development clauses is 8.5.1 f - and this is validation of production and services where the outputs can't be verified.

So unless you set an internal requirement to validate you order processing software, you don't need to.

Big Jim

The medical devices standard (13485) includes requirements for validation of software. Are your dental related customers expecting validation of software?
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