ISO 9001 is defined as the internationally recognized standard for Quality Management Systems (QMS). It is by far the most mature quality framework in the world. More than 1 million certificates were issued to organizations in 178 countries. ISO 9001 sets standards not only for the quality management system, but also for the overall management system. It helps organizations achieve success by improving customer satisfaction, employee motivation, and continuous improvement. * The ISO certificate is issued in the name of FS.com LIMITED and applied to all the products sold on FS website.
ISO 13485 is an internationally recognized standard for Quality Management Systems (QMS) specifically tailored for the medical device industry. It outlines the requirements for organizations involved in the design, development, production, installation, and servicing of medical devices, ensuring they consistently meet regulatory requirements and customer needs. Essentially, it's a framework for medical device companies to build and maintain robust QMS processes, ultimately enhancing patient safety and device quality.
ISO/IEC 27001 is an international standard for managing and processing information security. This standard is jointly developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It sets out requirements for establishing, implementing, maintaining, and continually improving an information security management system (ISMS). Ensuring the confidentiality, integrity, and availability of organizational information assets, obtaining an ISO 27001 certificate means that the enterprise has passed the audit conducted by a certification body, proving that its information security management system has met the requirements of the international standard.