Quality

We provide professional support for the following tasks:
  • Quality and compliance
  • Business process documentation
  • Training management
  • Customer and employee support
  • Internal audits
  • External audit preparations
  • Risk management
  • IT security
  • System troubleshooting
  • Technical specifications
  • Testing and validation
And this is why…

EN ISO 13485:2016 (paragraph 5.5.1 and 5.5.2)
Quality management systems

Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.

Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.

Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:

  • ensuring that processes needed for the quality management system are documented;
  • reporting to top management on the effectiveness of the quality management system and any need for improvement;
  • ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.