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25.09.2013BBC Cellpack Medical

Medical Packaging is certified!

Besides commissioning our new facilities and equipment, Medical Packaging has also completed its certification process successfully.

Parallel to the expansion of the Medical Packaging division, work on the certification process was tackled. 

In addition to the universal ISO 9001 standard, the medical products sector also has mandatory, branch-specific QM norms. The international EN ISO 13485 standard specifies these requirements for ISO 9001 and is a recognized model worldwide. For us, as the value-creation partner for our customers, it was obvious that we wanted and had to get EN ISO 13485 certification as well. The first specification sets were finished very early. Which equipment and devices were mandatory and which requirements had to be fulfilled. Processed were defined, procedures sketched out, and guidelines and work instructions prepared. Slowly but surely, legal provisions, standards and much more were implemented in our daily routine.

A comprehensive documentation requirement exists for Medical Packaging, which must be consistent along the entire supply chain. The objective is to bring together the processes and their defining descriptions in practice. The principle of “as much as necessary and as little as possible” helps us shape and retain a lean, practice-oriented system. Besides the standards and guidelines, it was also necessary to consider which of these are already integrated into daily routines in any case. These are primarily label printing, cleaning processes, low microbiological contamination packaging, sealing and sterilisation. All of this must be proved again through permanent monitoring, maintenance plans, periodic analyses and daily tests.

From the perspective that our services and our processes have a direct influence on product quality, which has an immediate impact on people, everything we do and all our activity must be at a very high quality standard.

Through this certification, we demonstrate our capability to deliver services and processes, which fully meet the needs of our customers. Besides fulfilling regulatory requirements and delivering the highest possible quality services and processes, continual improvement remains our highest priority.