Iso 13485 Benefits For Medical Devices Quality Management System

By Author: URS Certfications
Total Articles: 24
Comment this article

ISO 13485 is the standard for Quality Management systems (QMS) to design and manufacture Medical Devices. However, medical device manufacturing is a most regulated sector where the quality of the product requirements is necessary.

Regulatory requirements will ensure the manufacturers constantly design, produce, and improve the medical devices that are safe and fit to use. However, this certification is an effective solution to meet the comprehensive requirements for Quality Management System.

Getting ISO 13485 Certification will give you a practical foundation for
manufacturers to address the regulations and responsibilities. It also demonstrates the commitment to the safety and quality of medical devices.

Medical devices play an important role in medical departments. So, before using any medical device, we must first ensure their qualities and ways of application. Now, let us first understand it.

What is ISO 13485?

An ISO 13485 is derived from the internationally recognized and accepted
ISO 9000 management standard ...
... series. It adapts the previous version of ISO 9001 Certification
and ISO 9000:2008, a process-based model for the regulated medical device manufacturing environment.

It is used to support the medical device manufacturing units in designing a QMS that maintains the effectiveness of their work. With this, the organization will ensure consistent design, development, production, installation, and delivery. However, it is used to dispose of medical devices that are safe for the intended purpose.

Although several countries have their own set of regulations, the United States plans
to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485.

Now, let's understand the importance of it.

Importance of having ISO 13485

ISO 13485 certification is more important for designers, manufacturers, and distributors of medical devices. Even suppliers and service providers will enhance the organization's marketability so that more manufacturers require certifications to do business with vendors.

Patient safety is the topmost priority while manufacturing any medical device. However, medical devices with high quality and consistent medical products with effectiveness while maintaining the QMS are critical.

So, it is essential to ensure the safety of medical devices to the customers, stakeholders, patients, users, and regulatory agencies. It is not just in implementation, but it also provides a tool for thorough audit to test the system's effectiveness.

ISO 13485 certification provides the manufacturer with a higher level of confidence in achieving and maintaining the compliance and regulatory requirements constantly. With Quality Management System, it reduces the failures that might affect patient safety and further damage the manufacturer's reputation.

If you manufacture medical devices, it's time to claim your ISO 13485 certifications.

URS provides certification to all major ISO standards, as well as specialist industry standards and certification to address emerging risks