Quality Management & Quality Control for Medical Devices

LEAD AUDITOR TRAINING PROGRAM ON MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM - REQUIREMENTS FOR REGULATORY PURPOSES

Based on ISO 13485: 2016

Discover the changes in ISO 13485:2016 and boost your audit capabilities

ABOUT THE COURSE

This QMS lead auditor training course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

The success of an organisation, the penetration of its products and services in the market, efficient internal procedures, and a healthy economic status depends essentially on how MD-QMS requirements and requirements for regulatory purposes are consistently ensured, maintained, and improved. The ISO 13485 Lead Auditor training program fulfils these requirements.  

WHAT WILL YOU LEARN FROM THE COURSE?

The calibre of an auditor is crucial to the performance of companies and ultimately to the success of the management system. This comprehensive ISO 13485 Lead Auditor course provides hands-on training to ensure that the auditor thoroughly understands the role of an auditor and acquires the expertise needed or required to perform the audit effectively.

At the end of this course, participants will be able to attain:

Knowledge

  • Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality  management system.
  • Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.

Skills

  • Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and  applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

This intensive ISO 13485 Lead Auditor course is a key requirement in becoming a registered Lead Auditor. The ISO 13485:2016 Lead Auditor training is a participative training course, which uses case studies, role-plays, exercises, workshops, and group discussions.

The ISO 13485 Lead Auditor course is structured to provide an in-depth understanding of MD-QMS Requirements for regulatory purposes (ISO 13495: 2016) knowledge and skills required to assess the MD-QMS of an organisation.

Topics to be covered in this course include:

1) 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)

2) Auditing Principle 

  • Auditing objectives
  • Types of audits
  • Audit life cycle
  • Terms and Definition
  • Principle of Auditing
  • Annex A – Guidance of Auditors

3) Role and Responsibilities of Auditor 

  • Audit Programme objectives
  • The auditees responsibilities
  • The lead auditors’ responsibilities
  • Auditors qualification and certifications

4) Role Planning an Audit 

  • Pre-Audit planning
  • Reviewing documentation
  • Developing an audit plan
  • Preparing checklists or working documents
  • Communication factors

5) Conducting an Audit 

  • Opening meeting
  • Collecting objective/audit evidence 
  • Effective interviewing techniques
  • Identifying and recording nonconformities
  • Preparing for the closing meeting 

6) Reporting Audit Results 

  • Conducting the closing meeting 
  • Preparing the audit report
  • Distributing the audit report 

7) Corrective Actions 

  • Corrective action responsibilities
  • Follow up scheduling
  • Monitoring corrective action 

8) ISO 13485: 2016 Registration 

  • The registration processes
  • Surveillance audits 

WHAT IS THE COURSE METHODOLOGY?

Participants will learn through lectures, case studies, group exercises and discussions. There will be a written examination at the end of the course.

WHO SHOULD TAKE THE COURSE?

This course is specially designed for:

  • Medical device quality testing professionals interested in conducting first-party, second-party, and third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

Pre-requisites:

As the ISO 13485 Lead Auditor training covers auditing concepts utilising ISO 13485, a prior understanding of ISO 13485 and its implementation within a Medical Device business and internal audit experience is recommended.

WHO IS THE COURSE ADVISOR?

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

 

  • What are the benefits of enrolling in this course?
    • World-class training – by learning from TÜV SÜD’s industry experts and training specialists

    • Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used

    • Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training

    • Gain a competitive edge – by getting trained by experts known in the fields of safety, security and sustainability

 

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