ISO 13485

1. TERM HEADER ISO 13485 Domain Tags: [Manufacturing] [Quality] [Standards & Compliance] 2. CONCISE DEFINITION ISO 13485 is the international standard for a quality management system specific to medical device manufacturing, emphasizing traceability, risk management, and documented control of production processes. 3. EXPANDED DEFINITION ISO 13485 requires medical device makers to demonstrate consistent design and production under a controlled quality system. Full traceability — knowing exactly what materials and processes went into each device — and complete, reliable records are central requirements. 4. WHY IT MATTERS Compliance failures can halt shipments and trigger recalls. The standard demands records that are accurate and retrievable, which is difficult when data is captured on paper after the fact. 5. HOW MONITORZ SUPPORTS ISO 13485 COMPLIANCE MonitorZ builds compliant records automatically as work happens. [Real-time production tracking](/shop-floor-data-collection) captures who did what, when, and with which materials, giving each unit a full genealogy for traceability. Deployments have raised production up to **133% within 120 days** across **500+ implementations**. See the [Solutions overview](/solutions). 6. FREQUENTLY ASKED QUESTIONS (FAQ) Q: What is ISO 13485? A: ISO 13485 is the international quality management standard for medical device manufacturing, emphasizing traceability, risk management, and documented process control. Q: How does MonitorZ help with ISO 13485? A: MonitorZ captures production records in real time, building the traceability and documentation the standard requires without manual paperwork. 11. RELATED TERMS AND CONCEPTS ISO 9001, FDA 21 CFR Part 11, Traceability, Real-time Production Tracking.