What is a Project?

  • Projects can be described as a set of interrelated issues. An Issue is a basic element of a Project and it represents an event or a task

What is the “General Administration” project?

  • The ’’General Administration’’ project is for managing all the non-project-related company tasks of an administrative or managerial nature, i.e. everything that is not project-specific.
  • It is automatically created by default – it should be used for all tasks that are related to the company in general and not to certain projects of the company. This project cannot be closed or deleted. If you don’t use it, ignore it. If you do, smart!

How do I create an Issue?

  • To create an Issue, please select the 'Project' module in the sidebar on the left side, and click on the ‘+Create Issue’ button.
    Please select the type of Issue you want to create, fill out the required data fields in the ‘Create Issue’ window and click on ‘Create’.
    If you cannot see the type of Issue you are looking for, please check out the 'Issue types' in 'Project Settings' of your project.
    Click here to learn more about How to create an Issue.

What do 'Bug', 'Task', and all the other Issue types mean?

  • A Bug is a problem that impairs or prevents the function of the product.
  • A Task is a work that needs to be done.
  • A Custom Form is a pre-prepared form that you can use as a task.
  • A Feature is a component of a product.
  • A Meeting is a chat conversation between users.
  • A Milestone marks a specific point along the project timeline.
  • A To-Do is a quick note.
  • A Decision is an approval or a choice that needs to be made in the progress of the project.

How can I see all the Issues and tasks that I have created?

  • You can view all open Issues in the 'Reported Issues' section of your Dashboard, except closed Issues.
    All Issues can be accessed and filtered out in the 'Issues' list of the Project module.
    To display the Issues you created, you can select the 'Creator' filter and choose your username as the Creator of the Issue.
    Click here to learn more about How to Access Issues.

What is a Process?

  • A Process is a series of predefined tasks organized in steps, automatically initiated, and to be sequentially followed. It is how you organize work within your organization. In qmsWrapper, they are specifically called QMS Workflow-Processes and represent the easiest way of achieving Compliance.

How can I use Processes?

  • First, Processes are also commonly referred to as Workflows.
  • They can be used in the Project Management module by PTOs and Managers, after they are approved by an authorized person, through the appropriate approval workflow.

How do I start a Process?

  • To start a Process, please go to the Project module by clicking on 'Project' in the sidebar on the left side.
    Click on the ‘Processes’ tab in the menu on the left side. Look for the specific Process you want to start and click on the ‘Start button next to it.

Do I need to initiate all processes in each project?

  • You don’t need to initiate every process for each project. They are selected and dropped into any project at the appropriate point depending on the project's purpose and activities.

Can I create custom Processes?    

Where can I view which is the next step of a Process?

  • In the 'Processes' list, next to each Process there is a Preview button (‘eye’ icon) next to the ‘Start button. It opens up the flowchart that shows all the steps of the Process.

Why do some processes in the processes list have “13485-2016” suffix in their name and some of them don’t?

  • the qmsWrapper software gives users a choice to select and use processes per which standard, whether it is ISO 13485 2016 version or the 2003 version. Processes with the “13485-2016” suffix are related to the application of ISO 13485:2016 Standard and processes without this suffix are related to the application of its previous version (ISO 13485:2003).

How to create a private project?

  • Private projects are being created by the system automatically. Every new user has a private project by default. 

What is the purpose of the private project in qmsWrapper?

  • The point of the private project is to provide a place separated from any other projects. The user can do and track his/her private work without interfering with anybody's work. To-Dos, Calendar, and sub-projects help the work of the user in the private project.

Can I turn Unversioned Issues into Versioned Issues? Can I do that all at once?

  • You can change the Version of an Issue only manually one by one. Click here to learn more about How to manage Versions.

Can a Version be overdue if no release date is given?

  • No, the ‘Release date’ field is not mandatory, so that means the Version will never be overdue.

What if a user or a group has multiple Project Roles or even all Project Roles?

  • When a user or a Group has multiple Project Roles (e.g. PTO, Developer, etc.), the rights of the user add up and the Project Roles do not revoke each other.
  • For example, John Doe is a Developer and also a Manager in a project. It means that our user can manage the 'Developer' Workflow and the 'Manager' Workflow at the same time in the project. The user still has Manager level access to the project and can manage the project.
  • Here's another example that includes the concept of Groups/System Roles. Groups/System Roles grant access on the organization level, while Project Roles control access on the project level. 
    Let's say, John Doe is a Reporter in a project, so the user cannot manage the project. Currently, the user can manage only the 'Reporter' Workflow. But what happens in the case the user has been added to the 'Office Manager' Group that has a Manager Project Role in the project? In that case, the user is available to manage the project as a member of the Group.

Why do I need to add Groups into Members of a project?

  • Groups are very important in defining authorities and responsibilities in the company. Certain QMS Processes, certain sub-tasks, QMS Decisions, or QMS Events are usually assigned to a group. So, to be able to initiate processes, appropriate groups need to be stated in the Members section as well.

Can I track the overall progress of each team member in the project?

  • Yes, the overall progress of each team member can be tracked in the “My Team” section by the Project Manager.

What the PTO abbreviation stands for?

  • PTO stands for Project Technical Officer, and it is a Project Role.

When is a Version overdue?

  • A Version is overdue when the set date is past the Version’s Release date.

What happens if I check QMS when creating an Issue?

Why is only the Meeting Issue type available when I try to create an Issue?

  • The reason for this is because the project does not have any other Issue types associated with it. The Meeting Issue type is associated with every project by default, and it cannot be removed. Except for private projects. In private projects, only the To-Do Issue type is available.
    To add new Issue types to your project, please click on the ‘Project Settings’ button on the left side. Choose ‘Issue Types’ in the left side menu, and click on the ‘Edit Issue Types’ button. In the next window, please select the available Issue Types from the left side list, and click on ‘Add’ to add them to the associated Issue types. When you are done, click on 'Update'.
    Click here to learn more about How to create Issues.

Why is only the To-Do Issue type available when I try to create an Issue?

  • The reason for this is because only the To-Do Issue type is associated with the project. In private projects, only the To-Do Issue type is associated.

Why can I not delete a project?

  • A project cannot be deleted if users and/or Issues have already been created. Only empty projects can be deleted.

Can I delete a user?

  • No, users cannot be deleted. Users can be deactivated or reactivated.

Why can I not change the files in a closed project?

  • When a project has been closed, the files get a read-only attribute.

What is Gantt used for?

  • The Gantt shows all Issues of a project. It shows the start date, duration, and due date for each Issue. Click here to learn more about How to use Gantt.

In the Sub-project list, there is only 1 sub-project, but the number next to 'Sub-projects' in the left side menu shows 10. Why?

  • The total number of sub-projects is 10, but you have access to only that 1 sub-project as a member.

I forgot to add a user as a project member while I was creating a project through project wizard. What should I do?

  • If you forgot to add a user(s) through the project wizard, you can add them afterward in the “Project settings” in the Members section.
  • In “Project Settings”, the user can set available Issue types, edit the Versions of the project, edit the details of the project and manage Approval Workflows as well.
  • “Project settings” are only available for Administrators, Project Managers, PTOs, and Managers.