ISO 13485:2016 Medical Devices Management System
ASA has been providing Medical Devices Management System Certification audit since 2016.
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
The advantages of being ISO 13485:2016 Certified
- Improve customer satisfaction. The ISO 13485 standard is built on a set of quality managemen principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations, and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier that isn’t certified. Beyond that, ensuring the satisfaction of your existing customers keeps them coming back, and helps you sell your services to new customers. This translates directly to increased revenue.
- Improve your processes. Using the process approach outlined in ISO 13485, it’s much easier to discover opportunities for improvements. You’ll be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework facilitating greater efficiency and cost savings.
- Improve decision - making. Another quality management principle of ISO 13485 regards the use of evidence - based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the strategic goals of your company. While “gut feelings” may be appropriate in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of your processes, and any improvements that are made, once you keep track of the data.
- Create a culture of continual improvement. A third quality management principle making up the foundation of ISO 13485 is the concept of continual improvement. When adopted as the culture in your organization, management and staff will always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.
- Better employee engagement. When employees are asked to help look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity.