Glossary Term
ISO 13485 (Medical Device Quality Management Systems)
Definition
ISO 13485 is an international standard for quality management systems (QMS) tailored to the design, development, production, and distribution of medical devices. It emphasizes risk management, regulatory compliance, and maintaining consistent product quality to enhance patient safety and device effectiveness. ISO 13485 is widely recognized as the foundational standard for QMS in the MedTech industry.
Relevance to the MedTech Industry
ISO 13485 ensures that medical device manufacturers have a structured and reliable system for consistently delivering safe and effective devices. The standard aligns with global regulatory requirements and provides a framework for risk management, continuous improvement, and maintaining compliance throughout the product lifecycle.
Additional Information & Related Terms
Key Sections of ISO 13485
Quality Management System
Establishes documentation, policies, and procedures to manage all quality-related activities.
Management Responsibility
Ensures leadership commitment to maintaining and improving the QMS.
Resource Management
Outlines personnel, infrastructure, and environmental requirements necessary for quality operations.
Product Realization
Covers planning, design, development, and production processes to meet device requirements and customer needs.
Measurement, Analysis, and Improvement
Includes monitoring processes, internal audits, and CAPA to maintain and enhance system performance.
Related Terms
Risk Management (ISO 14971): A complementary standard that addresses risk management for medical devices.
ISO 14937: Focuses on sterilization processes, which are often part of an ISO 13485 QMS.
Post-Market Surveillance (PMS): Supported by ISO 13485 requirements for monitoring and addressing real-world device performance.
Corrective and Preventive Actions (CAPA): A critical component of ISO 13485 for addressing quality issues and preventing recurrence.