ISO 9001 Document Management

Nath_McC

Hi All,

I am very much in favour of moving everything to the cloud or SaaS, and Onshape is an outstanding example.

I wondered if any working to ISO 9001 would share how they work with their document management.

Do you use SaaS/Software or a traditional network folder structure (word documents saved in a Quality folder) to manage policies, procedures, work instructions etc?

S1mon

You can use Onshape's version control and permissions to manage any kind of files you want. If most of your team is using Onshape all the time, it could be reasonable, but if they are mostly non-CAD users, it's probably not a good fit. Google drive and OneDrive both have very basic version control and the ability to lock things down, but a big serious company is more likely to use a different tool to manage this stuff. I assume if you're getting 9001, there are other industry related certifications that might be relevant. That could drive the choice of tools. e.g. If you're in medical there are a bunch of things you're going to need to document in very particular ways and you're going to go through regular audits. If the auditors have never seen Onshape, they may dig in a little too deep and find something that's wrong, but if you use a known tool, they might be more likely to assume you've got things sorted.

Nath_McC

Thanks for the reply @S1mon. I understand where you are coming from. The company I work for is already ISO certified and uses the traditional folder route to manage the documents. I've been looking into it and was interested in anybody else's methods, and I know it is a nightmare for management.

My initial thoughts were the management through Onshape. As you mentioned, most people using it would be non-cad users. I had the same thought process as you. With auditors looking too deep into it, it could open up a can of worms.

As for google drive/docs, I was unaware you could lock things down. I used Gmail for my freelance business and I haven't dived into sheets/docs very much. Traditional Word/excel is still heavily used in the day job.

My research sent me towards cloud apps, which all seemed to have hefty price tags. I also looked into eQMS, which seems all-medical basis and follows the medical standards but nothing for 9001.

S1mon

Arena, which is also owned by PTC, has an integration with Onshape and has stuff for managing compliance and quality.
https://www.ptc.com/en/products/arena

It's also SaaS and it happens to be a great PLM tool, if that's something you also need....

Nath_McC

Arena looked like a great contender from the information I found, and I loved the integration. 

As a single-person company wanting to bring a product to market, I was not entertained. The PTC/Arena sales team would not discuss anything in great detail (I didn't even get a demo) because it was clear I was not a big fish and was pushed more to go through the day job (the bigger fish). I even asked what the minimum number of uses needed to run correctly, and they could/would not tell me. I was expecting maybe two users to be required. I through.

As an engineer at my day job (manufacturing), I have a lot of obstacles and approvals before the software can be integrated. With the likely 

From my research, it seems there is a gap in the market for a piece of eQMS/ePLM software for a one or two-person company starting with a product line and wanting to integrate a piece of software at the ground level, then being able to expand into it and add users, if needed.

S1mon

From my discussions with them, a seat of Arena was roughly the same cost per year as a seat of Onshape Enterprise. I’ve had pretty good chats with Sarah Fiorillo at Arena, even though if/when we implement it, we’re only looking at a few seats.

tim_hess

I've spent some time working on document management for a medical device startup in the US trying to follow FDA requirements. In my research, Onshape by itself wasn't sufficient for managing design documents because of signature requirements. However, from my reading, it seemed like it could work in a 9001 system with different requirements. 

Our company also used google docs - but it still had some functionality gaps at the time. 

For better or worse, Sharepoint seemed like the most reasonable option for a small team. It requires a lot of setup and customization to get what you want, but the cost is reasonable. 

The good thing about onshape is that you can get static links to specific versions. So, even if design content lives in Onshape, you can copy links to your other documents as needed. 

For a little more money (min $500/month for 20 users) you could look at Cognidox - they have pretty good integrations with MS office tools. This would be a step above sharepoint in terms of ease-of-use (and require less configuration, potentially).  Pricing Page | Cognidox Lean Document Management System

Nath_McC

@S1mon, This is good to know.

Thank you, @tim_hess some great information, and I hadn't thought about using Onshape links in documents.