Quality Management
The creation and maintenance of a quality management system is for many companies connected with a high effort, they often can not afford alone. To make your way to achieving and maintaining a certification or accreditation easier I offer the following services:
- Consulting for the establishment of process-oriented quality management systems according to EN ISO 13485, EN ISO 9001, MDR and EN ISO/IEC 17025 up to the successfull certification or accreditation
- Support for the maintenance and retention of existing quality management systems, amongst others as external quality representative
- Carrying out internal audits in preparation for certification
- Organizing seminars and lectures on the subject
Key aspects and proceeding
The key aspect of my work is the quality management for manufacturers of medical devices.
I understand the establishment of a quality management system as an individual process, which extends over a certain period of time. The aim of my consulting is to establish the quality management system in the company in a way that allows it to be "alive" and to be maintained after my work is done.
To this end, it has proved useful to draw up the quality management documentation in collaboration with the relevant staff within the company and to provide them with guidance on maintaining and independently developing the quality management system.
As a result, the responsibility for setting up the QM system is shared amongst many people, and the employees embrace the finished system as their ‘own’.
The type of quality management documentation is subject to the wishes of the customer and can take various forms. Besides the "classic" text representation, flowcharts, the use of linked HTML documents, the use of a wiki or "exotic" representations such as Mind Maps are possible.