The organization’s mission involves rethinking and revolutionizing the approach to providing orthodontic and restorative care to countless individuals worldwide. Align Technology believers in the profound impact of an improved smile on one’s future. Thus, it focuses on designing digital technologies and immersive encounters to assist individuals in progressing in their life journeys.
The company bagged IOAS-accredited ISO 13485:2016 certification to demonstrate the organization’s commitment to delivering safe and high-quality medical devices to customers and clients. The scope of the certification includes the Importation, Distribution, and Storage of Dental Medical Devices. Moreover, the certification demonstrates the organization’s commitment to delivering safe and high-quality medical devices to customers and clients. The scope of the certification includes the Importation, Distribution, and Storage of Dental Medical Devices.
What is ISO 13485:2016 Certification?
ISO 13485 is the gold standard in the medical device industry. ISO 13485:2016 certification is a management standard based on the ISO 9001 requirements, particularly for organizations manufacturing medical devices.
The primary purpose of ISO 13485 is to design coordinated medical device regulatory requirements. Moreover, ISO 13485 certification is a standalone standard that ensures the delivery of safe and healthy medical devices for professional and clinical use.
What are the benefits of implementing ISO 13485:2016 Certification for Align Technology?
ISO 13485:2016 certification offers the following benefits to Align Technology:
Improves customer satisfaction
The ISO 13485 standard follows the principles of a quality management system and monitors every step of the business operation to meet customer needs and expectations. Besides, the organization also ensures that the existing customers are satisfied with the product quality and services.
Improves your processes
ISO 13485 follows a process-based approach to find opportunities for improvement and implement appropriate controls to reap them. Moreover, it removes irrelevant things within and between processes to reduce errors, avoid redundancy, and cost savings.
Improve decision-making
The use of evidence-based decision-making is another quality management principle of ISO 13485. It uses facts and data to make decisions and aligns the data with the organization’s strategic goals.
Create a culture of continual improvement.
Organizations integrate the principle of Continual improvement within the organization and management to improve its functioning. It streamlines processes for eliminating problems and reducing their effects on rectifying mistakes.
Conclusion
Align Technology is a global organization working to bring people and smiles together worldwide. Align Technology is a worldwide medical device enterprise dedicated to transforming lives by enhancing smiles. Moreover, achieving ISO 13485 standards demonstrate their commitment to delivering safe and quality medical devices and helps them win new businesses, clients, and customers.
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