Icologiq Knowledge · Standard
ISO 13485
The international quality management system standard specifying regulatory-focused requirements for organizations involved in the design, manufacture and lifecycle of medical devices.
ISO 13485
Also known as:
ISO 13485:2016, medical device QMS standard
At a glance
Type
Standard
Topic
MedTech
Applies to
MedTech & Medical Devices
Current version
ISO 13485:2016
Status
Current edition at last verification
Last reviewed
September 14, 2026
Definition
ISO 13485 specifies quality management system requirements tailored to the medical-device sector. It places strong emphasis on regulatory requirements, risk-based controls, documented processes, supplier controls, traceability, complaint handling and other lifecycle activities relevant to medical devices.
Why it matters
ISO 13485 is the cornerstone MedTech term for Icologiq. It links directly to document control, CAPA, audit, change, competence, supplier quality and risk.
A structured system of processes, responsibilities, controls and documented information used to manage quality and continually improve organizational performance.
Quality Management System
Concept
· QMS
The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.
ISO 14971
Standard
· MedTech
A structured process for addressing causes of actual or potential problems through corrective or preventive measures and verifying that actions are effective.
CAPA
Process
· CAPA & Incidents
Explore further
Related knowledge
Explore related standards, processes and quality-management concepts.
MED-001
The international quality management system standard specifying regulatory-focused requirements for organizations involved in the design, manufacture and lifecycle of medical devices.
ISO 13485 specifies quality management system requirements tailored to the medical-device sector. It places strong emphasis on regulatory requirements, risk-based controls, documented processes, supplier controls, traceability, complaint handling and other lifecycle activities relevant to medical devices.