February 16-20, 2026 - Hyatt Regency, St. Julians, Malta
ISO 35001:2019 Implementation and Lead Auditor Course
After successfully completing this course, you will receive a BRMI training certificate acknowledging your competency to lead a team of auditors assessing conformity with ISO35001:2019 for laboratories.
Exemplar Global has certified this course and offers additional certification and credits for all successful participants. By learning the unique aspects of the ISO 35001 biorisk management system, you will also be able to assist in the successful implementation of this management system standard in your own organization and perform internal audits.
This Course will be limited to 25 participants
Who is this Course For?
Biosafety Officers
Strengthen systems that minimize biosafety risk.
Biosecurity Managers
Upgrade threat prevention & response practices.
Academic & Research Scientists
Translate standards into lab workflows.
Internal & Lead Auditors
Plan, run, and report effective audits against ISO 35001.
Quality & Compliance Leads
Build/align your Biorisk Management System to ISO 35001.
Laboratory Managers & Supervisors
Improve day-to-day risk controls and oversight.
Public Health & Hospital Labs
Apply biorisk best practices in clinical settings.
EHS Professionals
Integrate biosafety/biosecurity into broader HSE programs.
Course Outline
After successfully completing this course, you will receive a BRMI training certificate acknowledging your competency to lead a team of auditors assessing conformity with ISO35001:2019 for laboratories.
1- Foundations
Understand ISO 19011 principles and the role of the auditor.
2- Plan the Audit
Build and manage an audit program aligned with ISO 19011.
3- Dive into ISO 35001
Translate each clause into implementable controls and processes.
4- Audit in Practice
Use ISO 35001 audit tools, ask the right questions, and recognize evidence.
5- Demonstrate Competency
Tests, exams, and immersive role plays to validate skills.
Prerequisites:
Participants will bring a solid working knowledge of laboratory biosafety and biosecurity (biorisk management). This is not a biosafety/biosecurity workshop.
Frequently Asked Questions
Why ISO 35001?
This standard has become the de facto requirement for laboratories working with biological agents that want to move beyond the basic biorisk management program approach. It is the next logical step for moving from compliance-based programs to performance-based systems. Laboratories worldwide are now seriously looking at ISO 35001 for stakeholder confidence, reassuring the public, maintaining infectious disease research abilities and strong and demonstrable performance in biosafety and biosecurity. These labs need qualified biorisk management advisors and experts to help them achieve ISO 35001 implementation. In addition, the World Health Organization (WHO) has now based its certification requirements for polio laboratories on ISO 35001 as part of the WHO Global Action Plan for Polio Virus Containment (GAPIV).
Why ISO 35001 lead auditor?
An ISO management system lead auditor is the individual who leads a team of auditors and subject matter experts in the conformity assessment of ISO 35001 at an organization/laboratory. These individuals learn how to audit an ISO management system, ask relevant questions, assess conformity, and lead an audit team, as well as understand the details and requirements of the audit process. They know what to look for and consequently what is required to implement a biorisk management system within a laboratory. That’s why this workshop is combining the implementation with auditing.
Why an in-person course and not online?
At Biorisk Management International (BRMI), we believe in the unique advantage of spending quality time together to interact, learn, challenge and support each other and build a strong professional network that is available long after the course. Our highly interactive courses use real-life biorisk management examples and exercises and allow each participant to contribute to the group’s success and learning. In addition, each participant will be part of the soon-to-go-live BRMI continuous learning community and will have access to our future team of biorisk management system experts.
Why a BRMI lead auditor course?
Biorisk Management International Ltd (BRMI) was established to provide biosafety, biosecurity, and biorisk management professionals with a unique opportunity to access and learn directly from the best biorisk management and biorisk management system trainers and experts in the field. To accomplish that, this course will be presented and taught by Dr. Stefan Wagener, one of the leading experts in the field with over 20+ years of experience in managing high-containment laboratories, biosafety and biosecurity, biorisk research and science, and quality management systems. He is one of the few individuals with the demonstrated qualifications and years of experience to teach such a course. In addition, we will be using our highly qualified team members as co-instructors who will share with you their unique experience in biorisk management systems, implementation, and auditing. Our team members are strategically placed around the world and will join the workshop based on the location.
How to become a BRMI trainer and SME?
At BRMI, we believe in building local capacity. By training highly qualified individuals from around the world who successfully completed this workshop to become ISO 35001 auditor trainers, these individuals will be able to use the BRMI course materials and offer the course and their experience locally to share their knowledge and build capacity where needed. BRMI selects interested and qualified individuals to become team members and qualified Exemplar Global instructors.
Why Malta?
Malta, as a part of the European Union, is a set of three islands in the Mediterranean south of Sicily. Its strategic location and international airport make it easy to access from Europe, the Middle East and Africa. English is the second language, and the climate in February is very favorable.
Discover Malta
The course fee is set at € 2,250 and covers:
- Five-day workshop (Monday through Friday)
- Morning and afternoon break refreshments and lunch
- All course material on a USB stick
- One officially licensed copy of ISO 35001:2019 and ISO 19011:2018 per participant in PDF form
- BRMI certificate and Exemplar Global certification option
- Lifetime access to the BRMI learning network
Notice: Since BRMI is offering the “AI for Biorisk Management – Workshop” from February 11-13 at the same location, we will have a special discounted registration fee if you wish to attend both the AI Workshop and the ISO 35001 Workshop!
Please contact us at: om@bioriskinternational.com for more information.
Venue
The workshop will take place from February 16-20, 2025, for five full days (Monday through Friday). It is recommended that you arrive in Malta latest on Sunday the 15th and depart on Saturday the 21st or later if you would like to explore Malta. We have booked the Hyatt Regency in St. Julian’s (Malta), with a special room rate for participants of Euro 115 per day. The room rate includes breakfast! We will provide you with your room rate discount code as well as room reservation instructions upon receipt of your workshop registration!
The hotel is at the famous St. George’s Bay in St Julian’s, with excellent restaurants, bars, and shops within walking distance along the waterfront!
Tours
Malta has an incredible history and is famous for its churches (365), sea caves, and some of the oldest temples in the world (3600 BC). The capital city, Valetta, is the smallest capital city in Europe and is truly worthwhile to explore. If there is interest after the workshop (Saturday or Sunday), we can arrange tours. Please let us know when you register for the course.
Weather
In comparison to the rest of Europe, Malta’s weather in February is pleasant. The average temperature is 16°C (61°F), with highs of 20+°C (68°F). It can get cooler at night, so bring a warmer jacket.
Airport
The Malta International Airport (MLA), also known as the Valletta Airport, is the only airport in Malta and serves all the Maltese Islands (Malta, Comino, and Gozo). The workshop is on the main island (Malta), and the hotel is a 10-15 minute drive away via Taxi, Uber, or Bolt. If you like to use Uber or Bolt, make sure you have the app on your phone.