TS EN ISO 13485/AC

TS EN ISO 13485/AC is a corrigendum to EN ISO 13485:2016 for quality management systems in medical devices. The document concerns the management-system requirements that support an organization’s ability to consistently meet customer requirements and applicable regulatory requirements when providing medical devices and related services.

The role of a quality system in medical device control

In the medical device sector, a quality management system is intended to control processes from design and development through production, supply-chain control, distribution, and post-market activities. The ISO 13485 framework emphasizes not only general quality principles but also regulatory traceability, disciplined documentation, and process consistency. For that reason, the standard family is widely used as a framework for organizing the activities that support device conformity and dependable performance.

What this record covers

• Quality management system requirements for organizations that need to demonstrate the ability to provide medical devices and related services.
• A focus on meeting customer requirements together with applicable regulatory requirements.
• A systematic approach to controlling, monitoring, and maintaining processes across the medical device lifecycle.
• This listing is a corrigendum, so it belongs to the base standard’s subject area but is not itself the full core standard.

In general technical terms, a quality management system works through defined responsibilities, record control, supplier and process control, corrective action, and continual improvement. In highly regulated fields such as medical devices, that structure helps ensure product quality is managed in a repeatable and auditable way rather than by chance.