I'm trying to meet the requirements of ISO 13485:2016 4.1.4 within our wiki-based QMS. In previous organizations, I've made sure changes in the process were "evaluated for their impact on the QMS... medical devices produced on this QMS" via a checklist on an ECO/ECN form.
I've been looking at our document control and we're using a wiki to do most 'stuff', but then we also have a self-support website for customers, emails, accounts software, records in filing cabinets etc.
I'm assuming we need to account for these 'documents' as they're often shared with...
I understand that each document needs to have a version and you need to state the changes to that version.
However, do those changes need to be stated on the document itself or is it sufficient to have them stated elsewhere, as long as it's stated?
My reason for asking is that we have a...
I'm currently trying to work with my company to get ISO 9001 certification.
We're trying to use a wiki to help with that.
However, I'm struggling to understand how to achieve page ownership with the wiki.
Firstly, how to make someone own a page 'automatically', but also, how to show page...
I'm currently trying to get my company up to scratch to become certified (ISO 9001) using a wiki-based system.
However, we currently have no 'proper' way of tracking customer contact or following up leads. For example, we follow up leads by jotting it down on a piece of paper and if we...
I'm calling to attention all those who have know how to achieve ISO 9001 certification using a wiki.. I have a bit of a dilemma.
For the organisation I'm working for we are trying to achieve certification and have a wiki AND a server.
To just use the wiki for document control seems easy...
I searched at the Quality Assurance Terms Glossary/Q ELSMAR's wiki
...I couldn't find definition for quality of work or quality of the work.
Does anybody has a definition for it?
I look forward to your reply,
The Latest Version of the Assay Guidance Manual is now a Wiki.
NCGC High Throughput Screening Assay Guidance Criteria
LabAutopedia->Created by the Society for Laboratory Automation and Screening (SLAS), LabAutopedia is a collaborative compilation of the world's laboratory technology knowledge...
My company is struggling with having Controlled Documents and a Wiki that co-exist peacefully.
The Wiki is very easy to edit, so employees are much more eager to make updates when they see a problem... this does not happen as with our Controlled QMS documentation since there is more process...
I often get asked "What is the point of a wiki?" by folks that use MS Word extensively but aren't familiar with wikis. The question is usually followed by “Word has great formatting and we can track changes between versions. I don’t need a wiki.”
This article expands on my usual short, verbal...
As mentioned previously, we had a good experience at Geometrica using a wiki for our management system.
Hoping that this experience will help others, we have written a new article on it: Using a Wiki for Document Control. It starts like this:
Hope y'all will find it useful, and any...
I had an epiphany recently.
My company documented and implemented an ISO 9001:2008 compliant Quality Management System on a wiki.
The epiphany part is the realization of how incredibly, amazingly, unbelievably useful the wiki is to complete this process. In fact, it is so useful that I...
I can't find any information on the FDA website regarding companies using Wiki's.
Our company has a Wiki site for users to find procedures on how to perform certain operations that pertain to our products. The procedures are not controlled under our electronic document control...
Please note that definitions and other pertinent information can be located at the Elsmar Cove Quality Assurance and Business Standards Wiki.
Any questions specific to the wiki can be directed to the wiki questions thread.
This is carried over from this thread: A 'New' Aspect of the Cove - A Definitions and Acronymns page?.
Please visit the Elsmar Cove Wiki and tell me which 'format' you prefer.
Do let us know why in this thread.
I have a question, maybe a rhitoric one:
Why does not ISO publish the standards free of charge? At least the ones concerning management systems.
There is a thing I never could understand: why do they claim that they want the ISO 9000 (a.o.) be promoted as broadly as...