Why Is ISO 13485 Becoming Important for Medical Device Companies Today?
Medical devices are vital components that ensure safe operations in the healthcare sector everyday. They range from surgical instruments and diagnostic equipment to patient monitoring devices and healthcare products.
This has prompted most organizations in the healthcare industry to consider ISO 13485 as a guideline for establishing better quality management processes regarding the development of medical devices.
For those who want to know about ISO 13485 certification, the certification applies specifically to organizations that design, manufacture, install, distribute, and service medical devices.
While other types of quality management certifications apply to all kinds of organizations, ISO 13485 applies specifically to the healthcare and medical device industry. This means that quality concerns include factors such as safety, risk management, regulatory requirements, document control, traceability, supplier controls, and quality throughout the process.
Nowadays, ISO 13485 medical devices need to put in place stringent quality controls due to their impact on patients' health and the quality of healthcare services. Minor problems in the process will have adverse consequences in the healthcare industry.
Many organizations start to implement ISO 13485 to attain a more organized approach for managing their production and regulatory processes. During the certification procedure, companies are usually guided into evaluating their existing workflows and discovering methods of improving them.
The desire to respond to increasing demand from clients and regulatory authorities for manufacturers who apply acceptable quality management systems for medical devices will motivate many to pursue ISO 13485 certification. Hospitals and healthcare organizations, as well as other distributing businesses or international markets, typically choose to work with a manufacturer who has an ISO 13485 certification.
When an organization goes through the implementation phase of ISO 13485, they are likely to develop documentation, conduct risk assessments, train employees, complete internal audits, monitor processes and make improvements to their product's quality. Some may have established effective systems prior to pursuing the certification, but they may find that they require more development or improvements prior to completing the certification audit.
It's also common for companies to learn from the implementation process that ISO 13485 is not simply about acquiring a certificate in order to receive a marketing advantage. Implementing ISO 13485 typically will assist an organization to improve the consistency of its products, reduce the risk of operations failure, improve the quality of the products manufactured, and to have enhanced confidence in their manufacturing processes.
It is also appreciated by companies that such standards promote continuous improvement instead of making changes just once. Continuous evaluation, monitoring, and corrective measures allow organizations to keep control over the quality better.
It should be noted that implementation schedules may differ based on many factors including organization sizes, complexities of manufactured goods, and management systems that are currently available. For companies producing complex medical products, preparations for implementation might be more extensive than those of smaller organizations.
It should be also stated that when discussing development of the health care industry, quality of medical products and patient safety always come first. Such standards provide companies with tools for creating more robust management processes and increasing patient satisfaction.
To conclude, ISO 13485 is about much more than certification; it is about creating safer and more reliable systems for medical devices production and management.