What are the Benefits of Implementing ISO 13485 Quality Management System for Medical Devices?

The International Standard Organization first time published the medical device related standards. In 2003, ISO 13485 was revised and comprised the requirements of Process Approach. In 2016, the standard has gone through some changes, and is named as ISO 13485:2016. The intent of this revision is to make a global auditing process through the medical devices single audit program instead of having multiple audits through the year.

Medical devices are developing medicine with breath-taking advances in the recognition and treatment of several diseases. ISO 13485 is developing with medical devices to keep pace with modern innovation. Probably more than any other type of manufactured product, the quality of medical devices has a straight impact on their work effectiveness as well as the safety of patients. Therefore, most of the service providers in the medical device industry sector understand the main purposes of ISO 13485, which is to complement medical device regulatory requirements for quality management system in command to have a quality medical devices and safe patients. ISO 13485:2016 standard describes quality management system requirements for organizations that are complex from initial stage of conception to production and post-production. Requirements contain final decommission and disposal of the medical device’s life-cycle, design and growth, production, storage and distribution, installation as well as delivery of medical device or related services that are safe for their intended purpose.

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

What are the key benefits to implement ISO 13485 in Organization?

The benefits of ISO 13485 can’t be overstated. Companies of all sizes have understood important savings in cost and time, and other improvements that an efficient Quality Management System naturally bring about. The following reasons to implement ISO 13485 in organization:

• Improve business’s credibility and image:

ISO 13485 standard for quality in the medical device industry, ISO 13485 certification shows customers that company takes quality very seriously, and have a system in place to confirm it. QMS can be a powerful marketing tool, and it has become a requirement in many countries for suppliers to show obedience. This translates to more opportunity.

• Improve consumer satisfaction:

The well-established QMS system by ISO 13485 consultants is assembled on a set of quality management principles, one of which is confirming customer satisfaction. This can be accomplished by measuring customer needs and expectations, and striving to meet them. Consumers know what they want, and many of them will not even entertain a supplier that isn’t certified. Beyond that, confirming the satisfaction of existing customers keeps them coming back, and helps to sell services to new customers. This interprets directly to increased revenue.

• Improve Processes:

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

• Improve decision-making:

Quality management principle of ISO 13485 regards the use of evidence-based decision making. When use facts and data to drive decisions, those decisions tend to be well aligned with the strategic goals of company. While "gut feelings" may be suitable in some social situations, they can spell trouble in business. An added bonus is the increased insight into the health of processes, and any developments that are made, once keep track of the data.

• Create a culture of constant improvement:

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

• Well Employee Engagement:

When employees are asked to help look for ways to expand their own processes, not only will they often provide the best insight – they will also be much happier and more capitalized in the success of the business. The more employees understand their roles in delivering quality products and services, the more engaged they are, which leads to enlarged efficiency and productivity.

ISO 13485 documents helpful for the implementation of quality management system from the necessities of the standard in organizations. ISO 13485 documents covers a complete set of mandatory and supporting documentation, and readymade/ templates to accelerate documentation procedure that supports execution for quick ISO 13485 certification.

Iso 13485:2016 Medical Devices Quality Management System