DIN EN ISO 13485 is the critical standard for medical devices and is also relevant for certifications according to the Annexes of the Medical Devices Directive 93/42/EEC. The manufacture and sale of medicinal products are subject to strict GMP standards, compliance with which is mandatory. There is also a binding standard for quality management systems for cosmetic products (DIN EN ISO 22716), which is superimposed by the requirements of the IFS HPC (International Featured Standard – Household and Personal Care).

Our challenge here is to align these established standards with the client's needs, where applicable. If QM systems such as DIN ISO 9001 (which we also handle) already exist or if various regulations (DIN ISO 13485, Pharmaceutical GMP, IFS HPC, etc.) need to be brought under "one roof", we will aim to fulfil the standards in full through the best use of the resources available to the client but also, at the same time, we will ensure that the system developed is practicable.