Quality Management System

Quality Management System

Do you need help with?

  • Establishing a brand-new quality management system
  • Introducing new processes and/or procedures
  • Optimization and simplification of existing system/processes and/or procedures
  • Standardization and/or merge of various quality management systems
  • Audit of own processes for compliance and efficiency
  • Audit of suppliers
  • Education and training

I have many years of experience in building, auditing and optimization of quality management systems locally and globally in compliance with the following requirements:

  • ISO 9001
  • ISO 15378
  • ISO 13485
  • ISO 22000
  • FDA CGMP - 21 CFR
  • EU GMP - Eudralex Vol. 4
  • MDR - Medical Device Regulation

I am used to work with electronic document control, and can also help you to select, implement and validate such a system.

Furthermore, I have experience in implementation and validation of other IT systems such as SAP QM & SAP QIM.

For new start-ups and smaller companies, having a whole new quality management system can be a big task and expense. To help these companies get started, I therefore offer the sale of selected standard procedures, instructions and templates as well as online counselling for implementation.