July 6-10, 2026 - Johannesburg, South Africa

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 is in association with:

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

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.