What is ISO 13485:2016 (Medical Devices)

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Why ISO 13485?

As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.

What are the Benefits of ISO 13485:2016?

The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:

» Improve your company’s credibility and image
» Improve customer satisfaction
» Improve your processes
» Improve decision-making
» Create a culture of continual improvement
» Better employee engagement

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