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Quality is defined by ‘ISO 9000:2015 Quality management systems – Fundamentals and vocabulary’ as the degree to which a set of inherent characteristics fulfils requirement. To meet the definition prescribed by ISO, it is necessary to pre-determine the fundamental characteristics, standardise the approach and execution of work, as well as establishing tools and criteria to measure the degree of fulfilment. In short, it is almost impossible to run a successful and high-quality company without a Quality Management System (QMS) of some kind.
Natalia Janik - Natalia has clinical research experience across a wide range of sectors, from cosmetics to First-in-Man trials. She has an excellent understanding of risk and is an advocate of the risk-based-approach. Natalia’s current role is QA Associate at Illingworth Research Group Ltd. She has been a member of the RQA since 2014, and this is her first project as part of the RQA Volunteer Programme.