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QMS for manufacturing

From the line to a better instruction

Work instructions approved before they reach the line, and every problem found there followed until the corrected instruction is back in use. VisualQMS is a complete QMS for your instructions, non conformances, CAPA, audits and training.

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  • Already delivered in manufacturing
  • Approved before it reaches the line
  • Each problem linked to its fix
Three screens of VisualQMS: the complaint process map with an activity opened to its procedure, notes and the ISO 9001 clause it answers, the metadata card of a published procedure with its approver and next review date, and a person's training record with its portal
Where it slips today

Three copies. Which one is current?

The new revision of the work instruction sits on the shared drive next to three copies of the old one, and nobody is sure who approved it. The printout at the machine is from last year. When something goes wrong on the line, it goes on a paper form or into a spreadsheet. The corrective action stays open for weeks, and a month later the same fault turns up on another shift.

Then the surveillance audit is two weeks away. Someone spends days pulling evidence out of binders, inboxes and Excel: which revision was in use, who had read it, and what came of last spring's non conformance.

The metadata card of the published procedure SOP 004 Validate Delivery Acceptance: its class, published date, approver, reviewer and next review date, and under Relationships the process activity and the ISO 9001 clauses it is tagged with
At the station

Find each instruction by product, line or machine

Work instructions, SOPs, inspection plans, the blank forms your operators fill in and the quality manual are written in Word or Excel. They are reviewed and approved before they are published, and people who work to them see only the latest published revision in VisualQMS. The version number, the approver and the approval date are written into the document, so if you still print, an old copy is easy to check against the current one.

Each instruction can carry its product, line or machine, so people find it by what it is about rather than by the folder it sits in. With the process maps, an operator opens the instruction from their own activity, and the link always opens the newest approved revision. People open it on a PC, in the browser or on a phone.

One problem, start to finish

Follow a problem from the line and back again

This is how a problem on the line runs through VisualQMS.

  1. Recorded

    The problem is recorded against the work instruction it concerns and, with the process maps, the activity on the line. It lands with the person responsible in quality. A problem from a customer starts as a customer complaint in its own module and is linked the same way.

  2. Handled

    The quality team decides what it needs: a CAPA, a change to the instruction, or a note that no CAPA is needed. Where parts are affected, it can also be registered as a non conformance (your NCR), where the investigation records what went wrong and which parts it affected. Each step goes to a named person, with reminders.

  3. Fixed

    The CAPA is linked to the problem and to any non conformance. It names who approves it, who carries it out and who verifies it, and it moves through steps such as For Implementation, For Verification and Verified.

  4. Changed

    Where your rules require it, a change request is approved before anyone edits. The author opens the instruction in Word, locked to them while they edit. The new revision is approved, the approver and date are written into it, and a row is added to its version history.

  5. Back in use

    The corrected instruction is now the only published one. Where the training rule says so, the operators who work to it are asked to read and confirm it, and anyone late goes to their manager. With the process maps, the activity on the line opens the new revision as soon as it is published, and the map doesn't need to be republished.

  6. The fix lands where it started

    The problem, its non conformance and CAPA, the change and the read records stay linked, so the auditor can follow it either way.

See one problem go from the line and back

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When the auditor comes

Answer the auditor clause by clause

Each clause of ISO 9001:2015 lists the procedures, process activities and audits tagged to it. Internal audits are planned with reminders and show as planned, ongoing or completed, and each observation is linked to its corrective action.

Records can carry the product and customer from your ERP, so one view can list every non conformance on a product.

See quality standardsSee Internal Audit Management
The statements of ISO 9001 listed as a tree, with 7 Support opened and 7.2 Competence selected and expanded to its three documents, the process activity Recruit new employee and its CAPA group, and the statement's metadata card beside the tree
Your document numbers stay

Start with your work instructions

  1. Bring the instructions across

    Your document numbers stay, and the details are added in bulk from Excel templates. While you bring the instructions across, documents still on the shared drive can be found from M‑Files where they are. Only what is approved and published is in use.

  2. Map the line

    We run the mapping workshops with you, and a map can start as an outline and gain detail while it is in use.

  3. Set up training

    Training rules decide who reads what: by role, department, country, user group or any other detail about the employee.

  4. Add modules when you need them

    Non conformances, deviations, CAPA, internal audits and complaints can join at the start or later.

Already delivered in manufacturing

Bring a problem from your own line to a demo

Manufacturing is one of the sectors we have delivered VisualQMS to. Tell us about a recent problem on your line and how it was followed up, and we'll show you in a personal demo how VisualQMS takes it from the instruction where it was found to the corrected version. We answer the same working day.

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Questions about VisualQMS in manufacturing

Does VisualQMS support ISO 9001?
Yes. You import a standard's requirements or create them by hand, tag your controlled documents and process maps to them, and go through the standard requirement by requirement in the Compliance view, for example 8.7 Control of nonconforming outputs. If you work to more than one standard, the same documents can be tagged to the requirements of each.
Is VisualQMS certified to ISO 9001?
A certification body certifies your quality management system to ISO 9001. VisualQMS holds the evidence the auditor asks for: approved work instructions with every change in the version history, read records for each version, and non conformances, CAPAs and audits linked to the documents they concern.
How are work instructions controlled?
Every controlled document has a workable version and a published version, goes through review and approval, and carries a next review date. People who work to it see only the latest published version, and the version number, the approver and the approval date are written into the document. Start editing and it is locked to you until you check it back in. Each time it is checked back in, or its details change, a row is added to the version history.
How are non conformances and deviations handled?
In two add-on modules, Non Conformance Management and Deviation Management, and both link to CAPA. A non conformance runs through states such as registration, investigation, closure, review and approval, and the workflows can be configured to the method you use.
How do people on the line open the instructions?
On a PC, in the browser or on a phone. With the process maps, an operator opens the instruction from their own activity, and the link always opens the newest approved revision. M‑Files logs which maps are opened, when and by whom.
Can we use part, customer and supplier data from our ERP?
Yes. Products, customers and suppliers can come from your ERP, so quality work uses them without keeping them twice. We have connected Microsoft Dynamics, M‑Files has connectors for SAP, Dynamics 365 and Salesforce, and any system with an SQL database behind it can be connected directly. For anything else we build the connection. Tell us which system you use, and we'll scope the connection with you.
Our instructions are on a shared drive. How do we move them?
Your document numbers stay, and the details are added in bulk from Excel templates. While you move, documents still on the shared drive can be found from M‑Files where they are. If your vault is in M‑Files Cloud, reaching a network folder needs M‑Files Ground Link. Only what is approved and published is in use.
How do we know who has read the new revision?
Training rules decide who reads what, by role, department, country or any other detail about the employee. Where the rule says so, a new revision asks those people to read and confirm it again, and anyone overdue goes to their manager. When someone joins, changes role or moves to another department or country, their training follows automatically, and training they have already completed that is still valid counts. Employee details come from Entra or are kept in VisualQMS.
Built to connect

Add a module when the need turns up

Core and add-on modules link to each other, so a new one connects to what is already there.

Internal Audit Management

Know where every audit stands, with reminders for the people involved and observations tied to CAPA.

See Internal Audit Management 

Issue Management

Record an issue or a customer complaint, decide how each kind is handled, and keep it tied to the CAPA it leads to.

See Issue Management 

CAPA Management

Corrective and preventive actions with a person responsible and a deadline, linked to the finding that started them.

See CAPA Management 

Training Management

See who has read the new procedure. Assign training by role, department or any other employee detail, and the manager hears when it is overdue.

See Training Management 

Change Management

Change requests that say what changes and why, approved before a controlled document is edited.

See Change Management 

Deviation Management

Deviations handled the same way each time, and linked to CAPA.

See Deviation Management 

Non Conformance Management

Non conformances recorded in their own module, taken from registration to review and approval, and linked to the CAPAs that fix them.

See Non Conformance Management 

Risk Management

Risk assessments that follow your own method and stay linked to the CAPAs, changes and documents they concern.

See Risk Management