Auditor/Lead Auditor Training Course on Medical Devices

Auditor/Lead Auditor Training Course on Medical Devices

Quality Management System based on ISO 13485:2016 (CQI IRCA)

Quality Management System based on ISO 13485:2016 (CQI IRCA)

Training duration: 5 Days

Course Overview 

This comprehensive Lead Auditor training course is designed to equip participants with essential knowledge and skills to effectively audit Medical Device Quality Management Systems (MD-QMS) in compliance with ISO 13485:2016 and applicable regulatory requirements. Understand the purpose and benefits of MD-QMS, how it aligns with medical device regulatory authorities, quality management system standards, third-party certification, and its value to business sustainability. 

Participants will learn the roles and responsibilities of an auditor and gain practical expertise in planning, conducting, reporting, and following up MD-QMS audits according to ISO 19011 and ISO/IEC 17021. The course fulfills industry expectations for first, second, and third-party audits and enhances organizational success through consistent quality and regulatory compliance. 

What Will You Learn? 

  • Understand the goals and benefits of a medical device quality management system (MD-QMS) and regulatory requirements.
  • Master auditing principles and techniques to plan, execute, report, and follow up on audits of MD-QMS.
  • Gain proficiency to conduct audits conforming with ISO 13485 and medical device regulatory requirements, aligned with ISO 19011 and ISO/IEC 17021. 
  • Develop competence to contribute to continual improvement and regulatory compliance of medical device organizations. 
  • Course outline
    • MD-QMS Introduction and Process Approach
      • Purpose and benefits of MD-QMS-Requirements for Regulatory Purposes including understanding of the basic MD-QMS principles
      • Terms, Fundamentals and Principles
      • Process Approach with PDCA
      • Mandatory documents for regulatory purposes
      • Difference between compliance and conformance
      • Relationship between IMDRF and GHTF
      • Principles of IMDRF
      • MDR European Union Regulations
      • MD-QMS Requirements (Clause 1 to 8)
    • Auditing Principle
      • Auditing objectives
      • Types of audits
      • Audit life cycle
      • Terms and Definition
      • Principle of Auditing
      • Annex A – Guidance of Auditors
    • Role and Responsibilities of Auditor
      • Audit Programme objectives
      • The auditees' responsibilities
      • The lead auditors’ responsibilities
      • Auditors’ qualification and certifications
    • Role Planning an Audit
      • Pre-Audit planning
      • Reviewing documentation
      • Developing an audit plan
      • Preparing checklists or working documents
      • Communication factors
    • Conducting an Audit
      • Opening meeting
      • Collecting objective/audit evidence
      • Effective interviewing techniques
      • Identifying and recording nonconformities
      • Preparing for the closing meeting
    • Reporting Audit Results
      • Conducting the closing meeting
      • Preparing the audit report
      • Distributing the audit report
    • Corrective Actions
      • Corrective action responsibilities
      • Follow up scheduling
      • Monitoring corrective action
    • ISO 13485: 2016 Registration
      • The registration processes
      • Surveillance audits
    • Exercises/ Role play (50 % of course Time)
    • Written Examination

Who Should Attend? 

  • Medical device quality testing professionals conducting first, second, or third-party audits 
  • Management representatives 
  • Quality directors, managers, and engineers 
  • Consultants 
  • Internal auditors with prior understanding of ISO 13485 and QMS implementation in medical device businesses 

Pre-requisites:

  • Knowledge of MD-QMS and related terms and definitions
  • Familiarity with ISO 9000, IEC 62304, PD ISO/TR 80002-2:2017, IEC/ISO 60601, ISO 14937, ISO 14644, ISO 14698-1 
  • Understanding of key frameworks: GHTF, IMDRF, MDSAP
  • Prior experience in medical device QMS or auditing recommended

Learning & Career Benefits 

  • Describe the purpose and value of a medical device quality management system and related regulations
  • Understand auditor responsibilities in all audit phases per ISO 13485 and ISO 19011
  • Demonstrate ability to conduct and lead audits of medical device QMS effectively
  • Gain internationally recognized certification enhancing career prospects globally
  • Support organizational compliance and continual improvement

Examination & Certification 

To successfully complete this course, each participant must: 

  • Attend and complete all course elements
  • Pass continuous assessments, including participation, role-plays, presentations, and daily tests
  • Pass a written examination at the end of the course

Evaluation Parameters: 

  • Continuous Assessment: punctuality, presentation skills, engagement, role-play, tests
  • Written Examination: Closed book (unmarked copy of ISO 13485 allowed) with 4 sections totaling 90 marks
  • Passing Criteria: Minimum 70% overall (63/90 marks) and at least 50% in each exam section

Certification:

  • Participants who meet the passing criteria in both continuous assessment and written examination will be awarded the CQI IRCA Registered Lead Auditor Certificate by TÜV SÜD South Asia, an approved CQI IRCA Training Partner. This certificate is globally recognized and demonstrates proficiency in auditing medical device quality management systems per ISO 13485:2016.
  • Participants not meeting the pass criteria will receive a certificate of attendance from TÜV SÜD South Asia. 

Get in touch with us to know more.

Business address 

TÜV SÜD Bangladesh (Pvt.) Ltd.

Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh

Tel: +88 02 58954115, 58954120, Ext-119

Email: [email protected] 

 

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