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Global requirements of sustainability, quality, safety and competitiveness. It's about nothing less.
Use synergy effects sensibly and at the same time effectively anchor quality thinking in the organization. Employees understand and live by specifications when a system is set up or restructured transparently and sustainably. The pillars that matter are presented.
A holistic management system instead of several parallel systems with high expenditures in terms of personnel, time and money. The avoidance of parallel documentation, unclear CIP, double work, ambiguities and dangers in process transitions, multiple audits, and much more.
The high-level structure is an ideal basis for this – but how does it fit into the world of medical technology?
In this seminar, a possibility and procedure will be shown to transfer the many requirements with their similarities and differences holistically into an IMS.
On the first day, the basics of the normative relationships are on the program. Interactive exchange and practical examples loosen up the subject areas somewhat.
On the second day, what has been learned is combined after a short and joint reflection. Methods are presented that simplify the work and create transparency in order to keep the organizational effort as low and comprehensible as possible.
An effective synergy effect is shown using the example of the validation requirements of medical technology in connection with the area of maintenance and repair or in the area of auditing effort.
topic overview
- Normative basic understanding
- ISO 13485/MDR and the High Level Structure (HLS) of ISO 9001, 14001, 50001, 45001 and 27001
- The "management house" with its supporting pillars
- The process landscape
- Outlook on change management - the difficulties of restructuring
- The interaction and the peculiarities of quality, environmental, energy, IT management as well as occupational health and safety as an integrated management system
- Exercises and practical examples
target group
Management, specialists and executives from development, production, maintenance and/or quality control
previous knowledge
Not mandatory.
KONTAKT:
MedicalMountains GmbH
