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Wincomm Granted ISO 13485:2016 and 9001:2015 Certifications

 Hsinchu, TW, Aug 27, Wincomm, a leading manufacturer of medical grade, industrial grade and rugged embedded computer products, has been granted ISO 13485:2016 and ISO 9001:2015 following successful completion of an audit of its quality management system in July, 2018. The audit was performed in May by TUV Nord, one of the leading global certification bodies, and included a review of the company’s quality management system to ensure compliance with the newest version of the ISO 13485 and ISO 9001 standards.

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.

Medical device manufacturers are required to update their quality systems to the new standard by March 2019 in order to remain in compliance. The 2016 standard for quality management systems places an increased emphasis on risk management and harmonizes more closely with the quality system regulations found in FDA 21 CFR Part 820, the law for medical device companies manufacturing or selling products for the US, and the European Commission’s new IVDR 2017/746 for in-vitro diagnostics.

Achieving ISO 13485 certification is the result of continuous efforts and indicates that Wincomm has been committed to continuous quality improvement. It also demonstrates that our quality system ensures the in vitro diagnostics we develop and distribute, including our medical grade panel PC, display and box PC, which predicts the response to be manufactured in compliance with the highest standards for safety, product performance and reliability.

 

  

 

About Wincomm

Wincomm is one of Taiwan’s leading manufacturer of industrial computer and embedded computer products. Wincomm designs and develops all in one panel PC, large size all in one digital signage system, rugged box PC and embedded software products for a broad range of industries and applications. Wincomm aims to provide hardware and software integrated solutions for the most variant environments such as industrial automation/ human machine interface control, digital signage / infotainment Kiosk, and medical computing.

 

 

 


 
 
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