TS EN ISO 13485/AC

TS EN ISO 13485/AC is a corrigendum to EN ISO 13485, the quality management system standard for medical devices. It is tied to the framework used by organizations that need to demonstrate the ability to supply medical devices and related services while consistently meeting customer requirements and applicable regulatory requirements. The technical subject is not generic quality management alone, but a regulated quality system tailored to the medical device field.

Quality management in the medical device context

In the medical device industry, a quality management system supports controlled design, production, distribution, and related services. The emphasis is typically on process control, traceability, documented responsibilities, and maintaining conformity to intended use and regulatory expectations. ISO 9001 provides the general quality management foundation, while ISO 13485 adds more specific structure for medical device organisations and their supply chains. That makes it especially relevant where documentation discipline and consistent service delivery are essential.

What this listing represents

This is not the base standard itself, but an AC/corrigendum record associated with it. In practice, that means the listing points to a published correction connected to the standard’s text rather than presenting a standalone full requirements document. For users working with standards collections, this matters because medical device quality requirements are often used alongside the correct edition and its amendments or corrections.

• Connected to the quality management system framework for medical devices and related services.
• Focuses on the ability to meet customer requirements and applicable regulatory requirements.
• Provides a more specific medical-device-oriented approach than ISO 9001.
• This record is a corrigendum (AC) linked to the parent standard.