ISO 13485 Certification is an internationally recognised standard that sets forth requirements for a Quality Management System (QMS) used by Medical Device organisations. This certification applies to organisations engaged in the design, development, production, installation, and servicing of medical devices, as well as to organisations providing services for these devices.
The goal of ISO 13485 is to ensure the consistent compliance of organisations with both regulatory and customer needs while ensuring the safety, quality, and efficacy of medical devices during their lifecycle. In addition to being a standard that sets forth general quality assurance principles, it places an emphasis on risk management, product safety, regulatory compliance, and recordkeeping.
This certification can be obtained by those organisations who manufacture, supply, distribute, or provide services to the Medical Device Industry. It can improve the internal processes of an organisation, reduce risk levels, improve product quality, and establish a level of confidence with regulatory agencies and customers on a global basis. ISO 13485 is frequently required for organisations entering or expanding into the global health care market, including the US and Europe, as well as in other regulatory areas.
