Qimp Management Systems B.V. is an independent consultancy for life science industry founded by Henny Koch and offers quality management services based on 36 years of wide experience in global pharmaceutical industry.

 

Quality management is regarded to be the backbone of a life science organization and that the complex order of pharmaceutical quality greatly depends on all members participating in the applied processes. Respect to these elements have resulted in the set-up of services supporting life science QA management based on the philosophies of Total Quality Management.

 

Based on a Master in Quality Management, a QA management model has been developed to provide a process controlled approach in accordance with the principles of ICH Q8, ICH Q9 following the ICH Q10, ISO 9001:2008 and  ISO 13485:2003 for medical devices.

 

This has been realized by adapting the Deming Cycle to connect processes and systems within the complete product life cycle with attention for interaction and dependence to the hierarchical structure of the organization. The phases are defined and depicted in the adapted Deming Cycle:

 

 

 

 

 

 

 

 

 

Qimp Management Systems B.V. | De Haver 2 | 5384 XB Heesch | The Netherlands | (+31) – (0)6 – 421 34 721 | hmpkoch@qimp.nl

 

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