Quality for medical devices management system

  • meeting the customer and business partners requirements and the legal requirements
  • evidence of adherence to legal and regulatory or contractual requirements 
  • minimize and manage risks in the organization’s processes
  • preventing errors in making products and / or services
  • improved performance quality
  • transparency and clarity of internal processes
  • time and cost savings

This standard is addressed to:

  • companies operating in the field of medical devices: designers, producers, distributors / suppliers;
  • organizations performing installation, maintenance, service and training in the field of medical devices;
  • companies that produce subassemblies for medical devices

 

Why SRAC?

Upon the certification process successfully completed, SRAC certified organizations:

  • have the right to use SRAC and IQNet conformity marks for advertising purposes;
  • are regularly informed on the evolutions in the quality for medical devices and certification areas, by accessing SRAC website, events organized by SRAC.

 

Why certification?

Every successful organization should:

  • identify and satisfy the needs and expectations of its customers, as well as of its stakeholders, respectively employees, suppliers, owners, society, in order to obtain a competitive advantage, and to achieve this in an effective way;
  • obtain, maintain and improve on a continuous basis its general performances and capabilities;and the strong commitment to achieve the quality is the key.