ISO 35001:2019 Lead Auditor Training

PAS311   Type: E-Learning

This online ISO 35001 Lead Auditor Training is specifically designed to enhance your knowledge and skills to become a certified ISO 35001 Lead Auditor for Biorisk management system of laboratories and related organizations. This course will provide you in-depth knowledge of how to conduct and lead ISO 35001 audits as a third-party auditor.

ISO 35001:2019 Lead Auditor Training


This Online ISO 35001 Lead Auditor Training Course is designed to provide you high-level training and certification to become a certified lead auditor. On successful completion of this course, you will get ISO 35001 Lead Auditor Certificate with the logo of Exemplar Global (formerly RABQSA) – a world leader in training and certification programs.

In this online lead auditor training, you will learn everything you need to know in order to conduct and lead audits of ISO 35001 biorisk management systems on behalf of any company or certification body. This online ISO 35001 Lead Auditor Training course provides complete knowledge of ISO 35001:2019 standard and the requirements for a biorisk management system. It will also equip you with the knowledge and skills of auditing process, audit techniques, nonconformity reporting as well as your roles and responsibilities as a lead auditor for biorisk management system audits.  The training course comprises audio-visual presentations, handouts, ISO 35001 audit checklist, real-life case study of an ISO 35001 system manual and online exams, which will be quite beneficial for all those who want to qualify as certified Lead Auditor for ISO 35001 audit of laboratories and related organizations that works with, stores, transports, and/or disposes of hazardous biological materials, in any part of the world. The online training course is beneficial especially for those who prefer to learn auditing process and techniques from the comfort of their home or office at their own convenient time and get certified as lead auditor. After completion of this training course successfully, the participants will be awarded ISO 35001 Lead Auditor certificate as a trained lead auditor.

Topics Covered: ISO 35001 Lead Auditor Online Course

Punyam Academy’s online ISO 35001 lead auditor training course comprises following eight sessions:

  • Session - 1: Overview of Biorisk Management System Standard
  • Session - 2: ISO 35001 Requirements (Clause and sub-clause wise)
  • Session - 3: ISO 35001 Documented Information
  • Session - 4: Risk Management (includes risk assessment and risk treatment)
  • Session - 5: Audit Process
  • Session - 6: Audit Terms & Definitions and Roles & Responsibilities
  • Session - 7: Performing an Audit
  • Session - 8: Nonconformity Reporting and Corrective Action
  • Session - 9: Climate Action Changes - New Amendments (2024)

Each of the above sessions consists of audio-visual presentations, handouts, and session exams. In Session 7, a practical example of a real-life management system manual is given for performing document review and understanding adequacy audit findings. Such real-life case studies of a system manual will help participants to gain better knowledge and skill of auditing.

Overall, the contents of this online course include the following:

  1. Lectures: In this module, the user gets an audio-visual presentation explaining each of the above-mentioned topics to understand the subject well.
  2. Handouts: For all the above 8 sessions, the handouts are given in total approx. 200 pages in PDF format. The participant of this lead auditor course can download and save the handouts in their computer for future reference. Also, they can print or read the contents offline to get detailed knowledge of all the topics.
  3. Videos: Actual video of performing an actual audit with real and practical examples of audit questions and answers. Participants can watch and learn how to perform and lead the audit of an organization and manage the opening and closing meetings with the management and personnel of the organization.
  4. Exam: Each session of this course contains an online session exam. Participants have to pass the exam after the completion of each session. After passing the final exam, the auto-generated ISO35001 lead auditor certificate can be downloaded and printed by the participants. This certificate can be verified by anyone anytime from this website.
  5. Audit Checklists: ISO 35001 clause-wise audit checklist having more than 300 audit questions are given in handouts, which can be used as a readymade audit tool. Participants can download and use the checklists for future reference during the audit of a biorisk management system.


After completion of this Online ISO 35001 Lead Auditor Training course, the users will be able to:

  • Familiarize with standard for biorisk management system, including its benefits;
  • Know, in detail, the ISO 35001 requirements for biorisk management system;
  • Understand biorisk management system documentation structure and documented information required by ISO 35001;
  • Know about the types of auditing and questioning techniques;
  • Understand how to perform and/or lead certification audits with the use of audit checklist;
  • Understand the concepts of risk management, risk evaluation and treatment;
  • Get confidence to conduct opening and closing meetings during any audit;
  • Know about the types of nonconformities and how to close them;
  • Enable yourself to lead an audit team for ISO 35001 certification audits;
  • Get readymade ISO 35001 clause wise audit checklist to perform an effective audit;
  • Understand details of the opening meeting as well as closing meeting and auditing techniques to perform a certification audit as a certified ISO 35001 lead auditor.


  • Individuals, including working professionals and students, who want to become an ISO 35001 Lead Auditor having globally-recognized certificate with Exemplar Global logo.
  • Individuals involved in the implementation and/or audit of biorisk management system in a laboratory or related organization.
  • Individuals who want to have complete knowledge of ISO35001 standard for implementing biorisk management system with effective controls in any organization.
  • Other people who have found this course useful and who want to enhance their auditing knowledge and skills, and those looking to achieve formal recognition as a trained & certified ISO 35001 lead auditor.


Ability to understand information and instructions in English language is a must for participants. Following will be advantageous, though not pre-requisites:

  • Interest in assessment/audit work
  • Interest in biosafety and biosecurity issues.
  • Having read ISO35001 standard


For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.


This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.


All paid E-learning course includes the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student, if failed in any exam.


After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.

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What Our Customer Says...

Blaizon C Mathai
Abu Dhabi, UAE

I would like to extend my sincere gratitude in introducing this program. Course material and presentations very valuable indeed and informative too. Even presentations made in simple language

Maria Garcia
California, USA

Great e-learning course by Punyam Academy, easy to use and learning can be done at your own pace. Material and content provided is exceptional. I would definitely recommend to anyone

Paul Thompson
South Africa

My first online course experience and it was pleasant to attend PAS102. I found the course to be very thorough and covered all aspects that are needed to carry out auditing.

Mary Smith
Dubai, UAE

The course has good information for new auditors or anyone that wants to be an internal auditor for understanding the standard. The content was very relevant, and the process of assessment required me to really understand the coursework

Nancy Lewis
South Africa

I was very happy to be able to complete the course online. I enjoyed being able to complete the course at my own pace. The support from Punyam Academy team has been great. Thanks!

Edward Anderson
California, USA

A valuable online opportunity to further skills and knowledge. Enrol for ISO/IEC 17025 auditor course, and fills best certified course in minimum cost

John Davis
Abu Dhabi, UAE

Excellent training at Punyam Academy, friendly atmosphere and lovely staff, highly recommended. Voice enable presentation gives me filling like live training, which saves my time.

Jennifer Nelson

Best place to go for ISO/IEC 17025:2017 Internal Auditor training. I have attended classroom training and found them extremely beneficial and enjoyable. Trainers are very understanding and knowledgeable.

Daniel Johnson
Washington, USA

I appeared for ISO 45001 auditor training course. Highlight of this course is good audio visual presentation, study material to download as well as exams to review my knowledge.

Charles Wilson
Abu Dhabi, UAE

Congratulations to Punyam Academy team for providing best knowledge sharing platform online. Achieved ISO 9001 internal auditor certificate, looking forward to enrol next auditor course very soon.

Karen Smith
California, USA

The course more economical compared to classroom training and flexible timings make it more recommendable. Looking forward for more complex courses like PMP, IRCA certified courses etc.

Ajit Patel
Altrafine Gums

I am highly satisfied with your course on food safety management system. Now I am fully aware about FoSTaC requirements and appreciate efforsts of Punyam Academy throughout the training session.

Dr. Bharat Agrawal
Analytical Development Laboratory Torrent Research Center

The training materials given by Punyam Academy experts proved to be very useful in managing our own requirements. We appreciate trainer's knowledge and efforts in delivering good sessions. All the best for upcoming training programs.

Alpesh Patel
Meghmani Industries Limited

I am happy with the certified ISO/IEC 17025:2017 auditor training course at Punyam Academy. Now I am fully aware about ISO/IEC 17025:2017 transition auditing and quality management requirements for testing laboratory.

Shreeyansh Kumar

Thank you Punyam Academy for providing me world class learning at affordable cost. Trainer has very good knowledge about subject. Training environment & facility at training center is exceptional.

Dattatray Sawarbandhe
CEO, Bombaywalla Foods

A great step has been taken by organizing Food Safety Training and Certification (FoSTaC). This knowledge sharing will only bring all the business motive together of common standard, quality and good healthy surrounding. My India is growing - Keep it up Punyam Academy.

Subhashchandra Pathak
Terapanth Foods Limited

Attending FoSTaC training course for food safety management system is awasome experience. Now I am fully aware about food and quality management requirements in food manufacturing organization.

Sachin Patel
Mazda Limited

Attending classroom training at Punyam Academy was a wonderful experience. I got the opportunity to learn FSSAI requirements as FoSTaC training from experienced instructors.

Sajan Peter
Saudi Arabia

I have purchased and successfully completed ISO 9001:2015 certified internal auditor training course. It is Very professional and helpful training program customised to achieve maximum customer satisfaction.

John Watson
United Kingdom

Training material was of a high standard. Exams were very goo and made you think.

Billy Croker
United States of America

Very good and through course. Make you really think about somethings and the way you perform an audit.

Irron R Collins
United States of America

Course is very informative, easily understood and provides good understanding of requirements as needed. However could not print my certificate.

Bibi Ruwaydah Soreefan

I loved the course. Just what I needed for my calibration journey. Looking forward to taking more courses at Punyam Academy.

Jose Cabrera
United States of America

The material provided during the course was adequate to provide the required knowledge of ISO 13485:2016 in preparation for each session exam and final exam. Very happy with the course, will recommend it to other colleagues.

Dr. A. K. Gupta

Nicely prepared learning programme , helpful to prepare Quality Manual and accreditation for laboratory.

Trinidad and Tobago

The course was very comprehensive and practical! An indispensable training resource for prospective ISO 45001 lead auditors.

UK Lee
South Korea

It was very helpful to get ISO 14001 auditor qualification, thanks a lot.


Well defined Training Program... Thanks...!!!

Johan Pretorius
South Africa

The course was very comprehensive and practical! every thing is well explained.

Maud Van Looy

The content of the training was very useful to the team, and all of our team members have completed the training successfully.

Shiv Prakash Bhutra

There was a good pace and tone to the training in online E- learning course, which kept it interesting throughout.

Rohit Prajapati

The design of the course, including clarity of presentation, quality of video and audio, session exam are excellent.

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