ISO 13485 Medical Devices Management System
What is a Medical Device?
A medical device is an instrument or machine that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.
What is ISO 13485?
ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices.
The purpose of a medical device quality management system is to ensure that products are safe and effective for their intended use. A QMS provides a framework for consistent and documented processes throughout the product lifecycle, from design and development to post-market surveillance.
Benefits of using an ISO 13485:2016 Medical Devices Quality Management System:
Improve your company’s credibility and identity: The ISO 13485 certificate is the globally recognized standard for quality in the medical device industry. This certification is proof to the customers that the organization follows high-quality standards and informs them that they have a standard in place to ensure it.
Furthermore, the ISO 13485 implementation in any organization can serve as a powerful marketing tool and is an essential thing for medical device manufacturers to show compliance.
Evidence-based decision making: With the ISO 13485 certification in place, the company can stay focused and work towards quality goals. The management is provided with data on a continual basis. These facts and data can be used to take decisions that can align better with the strategic goals and objectives of the company. If the management sees any lack of progress towards the set goals, appropriate action will be taken.
Continuous improvement: Continuous improvement is one of the core principles of the ISO quality management systems. When a QMS is adopted in any organization, it leads to cultural change, where management and staff will be looking out for improvements.
Moreover, setting up systematic processes can eliminate problems and reduce the work burden, leading to high performance, strategic leadership, and employee engagement. This in turn can deliver high-quality products and services.
Increased employee involvement: With proper documentation and control of processes, employees can understand their role in ISO 13485 implementation. When they are asked to look for a way to enhance the processes, they feel so happy and give the best insight that can help the company succeed.
The more the employees understand their roles, the more they become engaged. This results in higher operational efficiency and productivity.
Enhanced customer satisfaction: One of the core principles of the ISO 13485 implementation is to ensure customer satisfaction. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. This is because the customers strongly believe that the company has a good QMS in place.
The goals of the company with ISO 13485 implementation are focused on the customer needs rather than focusing on the individual goals of the department. This will help get new customers for business and boost the revenue.
