ISO 13485 is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices. The full title of the standard is ISO 13485:2016, “Medical devices — Quality management systems — Requirements for regulatory purposes.”

Key features and requirements of ISO 13485 include:

1. Focus on Medical Devices: ISO 13485 is specifically designed for organizations operating in the medical device industry. It is applicable to manufacturers, suppliers, and other entities involved in the medical device life cycle.

2. Legal and Regulatory Compliance: The standard emphasizes the need for organizations to comply with applicable legal and regulatory requirements related to medical devices. This includes obtaining necessary approvals and maintaining documentation to demonstrate compliance.

3. Risk Management: ISO 13485 incorporates principles of risk management throughout the product life cycle. Organizations are required to identify, assess, and mitigate risks associated with their medical devices.

4. Product Realization: The standard outlines requirements for the entire product realization process, covering design and development, production, installation, and servicing of medical devices. It includes controls for design and development activities, validation of processes, and control of monitoring and measuring equipment.

5. Traceability and Documentation: ISO 13485 places a strong emphasis on traceability and documentation. Organizations are required to maintain comprehensive records to demonstrate the effective operation of the QMS.

6. Corrective and Preventive Actions: The standard includes requirements for implementing corrective and preventive actions to address nonconformities and prevent their recurrence. This contributes to the continual improvement of the QMS.

7. Monitoring and Measurement: Organizations must establish processes for monitoring and measuring the effectiveness of their QMS. This includes processes for customer feedback, internal audits, and management reviews.

8. Supplier Management: ISO 13485 addresses the importance of supplier management. Organizations are required to evaluate and select suppliers based on their ability to meet specified requirements.

ISO 13485 is recognized globally and is often a prerequisite for regulatory compliance in many countries. It is aligned with other quality management system standards, such as ISO 9001, but includes additional requirements specific to the medical device industry. Organizations seeking ISO 13485 certification undergo a certification process conducted by accredited certification bodies, which includes an initial assessment and periodic surveillance audits. Certification to ISO 13485 demonstrates a commitment to quality and regulatory compliance in the medical device sector.