ISO Certified Quality Management Systems

Every business strives for quality in the service it provides, to minimise its impact on the environment and to ensure a heatlty, safe and enjoyable working environment for its staff  Hydrix is no different in this regard. What makes the difference at Hydrix is the dedication and passion with which this goal is pursued, every minute of every day.

 

Quality at Hydrix transcends the product itself – it’s about an ability to deliver reliable, proven products and systems, which fully realise Client and User vision and to deliver at the right time thus maximising marketplace potential for the Client (the right product  form, function, reliability, cost  at the right time).

 

Hydrix are accredited to a number of international standards including:

 

      • ISO9001 - Quality Management Systems

 

      • ISO 14001 - Environmental Management Systems

 

      • OHSAS 18001 - Occupational Health & Safety Management Systems

 

      • ISO 13485 - Quality Management Standard for Medical Devices and Related Services

 

 

Design and development standards

 

Hydrix also has extensive experience in designing and seeking certification to a wide variety of local and international standards and other governing bodies and regulatory authorities across biomedical, industrial, wireless and other domains, including:

 

      • ISO 14971 – Risk Management System for Medical Devices

 

      • IEC 60601 - Safety and Essential Performance for for Programmable Electrical Medical Systems

 

      • IEC 62304 - Life Cycle Requirements for the Development of Medical Device Software

 

      • IECEx - International certification standard for equipment to be used in hazardous (classified)                 locations & explosive atmospheres

 

      • FDA - US Food and Drug Administration

 

      • FCC - US Federal Communications Commission

 

      • UL - US Underwriters Laboratory

 

      • CE- European Health, Safety and Environmental Legislation Compliance

 

      • TGA - Australian Therapeutic Goods Administration

 

      • C-Tick - Australian Electromagnetic Compatibility Requirements and Radio-communications                     standards

 

      • A-Tick - Australian Telecommunications Network connectivity compliance

 

      • RCM - Australian Regulatory Compliance Mark