ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. The standard outlines the requirements for the design, development, production, and distribution of medical devices, with a focus on ensuring their safety and effectiveness.
ISO 13485 is intended to ensure that medical devices meet regulatory requirements and are safe and effective for their intended use. The standard applies to all organizations involved in the development, manufacturing, and distribution of medical devices, including suppliers and service providers.
The requirements of ISO 13485 cover a wide range of areas, including risk management, design and development, production processes, storage and distribution, and quality management. The standard also requires organizations to have processes in place for the control of documents and records, as well as for the identification, traceability, and validation of products and processes.
One of the key requirements of ISO 13485 is the establishment of a QMS that is specifically designed to meet the needs of the medical device industry. This includes the development of policies and procedures that are focused on quality, risk management, and the needs of the end-users.
ISO 13485 also requires organizations to continually monitor and improve their QMS, through the use of internal audits, management reviews, and ongoing training and development. The standard emphasizes the importance of ongoing improvement, and encourages organizations to use the results of their monitoring and measurement activities to identify areas for improvement and to take corrective action when necessary.
In summary, ISO 13485 is an international standard that specifies the requirements for a quality management system for medical devices. The standard is designed to ensure that medical devices are safe and effective for their intended use, and it applies to all organizations involved in the development, manufacturing, and distribution of medical devices. ISO 13485 requires the establishment of a QMS that is specifically designed for the medical device industry, and emphasizes the importance of ongoing improvement through monitoring, measurement, and corrective action.