The medical industry is sensitive. Special rules, standards, regulations, and certifications are either applicable or required for the medical devices industry. All with the aim of maintaining quality and safety and most importantly meeting compliance.
The ISO 13485 certification does not spell out the specific measures for medical device manufacturers. However, the certification gives assurance to the people that quality happens at every stage of manufacturing which enables maintaining a high standard for medical devices.
Implementing ISO 13485 will have many benefits for your organization. Although changes in your QMS will take immediate additional energy, the results of having an ISO 13485 quality management system will provide you with many benefits in operations, sales, and customer satisfaction.
What is ISO 13485 certification?
ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series.
The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to the disposal of medical devices that are safe for their intended purpose.
The ISO 13485 standard also provides a planned structure and realistic foundation to stick to medical device directives, regulations, protocols, and responsibilities. The standard essentially enables you to fulfill the medical device manufacturers’ commitment to the safety and quality of medical devices.
The ISO 13485 certificate can be obtained by any company manufacturing medical devices irrespective of their size or location. The ISO 13485 implementation is carried out by companies in almost 21 countries.
Benefits of ISO 13485:2016 medical devices quality management system
Below are the key benefits of ISO 13485 implementation in any business related to medical devices manufacturing:
1. 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.
2. 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 make decisions that can align better with the strategic goals and objectives of the company.
If the management sees any lack of progress toward the set goals, appropriate action will be taken.
3. Continual 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.
4. Increased employee involvement
With proper documentation and control of processes, employees are able to 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.
5. Enhanced customer satisfaction
One of the core principles of 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 revenue.