ISO 13485 Quality Management System – What is it?

ISO 13485 Quality Management System – What is it?

ISO 13485 Quality Management System – What is it? 600 380 Elite Electronic Systems

The manufacturing of medical devices is one of the most regulated sectors in which many regulations and obligations must be achieved. If any of the requirements are not met or the registrations procedures are not completed, placing a product on the market is impossible. The purpose of these regulatory requirements is to ensure that electronic manufacturers can consistently deliver medical devices that are safe and fit for their intended purpose.

Organisations of any size are applicable for ISO 13485 requirement.

What is ISO 13485?

ISO 13485 – Quality Management System (QMS) was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.

It is an international standard defining the requirements for a QMS system applied to the stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

By introducing the quality management system a company indicates that they have documented all process and procedures involved enabling them to achieve their goals of high standard quality. This also means that all activities that are involved are supervised to ensure all legal requirements and customer’s expectations are met to guarantee continuous increase of efficiency and effectiveness.


What are the benefits of ISO 13485 implementation?

Organisations of all sizes have realised difference in cost and time that an efficient ISO 13485 – Quality Management System brings in.

Below are key benefits of ISO 13485 implementation in your organization:

Improved Processes

By using the approach outlined in ISO 13485, your company will be able to identify and reduce waste within and between processes, reduce errors and avoid rework resulting in greater efficiency and cost savings.

Improved Decision-Making

Another key quality management principle of ISO 13485 links to the use of evidence-based decision making. If your company uses facts and data to drive the decision, those decisions tend to align better with the strategic goals and objectives of your company. While decisions based on “gut feelings” may be appropriate for some situations, they are not always right. Therefore, an increased insight into your companies processes is a bonus to drive decision-making.

Improved Companies Image & Credibility

ISO 13485 is the internally recognized standard for quality in the medical device industry. This certification shows customers that your company has very high-quality standards and informs them that you have a system in place to ensure it. In addition, QMS can be a very powerful marketing tool and is a key requirement around the world for suppliers to show compliance.

Improved Satisfaction

One of the main principles of the ISO 13485 standard ensures customer satisfaction. Customers know what they want, and what they need. One of their main needs is a certified supplier.

Ensuring customer satisfaction can be achieved by assessing and meeting customer needs and expectations. This will result in your existing customers coming back for business and will help your business obtain new customers. Therefore, ISO 13485 will potentially increase your revenue.

Better Employee Engagement

Employees that understand their roles in delivering quality products and services are more engaged and more invested in the success of the company resulting in increased efficiency and productivity.

Consistent Culture of Continual Improvement

Another principle of ISO 13485 QMS is the concept of continual improvement. By creating a systematic process for reducing issues and mitigating their effects your company will be able to spend less time cleaning up mistakes and more time delivering quality services.

Once this system is adopted by an organization, all employees will always be looking out for ways to improve on how things are being done.

At Elite, we have obtained and maintained ISO 13485 for a number of years. We have also introduced and maintained a quality management system compliant with the requirements of this standard. All of our processes are carefully documented which enables us to offer full traceability & history of every product manufactured within our facility.


By Timmy Bubak | 09/09/21