In the context of a quality management system (QMS), one always refers to the corresponding applicable standard when creating QM documentation. This describes the different elements of a QMS. This is what the standard says about processes:
Any activity that receives an input and converts it into a result can be considered a process. Often the result of one process forms the direct input for the next process.
When used in a quality management system, such an approach emphasises the importance of understanding and meeting requirements.
BEO BERLIN is happy to advise on implementation of a QMS and on any questions that may arise. Furthermore, we offer a general provision of a qualified employee as QMB according to EN ISO 13485.
Do you have questions on this topic?
BEO BERLIN supports manufacturers with regulatory questions relating to MDR, technical documentation and market access.
