What is ISO 13485?
ISO 13485 is an internationally recognized quality management system (QMS) standard specifically developed for organizations involved in the design, production, and supply of medical devices and related components. This standard focuses on consistent product quality, risk management, and regulatory compliance throughout the manufacturing process.
Unlike general quality standards, ISO 13485 is tailored to the medical industry, where product safety, traceability, and process control are critical.
Key benefits of ISO 13485 Standard
- Enhanced patient safety through controlled manufacturing processes
- Compliance with global medical device regulations
- Improved traceability and accountability across production
- Reduced risk of product failures and recalls
- Increased confidence for medical OEMs and regulatory bodies
Who Needs ISO 13485 Certification?
ISO 13485 applies to organizations involved in any stage of the medical device supply chain, including:
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Medical device manufacturers
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Component and precision part suppliers
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Contract manufacturers and OEM suppliers
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Companies providing related production services
For suppliers, ISO 13485 certification demonstrates the ability to support medical customers with stable, compliant, and well-controlled manufacturing processes.
How AECA Applies ISO 13485
To support medical OEMs as an ISO 13485 verified manufacturer/supplier, ISO 13485 principles are applied across our operations, ensuring reliable and compliant production of precision components.
- Structured risk management throughout manufacturing processes
- Strict document and change control to ensure consistency
- Material and process traceability to support regulatory requirements
- Comprehensive inspection and verification using calibrated equipment
- Continuous improvement driven by data analysis and corrective actions
