ISO 35001:2019- Bio Risk Management for Laboratories and Other Related Organizations

How to Implement ISO 35001 in Your Organization?

Successful implementation of ISO 35001 requires a risk-based, structured approach:

• Step 1: Identify the biological agents and materials your organization handles or stores. Determine potential hazards and vulnerable points across your facility and procedures.
• Step 2: Conduct a biorisk assessment, covering both biosafety (accidental exposure) and biosecurity (intentional misuse).
• Step 3: Assign roles and responsibilities under a defined biorisk management structure, supported by a cross-functional BRMS committee or officer.
• Step 4: Develop operational controls such as standard operating procedures (SOPs), access controls, equipment safety, and incident response plans.
• Step 5: Train staff and contractors. Promote a culture of responsibility and compliance.
• Step 6: Monitor effectiveness using inspections, audits, and feedback mechanisms.
• Step 7: Conduct periodic reviews and updates to improve resilience against emerging biorisks.

Need a tailored certification roadmap for your facility? Pacific Certifications can help, email support@pacificcert.com.

Documentation Required of ISO 35001

Organizations implementing ISO 35001 must maintain documentation covering:

• Biorisk management policy
• Biorisk assessment reports and registers
• Operational controls and SOPs for risk mitigation
• Biosecurity and biosafety training records
• Emergency preparedness and response protocols
• Incident logs and corrective actions
• Internal audit and management review records
• Stakeholder and regulatory communication plans

We provide compliance support in preparing required records. Contact us at support@pacificcert.com!

Eligibility Criteria

ISO 35001 is intended for organizations that:

• Handle or store biological materials of concern (including toxins, pathogens, or genetically modified organisms)
• Have physical containment facilities (BSL-2, BSL-3, BSL-4)
• Conduct biological research, diagnostic testing, or production
• Require alignment with WHO biosafety guidelines or CDC recommendations

Even small research teams or startups working with non-pathogenic materials can benefit from adopting this standard to establish good governance and laboratory safety culture.

Certification Costs

Certification costs for ISO 35001 vary depending on:

• Number and size of laboratory sites
• Complexity and risk classification of biological materials handled
• Extent of existing compliance with biosafety or ISO standards
• Customization of training and documentation requirements
• Desired timeline for audit readiness

At Pacific Certifications, we offer transparent scoping and cost estimation based on an initial consultation. Contact support@pacificcert.com for a proposal.

Certification Timeline

Let us help you plan and manage your ISO 35001 certification schedule—email support@pacificcert.com!

Requirements of ISO 35001

ISO 35001 outlines a comprehensive management system that includes:

• Organizational Leadership and Commitment: Top management must define a clear biorisk policy and assign responsibility.
• Context of the Organization: Understand internal and external factors, regulatory obligations, and stakeholder expectations.
• Risk Assessment and Risk Control: Identify hazards, assess likelihood and consequences, and implement control measures accordingly.
• Operational Control: Establish SOPs, access management, equipment safety procedures, and contamination prevention strategies.
• Emergency Preparedness and Response: Develop and test plans for containment breaches, exposure incidents, or loss/theft of materials.
• Competence and Training: Staff must be trained and assessed for awareness of risks, safety protocols, and behavioral responsibilities.
• Performance Monitoring and Improvement: Regular inspections, audits, and management reviews ensure ongoing effectiveness of controls.

Pacific Certifications helps organizations interpret and apply these requirements based on their operations and sector-specific risks.

Benefits of ISO 35001

1. Implementing ISO 35001 ensures that organizations systematically control risks related to biological agents, reducing both accidental and intentional exposures.
2. Helps meet international guidelines from WHO, CDC, and national health bodies, ensuring conformance with legal expectations and licensing conditions.
3. Provides a structured method to assess and mitigate risks, enabling informed decisions that balance operational goals with safety priorities.
4. Reduces the likelihood of lab-acquired infections, environmental contamination, or community outbreaks due to poor risk management.
5. Certification assures stakeholders, funders, and regulators that the organization prioritizes biosafety, enhancing its reputation and funding prospects.
6. Improves readiness to respond to lab incidents, pandemics, and bioterror threats by embedding structured emergency protocols.
7. Easily integrates with other ISO systems (9001, 14001, 45001), enabling centralized governance and easier cross-standard audits.
8. Promotes a feedback-driven safety culture with regular audits, staff input, and incident reviews.

Lately, the importance of biorisk management continues to grow, especially after the COVID-19 pandemic underscored the need for robust laboratory safety systems. A report from the Global Health Security Index noted that only 35% of countries have strong governance over biosafety and biosecurity.

Pharmaceutical R&D, synthetic biology, and vaccine manufacturing sectors are now routinely adopting ISO 35001 to meet both regulatory and partner expectations. Furthermore, donor agencies and international research collaborations increasingly require proof of biosafety compliance.

ISO 35001 adoption is also driven by dual-use research concerns, as facilities handling sensitive biological agents must demonstrate that their research cannot be weaponized or misused.

How Pacific Certifications Can Help?

At Pacific Certifications, we provide complete support for ISO 35001:2019 including:

• Gap analysis and biorisk maturity assessments
• Audit and certification
• In-house training and awareness programs
• Certificate of conformity issuance
• End-to-end support through certification audit and closure

Our team works with biotech, academic, government, and healthcare labs globally to ensure full compliance with ISO 35001. To get started, contact us at support@pacificcert.com!