ISO 13485 Medical Devices | Quality Management Systems

ISO 13485 specifies requirements for a Quality Management System to produce ISO medical devices and related services that meet customer requirements. The regulatory requirements of ISO 13485 apply to all suppliers, regardless of company size or type, except where explicitly stated. The current version of the ISO 13485 standard is 13485:2016. This is stand-alone certificate which aligns with ISO 9001:2008, not the more recent ISO 9001:2015. ISO 13485 is also a global standard which is mandatory in some countries.

Benefits of ISO 13485

It is a process-based standard (it does not define product quality)
It shows you demonstrate a commitment to safety
You show potential customers you strive for quality and competence
It can reduce costs (a review of best practices in the product journey)
This standard is internationally recognised

To implement the ISO 13485, you need:

In-depth review of effectiveness of the quality management systems
Define processes and procedures
An a review and understanding of areas that require attention
Locate and fix areas of non-compliance and risk
Training and awareness program(s)

The Certification Process for ISO 13485 will include

For more information about the process of ISO 13485 please contact us and one of our team will be happy to discuss the standard in more detail.

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ISO 13485

Medical Devices

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Benefits of ISO 13485

To implement the ISO 13485, you need:

The Certification Process for ISO 13485 will include

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Other ISO Certifications

ISO 9001

ISO 14001

ISO 22301

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