DocumentationRequires Documented Procedures, Training Records, Incident Logs, Biosafety Manuals
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:\r\n\r\n\r\nLeadership and organizational roles\r\n\r\n\r\nBiosafety and biosecurity objectives\r\n\r\n\r\nCompetence and awareness\r\n\r\n\r\nEmergency 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\r\n\r\n
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