What stands for QMS?

Quality Management System (QMS) is a set of coordinated activities to direct and control an organization, to continually improve the efficiency of its performance, to implement quality.

How can I see if I am responsible for a step in a Process?

  • There will be a new Issue assigned to you in the ‘Issues assigned to me’ section of your Dashboard.
  • In QMS > Processes, you can check if there are any new Process steps on the details page of the Process.

Why can I not approve or decline a QMS Decision?

  • To be able to approve or decline a QMS Decision, you have to be a member of the Group/System Role with authority to approve or decline  QMS Decisions. If you were added to this group, you only need to log out from your account and log in again to be able to approve or decline the QMS Decision as a fresh member of the Group.
    Click here to learn more about How to manage QMS Issues.

I need to meet the requirements of ISO 9001:2015. Can I use qmsWrapper to meet its requirements?

  • In qmsWrapper offers 2 versions:
    1. qmsWrapper for MedDev - ISO 13485 and U. S. QSR (21CFR 820 part), and
    2. qmsWrapper ISO 9001.
  • Predefined processes and templates are made to meet their requirements. qmsWrapper can be easily adapted and customized to many other quality standards.
  • Using the Process Editor, you are easily able to make any process or workflow to suit all your compliance needs.

Can I track QMS related issues separately?

  • QMS related issues can be tracked separately in the QMS module. You need to select a project related to that QMS issue, then selecting the “QMS Issues” tab where you will find all QMS related issues for that particular project.

Can I track started processes by steps until they are finished?

  • Once started, Processes can be tracked, step by step, until they are finished. To view them go to the QMS module in the “Processes” section. After a Process is selected, you can follow up and coordinate each step. All steps are displayed and defined, you never have to guess what’s next.
  • By default, this section displays processes that are not finished, but if you want to see finished or canceled, mark the “Show finished and canceled processes” checkbox.