ISO 35001:2019
Biorisk Management for Laboratories
Achieve ISO 35001:2019 certification for biosafety and biosecurity compliance. Expert consultants for laboratory risk management and international collaboration.
WHAT IS ISO 35001:2019 CERTIFICATION?
ISO 35001:2019 is the international standard for Biorisk Management Systems in Laboratories and Related Organizations.
It provides a structured framework for identifying, controlling, and mitigating risks associated with biological agents and toxins in laboratories, research facilities, healthcare centers, and other related organizations.
The standard integrates risk assessment, hazard control, operational procedures, and continual improvement, helping organizations ensure safety, security, and compliance with applicable biosafety and biosecurity regulations.
THE IMPORTANCE OF ISO 35001:2019 CERTIFICATION
ISO 35001:2019 is important because it:
- Protects People and the Environment – Reduces risks of exposure to hazardous biological materials.
- Ensures Regulatory Compliance – Aligns with national and international biosafety and biosecurity requirements.
- Strengthens Organizational Safety Culture – Encourages responsibility and vigilance in handling biological agents.
- Prevents Biological Incidents – Minimizes the risk of accidental or intentional release.
- Enhances International Collaboration – Recognized globally in research and healthcare sectors.
Specialized consultants can help design and implement a robust biorisk management system in line with ISO 35001:2019.
ADVANTAGES OF OBTAINING ISO 35001:2019 CERTIFICATION
- Reduced Health and Safety Risks – Protects staff, visitors, and surrounding communities.
- Improved Laboratory Management – Standardizes biosafety and biosecurity practices.
- Global Recognition – Facilitates cooperation with international research institutions.
- Compliance Assurance – Meets requirements of funding bodies and regulators.
- Continuous Improvement – Encourages regular updates to safety protocols.
TYPES OF ORGANIZATIONS THAT BENEFIT FROM ISO 35001:2019
- Research Laboratories
- Medical and Diagnostic Laboratories
- Biotechnology Companies
- Pharmaceutical R&D Facilities
- Universities and Academic Research Centers
- Public Health and Forensic Laboratories
WHEN IS ISO 35001:2019 CERTIFICATION REQUIRED?
ISO 35001:2019 is relevant when:
- Working with hazardous biological agents or toxins.
- Meeting regulatory or funding requirements for biosafety.
- Enhancing international collaboration in biomedical research.
- Strengthening biosecurity in high-containment facilities.
THE ISO 35001:2019 CERTIFICATION PROCESS
- Gap Analysis – Compare existing biosafety systems with ISO 35001 requirements.
- Risk Assessment – Identify biological hazards and their potential impacts.
- System Development – Implement controls, SOPs, and emergency procedures.
- Training & Awareness – Educate staff on biosafety and biosecurity responsibilities.
- Internal Audit & Review – Test readiness for certification.
- Certification Audit – Accredited body evaluates compliance.
- Certification Award – Official recognition of ISO 35001:2019 compliance.
MAINTAINING ISO 35001:2019 COMPLIANCE
- Regular Safety Audits – Check for gaps in biosafety measures.
- Ongoing Staff Training – Keep teams updated on best practices and new threats.
- Incident Reviews – Learn from near misses and actual events.
- System Updates – Adapt protocols to new scientific and regulatory developments.
GLOBAL CONSIDERATIONS
ISO 35001:2019 aligns with:
- WHO Laboratory Biosafety Manual
- CDC/NIH Biosafety Guidelines
- Cartagena Protocol on Biosafety
- National and Regional Biosecurity Regulations
CHOOSING THE RIGHT ISO 35001:2019 CERTIFICATION CONSULTANT
When selecting a consultant, consider:
- Experience in laboratory biosafety and biosecurity.
- Knowledge of ISO 35001 and related regulatory frameworks.
- Ability to integrate biosafety systems with other management standards like ISO 9001 or ISO 45001.
- Track record of helping high-risk facilities achieve compliance.
- End-to-end support from risk assessment to certification maintenance.
Highlights
Central Objective
ISO 35001:2019 focuses your organisation on a single, measurable objective and keeps every process aligned to it.
Ensures Quality
ISO 35001:2019 sets out the controls that keep output consistent, so quality stops depending on who happens to be on shift.
Client Satisfaction
ISO 35001:2019 gives clients documented assurance, which shortens procurement questions and wins tenders.
Client Relationship Management
ISO 35001:2019 formalises how enquiries, complaints and feedback are handled, so nothing is lost between people.
Detailed Documentation
ISO 35001:2019 leaves you with records that prove what you did and when — the difference between passing an audit and arguing through one.
Greater Efficiency
ISO 35001:2019 removes duplicated effort and clarifies ownership, which lifts productivity across the whole organisation.
How ISO 35001:2019 certification works
- Upload your documents and business details to our portal.
- Speak to an advisor about the right accreditation body and scope for you.
- We verify your documents and confirm you are eligible for ISO 35001:2019.
- Make payment online through any of the available methods.
- We handle ISO 35001:2019 consultancy, documentation and implementation.
- An independent certification body audits and issues your ISO 35001:2019 certificate.
Documents required for ISO 35001:2019
- Business registration proof
Any document evidencing the business — certificate of incorporation, GST certificate, MSME certificate or trademark certificate.
- Letterhead or visiting card
Company letterhead or a visiting card for the business applying for ISO 35001:2019.
- Sales and purchase invoice
A sale and purchase invoice evidencing the nature of the business activity for which you are securing ISO 35001:2019.