Live QMS

NEW 2.0

Terminology

The quality management system of Matrix Requirements consists of two components

  1. LiveQMS Editor
  2. LiveQMS Viewer


The QMS Editor is used to write and maintain processes. The risk analysis, review and approval of processes is also done in the LiveQMS editor.

The LiveQMS viewer is described in this section.

What is the LiveQMS?

The LiveQMS is a web page with the published version of the QMS. It contains the current processes and work instructions that have been reviewed and approved. It is password protected and accessible for everyone that has at least “QMS Viewer” access rights. This web page includes all processes and work instructions and therefore acts as the Quality Manual as per ISO 13485:2016 requirements.

What does it look like?

Overview

The QMS website contains different areas

  1. navigation / search tools
  2. process list grouped by SOP:
    List of processes and work instructions: This list contains all published processes, ordered by SOP to which they belong and all work instructions
  3. process details of selected process

Navigation

  1. Filter on SOP: only processes that belong to this SOP will be shown in the list
  2. Filter on affected by the process: only processes that have this role selected as being affected by the process will be shown in the list.
  3. Filter on responsible for the process application: only processes that have this role selected as being responsible for the process application will be shown in the list.
  4. Search field: search for keywords in the processes and work instructions.
  5. Dropdown to select previous published versions of the QMS. You can go back to previous versions of the published QMS if needed
  6. Show History: this will show you what has changed in each version of the published QMS.


Process Details

Process Information

For each process that has been defined, the following information is displayed:

  1. Process Input
  2. Process Description
  3. Process Output
  4. Responsible for Process Application
  5. Affected by Process
  6. Related Work Instructions (if any)

Process Functions

For each process that has been defined, the following information is displayed:

     7. Edit

     8. History

When clicking on History, you will see reference to previous published versions of this process.

When clicking on Edit, you will be redirected to your QMS project in Matrix Requirements. You can only access this when you have at least read-access rights to that project.

Work Instruction Information


For each work instruction that has been defined, the following information is displayed:

  1. Description
  2. Attachments
  3. Related Processes