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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 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
  • Performance of internal audits as a preparation for the certification
  • Performance of seminars and lectures on that topic

Key aspects and proceeding

The key aspect of my work is the quality management for manufacturers of medical devices.

The establishment of a quality management system I understand 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.

For this purpose, it has proved to be useful to create the quality management documentation together with the employees involved in the company and give them instructions for maintaining and independent development of the quality system.

This rests the structure of the quality management system on many shoulders and the finished system is accepted by the employees 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.