HORIBA Medical Quality Policy

 

The ISO 9001-2008 (Quality Management Standard) is the internationally recognised standard for the quality management of businesses. It applies to the processes that create and control the products and services an organisation supplies. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met.

 

The ISO 14001-2004 (Environmental Management Standard)
is the internationally recognised standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.

 

The ISO 13485-2012 is a quality system standard designed specifically for medical device companies. It supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

 

The OHSAS 18001-2007 (Occupational Health and Safety Assessment Series) certification is designed to help organisations formulate occupational health and safety policies and objectives.

 

 

Key indicators

  • Over 1,100 employees
  • 5 production centers (Japan, China, France, Brazil, India)
  • 2 R&D centers (Japan, France)
  • Around 100 distributors
  • 14 local/direct operations
  • Around 30,000 laboratories supplied worldwide