Creating and organizing processes
In case you need to create a process, you can click on the main category title (PROC in this case).
- You will get the option to either create a folder or a Process.
- When clicking on Create Process, you will get a window to define a new process.
- When all fields are completed, click on Create.
- The process will be added in the PROC list.
- Processes can be dragged and dropped within the PROC category to change their order and to put them in specific subfolders.
Customizing predefined processes
In the QMS editor, you have a number of predefined processes, based on the requirements of ISO 13485:2016.
- In order to get started you should review these processes and adapt them to your organization.
- To do this, you’ll have to replace the smart texts like The Company, Please Specify, etc. with something that makes sense.
- Also make sure the processes reflect your organization’s way of working.
- Remember that processes can remain quite high-level as working instructions (WI items) can be much more detailed step-by-step instructions.
- All text boxes are freely editable. You can as well copy paste or drag and drop pictures into them.
Customizing Responsible for and Affected by dropdowns
In the PROC items, you need to assign who is responsible for the implementation of the process and who is affected by this process.
The roles that appear in these dropdowns can be customized.
This is done in the admin client. When selecting Project Settings and Dropdowns, you can edit the different dropdowns in the QMS project.
Assigning the process to the correct SOP
Every PROC item should be assigned to a specific SOP. This is done through a label. When clicking on this label, you see a dropdown of all predefined SOP. You can select one SOP per process.
In case you need to change, remove or add SOPs, this is again done in the admin client.
In Project Settings and Labels you can edit the existing SOP labels, delete them or add labels.
Risk Analysis on process level
Matrix QMS gives you the possibility to perform a risk analysis on process level. If you determined certain risks for a process, you can click on Create Risk or Select Existing (if the RISK item already exists). This will lead you to a window where you can define the risk (see section on risks).
Once the risk has been defined or selected, it will appear at the bottom of the screen in the PROC item.
Adding a work instruction
Similar to risks, you can link the process as well to a working instruction. This can be done by clicking on Create WI or Select Existing. This will lead you to a window to create a work instruction or select an existing one. (see more info in section Work Instructions)
Once a WI items has been linked to a process, it will appear at the bottom of the screen in the PROC item.
When a PROC item is fully ready with the according risks in place, it can be reviewed.
- A reviewer can either pass of fail the review of a specific process. This is done through a second label.
- The process can only be approved (Pass) when all checkboxes are checked and the reviewer electronically signs off.
- Otherwise, the reviewer can as well fail the review.
- When he does, he can leave comments in the Review Comments/ToDos text field. This is a way of communication between the reviewer and the author of the process.
- Only when the process is approved (with checkboxes and signature), the label will change to approved.