Quality Policy

iDNA Laboratories is committed to providing a comprehensive range of high-quality and innovative In Vitro Diagnostic (IVD) products and novel genetics and genomics-based bioinformatics solutions. Our goal is to enhance individual and public health by delivering precise results through reliable, safe, and effective diagnostic products that meet regulatory and customer expectations.

To achieve this, we have implemented a QMS that complies with ISO 9001:2015, ISO 13485:2016, IVDR (EU 2017/746), and Ministerial Decision DY8/G.P.oik. /1348.

Our commitment is based on key elements of the Quality Policy, which are presented below, organized into groups of closely related activities:

Ensuring compliance with all applicable National, European, and international regulatory requirements, ordinances and standards.
Establishing and monitoring quality objectives to drive continuous improvement.
Providing state-of-the-art diagnostic solutions through research, innovation, and technology-driven advancements.
Ensuring our products and services undergo rigorous quality control, risk management, and post-market surveillance.
Training and empowering our employees to maintain a quality, compliance, and excellence culture.
Implementing corrective and preventive actions (CAPA) to minimize risks and enhance product performance.
Continuously improving the effectiveness of our QMS to maintain customer satisfaction and regulatory compliance.

The overall Quality objective of iDNA Laboratories is therefore to establish, implement and maintain a system that assures the supply of robust and quality by design Innovative IVDs with quality attributes appropriate to the requirements of patients, healthcare providers and regulatory authorities.

iDNA Laboratories' management is fully committed to:

Patient Safety & Clinical Excellence: Providing accurate and clinically useful test results to healthcare providers and end users.
Regulatory Compliance: Ensuring that all products meet the requirements of ISO 13485, IVDR, and other relevant national and international regulations.
Innovation & Technological Advancement: Developing cutting-edge solutions that contribute to the evolution of precision medicine and personalized healthcare.
Data integrity: is a fundamental part of the QMS to ensure products’ quality. Data integrity requirements apply equally to both paper records and electronic data throughout the product life cycle.
Comprehensive, accurate and well-controlled documentation: is also critical to successful and compliant quality assurance.
Customer Satisfaction: Fostering long-term relationships by understanding and meeting customer needs, responding to feedback, and providing exceptional service
Operational Efficiency & Continuous Improvement: Establishing efficient workflows, conducting regular audits, and implementing quality enhancements based on data-driven insights.
Employee Training & Development: Establishment and maintenance of a satisfactory system of quality assurance relies on enough suitably qualified and trained personnel. Providing continuous learning opportunities to ensure all staff are equipped with the necessary skills to contribute to quality and compliance.
Annual Management Reviews: Reviewing quality objectives, QMS effectiveness, and regulatory updates to ensure sustained compliance and performance by using suitable performance indicators to measure its effectiveness and progress against quality objectives.

Communication & Implementation

The Quality Policy is communicated to all employees upon induction and through training, to external partners and stakeholders to ensure alignment with our strategic direction and quality objectives. This policy is regularly reviewed and updated to reflect regulatory changes, technological advancements, and organizational improvements.

The Management

Date: 10.04.2025