ISO 9001-Compliant Document Control?

SmoothBreaker writes "Coming into a new company, I have been tasked with sourcing Document Control software to meet ISO 9001 standards. From everything I can find, ISO places no requirements on the software itself, aside from maintaining control of documentation and process. This was discussed eleven years ago. I'd like software that allows intuitive use for our less savvy users, and in a perfect world, graphical access to previous revisions of a document. I've used Microsoft's SharePoint, which the higher-ups like simply because it's Microsoft, but thankfully they trust their Tech Department to find the cream of the crop. What experience do you have with this kind of software, what would you recommend using, and what should I avoid?"

Alfresco

[Anonymous Coward]

You might try checking out Alfresco which is an open-source Java based content management system with an excellent document module. In addition to ISO, it also meets many of the FDA requirements for medical product documentation. The link is http://www.alfresco.com

Re:KT

[solevita]

I clicked reply to say that very thing. We use KT here at work, is very nice, and we're not the only ones [knowledgetree.com]. We'd also looked at Alfresco in the past, but KT won on a number of factors, including ease of use and installation.

I'm going to get flamed all to hell for this...

[jockeys]

but I'm actually a fan of Sharepoint. Have used it for years and never found it lacking for documentation management in my line of work (engineering software development field). The price is an issue for some, but it requires very little maintenance and is fairly intuitive in it's workings, even to a newer user. Most of our co-ops figure out how to use it with little or no instruction, and our senior developers (myself included) haven't complained about lack of features or expressed frustration with not being able to get something done.

just my 2 cents.

Re:I'm going to get flamed all to hell for this...

[uberjack]

My problem with Sharepoint is that doesn't work equally well on non-IE browsers. For example, text formatting is completely unavailable unless you're running IE.

Alfresco is great

[Anonymous Coward]

We use alfresco it runs like a champ....setup can be a bit tough but its worth it.

Design Data Manager

[maillemaker]

I have had good success with Design Data Manager.

This tools is primarily for managing CAD documents, but can also deal with other kinds of data.

http://www.designdatamanager.com/ [designdatamanager.com]

What ISO 9001 is

[autophile]

Say what you do, and do what you say. I don't think you need software for that. What my company did was have a central document repository and a documentation standard, and everything boiled down to saying what we did, and doing what we said.

Re:Alfresco

[Gr8Apes]

Alfresco as far as I know still uses Acegi for security - just be aware that only one call per authorized user can be handled at a time.

Thing Long Term, Beware of Legacy Costs

[Cassini2]

Some of the ISO-9001 knowledge becomes very long-lived. Stick to things that will work for a very long time. It is not uncommon to see ISO, software, CAD, and project documentation files from 25 years ago. Having to support DOS PCs for legacy projects sucks.

Think about whatever software you use, and make sure it is formed around standards that will persist. For instance, does SharePoint depend on Microsoft Internet Explorer? Is Microsoft Internet Explorer V9 compatible with Internet Explorer V6? Take a look at all the other legacy software inside your organization dependent on Microsoft IE V6. Don't do it again.

In the end, there is a strong argument for keeping PDF, DOC, and XLS files around, and placing a version control system on them. Some systems, try to integrate the entire quality control system into a document management system, and the results cannot be maintained long-term. One expensive system that I deployed, didn't survive the 24-month rollout process. You need to stick to standards, and keep your options open, both short and long term.

Re:Liability?

[Cassini2]

Why did they go for this expensive solution? so that they could should at someone, demand support and sue someone if the shit hits the fan. With OpenSource the only one liable for fuckups

The problem with that logic is that expensive solutions can be abandoned on a whim. The supplier can make a simple business decision, they can go out of business, or taken over by a competitor. Depending on the contract, is it a term license or a perpetual license? Is the software dependent on other peoples code? With proprietary software, you can be locked out at any moment.

Additionally, have you ever actually tried to get a software company to pay out on a law suit for defective code? It is almost impossible. Check the disclaimers in the contracts.

Re:Retention Policy

[mjwalshe]

just make sure your QMS says this other wise you will fail your Audit

Re:I'm going to get flamed all to hell for this...

[moosesocks]

1) Sharepoint works in FireFox. Quite well in fact.

2) If you want to use some of the IE-only features, just install this extension [mozilla.org], and add Sharepoint to your IE-only whitelist, and you can use the "IE-only" features from within Firefox.

3) Microsoft's official recommendation for Web UIs is now to use JQuery [jquery.com] (and they're also contributing code to the project!). Assuming they eat their own dog food, Microsoft webapps should start being a lot more friendly toward non-IE browsers.

Re:Nuxeo

[batje14]

I looked at the 3 big ones, alfresco, KM and Nuxeo, and like the latter best. For one, their full version == their GPL version. So if you want to do it all yourself, you will get all the features.

Secondly, I found the interface nice and simple.

Thirdly, they have this option where you can open a document from your browser, edit it and save it back into the DM system directly. (That requires a plugin for your browser & office). They used to have an openoffice version of that plugin too. Very sweet.

There's not an app for that...

[ArundelCastle]

The best software will be useless without QA and/or RM/DC personnel that can enforce its use. This is because 9001 is a matter of quality processes, and the software can only implement those processes and policies that are already in place. An auditor wants to see that you can do what you say you'll do, whether that's one person with a key to a filing cabinet of contracts, or electronic file access tracking (knowing who has even looked at a document). There are businesses that can do that without software at all, I've worked with several. It really depends on the size of the employee base and their acceptance of a new tool. I don't believe it's possible for software to be certified for something that it can't accomplish, and it can't without complete buy-in from all employees. Good luck with that.

And just so you know, don't let your boss think you can get this done in six months, even if you pour your entire work week into it. The average mid-large corporation spends tens of thousands in hard and soft costs testing and implementing a new Content Management System in phases over years, which doesn't even include the vendor costs of licensing and supporting the thing. Unless you have categorical authority to pick a program and implement it, you will run in to a LOT of roadblocks, and even picking what to buy may not be something that you can put on your "completed tasks" list a year from now.

Lastly, if you are in fact part of your IT department, do check with your organization's org chart to find out if there are Quality/Document/Records people your choice will be impacting. The fact that you are asking Slashdot for software help instead of ARMA or a Quality organization for records procedure help, belies the possibility that your company is not mature enough to separate Information Science from Information Technology.