⚠️  UPDATE NOTICE ON NEW UPDATE OF THIS GUIDANCE STANDARD:

Important: This course was developed under the previous international guidance standard ISO 19011:2018. As of 27 May, 2026, the ISO withdrew ISO 19011:2018 and published ISO 19011:2026 

What changed: 

• Remote and hybrid auditing are now fully embedded.  
• The risk-based approach is stronger.  
• Technology and information security receive greater attention.  
• Auditor competence expectations have expanded.  
• Audit programme and reporting guidance has been clarified. 

What this means for you right now:  ISO 19011 remains a guidance standard, not a certifiable requirements standard, so there is no formal transition period.

Please note: this course is scheduled for update to align with ISO 19011:2026 in the near future. Additional information will be provided soon.

Introduction to this course: 

This course covers chapters 3 and 4 of ISO 19011:2018, exploring fundamental concepts and principles of auditing. Delve into performing a risk-based audit, including audit planning, audit realization, and reporting, to ensure effective audits.

Who should attend: 

This course is tailored for professionals in life sciences, including quality managers, auditors, compliance officers, etc. It also benefits individuals seeking to improve their understanding of ISO 19011:2018 guidelines and risk-based auditing techniques.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify key concepts and definitions related to ISO 19011:2018 and risk-based auditing.

• Explain the 7 principles of auditing as per ISO 19011:2018.

What will I gain: 

Participants will gain a deep understanding of ISO 19011:2018 audit guidelines and practical skills to conduct a risk-based audit effectively, ensuring organizational compliance and continuous improvement.

Prerequisites: 

Participants should have a foundational knowledge of quality management systems, familiarity with ISO standards, and basic experience in auditing or compliance roles within the life sciences industry.

Additional information: 

Course duration: 00:19:08

Course code/version (effective date): L-62_A/v1.0 (06/02/2024)