Versioning and validity
Every document carries its version and validity. The approved version applies, earlier versions stay traceable.
Document control under ISO 9001, with versioning and four-eyes approval
In QuKI every QM document has a version, a validity, a review date and an approval by a second person. In an audit you show the full chain rather than a folder of files.
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In short
What is document control under ISO 9001?
Document control means that the documents of a QMS are reviewed, approved and versioned, available where they are needed, and that nobody works with outdated versions. ISO 9001:2015 covers this in clause 7.5 under the term documented information. What must be controlled is what the standard requires and what you determine as necessary for the effectiveness of your system, such as process descriptions, work instructions and forms. In QuKI every document gets a version, validity, a review date and four-eyes approval.
Where document control fails day to day
- The shared drive holds three versions of the same work instruction and nobody knows which applies
- Approvals run by email and can no longer be traced in the audit
- A document has not been reviewed for years because the date is written down nowhere
- When a process changes, the related documents stay on the old version
QuKI
How you control documents in QuKI
The document management module is the central control of all QM documents and works closely with process management.
Four-eyes approval
Drafting and approving are separate. A second person reviews and approves, so the approval is evidenced.
Review dates
For every document you set when it is reviewed again. Documentation stays current all year, not just before the audit.
Linked to processes
Documents are linked to the process descriptions. Change one and you see immediately what follows.
From draft to valid version
- 1
Draft
Create a document or take over an existing one and assign it to a process.
- 2
Review
A second person reviews the content.
- 3
Approve
With approval the new version becomes valid.
- 4
Re-review
On the review date the document is checked again and revised if needed.
What changes for you
- Everyone works with the valid version, not a copy from the shared drive
- Every approval is evidenced, without an email trail
- Document status and process status no longer contradict each other
- Audit preparation becomes a query, not a search
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Frequently asked questions
When must a document be controlled?
Whenever it belongs to the QMS, meaning the standard requires it or you have determined it is necessary for the effectiveness of your system. Typical examples are the quality policy, process descriptions, work instructions, forms and test specifications. Documents of external origin, such as standards or customer specifications, belong to it as far as you need them for the QMS.
Is SharePoint enough for document control?
SharePoint is a good place to store files and versions them. Document control under ISO 9001 also needs four-eyes approval, validity, review dates and the link to processes and audits. You can rebuild that in SharePoint with your own effort, in QuKI it is already there. QuKI does not run inside SharePoint or Microsoft 365 but as its own web app in the browser, your people do sign in with their Microsoft account.
Can we take over our existing documents?
Yes. Existing documents and process descriptions can be taken over. How extensive that is we clarify in the initial consultation, because it drives the effort at the start.
We have no QMS yet. Where do we start?
Then start with the ISO 9001 Builder. It supports building a QMS up to certification, with learning modules and an AI assistant that drafts your documentation. QuKI is the system for running it afterwards.
| Product | QuKI, QM software with AI |
|---|---|
| Vendor | Digital Airways GmbH, Basel |
| Standards | any standard, such as ISO 9001, IFS, BRCGS, FSSC 22000, IATF 16949, VDA 6.3, ISO 13485 or your own rules |
| Modules | ten, booked individually |
| Delivery | web app in the browser, no installation |
| Hosting | in Switzerland |
| AI | proposes, approval always with the customer, no model training on customer data |
| Sign-in | Microsoft Entra ID (SSO) or email and password |
| Price | from CHF 110 per month by number of employees, all users included |
| Trial | 30 days free |
| Offline | no |
Reviewed by Dario Tomas, CEO of Digital Airways, former quality manager for ISO 9001 and 14001. Digital Airways is ISO 9001:2015 certified. Updated .
The valid version, without searching.
In 30 minutes we show you how versioning, approval and review dates work together in QuKI. On your own workflows, with no sales pressure.
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