Quality Management Systems

ISO 13485:2016 certification

ISO is the abbreviation for the International Organization for Standardization. There are many versions of ISO, depending on the industry and field of activity.

ISO 13485 is a standard that specifies requirements for quality management systems applied at facilities providing medical instruments and related services to ensure the ability to provide products that meet customer requirements. goods and legal regulations. ISO 13485 standard is built on the foundation of the ISO 9000 series of standards, the first version of which was issued by the international standardization organization ISO in July 2003 (equivalent to National Standard TCVN ISO 13485:2004 ).

The ISO 13458 standard has been widely adopted by medical device manufacturers worldwide.

What are the benefits of ISO 13485?

  1. The management system focuses on quality, oriented towards customers, determining product quality and the ability to satisfy customer needs and expectations.
  2. Process-based management – MBP (Management By Process) and decision-making based on actual events and data.
  3. Preventing non-conformities (NC) in relation to customers is a principal approach to satisfy the needs of both internal and external customers.
  4. Preventive measures right from the design stage, planning phase. Doing it right from the start is the most effective way of prevention.