ISO 35001:2019 Biorisk Management for Laboratories and Other Related Organisations

Standard Name: ISO 35001:2019 – Biorisk Management for Laboratories and Other Related Organizations
Scope: Establishes a risk management system for organizations that handle, store, transport, or dispose of biological agents and toxins
Applicability: Laboratories, research facilities, academic institutions, biotechnology firms, healthcare and diagnostic centers
Core Elements: Risk assessment, risk mitigation, performance evaluation, continual improvement, and compliance
Framework Basis: Follows Plan-Do-Check-Act (PDCA) cycle
Key Requirements:

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  Leadership and organizational roles

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  Biosafety and biosecurity objectives

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  Competence and awareness

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  Emergency preparedness and response
  Integration: Compatible with ISO 9001, ISO 14001, and ISO 45001
  Certification Type: Voluntary, Third-party Audited
  Implementation Duration: Varies (typically 3–6 months depending on facility size and complexity)
  Compliance Benefits: Enhances laboratory safety, reduces biological risk, ensures regulatory compliance, improves global credibility
  Documentation: Requires documented procedures, training records, incident logs, and biosafety manuals

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