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SERO Quality management system certification: ISO 13485

ISO 13485 and the role of Quality Control in Laboratory Testing

ISO 13485:2016 is the internationally recognized standard for quality management in the medical device and in vitro diagnostics (IVD) industry. It establishes strict requirements for the design, manufacturing, and distribution of medical device, including third-party quality control (QC) materials to ensure that their medical devices meet both customer and regulatory demands for safety and efficacy.

For laboratories, working with ISO 13485-certified quality controls means:

  • Lot-to-lot consistency: QC materials must demonstrate minimal variation between production batches, ensuring stable and reliable performance over time. This reduces the risk of shifting control values, which can compromise result interpretation.
  • Comprehensive traceability and documentation: Every component in our QC materials is fully documented, from raw material sourcing to final product release.
  • Validated manufacturing processes: Under ISO 13485, QC materials undergo rigorous validation, stability testing, and risk assessment. This ensures they meet predefined performance criteria, maintain long-term stability, and function as intended across different instruments.
  • Independent verification of test system performance: Third-party QC materials, manufactured under ISO 13485, provide an objective assessment of laboratory instruments and reagents. This allows laboratories to detect bias, drift, and systematic errors.
  • Regulatory alignment and future-proofing: As regulatory frameworks like the EU In Vitro Diagnostic Regulation (IVDR) and other national requirements evolve, laboratories must demonstrate greater control over their quality management processes. Using QC materials produced under ISO 13485 helps ensure compliance with evolving regulatory expectations while supporting continuous quality assurance.

ISO 13485 certification reflects our dedication to providing laboratories with high-quality, consistent, and compliant QC solutions that support standardized and long-term quality assurance.

For more information about our certified processes and quality control products, feel free to contact us.