Quality and management

The company Institute of Biostatistics and Analyses Ltd has a well-developed system of quality management. All our processes are described and properly documented in the form of standard operating procedures, work instructions, plans and records in compliance with the requirements of international norms:

Requirements of good pharmacoepidemiology practice (GPP) and good clinical practice (GCP) are also reflected in our quality management system.

We obtained the first certificate – ISO/IEC 20000-1:2006, guaranteeing the quality of IT services – in September 2008, as the Institute of Biostatistics and Analyses at the Faculty of Medicine of the Masaryk University (IBA FM MU). Two more certification audits – quality management systems (EN ISO 9001:2009) and information security management system (ISO/IEC 27001:2006) – were successfully passed in September 2009.

The quality management system as well as the IT service management system remain implemented, and have been maintained according to the latest versions of the respective standards. Based on requirements of the ISO 9001 norm, Institute of Biostatistics and Analyses Ltd has adopted the Quality policy.

Personal data might be processed as part of provided services, consisting particularly in running the registries and dealing with related technical, organisational and statistical aspects. IBA Ltd has implemented a process for handling personal data that is in compliance with Czech and European legislation in force (see Legal aspects). Due to the nature of provided services, IBA Ltd has appointed a data protection officer (DPO), who can be contacted at gdpr@biostatistika.cz. Read our Privacy policy to find out more.