NextGenPCR® | From hours to minutes | High throughput | Any assay

Quality Policy

Quality Policy

The primary orientation of MOLECULAR BIOLOGY SYSTEMS B.V. is to be recognized for quality in the life sciences and molecular diagnostics industries. The specialized fields of focus are ultrafast polymerase chain reactions in all applications. This Quality Policy is based on an ongoing strive for customer satisfaction, quality products and service provision.

This will be achieved through:

  • Management of organization, along with established quality objectives and defined responsibilities for their fulfillment
  • Establishing, applying, maintaining and continual improvement of the effectiveness of the Quality Management System according to ISO 13485:2016 in all stages, from order receipt, development and production of medical devices, shipment and activities following shipment, to personnel education.
  • Continual enhancement of customers’ satisfaction by applying a process approach
  • Ensuring patient safety through risk management, quality assurance of medical devices and compliance with Medical Device Regulations MDR 2017/745 and IVDR 2017/746
  • Tracking and applying new technologies and educating employees
  • Pursuing legal and standard requirements
  • Careful selection of suppliers and their adherence to relevant standards and regulations
  • Commitment to increasing the quality of PCR instruments and assays to exceed customers’ expectations
  • Commitment to quality in every aspect of business processes
  • Making continuous improvement a part of every day and every job
  • Ensuring that our Policy and Procedure Manuals reflect our work
  • Understanding how our jobs fit into the overall flow of work at the company by regular training

 

The framework for setting quality objectives is defined in the Quality Manual.

The Quality Representative is responsible for communicating the Quality Policy to all individuals working for or on behalf of the organization and making it available to the public.

 

Gert de Vos

CEO