Quality Management System Tool

What is a Quality Management System?

A Quality Management System is a process-based instrument for business development and optimization.

Quality Management is knowing the strategic direction and reaching the objective that is set, by establishing a clear definition of processes, monitoring, evaluation and improvement. This enables an effective, systematic and structured business, which implies consistent delivering and harmonized results of high-quality.

Quality Management sets the requirements for the entire life cycle, from requirements, implementation, maintenance, and continuous improvement. Using harmonized standards (i.e. ISO) ensures a solid foundation with a focus on improvements acknowledged worldwide.

What is a Quality Management System?

A Quality Management System is a process-based instrument for business development and optimization.

Quality Management is knowing the company’s strategic direction and reaching the objective set by establishing a clear definition of processes, monitoring, evaluation and improvement. This enables an effective, systematic and structured business, which implies consistent delivering and harmonized results of high-quality.

Quality Management sets the requirements for the entire life cycle, from requirements, implementation, maintenance, and continuous improvement. Using harmonized standards (i.e. ISO) ensures a solid foundation with a focus on improvements acknowledged worldwide.

What our tool offers?

ONLINE SOLUTIONS

Store all your information in one place to obtain full transparency across all ‘cricial-to-quality’ processes and documentation. Experience immediate value with a Ready-to-Use online solution that gives you an overview of all your processes.

STEP-BY-STEP GUIDE

Professional design & Development templates secure a guided and handheld process to ensure that the Quality assignment is solved right the first time.

ADVERSE EVENTS

An Adverse Event is any undesirable experience associated with the use of a medicinal (investigational) products. Worst-case an event is categorised as “serious” and can result in hospitalisation, events that are deemed life-threatening or death.

The information on an Adverse Event must be recorded, assessed and categorised. Stakeholders must take immediate control, identify and implement the corrective and preventive actions to minimize the impact of the event. The recorded event must function as a “lesson learned” and has to be applied into the process-oriented life cycle documentation of the products.

 

KNOW YOUR INFORMATION

Proper management of documentation optimizes your work processes and ensures that all documents are updated and contain the correct information.

With an integrated IT landscape, your company’s entire project team and all your stakeholders can get a full detailed overview of existing documentation, as well as needed expected actions on every project.

ADVERSE EVENTS

An Adverse Event is any undesirable experience associated with the use of a medicinal (investigational) products. Worst-case an event is categorised as “serious” and can result in hospitalisation, events that are deemed life-threatening or death.

The information on an Adverse Event must be recorded, assessed and categorised. Stakeholders must take immediate control, identify and implement the corrective and preventive actions to minimize the impact of the event. The recorded event must function as a “lesson learned” and has to be applied into the process-oriented life cycle documentation of the products.

 

KNOW YOUR INFORMATION

Proper management of documentation optimizes your work processes and ensures that all documents are updated and contain the correct information.

With an integrated IT landscape, your company’s entire project team and all your stakeholders can get a full detailed overview of existing documentation, as well as needed expected actions on every project.

 

ONLINE SOLUTIONS

Store all your information in one place to obtain full transparency across all ‘cricial-to-quality’ processes and documentation. Experience immediate value with a Ready-to-Use online solution that gives you an overview of all your processes. 

STEP-BY-STEP GUIDE

Professional design & Development templates secure a guided and handheld process to ensure that the Quality assignment is solved right the first time.

Why does a Quality Management System benefit my business?

To have a Quality Management System in your business is first and foremost a requirement in the EU Medical Device Regulation (MDR).

A Quality Management System can be used by all organisations irrespectively of size and operations, for the following reasons:

  • Professional business – meeting markets expectations and demands
  • Increased efficiency and productivity
  • Opportunity to gain a competitive advantage
  • Increased Quality of products and services
  • Reduction of adverse events and complaints
  • Monitoring Customer Satisfaction

 

Why does a Quality Management System benefit my business?

To have a Quality Management System in your business is first and foremost a requirement in the EU Medical Device Regulation (MDR).

A Quality Management System can be used by all organisations irrespectively of size and operations, for the following reasons:

  • Professional business – meeting markets expectations and demands
  • Increased efficiency and productivity
  • Opportunity to gain a competitive advantage
  • Increased Quality of products and services
  • Reduction of adverse events and complaints
  • Monitoring Customer Satisfaction

 

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50