Quality is at the heart of our work. Every diagnostic result we deliver has the potential to change lives, guide medical decisions, and advance scientific discovery. To ensure this responsibility is met with the highest standards, our laboratory operates under internationally recognized accreditations and rigorous compliance frameworks.

ISO 15189 – Medical Laboratory Accreditation

We are accredited according to ISO 15189: Medical Laboratories – Requirements for Quality and Competence.

This standard demonstrates our ability to deliver accurate, reliable, and clinically valid test results through:

  • Comprehensive quality management systems.
  • Verified technical competence of staff.
  • Continuous monitoring, audits, and improvement processes.

For patients, physicians, and research partners alike, ISO 15189 provides assurance that every result is trustworthy and actionable.

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ISO 27001 – Information Security Management

We recognize that patient data and diagnostic information are highly sensitive. That is why we operate under ISO 27001: Information Security Management Systems.

This ensures:

  • Secure handling of all electronic health and diagnostic data.
  • Robust protection against unauthorized access, cyber threats, and data breaches.
  • A culture of confidentiality and compliance with data protection regulations (e.g., GDPR).
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ISO 13485 – Quality Management for Medical Devices

Our operations also comply with ISO 13485: Quality Management Systems for Medical Devices.

This accreditation reflects our commitment to:

  • Developing, producing, and validating in-vitro diagnostic (IVD) assays under strict regulatory controls.
  • Ensuring diagnostic products and processes consistently meet safety and performance requirements.
  • Supporting innovation while safeguarding patient well-being.
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Good Laboratory Practice (GLP)

In addition to formal accreditations, our laboratory adheres to the principles of Good Laboratory Practice (GLP).

This means that:

  • All laboratory studies are conducted with full traceability, transparency, and reproducibility.
  • Processes are documented in detail to guarantee reliability and integrity of data.
  • Research and development activities meet internationally recognized standards, supporting scientific and regulatory acceptance.

In-house IVD (LDT) IVDR Declaration

Please find our In-house IVD (LDT) IVDR Declarations below:

  1. PDF
  2. PDF
  3. PDF

Continuous Improvement

Beyond compliance, we actively invest in:

  • Proficiency Testing (EQA): Regular benchmarking through international quality assessment schemes.
  • State-of-the-Art Technology: From mass spectrometry to next-generation sequencing, validated for clinical precision.
  • Training & Competence: Ongoing professional development to maintain expertise at the highest level.

Our Promise

By aligning scientific expertise with ISO 15189, ISO 13485, ISO 27001, and GLP principles, we ensure that every result we deliver is not only scientifically robust but also safe, secure, and reliable.

In diagnostics, quality is not optional—it is our promise.

Please contact us at info@archimedlife.com to receive more information on our Quality Management Systems.

*According to EN ISO 15189, ARCHIMEDlife Laboratory has been designated as a medical laboratory with the identification number 0407 from Accreditation Austria / Federal Ministry for Digitization and Business Location for the areas listed and published at: www.bmaw.gv.at/akkreditierung.