ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System in the medical device industry. Here is more about ISO 13485 as the leading ISO standard for medical devices.

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.

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. Together, these define the overall scope and implementation of the Quality Management System. 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.

For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016. Every year, the ISO organization conducts a survey of certifications to its management system standards.

The ISO survey counts the number of certificates issued by certification bodies accredited by members of the International Accreditation Forum (IAF). In 2021, the total number of valid certificates for ISO 13485 worldwide was 27,229, while in 2020, there were 25,656. Data is taken from the 2021 ISO Survey.

Why is ISO 13485 important?

ISO 13485 is important for medical device manufacturers because it provides a framework for ensuring that their products consistently meet regulatory and customer requirements. Compliance with this standard demonstrates a company's commitment to producing safe and effective medical devices. It also helps companies meet regulatory requirements in many markets around the world. ISO 13485 can help companies identify and mitigate risks associated with the design, development, and production of medical devices. Finally, it can help companies improve their processes and increase efficiency, leading to better products and higher customer satisfaction.

What is the current version of ISO 13485?

The latest revision of ISO 13485 for ISO medical devices is from March 2016. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design and development requirements to many regulations, more emphasis on control of suppliers, requirements for traceability procedures, addition of complaint handling, and enhancement of product cleanliness requirements. See all the changes here: Infographic: What’s new in the 2016 revision of ISO 13485.

The ISO 13485:2016 standard aligns with the previous version of ISO 9001, ISO 9001:2008. ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS), which is published by ISO (the International Organization for Standardization). Its requirements are recognized around the world as an acceptable basis for implementing a QMS. Although the ISO 13485:2016 standard came out after the major update of ISO 9001:2015, the ISO 13485 standard does not align with this new revision of ISO 9001. Instead, it was determined that the most recent changes in ISO 9001:2015 were not necessary for medical devices.