On 15/9/2015, the International Organization for Standardization (ISO) has officially issued the ISO 9001: 2008 standard to replace ISO 9001: 2008 standard.....
Medical devices play an important role in hospital which directly influence people’s health. This type of product not only meets producer’s standard but also follow regulations to ensure that medical devices fulfill quality and safety requirement.
What is ISO 13485 ?
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The latest version of ISO 13485:2016 sets out requirement for quality management system applied for organizations providing medical devices. ISO 13485 has the foundation of ISO 9001 standard.
ISO 13485 focus on the harmony of requirement on quality management of medical devices. Currently, medical equipment producers want to be recognized all over the world, so ISO 13485 is an critical point.
Hospital, medical units can set up ISO 13485:2016 system independently or collaborate with other management systems such as ISO 9001, ISO 14001, OHSAS 18001, etc.
Who can apply ISO 13485?
Benefits of ISO 13485:2016 application
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