Certificates

ISO 9001 – business processes

An international specification that sets minimum standards that define how to design business processes, in order to ensure that customers receive the expected quality. ISO 9001 relates to the quality and reliability of services and deliveries, but is not a product certification.

 

ISO 14001 – environmental management

Serves to align the entire company with environmental goals and requirements. The basis is compliance with all relevant legal and regulatory requirements. The company itself can decide on what additional environmental goals it would like to pursue. Improvements can be achieved in many different areas, e.g. use of material, use of energy, waste water and emissions management, green procurement, etc.

 

ISO 22000 – food safety

This standard harmonizes various standards in the food industry. ISO 22000 is based on ISO 9001 and has been expanded to include the special requirements for food producing, processing, and handling companies. ISO 22000 combines a quality management system with a HACCP concept and with a required preventative programme for improving food safety.

 

ISO 13485 – medical devices

Thereby the requirements related to medical air humidifying systems, that are not defined as medical devices in ISO 13485, were derived from Austrian standard ÖNORM H6020-1:2007 “Technical ventilation systems in healthcare facilities – project management, construction and inspection” and international standard ISO 13485 “Medical devices – quality management systems – requirements for regulatory purposes”. Compliance was checked based on a list of requirements compiled by TÜV NORD Austria. During this audit, Merlin was able to provide evidence that the relevant requirements had been integrated into its quality management system and that they are followed and regularly audited.