Quality management start-up
Active guidance in the implementation of quality systems ISO 9001; ISO 13485, GDP and GMP, ISO 22716 (GMP cosmetics), HACCP Process approached Guidance and scan of your existing documentation, establishing strategy and timeline for implementation. Our goal is to support you by focusing on simplicity and reliability, a practical and performance approach, transparent and compliance system.
Interact with relevant authorities, experts and certification bodies.
Quality management follow up
Starting up is one thing. Staying in good shape is different kettle of fish. Keep your systems in shape!
- Organization & planning, performing and/or help with internal audit (and getting another point of view).
- Coaching on management review, KPIs and your CAPA system.
- On-site training and education services.
- Process Risk analysis.
- Process Validation ( e.g. sterilization, packaging & cleaning validation).
Lieven van Landuyt is a qualified auditor in the following domains:
- ISO 9001
- ISO 13485 (Medical devices)
- ISO 22716 (GMP Cosmetics)
- ICH Q7 (GMP for active pharmaceutical ingredients)
- GDP (Pharmaceutical Good distribution Practices)