ISO 13485 is the world’s most recognized Medical Device Standard. It is recognised by WHO (World Health Organisation), FDA (Food and Drug Administration, USA), and the European Commission. ISO 13485 is the most rigid global standard in manufacturing, exceeding even those of the FDA.
What ISO 13485 means:
- Quality Management Assurance
- Increased Efficiency
- Supply Chain Performance
- Improved Manufacturing Processes
- Meeting Customer Requirements
- Legal Compliance
ISO 13485 specifies requirements for a quality management system for an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
How is ISO 13485 certification granted?
The requirements for each certification are based on ability to demonstrate compliance to standards by documentation, adherence to written processes, internal and external quality management, and material traceability record keeping. The certification also needs to be maintained by annual surveillance visits by ISO to the manufacturing facilities.