CQI and IRCA Certified ISO 13485:2016 Lead Auditor Training

Level Lead auditor Duration 5 days

Available to book: Virtual classroom Contact us for booking

Upcoming schedule

Live online schedule
12-16 January 2026
9-13 March 2026

Public classroom schedule
23-27 February 2026 (Kuala Lumpur)
13-17 April 2026 (Kuala Lumpur)

Can’t find the right courses or dates? Get our full schedule and training guide, or talk to our training advisor for assistance.

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IRCA course reference number: A18190

Develop the expertise and confidence to lead Medical Device quality management system audits with this CQI & IRCA Certified ISO 13485:2016 Lead Auditor Training Course. The programme builds the knowledge and practical skills needed to plan, conduct, and report audits that support continual improvement.

Guided by experienced BSI tutors, you’ll apply ISO 13485:2016, and best-practice auditing methods in a structured, practical environment that builds confidence in delivering first, second, and third-party audits.

Earn a BSI Auditor Qualification

This course forms part of the BSI Auditor Qualification pathway. On successful completion of the online exam, you’ll achieve a BSI Qualification, recognised with the BSI Mark of Trust, an international symbol of auditing competence that you can showcase across your CV, digital profiles, and workplace communications.

Why learners choose BSI

A clear qualification pathway: With BSI, your training supports progression toward an internationally recognised professional credential.
A proven learning experience: Activity-based, scenario-driven teaching helps you turn knowledge into practical auditing performance.

- Identify the aims and benefits of an ISO 13485:2016 audit
- Plan, conduct and follow up on auditing activities
- Build stakeholder confidence by understanding the latest requirements
- 4 hours of on-demand eLearning on ISO 13485 requirements - flexible, self-paced, and accessible anytime. Start as soon as you receive your login details, before, during, or after the live training.
- 5 days of live virtual training or instructor-led sessions focused on audit preparation, execution, and evaluation.
- Online examination - assess your learning and eligibility for the BSI Mark of Trust.
- Successful participants receive the BSI Mark of Trust, a symbol of globally recognized achievement that demonstrates your competence, integrity, and commitment to quality.
- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Consultants
Before attending this course, delegates are expected to have:
- Knowledge of the following quality management principles and concepts:
  
  The Plan, Do, Check, Act (PDCA) cycle
  
  The relationship between quality management and customer satisfaction
  
  Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
  
  The process approach used in quality management
  
  The Model of a Process Based Quality Management System, the structure and content of ISO 13485
- Knowledge of the requirements of ISO 13485
It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits.
On completion, you’ll be awarded a CQI and IRCA Certified course certificate.
This training is fully claimable under HRD Corp claimable course, eligible under the HRD Corp claimable programme in Malaysia. Once your booking is confirmed, our team will provide the required documents and guidance to support your company’s grant application.

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CQI and IRCA Certified ISO 13485:2016 Lead Auditor Training

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