Meaning
International certification rules establish the standard for the competence, impartiality, and consistent operation of biobanks. Organizations seeking ISO 20387 compliance must implement a comprehensive quality management system that governs the collection, preservation, and distribution of biological materials. The scope of this standard applies to all entities handling human, animal, plant, and microbial resources for research and development.
It does not apply to biological materials intended for direct clinical or therapeutic use. Entities must undergo independent assessment to verify their operational conformance to these strict requirements.
Operational Requirement
Standardized collection and preservation workflows ensure that biological specimens retain their structural and molecular integrity. To achieve iso 20387 compliance, Chinese biobanks must establish clear custody chains and documented handling procedures. The temperature of storage units is monitored continuously to prevent degradation of proteins and nucleic acids.
These procedures require redundant power systems and automatic liquid nitrogen refilling systems.
Quality Assurance
Accreditation bodies review the standard operating procedures and technical competency of the laboratory personnel during on-site assessments. In China, the national accreditation service for conformity assessment evaluates compliance through audits. This evaluation process checks sample identification methods and data security protocols.
Laboratories must participate in proficiency testing programs to prove their analytical accuracy.
Administrative Supervision
The Ministry of Science and Technology monitors genetic resources to ensure national biosecurity and compliance with administrative rules. Foreign entities collaborating with domestic biobanks must obtain special approvals before any genetic material is transferred abroad. This protective system uses the international standard as a baseline to verify that collaborating domestic laboratories operate at a high level of competency.
