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
16-20 December 2024
13-14 January 2025
24-28 February 2025

Public classroom schedule
17-21 February 2025 (Kuala Lumpur)

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From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit.

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification.

BSI's CQI and IRCA ISO 13485 Medical Devices QMS Lead Auditor: Practitioner Package

This package is a structured learning pathway that combine carefully selected courses with rigorous assessments that guarantee their relevance. In this practitioner package, it includes:

4 hours on-demand eLearning ISO 13485 requirements training course (available 24/7, complete flexibility and time-efficient) and;
5-days CQI and IRCA ISO 13485 Medical Devices QMS lead auditor training course (virtual instructor led training)

Assessment
Each course is followed by a mandatory online multiple-choice examination. Delegates must pass the examination to be awarded the qualification - BSI Mark of Trust.

Why practitioner package?

This qualification focuses on building a strong understanding of the fundamentals of the subject, enabling you to increase your performance and effectiveness within your role to the standard expected.
Unlimited access to ISO 13485 Medical Devices QMS requirements on-demand eLearning training course prior the lead auditor training course for better understanding.
Opportunity to level up your achievements to professional level and the highest level of qualification, certified professional.
Showcasing your expertise with BSI’s Mark of Trust on business cards, social media and official documents.
Fully claimable under HRD Corp claimable course.

How will I benefit?

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

On completion of this training, participants will be able to:
- Interpret the requirements of ISO 13485:2016 in the context of an audit
- Describe the purpose of a quality management system and explain the 8 principles of quality management
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
- Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485:2016
- Manage the duties of a lead auditor in their organization or for a third-party
- 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.
Successful completion of this IRCA certified training course by passing the relevant IRCA examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit.
This training course is HRD Corp claimable programme.
You will sit a 2 hour exam to test your knowledge and understanding. Detailed course notes and lunch provided. IRCA course reference number: A18190.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

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