Quality and Risk Management
ISO 13485 establishes quality management system requirements for medical device organisations, while ISO 14971 provides the framework for managing risks throughout the product lifecycle.
The two standards are closely connected. Product safety, design controls, supplier management, production controls and post-market information all depend on effective risk-based decision-making.
A Lifecycle Approach
Risk management begins with intended use and foreseeable misuse, continues through design and production, and remains active during post-market monitoring.
The organisation must maintain traceable evidence showing how risks were identified, evaluated, controlled and reviewed.
Making the Systems Work Together
The strongest medical device systems do not operate ISO 13485 and ISO 14971 as separate activities. Risk controls inform quality planning, design decisions, verification, validation, supplier controls and corrective action.
Integration creates clearer evidence, better decisions and stronger confidence in product safety and regulatory compliance.