Content

Anchor quality sustainably in the organization. ISO 9001, 14001, 50001, 45001, 27001 and 13485, FDA and EU-MDR - or: Global requirements for sustainability, quality, safety and competitiveness.

The High Level Structure is an ideal basis for this – but how does it fit into the world of medical technology? Use synergy effects sensibly and at the same time effectively anchor quality thinking in the organization. Employees understand and live by guidelines when a system is set up or restructured transparently and sustainably. The pillars that matter are presented.

In this two-day seminar, a possibility and procedure will be shown and partially developed to holistically transfer the many requirements with their similarities and differences into an IMS.

Topic overview

  • Normative basic understanding
  • DIN EN ISO 13485/EU-MDR, QSR and the high level structure of ISO 9001, 14001, 50001, 45001 and 27001
  • The “management house” with its supporting pillars
  • The process landscape – an approach
  • Outlook on change management – the difficulties of restructuring
  • Exercises and practical examples

target group

Management, specialists and managers from development, production, maintenance and/or quality management.

Prior knowledge

Not required.

Funding opportunity




ESF funding is possible. Further information can be viewed here .

Early bird discount

If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.

KONTAKT:
Tuttlingen
Tuttlingen & Online

 

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