How the ISO 13485 Certification Helps Ascertain Quality in Medical Devices

This article explains how the ISO 13485 certification helps medical device manufacturers to deliver supreme quality in each product and assure higher customer satisfaction. Among all industries or sectors, medical device quality is perhaps the most regulated one. Medical device engineering units or manufacturers need to fulfill or meet some of the strictest regulations for quality assurance of their products or items in order to sell them worldwide. The ISO 13485 certification is the specific medical devices certification that validates their quality management system (QMS). Achieving it helps all manufacturers or related services companies to demonstrate their commitment and ability to deliver devices that meet customers’ quality expectations. This certification enables companies to ensure compliance with all essential regulatory requirements that create a competitive advantage for their devices in the market. Customers of medical devices or products i.e. patients, health clinics, hospitals, and pathological centers, seek companies that have a strong QMS. In other words, this certification not only drives quality in medical device businesses but also increases their scope for sales and other business opportunities.

Here are some brief points on how the ISO 13485 certification helps medical devices companies to stick to quality and gain customers’ confidence in their products.

Results in Defined Processes

Most companies or manufacturers already have some quality control measures or practices in place, but getting ISO certification calls for a definite QMS. This means there should be proper defined processes that are able to interface as the QMS and can assess or manage the entire production line of the company. The QMS should be able to evaluate all manufacturing aspects, starting from product conceptualization and design to its final development. With it, the company can check any risks and also identify scopes for improvements.

Achieving an international quality certification also indicates that the company has in-depth understanding of quality regulations and has actually implemented them with a formalized QMS.

Keeps Away Device Recalls

A lot of medical devices manufacturers have agreed with this. They claim that the number one advantage they have experienced with an ISO 13485 QMS is a significant reduction in device recalls. A majority of product recalls happening in the medical sector is due to flaws or defects in the product development.

With a uniform QMS in place which integrates with the end to end process of product development, it becomes easier for manufacturers to trace everything. From inputs or product requirements, supplier processes, product development stages, to packaging and distribution methods, a QMS helps in accessing everything. A manufacturer can hence trace nonconformity or risks anywhere in the production line and eliminate them. The QMS does not directly address recall issues, but actually can help in avoiding errors or risks in production that can cause the delivery of substandard or unsafe products. Business Performance is Improved

An ISO 13485 certified QMS can help medical device manufacturers to gradually enhance their business performance which can include sales figures, growth, employee satisfaction, client satisfaction and so forth. An essential clause of the ISO standard is meeting the customers’ needs and assuring fuller satisfaction.

Implementation of a structured QMS results in accountability of employees. They need to work for product development processes and exercise all quality controls as per the documented QMS. They also need to maintain records of their tasks and key findings from quality assessment methods. When every action of employees is being tracked or recorded, they tend to become more responsible and aware of their performance.

Lastly, when fine-quality medical products are produced and delivered to customers, they are more likely to become loyal repetitive customers. Moreover, with a QMS, a manufacturing company seeks to continually improve its product quality and services. They address customer complaints or feedback and try to impose changes in their next line of production to keep up with the expectations of the customers. Conclusion

In the end, it can be easily said that the ISO 13485 certification is the most requisite tool for medical devices businesses to establish their quality conformity. It is equally important for both small and large-sized medical companies. It can help large companies to consistently maintain their quality commitment and improve the quality of processes and products further. But, if you are a small organization with operations just starting up, having an ISO certified QMS can act as a catalyst for your growth and performance.

Damon Anderson is the director of an ISO certification consultancy which advises businesses in different sectors to achieve a required ISO certification easily.