The medical industry is considered more sensitive. Any business venturing into the medical industry is required to follow stringent regulatory requirements. Furthermore, when it comes to the health and safety of the patients, healthcare professionals depend on medical devices. Therefore, ensuring that the medical devices manufactured are of high quality is crucial for customers, stakeholders, patients, and others.

There are quality systems like ISO 13485 certification and standards for medical devices manufacturing and managing that must be met. These practices ensure the quality, safety, and function of medical devices. It can also convince the customers that the medical devices are reliable for them to use.

The ISO 13485 certification does not spell out the specific measures for medical device manufacturers. However, the certification gives assurance to the people that quality happens at every stage of manufacturing that enables maintaining a high standard for medical devices.

What is a Medical Device?

A medical device is an instrument or machine that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.

What is ISO 13485 Certification?

ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series.

The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to disposal of medical devices that are safe for their intended purpose.

The ISO 13485 standard also provides a planned structure and realistic foundation to stick to medical device directives, regulations, protocols, and responsibilities. The standard essentially enables you to fulfill the medical device manufacturers’ commitment to the safety and quality of medical devices.

The ISO 13485 certificate can be obtained by any company manufacturing medical devices irrespective of their size or location. The ISO 13485 implementation is carried out by companies in almost 21 countries.

Who Requires ISO 13485 Implementation? 

ISO 13485 certification is required for designers, distributors, and manufacturers of medical devices. However, suppliers and service providers can implement ISO 13485 and gain a competitive advantage by enhancing the brand’s credibility and recognition.  

The ISO 13485 standard is applies to 

•         Medical device manufacturers (MD) or manufacturers of in vitro diagnostic products (IVD)
•         Manufacturing of reagents or substances for use in IVD or MD
•         Medical device suppliers

What Is the Process of ISO 13485 Implementation? 

Like any other ISO standards, the ISO 13485 implementation also follows the Plan, Do, Check, Act (PDCA) framework. After considering the customer requirements, the medical device manufacturers can find out the quality objectives and prepare the quality manual and policy documents. The ISO 13485 implementation ensures that the company is able to achieve and maintain the quality requirements and comply with the internationally recognized quality standards.

Benefits of ISO 13485:2016 Medical Devices Quality Management System

Below are key benefits of ISO 13485 implementation in any business related to medical devices manufacturing:

1.   Improve your company’s credibility and identity

The ISO 13485 certificate is the globally recognized standard for quality in the medical device industry. This certification is proof to the customers that the organization follows high-quality standards and informs them that they have a standard in place to ensure it.

Furthermore, the ISO 13485 implementation in any organization can serve as a powerful marketing tool and is an essential thing for medical device manufacturers to show compliance.

2.   Evidence-based decision making

With the ISO 13485 certification in place, the company can stay focused and work towards quality goals. The management is provided with data on a continual basis. These facts and data can be used to take decisions that can align better with the strategic goals and objectives of the company.

If the management sees any lack of progress towards the set goals, appropriate action will be taken.

3.       Continual improvement

Continuous improvement is one of the core principles of the ISO quality management systems. When a QMS is adopted in any organization, it leads to cultural change, where management and staff will be looking out for improvements.

Moreover, setting up systematic processes can eliminate problems and reduce the work burden, leading to high performance, strategic leadership, and employee engagement. This in turn can deliver high-quality products and services.

4.   Increased employee involvement

With proper documentation and control of processes, employees are able to understand their role in ISO 13485 implementation. When they are asked to look for a way to enhance the processes, they feel so happy and give the best insight that can help the company succeed.

The more the employees understand their roles, the more they become engaged. This results in higher operational efficiency and productivity.

5.   Enhanced customer satisfaction

One of the core principles of the ISO 13485 implementation is to ensure customer satisfaction. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. This is because the customers strongly believe that the company has a good QMS in place.

The goals of the company with ISO 13485 implementation are focused on the customer needs rather than focusing on the individual goals of the department. This will help get new customers for business and boost the revenue.

ISO 13485 Certificate Reinforces Medical Device Manufacturers

As stated earlier, the medical device industry is a highly complex industry where people approve of innovation as long as it doesn’t sacrifice safety and quality.

Getting an ISO 13485 certification can help medical device manufacturers make quality and process improvements. It’s not right for every organization, but the associated benefits make it well worth consideration.

Are you a medical device manufacturer looking to get an ISO 13485 certification? Your search ends here. Contact us today for hassle-free ISO 13485:2016 Medical devices certification.