ISO 13485:2016 Quality Management System for Medical Devices
ISO 13485 provides a comprehensive framework for organizations to establish an effective quality management system. By adhering to ISO 13485, companies can enhance their ability to consistently deliver safe and reliable medical devices, meet customer expectations, mitigate risks, and demonstrate their commitment to quality and patient safety.
What is ISO 13485:2016 Quality Management System for Medical Devices?
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The ISO 13485 standard was published by the International Organization to provide medical devices companies with a framework to establish and maintain a quality management system. ISO 13485 certification is required companies who wished to market their medical devices in international markets.
ISO 13485 was first published in 1996 as a quality management system for medical devices companies based on ISO 9001 framework. The standard was originally published in two versions: ISO 13485 for manufacturers and ISO 13488 for contract manufacturers. But in 2003, the standards were combined into one quality management standard that can be used universally by medical device manufacturers.
In 2016, the standard was revised to highlight the following changes:
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New design specification based on ISO Guide 72,
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Harmonization with US CFR, Brazilian law (ANVISA), CMDR (Canada), and other law,
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The standard has integrated risk throughout the quality management system, and product lifecycle, risk-based decision-making has been incorporated,
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Emphasis on documentation for regulatory purposes,
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Integration with QMS software,
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Emphasis on appropriate infrastructure,
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New references to other standards have been included for usability, sterile barrier, etc
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New sections on complaint handling and reporting to regulatory authorities,
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Clarity for auditing,
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Planning and documenting corrective action and preventive action.
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Benefits of ISO 13485 Certification
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Ensure quality, safety and performance of your medical devices,
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Increase brand awareness and customer trust & confidence,
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Enhance the organization’s ability to meet customers and regulatory requirements.
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Ensure quality, safety and performance of your medical devices,
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Increase brand awareness and customer trust & confidence,
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Enhance the organization’s ability to meet customers and regulatory requirements.
Why get certified with SOCOTEC Certification Singapore?
SOCOTEC Certification Singapore is accredited by Singapore Accreditation Council (SAC) for ISO 13485 Quality Management System for Medical Devices, and we are also able to provide one-stop certification services with integrated management system services (ISO 9001 & ISO 13485).
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