SBS - The best value in QMS software

Which Wiki Software is ISO9001 Compliant (Document Control)

Pancho

wikineer
Super Moderator
#21
Re: I need to know which wikis are ISO9001 compliant

Pancho,

I understand a significant expense of running a public wiki is protecting it from vandalism.

Do you see the wiki approach to standards-making as feasible?

Contributors, whose input is accepted, may then be able to use the standards for free.

It could widen inputs to standards beyond those who work for large companies and can afford the travel costs for TC176 meetings for example.

Does anyone know of any examples of standards-making (and maintenance) by wiki?

John
Hi John,

I think there is great potential in using wikis for composing and improving standards. A couple of key ingredients would be, in my opinion:

  1. Strong leadership by a small group committed to gardening the wiki. This group should have authority and willingness to resolve disputes.
  2. A wider, but interested, base of participants. Selection criteria might include having been members of a professional society or industry association for a set period, or known participants in the field, or registered under the standard, etc.
Wikipedia's public nature and public disputes are well known, but in a narrow endeavor, like standard writing or company documentation, the alignment of interests by #2 above make maintenance of the wiki much easier. Still, Wikipedia's Policies and Guidelines and associated pages linked from there are a useful read if you are considering this.

But the guidelines might not be useful with perhaps the biggest challenge: Convincing current committee members. Using a wiki requires quite a shift in thinking by them. Folks that currently hold custody over a master document might feel threatened, and those that don't have experience using wikis might be reluctant to contribute through it.

I do think that any standards committee that gets over the initial hurdles would be rewarded with a rapidly and constantly improving document.

Good luck,
Pancho
 
Elsmar Forum Sponsor

QATN11

Involved In Discussions
#23
Re: I need to know which wikis are ISO9001 compliant

I was on the verge of starting to use wiki to deploy a QMS. Mgt want a cheap (read free) platform that did not require heavy support from the IT dept to keep it up and running. Before I got beyond the initial steps, we departed ways. My concerns with anything free is local support to keep this running, debugging and security. The one I had selected was free and seemed stable. Another department had been using it as a knowledge base for a help desk. All documents were written directly into the wiki screens.

I prefer to keep the documents in Word, Excel and other office apps, but this requires all users having those apps on each PC. Any comments on these pros/cons and general paranoia on my part would be appreciated.
 

Le Chiffre

Quite Involved in Discussions
#24
Re: I need to know which wikis are ISO9001 compliant

I went through the same process with documents and records created with MS Office apps, when we put up the wiki. There is a solution that satisfies your situation and will allow for a transition phase or for a hybrid system to persist indefinitely.

Initially our wiki pages were very brief, just reflecting the title of the document with a link to the Office file and perhaps an abstract, author, rev level, etc. or contained a table indexing records, again as links. We migrated slowly to a more wiki-hosted system. To satisfy the requirement for information to be available where required, we made sure Office viewers were installed wherever a full Office license didn't exist.

First, check how easily you can access your document library from a browser and from your wiki. There was some tweeking required to get the wiki to link directly to a shared file server (to recognize a url formatted as "file://"). If everything's accessible via http:// then it's a lot easier and will work on any platform - mobile included.

I also came across a useful Word macro that did a reasonable job of wiki'fying a Word document to help you migrate to a full wiki implementation. A web search should find a free utility.
 
Last edited:

QATN11

Involved In Discussions
#25
Re: I need to know which wikis are ISO9001 compliant

Can you share the word macro and elaborate what it does. Thanks for the rest of comments.
 

Le Chiffre

Quite Involved in Discussions
#26
Re: I need to know which wikis are ISO9001 compliant

It was an early version of Word2MediaWiki as we chose MediaWiki as our host. The documentation was in German and it did just an ok job. Once you get comfortable with wiki editing you'd probably go without it, but as a starting point it has its uses. I see there's now info on it here: http://en.wikipedia.org/wiki/Help:WordToWiki
There's probably lots of other options available now...
 
P

Peeceepeh

#27
Re: I need to know which wikis are ISO9001 compliant

Hi! Thank you for sharing you experience. One thing I would like to use is some add-in or the like that find out all pages/documents/entries that haven't been edited for a long time. Do you have any advice for me on how to achieve this?
Thanks!

Peeceepeh
 

Pancho

wikineer
Super Moderator
#28
Re: I need to know which wikis are ISO9001 compliant

Hi! Thank you for sharing you experience. One thing I would like to use is some add-in or the like that find out all pages/documents/entries that haven't been edited for a long time. Do you have any advice for me on how to achieve this?
Thanks!

Peeceepeh
Welcome, Peeceepeh!

The wiki that we use, ProjectForum, provides to administrators a list of all pages and the date of their last edit. This list can be sorted by that date to achieve your need. Unfortunately, ProjectForum is being dicontinued as a product, so I wouldn't recommend it. But other wikis should also have this functionality.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#29
Re: I need to know which wikis are ISO9001 compliant

Pancho, with ProjectForum being discontinued what are your plans for the future?
 

Pancho

wikineer
Super Moderator
#30
The code is pretty stable, so there is no emergency.

We will evntually port our content to another wiki engine. Looking at Confluence, Mediawiki and a few others.
 
Thread starter Similar threads Forum Replies Date
John Broomfield Design and Construction wiki Misc. Quality Assurance and Business Systems Related Topics 9
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
C Google Apps vs. Wiki for ISO 9001 documentation Document Control Systems, Procedures, Forms and Templates 30
C Identification of Document Changes in a Wiki Document Control Systems, Procedures, Forms and Templates 6
C How to achieve Page Ownership with a Wiki Document Control Systems, Procedures, Forms and Templates 2
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
Pancho WIKI: Grow Your Own for Fun and Profit Imported Legacy Blogs 2
E Wiki vs. Controlled Documents - Eliminating Conflicts Quality Manager and Management Related Issues 5
Pancho Oquma - a new QMS-on-wiki commercial offering Imported Legacy Blogs 3
Pancho What is the Point of a Wiki? The Reading Room 13
Pancho Using a wiki for Document Control The Reading Room 10
Pancho Interesting Discussion Using a Wiki to implement a Quality Management System (QMS) Document Control Systems, Procedures, Forms and Templates 273
kisxena FDA's view on Wiki's for users to find equipment operation procedures 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
Scott Catron Definition Definitions Forum and the Cove Wiki Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc The Elsmar Cove Wiki Questions Discussion Thread Forum News and General Information 50
Scott Catron Elsmar Cove Quality Assurance BOK (Body of Knowledge) Wiki Forum News and General Information 82
Marc Definition Wiki vs. A Specific Forum for Acronyms, Definitions, Etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 4
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom