ISO 13485 & MDR Knowledge base

Six key benefits of ISO 13485 implementation

Trying to convince top management of the value of any project can be intimidating – especially when the ROI isn’t immediately apparent. Implementation of a Quality Management System (QMS) based on ISO 13485 is one such project, where it’s difficult to put a dollar amount on the eventual benefits. Instead, it’s necessary to identify the potential benefits that your company will realize through implementing a QMS, and then help top management get a feel for what these could be worth – and not only in terms of dollars and cents.

Why is ISO 13485 a good idea for your organization?

The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:

Improve your company’s credibility and image. ISO 13485 is the internally recognized gold standard for quality in the medical device industry. Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it. Your QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show compliance. This translates to more opportunity.

Improve customer satisfaction. The ISO 13485 standard is built on a set of quality management principles, one of which is ensuring customer satisfaction. This can be achieved by assessing customer needs and expectations, and striving to meet them. Customers know what they want, and what they need, and many of them will not even entertain a supplier that isn’t certified. Beyond that, ensuring the satisfaction of your existing customers keeps them coming back, and helps you sell your services to new customers. This translates directly to increased revenue.

Improve your processes. Using the process approach outlined in ISO 13485, it’s much easier to discover opportunities for improvements. You’ll be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.

Improve decision-making. Another quality management principle of ISO 13485 regards the use of evidence-based decision making. When you use facts and data to drive your decisions, those decisions tend to be better aligned with the strategic goals of your company. While “gut feelings” may be appropriate in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of your processes, and any improvements that are made, once you keep track of the data.

Create a culture of continual improvement. A third quality management principle making up the foundation of ISO 13485 is the concept of continual improvement. When adopted as the culture in your organization, management and staff will always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.

Better employee engagement. When employees are asked to help look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company. The more your employees understand their roles in delivering quality products and services, the more engaged they are, which leads to increased efficiency and productivity.

Why ISO 13485?

As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.

Click here for a free PowerPoint presentation Project proposal for ISO 13485:2016 implementation.