Operations and Business Environment - Fresenius Medical Care

Quality and Environmental Management
To ensure constantly high quality standards, we developed
the Integrated Management System (IMS). It
works with the legal and normative guidelines for our
products and services and focuses on established operational
workflows. The IMS fulfills the ISO 9001:2000
requirements for quality control systems in combination
with the ISO norm 14001:2004 for environmental
control systems. At the same time, it conforms
to the requirements for medical devices of ISO norm
13485:2003.
The IMS has already been implemented in all of our
European production sites and will now gradually be
introduced in our dialysis clinics as well. In parallel,
we are constantly refining the system. In 2006, we
introduced the quality control norm ISO 9001:2000 in
about 50 additional European dialysis clinics, including
facilities in Slovakia. As a result, approximately 65 %
of our clinics in Europe are certified, compared to
about 55 % in the previous year. Certification according
to environmental control norm 14001:2004 has also
made headway, and now more than 50 dialysis clinics
work in accordance with this norm, including, since
2006, dialysis centers in Poland, Slovenia, Turkey and
Italy. As planned, we trained a total of 50 employees,
so-called corporate auditors, to perform internal audits
based on the IMS.
Another focus of our work is to prepare drugs for
approval and submit the necessary applications. The
approval of drugs is subject to national and international
regulations, and quality management is in charge
of controlling their internal realization. The aim is to
speed up approval of products to shorten the time
between development, clinical testing and marketing
of products.
To meet this goal, the Mutual Recognition Procedure is
particularly important. Valid throughout the EU, this
directive allows for the accelerated approval of medical
products – if they have already been approved by another
EU member state. In 2006, a total of 28 peritoneal
dialysis products were approved, including products
for PD solutions from the balance series (see the glossary
beginning on page 114 ), as well as for dialysis drugs in
Europe and Asia.
As previously mentioned in the “Strategy” section on
page 50
, we intend to become more involved in the area
of dialysis drugs in the future. Preparing these drugs
for approval will be a focus of our quality management.
We took the first steps in 2006, adapting, for example,
internal structures and processes accordingly.
Apart from introducing the environmental control system
in our clinics, our work focused on the implementation
of the RoHS and WEEE EU guidelines. RoHS
stands for “Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic Equipment”.
Since mid 2006, this guideline has limited the usage
of certain hazardous substances in electrical and electronic
devices and completely forbids the usage of
lead, cadmium and quicksilver in these devices. WEEE
stands for “Waste of Electrical and Electronic Equipment”.
The guideline regulates collection, disposal
and treatment of electronic waste. In 2006, Fresenius
Medical Care updated the labeling of products in
accordance with WEEE at its Schweinfurt factory,
among others.
Active environmental protection at our production sites
means continuous improvement of our processes, in
order to be more environmentally compatible and,
usually, more cost-efficient. For example, by using heat
recovery systems at our St. Wendel plant we considerably
reduced the amount of steam used and thus cut
the amount of natural gas we needed as an energy
source by 4 %.
We were able to reduce the energy consumption at
our factory in Cremona, Italy, by 15 %, simply through
optimizing the use of lighting systems and air conditioning.
In addition, logistics costs for truck transports
were cut by 10 % thanks to improved coordination of
transport routes between individual suppliers.
Waste separation has considerably reduced the amount
of residual trash at Fresenius Medical Care’s dialysis
clinics in North America. Waste is now separated in
more than 900 clinics. As a result, we recycled 3,500
tons of cardboard and paper packaging in 2006.
Saving water is also an important contribution to resource
conservation. In 2006, we installed more than
80 water preparation systems to produce ultrapure
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Fresenius Medical Care 2006