ISO 13485 CERTIFICATION - iso certification in kuwait

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ISO 13485 Certification

ISO 13485 certification is the independent benchmark all medical devices and related suppliers must go by to maintain their quality.


Organizations manufacturing or handling medical devices are required to follow ISO 13485. ISO 13485 is the Quality Management System for Medical Devices.

Good quality and safe healthcare products come from companies that have ISO 13485 certification. The latest version was published in 2016 and is called ISO 13485:2016.

ISO-13O4 is a quality management system that contains a strategy for mitigating threats to medical devices. It focuses on identifying potential risks and documenting them significantly.

ISO 13485 Certification Principles

To get increased customer base, one must focus on satisfying their needs and expectations. Customer focus leads to self-sustaining communication throughout the organization, which also improves for the betterment of all parties.


To achieve quality objectives, leaders need to create a culture of trust and integrity. They should also establish unity of purpose by aligning strategy, policies, procedures and resources. This will lead to better coordination by allowing people to work together on the same projects.

Our tunnel services include:

  • Managers should communicate needs at all levels, also provide knowledge and experience to their employees, recognize contributions from their employees, and build an environment of learning, improvement and success.
  • In order to increase efficiency, it is important to understand activities and process them based on what the organization is capable of and constraints.


To optimize the performance, you will want to review and audit your processes, implement them ( with training), and anticipate internal and external risks.

Evidence-based decision making

  • When making decisions, you should base them on data. This will help you take better decisions and avoid mistakes.
  • One can achieve an effective and well-managed relationship with a supplier by supplying them with the required products and services, maintaining a stable supply, and determining which suppliers need a managed relationship.

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