EN ISO 13485 is an international standard that is concerned with the requirements of the Quality Management System (QMS) for medical devices. More precisely, this standard deals with the design, manufacture, and installation of medical devices across the globe. The EN ISO 13485 helps organizations and companies comply with regulations for medical products, and it demonstrates the commitment of the same organizations and companies to quality and customer satisfaction. With this standard businesses are able to show their dedication to the work they do while making sure that the products and services are offered at the highest level.
Main Advantages of EN ISO 13485 Certification
The EN ISO 13485 standard has the ability to put every organization or company in an advantageous position considering the advantages that come with the certification. Working with medical devices is known to be a delicate task, so this standard makes it easy for the organization to accomplish goals while making sure that everything is performed at a high level and customer satisfaction is established. In other words, the EN ISO 13485 allows your business to develop without any obstructions while making sure that everything is done in compliance with particular regulations.
Once you get your organization or company certified in EN ISO 13485, you obtain the chance for your business to have the following advantages:
- Improving customer satisfaction and establishing customer loyalty,
- Boosting customer retention,
- Demonstrating compliance with medical regulatory regulations and requirements,
- Developing new markets, and obtaining the chance to apply for tenders that ask for the EN ISO 13485 Certification,
- Getting an advantage over competitors,
- Gaining the ability to meet customer requirements without breaking regulations.
What Is EN ISO 13485?
The EN ISO 13485 Certification is designed to serve companies and organizations that work with the manufacture, design, and installation of medical devices. This standard provides the framework that is necessary for the implementation of a quality management system for medical devices. More precisely, it helps organizations produce and install medical devices in compliance with given regulations and legislation. In addition, it ensures that all of the medical devices will be installed with the same quality within a particular organization.
The EN ISO 13485 is significantly beneficial for suppliers and external parties who are concerned with providing medical device products. It is a common standard across the world, and it helps with establishing the framework needed for handling medical devices within an organization or a company:
- Ensures compliance with regulations and legislation aimed at the production and installation of medical devices,
- Ensures consistency in the production and delivery of medical devices,
- Builds up customer loyalty and trust,
- Increases competitiveness across the company or organization,
- Allows organizations or companies to identify malfunctions in the production and installation of medical devices, and lets them improve on them.
Benefits of Getting EN ISO 13485 Certification
Getting certified in EN ISO 13485 unlocks a lot of benefits that your company or organization gets to use in its operations. The implementation of a quality management system for medical devices can significantly aid in the manufacture, design, and installation of medical devices while demonstrating an organization’s commitment to quality. It significantly reduces the risks that may occur due to the low quality of handling medical devices, and it can visibly increase customer satisfaction.
Once you get certified in EN ISO 13485, your organization gets access to the following benefits:
- Improving internal processes and decision-making,
- Establishing the possibility of contracting with bigger companies,
- Demonstrating commitment to safety and quality,
- Creating the tendency for continual improvement,
- Improving risk management,
- Meeting customer expectations successfully, and responding to requirements with ease,
- Maintaining the quality of the supply chain,
- Ensuring compliance with regulations related to medical devices.
How to Become EN ISO 13485 Certified?
In order to obtain an EN ISO 13485 Certification, a company or organization must implement a quality management system (QMS) for medical devices. The achievement of this certification is implemented through a comprehensive assessment that is done in multiple stages.
The ISO auditors need to determine that your organization has successfully implemented the quality management system for medical devices while complying with all ISO requirements. Once your organization gets certified, you can use the EN ISO 13485 Certification in marketing and promotional materials.
Start Your Journey To EN ISO 13485 Certification
To start your journey to EN ISO 13485 Certification, you can contact us for a free quote. We will deliver a quote that is specifically made to meet your requirements, and we support various ISO standards.
FAQ
What industries implement EN ISO 13485?
The EN ISO 13485 Certification is suitable for any kind of company and organization that needs to implement a quality management system for medical devices successfully. By getting certified, organizations want to show to their customers that they are committed to quality and that they work following all given practices. This certification means that the EN ISO 13485 is eligible to ensure that a particular company can implement quality management practices for medical devices, and follow the best measures that relate to producing, designing, and installing medical devices within an organization.
How long does the EN ISO 13485 Certification last?
The EN ISO 13485 Certification lasts for three years, and it is regularly checked and audited every year to ensure that your organization is compliant with all regulations. Once the three years have passed, you will be required to do a recertification.
How do I implement EN ISO 13485?
EN ISO 13485 is a framework that includes the details and the requirements of the quality management system for medical devices. The QMS for medical devices can be implemented by using an independent ISO expert or ISO consultant that will support you throughout the whole process.
The implementation of the QMS system for medical devices includes determining organizational goals, establishing quality efficient requirements, and managing and controlling risks related to the production and installation of medical devices that will be monitored through the operations of your organization.
