5 Key Takeaways from the ISO 35001:2019 Lead Auditor Course
March 6, 2025
Since its launch in 2019, ISO 35001 has gained significant global interest, particularly among organizations seeking to strengthen biosafety and biosecurity risk management in the workplace. Learning from Dr. Stefan Wagener of Biorisk Management International (BRMI) during this course was both intensive and enriching.
Representing our teams across Asia, North America, and Latin America, here are five key takeaways from the course.
- Enhancing Our Value as Certifiers and Consultants
At World BioHazTec, we serve our clients in both certification and consulting roles, though never simultaneously—a critical principle emphasized in this course.
As lead auditors, we must assess every clause of ISO 35001, as none can be excluded. With limited time on-site and hundreds of mandatory “shall” requirements, how do we efficiently gather evidence? Learning to think like a lead auditor not only strengthens our audit process but also enhances the quality of our consulting services.
- A Hands-On, Interactive Learning Experience
ISO 35001 sets a high bar, and so does this course—daily individual and group exercises, quizzes and a final exam demand full attention and deep engagement. Fortunately, Stefan Wagener and the team at BRMI ensure the material is far from dry or overly technical.
Through interactive exercises, real-world case studies, and engaging discussions, participants gain hands-on experience applying ISO 35001 principles.
What made this experience even more valuable was the diverse perspectives in the room. With attendees from around the world—biosafety professionals, biosecurity experts, scientists, and engineers—discussions often revealed different interpretations shaped by cultural and regulatory contexts. This collaborative learning environment made the course dynamic and insightful, while also providing practical strategies for auditing clients from various industries.
- ISO 35001:2019 Requires Serious Commitment
Adopting ISO 35001 is not just a box-checking exercise—it demands a long-term commitment from organizations. Successful implementation requires:
✅ Strong leadership support to drive adoption
✅ Comprehensive training to ensure conformity
✅ Adequate financial resources for a sustainable biorisk management system
Without these elements, achieving and maintaining conformity becomes incredibly challenging. However, ISO 35001 incorporates a structured “Plan, Do, Check, Act” approach to biorisk management, ultimately strengthening an organization’s biosafety culture and moves biorisk management to the system level.
- The Course is Designed for Subject Matter Experts (SMEs)
ISO 35001 follows a familiar clause-based framework, but its specialized focus on a biorisk management system sets it apart from other ISO standards and requires an upfront knowledge of laboratory biosafety and biosecurity,
As our instructor pointed out, it’s easier for a biosafety SME to learn auditing than for an ISO 9001 auditor to transition into ISO 35001 auditing.
For biosafety practitioners, this course provides the necessary structure, tools, and knowledge to successfully conduct both internal and external ISO 35001 audits. If you’re already working in biosafety or biosecurity, this training will significantly enhance your auditing capabilities.
- Before Learning ISO 35001:2019, You Need to Understand ISO 19011
ISO 35001 does not stand alone—it relies heavily on ISO 19011, the global guideline for auditing management systems.
ISO 19011 provides the principles, procedures, and competency requirements for auditors across various fields, including quality, environmental, safety, and information security. A solid understanding of ISO 19011 is essential for conducting effective and structured ISO 35001 audits.
At World BioHazTec, we have long adhered to these principles as certifiers. Applying ISO 19011’s systematic approach has allowed us to continuously improve our audit processes and enhance our team’s competencies.
Final Thoughts
The ISO 35001:2019 Lead Auditor Course is an intensive yet high-value training program designed for biosafety and biosecurity professionals looking to deepen their expertise in biorisk management system implementation and auditing.
This course goes beyond theory, offering real-world applications of ISO 35001 while fostering global collaboration among industry experts.
For those looking to elevate their knowledge of biorisk management systems, this BRMI course is an investment worth making—but be prepared for a challenging, rewarding, and highly engaging experience!
Learn more about how World BioHazTec can assist you with your biorisk management system.
Featured Posts
5 Key Takeaways from the ISO 35001:2019 Lead Auditor Course
Since its launch in 2019, ISO 35001 has gained significant global interest, particularly among organizations seeking to strengthen biosafety and biosecurity risk management in the workplace. Learning from Dr. Stefan Wagener of Biorisk Management International (BRMI) during this course was both intensive and enriching. Representing our teams across Asia, North America, and Latin America, here are five key takeaways from the course. Enhancing Our Value as Certifiers and Consultants At World BioHazTec, we serve our clients in both certification and consulting roles, though never simultaneously—a critical principle emphasized in this course. As lead auditors, we must assess every clause of ISO 35001, as none can be excluded. With limited time on-site and hundreds of mandatory "shall" requirements, how do we efficiently gather evidence? Learning to think like a lead auditor not only strengthens our audit process but also enhances the quality of our consulting services. A Hands-On, Interactive Learning Experience ISO 35001 sets a high bar, and so does this course—daily individual and group exercises, quizzes and a final exam demand full attention and deep engagement. Fortunately, Stefan Wagener and the team at BRMI ensure the material is far from dry or overly technical. Through interactive exercises, real-world case studies, and engaging discussions, participants gain hands-on experience applying ISO 35001 principles. What made this experience even more valuable was the diverse perspectives in the room. With attendees from around the world—biosafety professionals, biosecurity experts, scientists, and engineers—discussions often revealed different interpretations shaped by cultural and regulatory contexts. This collaborative learning environment made the course dynamic and insightful, while also providing practical strategies for auditing clients from various industries. ISO 35001:2019 Requires Serious Commitment Adopting ISO 35001 is not just a box-checking exercise—it demands a long-term commitment from organizations. Successful implementation requires: ✅ Strong leadership support to drive adoption ✅ Comprehensive training to ensure conformity ✅ Adequate financial resources for a sustainable biorisk management system Without these elements, achieving and maintaining conformity becomes incredibly challenging. However, ISO 35001 incorporates a structured "Plan, Do, Check, Act" approach to biorisk management, ultimately strengthening an organization’s biosafety culture and moves biorisk management to the system level. The Course is Designed for Subject Matter Experts (SMEs) ISO 35001 follows a familiar clause-based framework, but its specialized focus on a biorisk management system sets it apart from other ISO standards and requires an upfront knowledge of laboratory biosafety and biosecurity, As our instructor pointed out, it’s easier for a biosafety SME to learn auditing than for an ISO 9001 auditor to transition into ISO 35001 auditing. For biosafety practitioners, this course provides the necessary structure, tools, and knowledge to successfully conduct both internal and external ISO 35001 audits. If you’re already working in biosafety or biosecurity, this training will significantly enhance your auditing capabilities. Before Learning ISO 35001:2019, You Need to Understand ISO 19011 ISO 35001 does not stand alone—it relies heavily on ISO 19011, the global guideline for auditing management systems. ISO 19011 provides the principles, procedures, and competency requirements for auditors across various fields, including quality, environmental, safety, and information security. A solid understanding of ISO 19011 is essential for conducting effective and structured ISO 35001 audits. At World BioHazTec, we have long adhered to these principles as certifiers. Applying ISO 19011’s systematic approach has allowed us to continuously improve our audit processes and enhance our team’s competencies. Final Thoughts The ISO 35001:2019 Lead Auditor Course is an intensive yet high-value training program designed for biosafety and biosecurity professionals looking to deepen their expertise in biorisk management system implementation and auditing. This course goes beyond theory, offering real-world applications of ISO 35001 while fostering global collaboration among industry experts. For those looking to elevate their knowledge of biorisk management systems, this BRMI course is an investment worth making—but be prepared for a challenging, rewarding, and highly engaging experience! Learn more about how World BioHazTec can assist you with your biorisk management system.
Read More
Celebrating 30 Years of Excellence: World BioHazTec’s Journey in Biosafety and Biosecurity
For three decades, World BioHazTec has been at the forefront of biosafety and biosecurity consulting, helping countless organizations meet rigorous standards and create safer laboratory environments. What started as a small, specialized consulting firm has evolved into a global leader known for its innovative solutions, expert guidance, and unwavering commitment to protecting both people and the planet. As we celebrate our 30-year milestone, we’d like to reflect on how we got here and share what’s on the horizon. A Legacy of Expertise and Innovation When World BioHazTec opened its doors 30 years ago, biosafety was still an emerging field. Laboratories and research facilities often grappled with a patchwork of safety guidelines and minimal oversight. Recognizing a need for clear, consistent standards, we set out to develop comprehensive consulting services that would empower organizations to reach the highest level of safety and regulatory compliance. Over time, we’ve embraced technology-driven solutions—from advanced laboratory design tools to sophisticated HVAC diagnostics—that continue to shape the future of biosafety. Guiding the Evolution of Biosafety Standards and Regulations Our influence extends beyond day-to-day consulting projects, as we actively participate in shaping and refining industry guidelines. Over the years, World BioHazTec has consulted on and contributed to the development and review of essential biosafety standards and regulations, such as the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the National Institutes of Health Design Requirements Manual, ANSI/ASSP Z9.14-2020, and the NIH BSL-3 Laboratory Certification Requirements and Checklist. We have also been involved in reviewing the CEN Workshop Agreement 15793: Laboratory Biorisk Management Standard which has been converted to ISO 35001:2019, as well as advising on the Singapore Standard Biorisk Management and the Singapore Biological Agents and Toxins Act. Our deep familiarity with these regulations—and our hands-on industry experience—ensures that the solutions we provide keep laboratories worldwide at the cutting edge of safety and compliance. Driving Global Impact Over the past 30 years, World BioHazTec has established a strong global presence by addressing operational challenges in BSL-2 and BSL-3 laboratories, utilizing in-country resources, and training local personnel to manage biosafety and preventative maintenance effectively. We’ve expanded our reach by opening offices in Singapore and Latin America, where we’ve delivered impactful results. Highlights include becoming the first Ministry of Health-approved facility certifier for BSL-3 and ABSL-3 laboratories in Singapore, certifying the country’s first BSL-3 laboratory under the Biological Agents and Toxins Act, and consulting on the design and construction of Singapore’s first BSL-4 laboratory. In Latin America, we are currently consulting on the design of a BSL-3/BSL-4 cabinet lab in Chile—the first of its kind in the region—and have delivered significant biosafety training by partnering with the Organization of American States to enhance biosafety practices throughout Latin America. In Brazil, we contributed to the design of the nation’s first BSL-4 laboratory, showcasing our expertise in high-containment facilities. Additionally, we’ve engaged with the biosafety community by attending inaugural conferences in Singapore, Indonesia, Korea, the Philippines, and Malaysia. This extensive experience underscores our capability to collaborate on addressing administrative and engineering control challenges in these regions. Collaborative Approach and Trusted Partnerships One key to our longevity has been building strong relationships with clients and collaborators. Over the last 30 years, we’ve partnered with leading academic institutions, research hospitals, and private corporations, supporting them through complex projects. By listening carefully to each organization’s needs—whether it’s a university seeking a new lab layout or a multinational company aiming to comply with evolving regulations—we tailor our solutions to deliver measurable, sustainable results. Our team of engineers, biosafety professionals, scientists, and project managers works closely with every client to ensure transparency, effective communication, and long-term success. Looking Forward While our journey so far has been remarkable, we know that the future holds even more possibilities for growth and innovation. Emerging infectious diseases, evolving regulatory frameworks, and the expansion of high-containment research facilities underscore the ongoing need for diligent, effective biosafety measures. World BioHazTec is dedicated to staying on the cutting edge of this field, combining our decades of experience with new technologies and best practices to safeguard the well-being of lab personnel, surrounding communities, and the environment. Thank You for 30 Years As we commemorate this special anniversary, we want to extend our heartfelt thanks to everyone who has been part of our story: our dedicated employees, loyal clients, and industry partners. Your trust and collaboration have fueled our passion and helped us grow into the organization we are today. We look forward to continuing this journey together—providing top-tier biosafety and biosecurity consulting, adapting to new challenges, and making the world a safer place for groundbreaking research. Here’s to the next 30 years of innovation, collaboration, and excellence in biosafety. We’re excited to see where this path leads, and we invite you to stay tuned for the next chapter in World BioHazTec’s story. If you have any questions or want to learn more about our services and projects, feel free to contact us. We’d love to hear from you!
Read More
The Critical Role of a Commissioning Agent in BSL-3 Laboratory Design and Operation
The commissioning agent plays a vital role in ensuring the BSL-3 laboratory operates safely, effectively and meets the design intent. This subject matter expert is responsible for rigorously challenging a new or renovated laboratory's critical MEP systems and other containment features. A commissioning agent's expertise goes beyond just testing equipment; they ensure that all systems work together as intended under real-world operating conditions. By simulating potential failures through Integrated Systems Functional Performance Tests (ISFPTs), conducting performance verification tests, and ensuring compliance with biosafety standards, the commissioning agent confirms that the facility is ready for safe operation. It is ideal to involve the BSL-3 commissioning agent as early as possible in the programming/design phases of the laboratory. Early engagement ensures that critical building systems and operational requirements are seamlessly integrated into the design, reducing the likelihood of costly modifications or delays later in the project. As a rule of thumb, the commissioning agent should consist of a multidisciplinary team of engineers and biosafety professionals. This combination of expertise ensures not only a deep understanding of critical building systems, such as HVAC, pressure controls, and decontamination systems, but also the ability to translate scientific and biosafety requirements into practical, effective design solutions. By incorporating their insights from the outset, the project team can align the laboratory's design with its functional and safety goals, paving the way for a smooth commissioning process and long-term operational success. The commissioning process involves detailed documentation, culminating in a comprehensive report that extends beyond a simple compilation of test results. This report includes ISFPT (Integrated Systems Functional Performance Testing) sheets, detailed risk assessments, graphical depictions of directional airflow and laboratory layout, validation checklists, calibration verification, differential pressure readings under normal and abnormal conditions, annotated photographs, quality improvement recommendations, and certificates for the equipment used during data collection. Serving as both a record of compliance and a valuable resource, the report provides critical guidance for future maintenance, certification/recertification, and continuous quality improvement. Choosing an experienced commissioning agent is essential to the success of your BSL-3 laboratory project. The ideal candidate should have a strong background in biosafety, engineering, and regulatory compliance, along with a proven track record of commissioning high-containment facilities. Collaborating with a knowledgeable third-party commissioning agent ensures that your laboratory is not only operationally sound but also fully compliant with all relevant guidelines and regulations. It’s important to select a commissioning agent who routinely visits BSL-3 laboratories for annual HVAC verification and validation testing. This hands-on experience provides critical insights into how laboratories operate over time, which can be applied during design, construction, and of course commissioning. A seasoned commissioning agent understands these lessons learned to optimize your laboratory’s functionality, safety and sustainability. Their expertise ensures your facility is built to meet both current and future demands. Investing in the right BSL-3 commissioning expert is a crucial step toward achieving a successfully laboratory project, ensuring that the facility meets its design intent, safeguarding both personnel and the environment while supporting the laboratory’s research objectives. To learn more about World BioHazTec’s commissioning approach, contact us for a free consultation.
Read More
