Does ISO 9001 require procedures and work instructions?
ISO 9001:2015 says a quality management system needs documented information and leaves the extent to the organization: its size, type of activity, the complexity of its processes and the competence of its people. The standard does not demand a document titled “SOP” for every process. Procedures and work instructions are widely used ways of meeting the requirement.
What does document control expect?
The document control clause of the standard (7.5.3) asks that documented information be available and suitable for use where and when it is needed, adequately protected, and that changes be controlled. In practice, questions an auditor may ask include:
- Was the document approved before use, and by whom?
- Is it clear which version is current, and can old versions be used by mistake?
- Is the document available where the work is done?
- Are changes recorded (when, who, what)?
- Do the people who use the document know about the latest version?
For more, see document control and documented information.
Why do illustrated procedures and work instructions help?
Describing tasks in software (entering a record, approving, running a report) in words alone invites different readings. An illustrated work instruction shows the operator which button to press and shows an auditor how the work is really done. For ready skeletons see the SOP template and the work instruction template.
| Document | Suggested format | Why |
|---|---|---|
| Procedure (SOP) | Numbered steps, a flowchart where needed | Shows responsibilities and flow |
| Work instruction (interface) | Illustrated steps | Makes clear which field takes which value |
| Work instruction (physical) | Photo steps with safety warnings | Suits the shop floor |
| Checklist | Tickable list | For handover and records |
How does a quality team set up the document lifecycle?
- Define document types and numbering. Separate numbers for procedures, work instructions, forms and records.
- Name the owner and the approver. Author, reviewer and approver may be different people.
- Test the document against the real work. Can someone who does not know the task do it from the document?
- Publish and mark the old version. Superseded versions are archived with a “withdrawn” note and removed from where people work.
- Keep a change record. When, who and why it changed.
- Set a review calendar. Changes in process, tool or regulation trigger a review. See keeping docs current.
How do you present illustrated documents in an audit?
- Make each document’s version, date, owner and approver visible.
- Give the auditor a controlled PDF copy next to the link; put the version and date in the PDF file name yourself.
- Be ready to demonstrate the task live: an auditor may ask you to demonstrate the task live.
- Show that old versions sit in a separate archive and are withdrawn from use.
- Check that no personal data remains in screenshots.
Where does Izly fit in quality procedures?
Izly produces the “steps done in a web interface” part of quality documents. It has no approval workflow and no version history screen yet; you keep the approval and revision record in your quality system’s own tool.
- Do the task once with the extension and get an illustrated work instruction; edit the text to your quality language.
- Download a PDF and file it in the document management folder as a controlled copy; put the version and date in the PDF file name yourself.
- Share the link for live use; when the guide is edited the same link shows its current state.
- In the library, sort guides by last update and put the oldest on a review list.
- An admin can turn public links off and set raw image retention.
Izly is not a quality management system and does not provide certification. It records tasks in the browser, in Chrome only. Pricing.
Frequently asked questions
Are work instructions mandatory for ISO 9001?
The standard does not require a document called a work instruction; it requires documented information and says the extent varies with the organization. Anything needed for people to do the work correctly is judged within that frame. Ask your certification body about your case.
Will an auditor accept illustrated instructions?
There is no single rule on format. What matters is that the document is approved, current, reachable and describes the work correctly. An auditor may check whether the work is done as the document says.
Can Izly do document control?
No. Izly offers no approval workflow or formal version control. You create, edit and share the documents, and keep the approval and revision record in your quality system.
How do I stop old versions from being used by mistake?
Name one source of truth, remove and archive the old version where people work, and show version and date on the document. If you use a live link, the link always shows the current state.
Related pages
Sources
General information, not legal advice.
Record it once and let the guide write itself
With Izly you do the task once in the browser. Clicks and screenshots become a step-by-step guide that you edit and share by link.