ISO 35001:2019 Documentation Kit

Protect your laboratory, research facility, or biotechnology operation from biological risks with our ISO 35001:2019 Documentation Kit — a complete, ready-to-use, and fully customizable package designed to help organizations implement a Bio-risk Management System in alignment with ISO 35001:2019 requirements.

This kit is ideal for clinical labs, pharma R&D units, biotechnology companies, academic institutions, manufacturing plants, and diagnostic centers handling biological agents. It enables structured control over containment, handling, transportation, waste disposal, emergency response, and personnel safety — ensuring compliance with global biosafety standards.

What’s Included:

Biorisk Management Manual

A clause-wise structured manual aligned with ISO 35001:2019, defining system scope, biosafety objectives, responsibilities, and risk management methodologies.

Mandatory Procedures

Comprehensive procedures covering risk assessment, containment protocols, access control, material transport, incident reporting, decontamination, waste management, and corrective actions.

Work Instructions & SOPs

Step-by-step operational guidelines for sample handling, disinfection, PPE usage, equipment operation, and emergency response.

Forms & Formats

Editable templates for risk registers, inventory logs, training records, incident reports, audit logs, waste disposal checklists, and biosafety approvals.

Internal Audit Checklists

Clause-wise checklists to evaluate compliance readiness and system effectiveness.

Management Review Meeting (MRM) Documents

Structured formats to review biosafety performance, incident trends, risk mitigation actions, and resource needs.

Key Benefits:

• Aligned with ISO 35001:2019 for globally recognized bio-risk management compliance
• Saves documentation effort with pre-built, fully editable Word & Excel templates
• Enhances safety of personnel, environment, and biological materials
• Strengthens incident preparedness and emergency response reliability
• Supports regulatory, ethical, and institutional biosafety requirements

Build a safer and compliant biosafety system. Get your ISO 35001:2019 Documentation Kit today and implement a responsible, resilient, and auditable bio-risk management framework.