QMS
Quality Management System
Sustainable growth through quality management
Do you need help or advice with an implementation of partial processes or setting up a Quality Management System (QMS) in your company? QMFocus is a specialized consultancy provider focusing especially on implementation of quality management systems. We can help you analyze your current situation and set up a fully customized QMS for your company.
Our experts have many years of experience in the field of medicinal products and medical devices and are well versed in relevant Czech and European regulations. They continuously monitor changes in the regulations and can advise on their well-timed implementation.
In the field of QMS, we can:
- Provide compliance in the field of medicinal products and medical devices legislation, in particular:
- Medicines Act
- Medical Devices Act
- Control Act
- Commission Implementing Regulation (EU) No 520/2012
- Guidance from national authorities (PHV / DIST)
- GDP, GxP, GVP
- ISO 9001, ISO 14155, ISO 31000, ISO 19011, ISO 22301, ISO 13485, NIST 800-34
- MEDDEV interpretation documents
- Set up processes to ensure Business Continuity
- Prepare and maintain methodologies (SOPs and Working Instructions)
- Establish risk and risk/benefit management models
- Establish automated systems
- Set up KPI rules and models for managing staff and vendors
- Provide comprehensive vendor management
- Provide staff training
- Set up a quality Home Office process
- All documentation can be processed in Czech, Slovak or English according to your requirements.
Ing. Richard Kodat
I have been working in Good Clinical Practice and Pharmacovigilance since 2010. I have worked for large pharmaceutical companies with a portfolio of original medicinal products as well as for smaller companies with generics. I was very interested in how the management of large and complex QMS with a high number of robust mathematical models and automated systems for process control and execution works. So I started working for the ČNB where I worked my way up to the position of Senior Expert in Advanced Quantitative Methods.