Our products have an
influence on people's health. biocon and all its employees do bear a special
responsibility for this. None of our working steps is carried out without
prior training and intensive briefing, not only in production, but also in
administration and in all areas of incoming and outgoing goods. Careful quality
control in all areas is particularly important to us, which is why we attach
great importance to ensuring that sufficient time is available for this.
For us, quality management
means manufacturing high-quality sterile medical devices, living quality and
constantly optimizing our QM system and adapting it to growing demands.
Quality, fast problem solving and customer satisfaction are our top priorities.
The recording of all
processes from development to shipping guarantees a consistently high level of
quality. Each production step is controlled and documented. The traceability of
all processes is possible without any gaps and offers additional transparency
to the users. Our QM system not only covers product-related processes such as
purchasing, production, storage and distribution, but also includes hygiene,
cleaning, machinery and work safety.
management system ensures that we achieve the quality demanded by our customers
and at the same time guarantee the safety of our medical devices as required by
auditors evaluate our quality management system as extraordinarily effective
and targeted. In regular internal audits, we check ourselves and systematically
eliminate identified deficiencies. We gladly accept suggestions for
improvements to our quality management system and work as a team to find
Katharina Schaber, Head
of Quality Management
Incoming goods, in-process and final controls are
carried out beyond the prescribed requirements where special responsibility for
the patient is involved. Qualified and
experienced employees in all areas and their continuous training ensure a high
level of product safety. We
manufacture in clean rooms whose hygienic conditions are subject to regular
external and internal controls in order to identify and minimize potential
risks at an early stage.
We are certified according to DIN EN ISO 13485:2016
and Directive 93/42/EEC, Annex V. Certification in accordance with Directive 93/42/EEC
is an absolute requirement for the CE marking of our Class IIa, Is and Im