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Article: Certifications & Awards

Certifications & Awards

Did you know that MEI-CHA manufactures all devices and needles in house and has been ISO* certified since 2003? It certifies that we follow a high level of quality management system that is effective, consistent, and efficient. 

We take quality seriously. It’s one of our core values here which is why we have the highest level of certifications. 

*The International Organization for Standardization, better known as ISO, is an international standard-setting organization that develops and publishes worldwide technical, industrial and commercial standards. All ISO standards are reviewed every 5 years in order to keep it current and relevant.

ISO 9001

To become ISO 9001 certified, we went through an internationally recognized evaluation process that ensures we create, implement, and maintain a Quality Management System. We underwent a lengthy process that includes quality management system development, documentation review, audit, initial assessment, and clearance of non-conformances (which none were identified!). Being awarded ISO 9001 means we have a robust quality management system in place to deliver high quality products, at the same time meeting customer satisfaction and continuously reviewing and improving the way we work.

*To read more about ISO 9001

ISO 13485

The medical device industry’s most widely used international standard for quality management. This certification is an extra step up from ISO 9001. Being ISO 13485  certified means that we have an effective and clearly defined procedure in the area of R&D, production, assembly, supply chain management, risk management, customer requirements, and regulatory compliance specifically for medical devices. We have been successfully audited following the most stringent guideline in the medical industry, which includes but not limit to:

  • Controls in the work environment to ensure product safety
  • Risk management and design control during product development and production
  • Requirements for inspection and traceability for implantable devices
  • Requirements for documentation and validation of processes for sterile medical devices
  • Requirements for verification of the effectiveness of corrective and preventive actions
  • Requirements for sanitary of products
  • Effective product traceability and recall system

*To read more about ISO 13485

We are incredibly proud to make real good products so you can make people look real good.

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