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ISO 13485:2016 Medical devices — Quality management systems

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COMMENT 0 VIEW 1,135TIME DATE 21-08-11 13:02

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ISO 13485:2016  Medical devices - Quality management systems]
[ Certification Information ]

ISO 13485:2016 is a medical device quality management system certification standard enacted by the International Organization for Standardization. This standard is based on ISO 9001:2015 (Quality Management System Certification) and is added special requirements for medical devices.

[ Estimated Effectiveness of ISO 13485:2016 ]

•  Because of the acquisition of ISO 13485 certification of many medical device manufacturers, this has become a basic condition for maintaining competitiveness in the market. This certification is essential for companies preparing to enter the medical industry and export overseas.

•  Through the ISO 13485 quality management system, the organization's overall process management can be facilitated and maintain processes and services such as design, development, production and installation being stable. This lowers costs and increases efficiency.

•  It enhances the awareness of quality management systems for all employees by helping to improve the work environment.

•  Since proactive quality management is applicable, ensures accident prevention and customer safety by minimizing the risk of product defects.

•  Increase the safety of the product through continuous quality improvement and ensure reliability about the entire lifecycle process of the medical device.

•  It satisfies the requirements for entering the overseas market and helps to assess the suitability of CE in Europe.

[ System Certification Services from GIC ]

•  ISO 9001

•  ISO 14001

•  ISO 45001

•  ISO 13485

•  ISO 37001

•  ISO 37301

•  ISO/IEC 27001

•  ISO/IEC 27701

•  ISO 21001

•  ISO 22000

•  FSSC 22000

•  ISO 22716

* If you would like to check more detailed information of Management System and other services, please find the attachment.

ISO 13485_brochure

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