Our quality and environmental management

In addition to the consistently high quality of our internationally renowned LIGASANO® products, we have always wanted to produce as environmentally friendly as possible, which has been documented by external examinations since 1998. All processes are constantly questioned and improved.

In fact, we were the first company in our county that passed the EMAS environmental audit. At the time, a journalist asked me why we are dealing with environmental management at all. This question surprised me so much that I came to a halt. It has always been natural for me. That's exactly what my answer was.

Leonhard Hüttner, managing director, co-founder and shareholder of LIGAMED® medical Produkte GmbH

Demanding quality and environmental policy for over 20 years

1996

LIGAMED® has started to set up the QM system

1997

First contact to the working group environment with registration for the company circle "eco audit"

1998

Successful certification of the QM system or validation of the UM system

2018

Start of preparation for the changeover to MDR (Medical Device Regulation)

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Continuous quality management and environmental management, through annual reviews

The management of LIGAMED® medical Produkte GmbH is committed to the implementation of quality / environmental management for:

  • Fulfillment / compliance with the requirements
  • Continuous improvement of the effectiveness of the systems according to the valid DIN EN ISO 9001 and EMAS including the applicable legal regulations and involving the employees, customers and suppliers. Furthermore, it informs the public and increases the quality awareness of employees and customers.

All employees are instructed to always pay attention to:

  • avoid waste
  • save energy
  • avoid accidents
  • maximize customer satisfaction

This environmental information has been validated by our environmental verifier in accordance with Article 10 (5) of the EMAS Regulation. Comprehensive information can be found in our current environmental statement, which you can request.

 

Our certificates

Our dressing material LIGASANO® is classified according to EC directive 93/42 / EEC in class IIb.

What does that mean? It entitled us together with our certification of the QM system according to the valid standard DIN EN ISO 13485 for affixing the CE mark on the product and for classification as a medical device. Class IIb medical devices may e.g. used on wounds whose dermis has been severed and can only be healed by secondary wound healing.

EMAS: the premium label of the EU

EMAS is the world's most sophisticated system for sustainable environmental management and stands for Eco-Management and Audit Scheme. Only those organizations that meet the stringent requirements of the European EMAS Regulation will be awarded the EMAS logo.

All EMAS participants voluntarily undertake to systematically improve their environmental impact. Here they can be permanently monitored.

The individual elements of an EMAS environmental management system:

► A communicated environmental policy

► The determination and evaluation of the operational environmental aspects, i.a. with key figures

► Compliance with standards, regulations and applicable legal provisions

► Setting annual targets and drawing up an action plan

► The annual review and evaluation of the system in the internal audit and management review

► Publication of the Environmental Statement

► Regular independent validation by an approved environmental verifier

► Entry in the EMAS participant register by the respective IHK or chamber of trade

EMAS is not an off-the-peg scheme. It is important to have initiative, new ideas and the willingness to question your own actions - and have them questioned.

To take responsibility!

This not only enables efficient environmental protection, which goes far beyond the statutory requirements.

EMAS also means accepting more responsibility for society.

Intechnica Cert GmbH regularly validates our environmental statement

An accredited environmental verifier checks LIGAMED® medical Produkte GmbH for compliance with all regulations with Regulation EC No. 1221/2009 and determines the compliance of the environmental management system, the internal environmental audit and the environmental statement with the requirements of the regulation.

This then complies with the requirements for an environmental management system in accordance with ISO 14001 + Cor.1: 2009.

Environmental Pact Bavaria (Umweltpakt Bayern) & Seal of Approval QuB

LIGAMED® medical Produkte GmbH has also been a participant in Environmental Pact Bavaria (Umweltpakt Bayern) since 1998. In addition, it is entitled to use the seal of approval QuB (Quality Association of Environmentally Conscious Companies) and thus documents particularly sustainable operations management.