What does ISO 13485 certification entail?

ISO 13485 is a separate Quality Management System standard for medical devices derived from the internationally recognized and recognized ISO 9000 QMS series.

The ISO 13485 certification assists medical device manufacturers in developing a QMS that ensures the efficacy of their procedures. It assures the consistent design, development, production, installation, and distribution of medical devices that are safe for their intended use, all the way through to disposal.

The ISO 13485 standard also provides a structured framework and a realistic foundation for adhering to medical device directives, laws, protocols, and duties. The standard fundamentally allows you to meet the responsibility of medical device makers to the safety and quality of medical equipment.

The advantages of the ISO 13485:2016 medical device quality management system

1. Increase the reputation and identity of your company.

The ISO 13485 certificate is the internationally recognized quality standard in the medical device business. This certification proves to clients that the business adheres to high-quality standards and notifies them that a standard is in place to ensure this.

2. Making decisions based on evidence

With the ISO 13485 certification in place, the organization can remain focused on quality objectives. On a continuous basis, data is delivered to management. These facts and data can be used to make decisions that are more in line with the company's strategic goals and objectives.

If management notices a lack of progress toward the objectives, suitable action will be taken.

3. Constant improvement

One of the fundamental principles of ISO quality management systems is continuous improvement. When a QMS is implemented in any firm, it results in a cultural shift in which management and employees are constantly searching for ways to improve.

Furthermore, establishing regular processes can remove difficulties and reduce work load, resulting in excellent performance, strategic leadership, and employee engagement. As a result, high-quality products and services can be delivered.

4. Increased employee participation

Employees can understand their role in ISO 13485 implementation with sufficient documentation and process control. When they are asked to seek for ways to improve operations, they are overjoyed and provide the greatest information that can help the firm flourish.

The better employees understand their duties, the more engaged they become. As a result, operational efficiency and productivity improve.

5. Higher levels of customer satisfaction

Customer satisfaction is one of the key concepts of ISO 13485 implementation. Customers regard companies that are ISO 13485 certified as more trustworthy than those that are not. This is because customers are confident that the company has a good QMS in place.

With ISO 13485 implementation, the company's goals are centered on the needs of the customer rather than the specific goals of the departments. This will assist the company gain new consumers and increase income.