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> What is ISO 13485?

What is ISO 13485?

The field of medicine is one of the most important fields as it directly affects human health and quality of life. ISO 13485:2003 is a standard process model based on the ISO 9001:2000 and it helps the management and application of a system that ensures quality management in the manufacturing of the medical devices.

The ISO 13485 Certification UAE is a stand-alone document based on the ISO 9001 but the difference is that the former requires the organization to demonstrate a system that implements and maintains a quality system while the latter document requires the organization to continuously improve.

Who is it applicable to?

The ISO 13485 Standard is specifically designed for organizations that provide medical devices, regardless of the size of the organization.

What are the benefits?

The ISO 13485 increases the probability of making safe and effective medical devices that not only meet the regulatory requirements by the medical board but also helps meet customer expectation. The standard also helps monitor the effectiveness of supply chain.

Apart from the above benefits the ISO 13485 also helps increase efficiency, saves cost, helps with risk management and improves the ability to respond to customer requirements.

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