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ISO 13485

Quality Management System (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.


Key benefits of the ISO 13485 standard include

* Its provides a systematic framework for to define, implement, measure and analyze the process of business operation and customer opinion.

* It provides a systematic framework on monitored base that resulting in less waste and fewer complaints.

* Reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources saving.

* This standard focused to improve the performance in areas such as sales, product delivery, and process efficiency.

* Its reduce costs as a result of minimizing product failures.

* Through ISO 13485 standard organization access to the competitive edge with our independently.

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