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wiki (general)

  1. K

    Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS

    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. Has anyone...
  2. C

    Do Emails count as a Document/Record

    Hi, 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...
  3. C

    Identification of Document Changes in a Wiki

    Hi, 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...
  4. C

    How to achieve Page Ownership with a Wiki

    Hi, 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...
  5. C

    CRMs (Customer Relationship Management) to help achieve ISO 9001

    Hi, 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...
  6. C

    Document Control using Wiki - Cannot Create all Documents as Wiki Pages

    Hi 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...
  7. A

    Quality of Work - Definition of

    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, :thanx:Thank you Ana
  8. A

    Assay Guidance Manual v.6 + LabAutopedia + HTSA guidance criteria

    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...
  9. E

    Wiki vs. Controlled Documents - Eliminating Conflicts

    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...
  10. Pancho

    What is the Point of a Wiki?

    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...
  11. Pancho

    Using a wiki for Document Control

    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...
  12. Pancho

    Interesting Read Using a Wiki to implement a Quality Management System (QMS)

    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...
  13. kisxena

    FDA's view on Wiki's for users to find equipment operation procedures

    Hello: 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...
  14. Scott Catron

    Definitions Forum and the Cove Wiki

    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.
  15. H

    Which Wiki Software is ISO9001 Compliant (Document Control)

    I need to know for sure which wikis are iso9001 compliant. can anyone help?
  16. Marc

    The Elsmar Cove Wiki Questions Discussion Thread

    If you have any questions about making wiki edits, or any other aspect of the wiki, please ask them in this thread.
  17. Marc

    Wiki vs. A Specific Forum for Acronyms, Definitions, Etc.

    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. Thanks!
  18. A

    Why not make 'standards' free?

    Hello all! 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...
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