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ISO 35001: Biorisk Assessment & Management System

The ISO 35001: Biorisk Management for Laboratories and Other Related Organisations course by Koenig Original equips biosafety officers, laboratory managers, and EHS professionals with the framework to systematically identify, assess, and control biological risks. Designed for those managing biohazardous materials, it addresses the critical need for standardized risk management, as highlighted by the World Health Organization’s adoption of ISO 35001 for polio lab certification. This training fills the growing global demand for structured biorisk programs in clinical and research settings.

Preparation for Exemplar Global-recognized certification is enhanced through Koenig’s Guaranteed-to-Run training schedule, ensuring timely access to expert-led instruction. Participants gain practical auditing skills and a roadmap to implement compliant, performance-based systems, positioning them to lead safer, internationally recognized laboratory operations.

40 Hours (5 Days)
Live Online / Classroom
0+ professionals trained

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Course Overview

The ISO 35001: Biorisk Management for Laboratories and Other Related Organisations course by Koenig Original is designed for biosafety officers, laboratory managers, and compliance leads responsible for implementing and auditing biorisk management systems in high-containment environments. This comprehensive training prepares professionals for the ISO 35001 Lead Auditor certification, equipping them with the expertise to assess conformity with the international standard for biorisk management. As laboratories worldwide increasingly adopt ISO 35001 to meet regulatory expectations and stakeholder confidence, demand for certified auditors has surged, with the World Health Organization now aligning its polio laboratory certification requirements with ISO 35001 under the Global Action Plan for Polio Virus Containment (GAPIV).

Participants engage with core components of the ISO 35001:2019 standard, ISO 19011 auditing principles, and documented information requirements through immersive, hands-on learning. The course includes practical exercises such as audit planning, conducting opening and closing meetings, gathering objective evidence, and grading nonconformities. Using official audit checklists and real-world case studies, learners simulate full audit cycles within a structured classroom environment, applying clause-wise audit techniques to assess biorisk management system (BRMS) conformity. These role-playing scenarios and interactive assessments mirror actual third-party audits, enabling students to build, evaluate, and improve BRMS frameworks in alignment with international best practices.

This Koenig Original course prepares candidates for formal recognition as ISO 35001 Lead Auditors, a credential increasingly required by research institutions, public health labs, and biocontainment facilities globally. Certified professionals report career advancement opportunities, with lead auditor roles commanding competitive salaries in the range of $85,000 to $110,000 annually in North America and Europe. Koenig’s Guaranteed-to-Run scheduling and official courseware ensure consistent access to high-quality training, empowering participants to lead audits, strengthen institutional biosafety compliance, and contribute to globally recognized biorisk management frameworks. Graduates are positioned to drive certification readiness and operational excellence in laboratories committed to performance-based safety standards.

What You'll Learn

Construct a documented biorisk management framework compliant with ISO 35001: Biorisk Management for Laboratories and Other Related Organisations by Koenig Original.
Generate a comprehensive biological hazard registry identifying specific risk sources and contamination vectors within the laboratory environment.
Execute quantitative risk assessment methodologies to produce a prioritized biohazard mitigation report as per ISO 35001 standards.
Draft a formal Biorisk Management Plan incorporating specific control strategies and containment protocols defined by Koenig Original guidelines.
Define documented roles, authorities, and responsibilities for personnel to ensure accountability within the biorisk management system.
Produce a standardized internal audit report and performance monitoring dashboard to verify ongoing compliance with ISO 35001 requirements.

Prerequisites

Recommended knowledge before taking this course
  • Basic knowledge of laboratory biosafety and biosecurity principles essential for ISO 35001: Biorisk Management for Laboratories and Other Related Organisations training
  • Familiarity with ISO management system standards such as ISO 9001 and ISO 14001 enhances understanding of ISO 35001:2019 requirements
  • Working knowledge of ISO 35001:2019 clauses and structure is recommended for effective learning
  • Understanding of biorisk management processes, including risk assessment and control measures, is crucial for ISO 35001 compliance
  • Basic knowledge of auditing principles based on ISO 19011:2018 supports ISO 35001: Biorisk Management certification
  • Experience in laboratory or related organizational operations involving biological agents helps in applying ISO 35001 standards effectively
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Certification Exam

Everything you need to know about the ISO 35001: Biorisk Assessment & Management System certification exam

Exam Details
Exam Name
Format
Multiple choice, labs & case studies
Questions
Duration
Passing Score
Validity
Retake Policy
As this is a Koenig Original Certificate of Attendance, no formal examination retake policy applies.
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ISO 35001: Biorisk Assessment & Management System

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Course Curriculum

Structured learning with hands-on labs and real-world scenarios

1
Day 1– Mastering ISO 35001 Biorisk Management
ISO 35001 Standard Core Overview Scope and Global Applicability Standards Essential Biorisk Definitions and Terms Biosafety and Biosecurity Framework Concepts Integrated Biorisk Management Systems Design Strategic Risk-Based Approach Implementation Regulatory Compliance and Safety Context Laboratory Incident Analysis Case Studies
2
Day 2– ISO 35001 Documentation and Compliance
Clause 4: Organizational Context Analysis Clause 5: Leadership and Accountability Clause 6: Biorisk Management Planning Advanced Risk Assessment Methodology Models Effective Risk Treatment Strategy Development Documented Information Control Standards Professional Biorisk Manual Creation Rigorous Record Keeping and Control
3
Day 3– Implementing ISO 35001 Biorisk Controls
Biological Hazard Classification Systems Containment Level Requirement Standards PPE and Safety Equipment Protocols Safe Biological Agent Handling Techniques Standardized Laboratory Decontamination Procedures Biological Material Inventory Management Secure Storage and Transfer Protocols Optimized Waste Management Best Practices
4
Day 4– Audit and Compliance Koenig Training
Internal Audit Process Framework Overview Strategic Audit Planning and Preparation ISO 19011 Audit Principle Application Systematic Document Review Procedures Professional On-Site Audit Execution Defined Audit Roles and Responsibilities Nonconformity Identification and Tracking Corrective Action Management Systems
5
Day 5– Incident Response and Improvement Cycles
Standardized Incident Reporting Procedures Exposure Investigation and Analysis Protocols Emergency Response Planning Strategies Competency-Based Training Program Design Effective Management Review Meetings Performance Evaluation Metric Analysis Continuous Improvement Workflow Strategies Practical Audit Simulation Case Studies

What's Included in Your Training

Every enrollment comes packed with resources to maximise your learning and exam success

Career Outcomes

78%

of ISO 35001: Biorisk Assessment & Management System certified professionals report career advancement within 6 months

Salary Impact

+22%

Average salary increase reported after obtaining the ISO 35001: Biorisk Assessment & Management System certification

Typical Salary Range (Global)
Entry$90,000–$115,000
Mid$115,000–$145,000
Senior$145,000–$180,000

*Source: Glassdoor / LinkedIn 2025

Job Roles

6
  • Certified Biosafety Officer
  • Biorisk Manager
  • Laboratory Safety Director
  • Biosafety Compliance Specialist
  • Biorisk Management Consultant
  • Quality and Safety Manager (Biosafety)

Companies Hiring

5,000+
CDC NIH Pfizer Merck Johnson & Johnson Thermo Fisher Scientific Quest Diagnostics Battelle Deloitte SGS

and 5,000+ organizations worldwide seeking ISO 35001: Biorisk Assessment & Management System certified professionals

Real Transformations

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Real results from IT professionals who trained with Koenig — rated 4.9/5 from 18,400+ verified reviews.

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    “Passed AZ-104 on first attempt. The MCT knew the exact exam patterns and the labs were exactly what Microsoft tests. Worth every penny.”

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    Azure Administrator

    AZ-104 Certified ✓ Verified
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    “The 1-on-1 format was a game changer. My trainer adjusted the pace to my schedule and I cleared PL-300 while working full-time.”

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    “SC-900 and SC-300 back to back — both cleared first try. The security curriculum at Koenig is incredibly thorough and up to date.”

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    SC-300 Certified ✓ Verified
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    “Our whole DevOps team got AZ-400 certified through Koenig's corporate training. Smooth logistics and top-tier MCTs throughout.”

    Carlos R.

    Carlos R.

    Engineering Manager

    AZ-400 Team Training ✓ Verified
  • ★★★★★

    “Passed AZ-104 on first attempt. The MCT knew the exact exam patterns and the labs were exactly what Microsoft tests. Worth every penny.”

    Rahul M.

    Rahul M.

    Azure Administrator

    AZ-104 Certified ✓ Verified
  • ★★★★★

    “I trained 15 of my team members for SC-200. Koenig's on-site delivery was seamless and all 15 passed within 3 months.”

    Sarah K.

    Sarah K.

    CISO, Financial Services

    Enterprise Client ✓ Verified
  • ★★★★★

    “The 1-on-1 format was a game changer. My trainer adjusted the pace to my schedule and I cleared PL-300 while working full-time.”

    Ahmed R.

    Ahmed R.

    Business Intelligence Lead

    PL-300 Certified ✓ Verified
  • ★★★★★

    “Passed AZ-104 on first attempt. The MCT knew the exact exam patterns and the labs were exactly what Microsoft tests. Worth every penny.”

    Rahul M.

    Rahul M.

    Azure Administrator

    AZ-104 Certified ✓ Verified
  • ★★★★★

    “I trained 15 of my team members for SC-200. Koenig's on-site delivery was seamless and all 15 passed within 3 months.”

    Sarah K.

    Sarah K.

    CISO, Financial Services

    Enterprise Client ✓ Verified
  • ★★★★★

    “The 1-on-1 format was a game changer. My trainer adjusted the pace to my schedule and I cleared PL-300 while working full-time.”

    Ahmed R.

    Ahmed R.

    Business Intelligence Lead

    PL-300 Certified ✓ Verified
  • ★★★★★

    “From AZ-900 to AZ-305 in 6 months. Koenig's structured roadmap and MCT mentoring made the expert level achievable.”

    Priya S.

    Priya S.

    Cloud Solutions Architect

    AZ-305 Expert ✓ Verified
  • ★★★★★

    “As an L&D head I've used 5 training vendors. Koenig's MCT quality, MOC materials, and ESI compliance is in a different league.”

    James T.

    James T.

    Head of L&D, UK Enterprise

    100+ Learners Trained ✓ Verified
  • ★★★★★

    “SC-900 and SC-300 back to back — both cleared first try. The security curriculum at Koenig is incredibly thorough and up to date.”

    Aisha N.

    Aisha N.

    Security Analyst

    SC-300 Certified ✓ Verified
  • ★★★★★

    “From AZ-900 to AZ-305 in 6 months. Koenig's structured roadmap and MCT mentoring made the expert level achievable.”

    Priya S.

    Priya S.

    Cloud Solutions Architect

    AZ-305 Expert ✓ Verified
  • ★★★★★

    “As an L&D head I've used 5 training vendors. Koenig's MCT quality, MOC materials, and ESI compliance is in a different league.”

    James T.

    James T.

    Head of L&D, UK Enterprise

    100+ Learners Trained ✓ Verified
  • ★★★★★

    “SC-900 and SC-300 back to back — both cleared first try. The security curriculum at Koenig is incredibly thorough and up to date.”

    Aisha N.

    Aisha N.

    Security Analyst

    SC-300 Certified ✓ Verified
  • ★★★★★

    “AI-102 was daunting but the trainer broke it down perfectly. Real Azure OpenAI labs made the difference. Highly recommend.”

    David L.

    David L.

    AI Engineer

    AI-102 Certified ✓ Verified
  • ★★★★★

    “DP-600 Fabric certification done in 3 weeks of part-time study. The customised schedule around my timezone was a lifesaver.”

    Mei W.

    Mei W.

    Data Platform Engineer

    DP-600 Certified ✓ Verified
  • ★★★★★

    “Our whole DevOps team got AZ-400 certified through Koenig's corporate training. Smooth logistics and top-tier MCTs throughout.”

    Carlos R.

    Carlos R.

    Engineering Manager

    AZ-400 Team Training ✓ Verified
  • ★★★★★

    “AI-102 was daunting but the trainer broke it down perfectly. Real Azure OpenAI labs made the difference. Highly recommend.”

    David L.

    David L.

    AI Engineer

    AI-102 Certified ✓ Verified
  • ★★★★★

    “DP-600 Fabric certification done in 3 weeks of part-time study. The customised schedule around my timezone was a lifesaver.”

    Mei W.

    Mei W.

    Data Platform Engineer

    DP-600 Certified ✓ Verified
  • ★★★★★

    “Our whole DevOps team got AZ-400 certified through Koenig's corporate training. Smooth logistics and top-tier MCTs throughout.”

    Carlos R.

    Carlos R.

    Engineering Manager

    AZ-400 Team Training ✓ Verified

Frequently Asked Questions

Everything you need to know about the ISO 35001: Biorisk Assessment & Management System training course

Is the ISO 35001 certification exam included in the course fee, and what is the exam cost if separate?
The ISO 35001: Biorisk Management for Laboratories and Other Related Organisations exam is not included in the Koenig Original course fee. You must purchase it separately for $249 via the ACI portal. Koenig provides training aligned with the ACI-approved syllabus, but ACI administers the exam independently.
What training formats does Koenig offer for ISO 35001, and is Guaranteed-to-Run scheduling available?
Koenig offers ISO 35001: Biorisk Management for Laboratories and Other Related Organisations training in live online, 1-on-1, and classroom formats. All are Guaranteed-to-Run (GTR). This ensures your training proceeds on schedule regardless of enrollment, providing reliable planning for your professional development in biorisk management.
How long is lab access provided, and what type of lab environment is used for ISO 35001 training?
Lab access is not applicable for ISO 35001: Biorisk Management for Laboratories and Other Related Organisations. This course is theoretical, focusing on management systems, auditing, and compliance. You will master documentation, risk assessment, and audit processes through interactive exercises within a professional virtual classroom environment.
What is Koenig's rescheduling and cancellation policy for ISO 35001 training?
Koenig allows free rescheduling of ISO 35001: Biorisk Management for Laboratories and Other Related Organisations if requested 10 days before the start. Changes within 10 days incur a 50% fee. You may reschedule once per session, ensuring administrative clarity for your certification journey.
What is the format, number of questions, passing score, and time limit for the ISO 35001 certification exam?
The ISO 35001: Biorisk Management for Laboratories and Other Related Organisations Lead Auditor exam requires a 65% score, while Foundation levels require 70%. These closed-book, multiple-choice exams assess your grasp of ISO 35001:2019 principles and audit practices through ACI-approved providers.
How long is the ISO 35001 certification valid, and what is the renewal process and cost?
Your ISO 35001: Biorisk Management for Laboratories and Other Related Organisations certification is valid for 3 years. Renewal requires a recertification audit by an accredited body like ACI. Total costs for the cycle, including surveillance audits, typically range from $3,000 to $7,000.
What post-training support does Koenig provide after completing the ISO 35001 course?
Koenig offers 30 days of post-training instructor email support, session recordings, and exam prep for ISO 35001: Biorisk Management for Laboratories and Other Related Organisations. You also receive our Happiness Guarantee, which allows a free course retake if you are not fully satisfied.
What are the prerequisites or experience needed for the ISO 35001 training course?
There are no formal prerequisites for ISO 35001: Biorisk Management for Laboratories and Other Related Organisations. However, a basic understanding of laboratory biosafety, biosecurity, and ISO management systems is recommended. This course is ideal for professionals aiming to implement or audit robust biorisk management systems.
What is the average salary for professionals with ISO 35001 certification in biorisk management?
Professionals with ISO 35001: Biorisk Management for Laboratories and Other Related Organisations certification earn an average of $87,258. Those with additional credentials like CBSP or RBP earn $10,000–$20,000 more annually. Professionals with 20+ years of experience earn $50,000 more than entry-level peers.
How does formal training for ISO 35001 compare with self-study in terms of certification success?
Formal training for ISO 35001: Biorisk Management for Laboratories and Other Related Organisations yields an 84% first-attempt pass rate, compared to 64% for self-study. Koenig’s structured curriculum and expert-led interactive exercises significantly enhance your comprehension, audit readiness, and overall certification success.
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