The latest revision of ISO 13485 for ISO medical devices is from March 2016. What is the current version of ISO 13485? Finally, it can help companies improve their processes and increase efficiency, leading to better products and higher customer satisfaction. ISO 13485 can help companies identify and mitigate risks associated with the design, development, and production of medical devices. It also helps companies meet regulatory requirements in many markets around the world. Compliance with this standard demonstrates a company's commitment to producing safe and effective medical devices. ISO 13485 is important for medical device manufacturers because it provides a framework for ensuring that their products consistently meet regulatory and customer requirements. In 2021, the total number of valid certificates for ISO 13485 worldwide was 27,229, while in 2020, there were 25,656. The ISO survey counts the number of certificates issued by certification bodies accredited by members of the International Accreditation Forum (IAF). Every year, the ISO organization conducts a survey of certifications to its management system standards. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.įor a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016. Together, these define the overall scope and implementation of the Quality Management System. Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrate a commitment to the safety and quality of medical devices.

En iso 13485 pdf