13485

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) used by organizations involved in the lifecycle of medical devices. It is designed to help ensure that medical devices consistently meet applicable regulatory requirements and customer expectations throughout development, production, installation, servicing, and final disposition.

The scope covers design and development, production, storage, distribution, installation and servicing of medical devices, as well as related activities such as purchasing controls, supplier evaluation, risk management, corrective and preventive actions (CAPA), complaint handling, post-market surveillance, and documentation control. The emphasis is on demonstrating regulatory compliance and product safety across the entire lifecycle rather than on marketing claims.

Key features include a risk-based approach to product realization, design controls, documentation and traceability, validation and verification of processes, equipment and software, supplier management, personnel qualification, and management responsibility. The standard requires continuous improvement of the QMS and adherence to regulatory requirements pertinent to the jurisdictions where devices are sold.

Edition and adoption notes indicate that ISO 13485:2016 is the current version, aligned with ISO 9001:2015 to facilitate integration while maintaining a focus on regulatory compliance for medical devices. Many jurisdictions, including the European Union (EN ISO 13485:2016) and other regions, recognize or require ISO 13485 certification as part of market access and regulatory submissions.

Certification and use: Organizations obtain ISO 13485 certification through third-party audits by accredited registrars. Certification demonstrates QMS conformity for medical devices and is often a prerequisite for regulatory approvals and supplier relationships; it is not a product certification in itself.