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Overview

The ISO 13485:2016 Lead Auditor course is a specialized training program tailored for professionals in the medical device industry who aim to become proficient in auditing quality management systems specific to medical devices. This course equips participants with advanced knowledge and skills to lead and manage audits based on the ISO 13485:2016 standard, which focuses on quality management for medical devices. Participants will gain expertise in audit planning, risk assessment, compliance verification, and the application of ISO 13485 standards to enhance the quality and safety of medical devices.

Qualification Awarding Body

IRBA - USA

​​​Mode of Study

Online

​​​Mode of Exam

Online

Duration

The qualification has recommended course duration of 7 Days
Note: However the course duration may be increased to meet additional learning needs if required but not reduced.

Training Schedule

The training schedule will be set according to your available times: one-to-one. No need to wait for a fixed schedule.

Evaluation Criteria

  • Written exams and assignments to evaluate understanding of of ISO 13485:2016.

  • Active participation in discussions, case studies, and practical exercises.

  • Successful completion of lead auditor role-plays scenarios.

  • Performance in written examinations or assessments covering course content.

Learning Outcomes of This Course

  • Master the principles and intricacies of ISO 13485:2016 for quality management systems in the medical device industry

  • Lead all phases of the audit process, from planning to report.

  • Apply advanced auditing techniques and methodologies specific to medical devices.

  • Plan and conduct audits effectively, including risk assessment and objective setting.

  • Evaluate the compliance of quality management systems in medical device organizations.

  • Communicate audit findings persuasively and provide actionable recommendations.

  • Lead continuous improvement initiatives in quality management for medical devices.

What Will You Learn?

  • Introduction to ISO 13485:2016 and Quality Management Systems in the Medical Device Industry

  • Role and Responsibilities of a Lead Auditor in Medical Device Quality Audits

  • Understanding Quality Management Principles and ISO 13485:2016 Requirements

  • Planning and Preparation for Medical Device Quality Audits

  • Conducting Effective On-Site Audits: Techniques and Strategies

  • Risk-Based Audit Planning and Objective Setting

  • Documenting Audit Findings and Observations in the Context of Medical Devices

  • Non-Conformity Identification and Root Cause Analysis

  • Developing Corrective and Preventive Action Plans for Medical Device Quality

  • Reporting Audit Results and Recommending Improvements in Medical Device Quality

  • Managing Auditor Teams and Audit Program for Medical Devices

  • Leading Continuous Enhancement in Medical Device Quality Audits

​Certification

Successful candidates receive a certificate from the IRBA USA

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