Medical science is evolving day by day, and so are the medical equipment pieces. The industry of medical devices has improved a lot. The healthcare industry is a critical one as it deals with medical devices that can be life-saving. However, one cannot ignore the business aspect of these medical devices and the medical industry. Every commercial industry needs to follow a quality management system. But the need for ensuring the quality of medical devices and equipment pieces is critical. It concerns the safety of the patient, and healthcare professionals need to be careful about them. It is related to the clients, patients, stakeholders, and healthcare professionals.
The ISO 13485 certification provides a set of regulation that concerns medical device production. Any manufacturer of medical devices needs to follow the regulations provided by ISO 13485. Read on to know more about the certification and the quality guidelines, as stated in ISO 13485.
What is ISO 13485 certification – Medical Devices Quality Management System (MDQMS)?
Before getting into the details of ISO 13485 and the manufacturing quality aspect of medical devices, understand the classification thoroughly. What falls under the classification of medical devices and equipment pieces? Simply put, a medical device is an equipment piece or a machine employed in the medical field for the diagnosis, treatment, or prevention of diseases. All these devices are concerned with medical treatments or healthcare requirements. So, you can understand that the manufacturing quality guidelines need to be strict. Unless this device exhibits optimal quality and operational advantage, this cannot be labeled as appropriate for the medical requirements.
A brief outline – ISO 13485 is a unique quality management system standard. It aims at manufacturing procedures for medical devices. The standardization regulations are globally acknowledged by the ISO 9000 QMS series. The framework of ISO 13485 helps the device manufacturer in finding a quality management system that ensures optimal efficiency of the process. It includes consistent design, meticulous development, better production, ease of installation, and efficient delivery. All these aspects mentioned in ISO 13485 aim at providing a safe and secured operational advantage of the medical devices made with optimal care for quality.
Benefits of ISO 13485 certification
Having the ISO 13485 certification for medical devices certainly helps in brand creation. The manufacturing resources can utilize the tag of the ISO 13485 certification and ensure better performance. Besides these, the safety of medical devices is a big bonus. The customers can rely on the products and thus it influences your business to grow more. There are other benefits as well. Read on to know more.
- Overall improvement of operations and quality – ISO 13485 helps in overall improvement. The process approach, as described in the ISO guidelines makes it convenient and easy for the manufacturers to identify opportunities to improve the manufacturing process of medical devices. The ease of identifying the shortcomings, eliminating the errors, and rework of the process facilitates and ensures better efficiency. In fact, it is also a cost-effective choice for the manufacturers. Why? Because it eliminates the chances of rework and rectification, thus reducing the overall cost.
- Better decision-making with a focus on evidence – The evidence-based decision-making is an excellent advantage brought by ISO 13485. The quality management principle helps in understanding the data that drive the decisions of manufacturing. Hence, the decision can align well with the strategic goals of the manufacturing business. One can obtain an increased insight into the business and the health industry. Database improvement is an excellent opportunity to ensure quality and improve with time.
- Customer satisfaction and services – Do you know the goal of applying the ISO 13485 principles for manufacturing resources? The product developed with optimal care to quality ensures consumer satisfaction. The manufacturers of medical devices can meet the expectation of the clients. It also helps the suppliers as they get better opportunities to serve. Also, the chances of client retention get high if the quality is maintained all through. In terms of business, having the ISO certification helps you expand your client base and implies increased revenue.
- A step to gain competitive advantage – Quality is vital in any industry and manufacturing company. Especially with medical devices, one cannot ignore the vitality of the quality. The ISO guidelines help you maintain the quality and thus gain a competitive advantage over your industrial peers. If a company can’t retain the quality, the customers will automatically connect to them. It helps in the growth of a loyal client base.
- A culture of continuous enhancement of operations – The quality management principle focuses on ensuring continual improvement. When a company acquires the certification, the management and employees get more involved and alert of the quality. It is an advantageous part of the certification. Thus it helps in the development of a systematic operational chain and reduces the problems in production. It also mitigates the risks and enhances the chances of continuous improvement. Lesser mistakes and organized operations are the two prime benefits of the ISO 13485 certification.
What is the difference between ISO 13485 and 21 CFR 820?
ISO 13485 is a globally acknowledged QMS certification program derived from ISO 9001. Unlike ISO 9001, ISO 13485 defines the various quality principles for manufacturing medical devices and equipment pieces. In fact, the FDA has also acknowledged the standard in 2019. The FDA 21 CFR part 820 is a regulation for quality system management. It is a mandatory quality system for medical equipment distribution in the US.
The aim of ISO 13485 is to provide optimal customer satisfaction. On the other hand, maintaining the FDA 21 CFR part 820 is part of US government compliance.
Closing note – Getting the certification for your company
Medical device manufacturers need to apply for the ISO 13485 certification to ensure a better operational image in the industry and maintain quality. Get certified from IRQS (Indian Register Quality Systems) for ISO 13485 MDQMS.
With IRQS, we perform a methodical audit process to recognize the credibility and operational aspects of your company to qualify for accreditation.
Make a wise step in developing better medical equipment pieces and consider applying for the certification.
