ISO 13485 formulated by ISO/TC 210 Medical Device Quality Management Technical Committee of the International Organization for Standardization is a set of medical devices quality management systems standards. It can assist organizations in assessing potential risks in the supply chain of medical devices and further effectively controlling product quality to meet legal regulations and international customer needs.

Benefits of ISO 13485:

• 1.Comply with regulatory requirements and meet customer expectations to enhance product value and corporate image.
• 2.Review and improve the processes within the organization to increase productivity and mitigate post-launch risks.
• 3.It is proven to showcase the capability to provide safe products, which could strengthen the ability and increase the opportunity to enter into the international medical industry supply chain.
• 4.Break through the barriers of international trade and expand the global medical equipment market.

ISO 9001 is an international quality management system standard, which is the most widely recognized quality management standard worldwide. The new version of the quality management system presented via the monitoring of risk indicators or process performance indicators can bring enterprises substantial quality management performance, mitigate business operating risks, enhance corporate competitiveness, and keep controlling the quality of the overall operation process, so as to achieve consistent performance and service levels and set benchmarks for perfecting the operation for each stage and achieving process improvement.

Benefits of ISO 9001:

• 1.Comprehensively improve product quality and customer satisfaction.
• 2.Establish a customer satisfaction survey system to understand the levels of customer satisfaction with the company products and services, and timely improve deficiencies, solve potential customer complaints, and improve customer satisfaction.
• 3.Monitor and measure various processes of quality management, improve process performance, and enhance corporate efficiency.
• 4.Establish an effective internal audit system for facilitating the implementation of the system and mitigation of the risks of fraud and errors.。
• 5.Establish an effective internal communication system to improve operational efficiency.

ISO 14001 formulated by the International Organization for Standardization is a set of global environmental management system standards with the purpose of encouraging organizations to build integrated environmental management systems that allow energy conservation and pollution mitigation including selecting low-pollution raw materials and more environmentally friendly production technologies, so that organizations could continue to improve environmental quality, protect the global environment, and further achieve enterprise sustainable development. The levels and subjects covered include not only customers, but also government environmental protection units, environmental protection agencies and groups and general consumers.

Benefits of ISO 14001:

• 1.Allow better environmental management that mitigates waste and energy consumption.
• 2.Improve efficiency to reduce business operating costs.
• 3.Expand business opportunities through compliance practices.
• 4.Fulfill statutory obligations to win more trust from stakeholders and customers.