IOTA DIAGNOSTIC, holding a manufacturing license and ISO 13485 QMS certification (TUV Nord), is committed to high-quality standards and continuous improvement in providing superior medical devices and diagnostic products. We ensure employee safety and compliance with ISO 13485:2016 and Indian Medical Device Rule 2017.

Key principles of our Quality Management System:

1. Simplicity: User-friendly, advanced solutions.
2. Quality: Robust, reliable products and services.
3. Sustainability: Cost-effective solutions maintaining quality and integrity.

Each employee is responsible for adhering to these standards and is accountable for their performance and the performance of their team. We ensure that all suppliers meet our stringent quality requirements. All quality incidents are promptly reported, investigated, and addressed with verified corrective actions.

We continuously assess and improve our QMS through regular audits and performance reviews, measuring our effectiveness against set objectives and goals. By upholding these principles, we ensure access to accurate, essential information through our high-quality medical devices and services.

Find the PDF of Quality Policy Here.