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Regulatory Framework

International Quality Standards

  • ISO 15189:2022: Medical laboratories — Requirements for quality and competence.

  • ISO 20387:2018: Biotechnology — Biobanking — General requirements for biobanking.

  • GCLP: Good Clinical Laboratory Practice for international clinical trials.

Specialised Diagnostic Standards

  • CAP Standards: Following the College of American Pathologists protocols for IHC and oncomorphology.

  • CLSI: International guidelines for reference values in infectious and autoimmune testing.

  • ISO 13485: Quality management for medical devices.

Ethical and Legal Standards

  • GDPR: Data protection for personal and genetic information.

  • WMA Declaration of Helsinki & Taipei: Ethical principles for medical research and biobanking.

  • ISO/IEC 27001: Information security management.

Internal Standard Operating Procedures (SOPs)

  • SOP-QA-01: Double Control (Four-Eyes Principle).

  • SOP-INT-05: International Verification (Second Opinion) protocols.

  • SOP-BIO-03: Cryopreservation and Logistics (Storage at -80°C or in liquid nitrogen).