Pancho

wikineer
Super Moderator
I am late to joining this Wiki QMS party, but I wanted to chime in on our success with using a WIKI to manage our QMS. We implemented TWIKI as our platform in 2008 and have been rolling with it ever since. Originally we were registered to ISO - our current registration is AS9100 C. There was lots learned along the way but for the most part it was relatively easy to feel our way along. Our registrars and auditors have all bought in and support the platform.

If I had to do it today I might not use TWIKI- the system has become somewhat stagnant the last few years - but without a doubt I believe a WIKI implementation of Quality documentation is the way to go.

I am happy to answer specific questions if you would like some feedback. Good luck!
Thanks, Skreis!

ProjectForum, the engine that we are on, has also stagnated over the last few years. Coincidentally, today we received a notice from the developer that he's discontinuing the product shortly, so we will be looking to port our content to another wiki. We started running ProjectForum almost exactly 10 years ago, in April of 2007. It was a good run. I'm definitely not looking forward to the move.
 
I'm not sure I understand. If the engineers don't know what they will need, wouldn't offline browsing require downloading the whole wiki? Wikis might not offer this feature directly, but it seems an easy, if a bit impractical, requirement. Copy the whole terabyte of a database? Small portable disks can easily hold that several times over.

Any time you copy from the wiki (or any other repository of your system's documents, such as G Suite), be it the whole thing or only a document, you've created either an uncontrolled copy or a record. Make sure your personnel know how to handle to avoid misuse.

We often work at remote construction sites without internet. With or without internet, though, as part of our deliverables to the client, we prepare an "installation manual" that contains all procedures that are anticipated to be required at the site. But the procedures are copies or even adaptations of the live ones in our QMS. Once delivered, such manual is a record of the project. The live procedure may continue to improve in the wiki, but the record stays as it was delivered or approved, except when specifically revised through an agreed upon change. And despite it perhaps being not the most current info, the record is what we use at the subject site.
I guess offline browsing would require a download of the entire thing! Not ideal I know...I was wondering if there was a wiki software that worked in a browser or maybe was an installable software on a PC where it downloads content (similar to how a dropbox or google drive desktop app works). I think my question may be null and void if we use G Suite since it is capable of being accessed offline.

Good thought on creating a procedure on how to handle downloadable content - an issue we have now is not having the most current doc because it was whatever pdf was downloaded last time.

That manual idea is also cool. I'm not sure if we do that now (I don't deal with customers often), but it would be a good thing to start because of the benefits you stated.
 
I am interested in using a wiki for our QMS after reading through this thread. However, I wonder if Gsuite would not work even better than a wiki. It would allow for all the tracking and edits of a wiki with the user friendliness of your favorite word processor.

Does anyone know if Gsuite allows you to create workflows and things to make a CAPA system, and other tracking features that you get in the big paid systems? That is the only thing I am not sure of, and have not been able to find a great answer on.
 
Hi,
I am hoping to implement Confluence as a ISO 9001/13485 compliant QMS, starting, relatively from scratch. There are many different software options out there now, including Greenlight Guru, qmsWrapper, and one I am particularly interested, M-Files (with Compliance Kit). Surprisingly, I have not found any reference to M-Files on this website, and I find its document management system quite amazing. Unfortunately the price tag for the compliance kit is very daunting.

I think this thread will be understandably biased toward the wiki approach. I have already started to setup a Confluence/JIRA solution, but other members of the team have concerns about validating the system for ISO. Mostly around this requirement:

11.10 (a)
Compliant Electronic Document Management Systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.


Questions:
1) Has anyone recently set up a QMS, and tried some of the new software packages and Wiki's and chosen one over the other?
2) Has anyone been audited while using Confluence for 13485? What was done to validate the 'accuracy/reliability'? (Similar to previous posts, i have not seen a post explicitly stating validation of Confl. for 13485).
3) Has anyone tried M-Files for QMS purposes?

ps - Thanks for the looong thread with lots of great info
 

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