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ISO 9001 and other standards

Show how you meet each clause

An auditor points at a clause and asks how you meet it. In VisualQMS, a complete QMS on M‑Files, every clause of your standard lists the work that meets it: the procedures, the activities on the process map and the quality records behind it.

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  • Requirements imported from a file or written in
  • Several standards on one set of documents
Three screens of VisualQMS: the statements of ISO 9001 as a tree with 7.2 Competence opened to its documents and its process activity, the complaint process map with standard tags on its activities and a key naming the standards, and the statement's metadata card
Before the audit

A cross-reference list is right for one day

The answer to "how do you meet this clause?" is often spread over three places: the procedures in a document library, the process in a flowchart or in people's heads, and the audits in the audit plan. What ties them to the standard is a spreadsheet someone keeps by hand. It is right on the day it is made. Change one procedure and it is out of date, and before the next audit someone goes through it line by line.

The complaint process map with the activity Assess severity and contain opened beside it. The panel lists its procedure, QP-08 Complaint handling procedure, notes on severity, a view of open complaints and, at the bottom, the ISO 9001 clause the activity answers.
Tag it once

Link each requirement to the work

In VisualQMS the link sits on the work itself. You tag a procedure, or an activity on a process map, with the requirements it answers, and VisualQMS shows the same records arranged by standard. On the map, a tag marks each activity where a standard applies, and the activity names the clause beside its procedure.

See the process maps
In front of the auditor

Every clause lists what answers it

This is what you show the auditor. Nobody put the list together for the audit: it comes from the tags on the work.

  • The documents — Three controlled documents are linked to it, each the published version.
  • The process activity — Recruit new employee, with its map beside it.
  • The quality records — CAPAs and internal audits linked to the clause, so the next question is answered there too.
See training management See internal audit
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 with its title, description and clause number

See a clause opened, live, in a personal demo

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Room for the next standard

Add the next standard to the procedures you already have

You can work to several standards in VisualQMS. Each one brings its own requirements, and you tag the same procedures and process activities with them. On one process map, an activity can carry a tag for one standard and the next activity a tag for another, with one set of documents behind both. Another ISO standard, a regulation or a customer's requirements go in the same way, and bringing them in is one of the steps when we set up VisualQMS with you.

Import it

The requirements usually come as a CSV or similar file.

Or write them

Create the requirements by hand, for a customer's demands or a framework of your own.

Tag what you have

Link each requirement to the procedures and process activities that answer it.

Tell us which standards you work to

Name them, and tell us how you keep track of them today. In a personal demo we open an ISO 9001 clause, show you what sits behind it, and go through how yours would be set up. We answer the same working day.

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Questions about standards support

Does VisualQMS make us ISO 9001 certified?
An accredited certification body certifies your quality management system, and no software can do that for you or make you compliant. VisualQMS keeps each requirement linked to the work that meets it, so you can show the auditor how you meet it.
Which standards can we work to?
By design, VisualQMS supports the requirements of the most common quality standards. You bring in the requirements of each standard you work to, ISO 9001 for example, and tag your procedures and process activities with them.
What if the requirements are our own?
Write them in by hand, for a customer's demands or an internal framework, and tag your procedures and process activities with them as you would for a published standard.
What if we don't work to a standard?
Then leave this part out. You don't have to use every module.
What is listed under a requirement?
The controlled documents tagged with it, the activities on your process maps that carry its tag, and the quality records linked to it, such as CAPAs and the internal audits run in the Internal Audit module.