ISO 13485 Medical Devices: Quality Management Systems
What is ISO 13485?
Put simply, ISO 13485 is the QMS standard for the medical device industry. Based on the ISO 9000:2008 series, ISO 13485 uses a process-based approach to ensure the quality of the medical device design, manufacturing, installation and service, and is applicable for all stages of the product life cycle.
It supports medical device manufacturers by demonstrating compliance with regulatory requirements in the following areas:
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
ISO 13485 is also at the core of the Medical Device Single Audit Program (MDSAP).
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ISO 13485 is the quality management system (QMS) standard that provides the framework by which manufacturers of medical devices can demonstrate their ability to consistently meet customer and regulatory requirements, as well as their commitment to quality and patient safety.
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