HygCen

Austria

Accreditation List

Origin

As a medical practitioner, the good of humanity is my top priority. As my life's work, HygCen is the perfect implementation of this intention through tested safety in the widest variety of sectors.

Prof. Dr. med. H.-P. Werner
Medical Specialist for Hygiene and Microbiology, Managing Director

Prof. Dr. med. Heinz-Peter Werner is the founder, Managing Director, and Technical Director of HygCen Austria GmbH. After studying medicine at the University of Vienna and being granted the title of Doctor medicinae universae (Dr. med. univ.), he performed his residency in microbiological and serological routine diagnostics at the University of Vienna's Institute for Hygiene and in the vaccination center.

From 1970 to 1973 he was head of the Laboratory for Hospital Hygiene in Vienna and during this period he studied the organization of infection control committees in the USA. In 1977 he earned the Venia Legendi license to teach the subject of hygiene, in 1980 he was appointed professor for life at the Johannes Gutenberg University Mainz, and in 1988 he obtained a diploma in tropical medicine.

Following his university career he decided in 1996 to broaden the scientific foundations and experience of the public health service to all sectors of healthcare.

This idea was put into action through the founding of a politically and economically independent company, the testing laboratory HygCen, Center for Hygiene and Medical Product Safety in Schwerin, Germany.

In 1999, the 100% independent testing laboratory HygCen, Center for Hygiene and Medical Product Safety was founded in Bischofshofen, Austria.

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Goals

As an accredited testing laboratory and accredited inspection body, our great responsibility to our customers is always present in the minds of all employees during every individual decision.

Monika Feltgen

Vice technical manager, Quality Management, Medical Devices

The following applies for us and our customers: "Only the responsible way is the right way to the goal - committed to responsibility and hygiene" 

Confident in the responsible thinking and actions of the other party, HygCen as an accredited testing laboratory and inspection body and its employees take responsibility for and together with our customers.

This is already apparent from the mere fact that the technical management is carried out by a medical specialist for hygiene and microbiology.

In particular due to the fact that questions regarding infection prevention and hygiene are very difficult to answer through pure evidence-based medicine, a qualified and well-founded expert opinion will continue to be indispensable in the future as well.

This necessarily leads us to only make decisions with the involvement of medical responsibility, not only with regard to our direct customers but also to the users or patients of the services and products of our customers.

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Values

As an accredited testing laboratory and accredited inspection body, our great responsibility to our customers is always present in the minds of all employees during every individual decision.

Margarita Gilowsky, MBA
Head of Quality Management

All employees of HygCen are committed to this responsibility in a credo not only to the customer but also to their colleagues in particular.

We see this as the basic requirement in order to always provide high-quality services while working with and for our customers in the long term and to offer better benefits and safety to the user. "Hygiene is not EVERYTHING, but without hygiene EVERYTHING is nothing."

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Credo

HygCen has committed itself to ensuring the comparability of its test results in the interests of worldwide harmonization. The enduring fulfillment of the agreements concluded with our customers is the basis of our reputation for quality and serves the purposes of quality assurance, the safety and efficacy of medical devices, pharmaceuticals, and food as defined by the Medical Devices Act, the Pharmacopoeia, the Food Act, and the Pharmaceuticals Act. The quality objectives are defined and taken into account in the management review as follows.

Customers can trust in the test and inspection results from HygCen. All of the results from HygCen are ensured through validation, control standards, and gapless documentation. In order to be able to document this externally as well, HygCen implemented a QM system in accordance with EN ISO 17025 and EN ISO 17020. Conformity with this system is confirmed by Akkreditierung Austria, the Austrian National Accreditation Body of the Federal Ministry of Digital and Economic Affairs in Vienna.

The individual determination of customers' wishes, rapid and high-performance customer support, targeted specialist consulting, and qualified as well as on-schedule services are our primary objectives with regard to satisfying our customers. Customers can receive a copy of our quality manual upon request. Customers can make an appointment to visit the institute and learn more about the test and inspection methods or have an audit conducted there upon request. Customers can rely on HygCen. This means responding to customer requests, the adequate ensuring of test and inspection results, the absolute confidentiality of the test and inspection results, and informing customers about the further steps required as a consequence of the test and inspection results.

The innovativeness and quality consciousness of our employees are promoted through continuous training and advanced training. In addition, the motivation of the employees is increased through self-monitoring and organization of the working method and workplace.

Our employees handle hazardous agents, substances, and materials in the service of customers. We place great value on all employees being able to feel safe during their activities.

Our modern laboratory facilities and equipment guarantee the highest possible quality of work. Preventative measures for fault avoidance enable efficient use of operational resources.

Our quality management system is also certified through our accreditation in accordance with EN ISO 17025 and EN ISO 17020. Our QM system enables us to meet the most diverse requirements. Our QM system is reviewed, evaluated, and thereby continuously advanced through both external as well as internal audits. Quality is the basis for us. We can react flexibly to changes in things such as legal and normative provisions as well as the needs of the market.

We also assume our ecological responsibility through compliance with legal regulations as well as open discussion of social and environmental issues.

HygCen and all of its employees are committed to impartiality, independence, and integrity in the performance of its tasks. Every employee is personal responsible for their own ability to make technical judgments and thereby for the objectivity of test and inspection results/statements.

"Hygiene is not EVERYTHING, but without hygiene EVERYTHING is nothing."


Timeline

Our milestones

HygCen GmbH Austria – a history of success that has lasted for over 20 years and is continuing to be written for the benefit of our customers.

2021

Groundbreaking ceremony 2021-08-16

2021

HygCen builds a new 2500 m² company building in Schwarzach

2021

Start shortened mask testing of respiratory protective devices according to EN 149 respiratory protective devices - filtering half masks to protect against particles - requirements, testing, marking

2020

Application to expand the scope of accreditation with regard to test methods for personal protective equipment (PPE)

2020

Expansion of the scope of accreditation with regard to test methods for the biological safety of medical devices in EN ISO 10993 "Biological evaluation of medical devices".

2020

Expansion of the scope of accreditation with regard to test methods for the virucidal effectiveness of disinfectants

2019

"20 years of HygCen Austria GmbH" anniversary

2018

Expansion of the scope of accreditation with regard to test methods, medical device safety, biocompatibility, and airborne disinfection

2013

Change of name from HygCen International GmbH to HygCen Austria GmbH

2011

Founding of the testing laboratory UMS Medikal GmbH in Ankara, Turkey

2007

Accreditation as an inspection body in accordance with EN ISO/IEC 17020

2007

Change of name from HygCen Bischofshofen to HygCen International GmbH

2006

Establishment of the testing laboratory in Grenzach-Wyhlen

2002

Accreditation as a testing laboratory in accordance with EN ISO/IEC 17025 

1999

Founding of the 100% independent testing laboratory HygCen, Center for Hygiene and Medical Product Safety in Bischofshofen, Austria


Team

Working together for success

If you are looking for a challenge, we are looking for you!

We are a young, dynamic, high-performance, and internationally active company with 100% motivation, commitment, and precise work in the service of our customers.


Career

To take responsibility for hygiene together with you!
It is not enough to want. One must also do. - J.W. Goethe

Unfortunately there are no job offers at present