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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?"
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
I clicked reply to say that very thing. We use KT here at work, is very nice, and we're not the only ones. We'd also looked at Alfresco in the past, but KT won on a number of factors, including ease of use and installation.
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.
In Soviet Russia jokes are formulaic and decidedly non-humorous.
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.
Towards the Singularity.
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.
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.
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.