At Hitma, we employ a structured approach to continuously improve the quality of our internal processes and services. We do this not only to comply with regulations, but primarily to ensure and enhance safety and customer satisfaction. This is reflected in our certifications.
ISO 9001:2015 – quality certification of Hitma
Hitma is certified according to ISO 9001:2015, an international standard for quality management. This certification shows that we have our processes in order, continuously optimize them and are able to consistently meet customer requirements and legislation and regulations. In January 2025, we were again successfully recertified by an independent audit firm, thereby being approved for a new three-year period.
ISO certifications of our assembly partner UltraPure International
Our partner UltraPure International, responsible for assembling our single-use systems, is also ISO 9001 certified. As a result, their processes also meet international quality standards. The production of the single-use assemblies takes place in a modern ISO Class 7 cleanroom. This cleanroom environment guarantees a controlled, clean, and safe production environment, which is essential for delivering high-quality assemblies for (bio)pharmaceutical applications.