ICTQual ISO 13485 Medical Devices Quality Management System Lead Auditor Course
This five-day lead auditor course equips learners to audit ISO 13485 medical device QMS, assess compliance, manage nonconformities, and support regulatory quality in medical device organizations.
Course Features
This course is designed as a specialized ISO 13485 medical device quality management system lead auditor training programme with structured study units, approved-centre assessment, and audit-focused learning.
- Five-day ISO 13485 lead auditor training programme
- Focuses on medical device quality management system audits
- Covers ISO 13485 requirements and ISO 19011 audit guidance
- Includes audit planning, conducting, reporting, and follow-up
- Assessment conducted through ICTQual AB Approved Training Centres
- Includes 100 multiple-choice questions with a 75% minimum pass score
About This Course
The ICTQual ISO 13485 Medical Devices Quality Management System Lead Auditor Course is designed for professionals who need the knowledge and skills to conduct audits of quality management systems in the medical device industry according to ISO 13485. ISO 13485 specifies quality management system requirements for organizations involved in the design, development, production, installation, and servicing of medical devices, helping them meet regulatory requirements and deliver safe and effective products. This course supports learners in understanding ISO 13485 requirements, applying auditing principles, evaluating medical device processes, managing nonconformities, and fulfilling the responsibilities of a lead auditor.
Develops competence to audit medical device quality management systems
Supports understanding of ISO 13485 requirements and structure
Builds skills for planning, conducting, reporting, and following up audits
Covers nonconformities, root cause analysis, and corrective actions
Addresses medical device regulatory requirements and industry practices
Prepares learners for lead auditor responsibilities in QMS audits
What You'll Learn
Learners will develop practical knowledge of ISO 13485, audit methods, medical device process auditing, regulatory compliance, corrective action, and lead auditor responsibilities.
Understand the purpose, scope, benefits, components, and structure of ISO 13485
Interpret and explain ISO 13485 requirements clause by clause
Apply ISO 13485 requirements across the medical device lifecycle
Plan, conduct, and report QMS audits according to ISO 19011 guidelines
Audit medical device design, development, production, and service provision processes
Identify nonconformities, apply root cause analysis, and manage corrective and preventive actions
Who Should Attend?
This course is suitable for professionals involved in quality assurance, auditing, regulatory affairs, compliance, implementation, or maintenance of quality management systems in the medical device industry.
Quality assurance professionals in medical device organizations
Internal auditors and QMS auditors
Regulatory affairs specialists
Compliance officers and quality managers
Professionals implementing or maintaining ISO 13485 systems
Consultants and personnel working with medical device quality management
Course Content
Explore the comprehensive ICTQual ISO 13485 Medical Devices Quality Management System Lead Auditor Course course content designed to help you master the material through structured modules and lessons.
Quality Management Principles
Requirements of ISO 13485
Auditing Principles and Techniques
Auditing Medical Device Processes
Nonconformities and Corrective Actions
Regulatory Requirements and Industry Best Practices
Role of the Lead Auditor
Course Requirements
Learners should have a foundational understanding of ISO 13485 and relevant experience or knowledge in quality management, auditing, healthcare, engineering, or the medical device industry.
Foundational knowledge of ISO 13485 standards and requirements
Relevant education, practical experience, auditing exposure, and language proficiency to understand course materials and assessments
Assessments
Assessment is mandatory and is conducted through ICTQual AB Approved Training Centres using quizzes designed to evaluate understanding and practical application of the course material.
100 multiple-choice questions
Knowledge-based quizzes covering course material
Application-focused questions based on practical audit situations
Minimum score of 75% required to pass
Progression
Completion of this course supports progression into auditing, quality assurance, regulatory compliance, consulting, training, and leadership roles within the medical device industry.
Progress into roles such as Quality Manager, Regulatory Affairs Manager, Compliance Officer, or Consultant
Pursue advanced certifications in quality management, auditing, and medical device regulations
Specialize in regulatory affairs, quality assurance, or risk management
Move into consulting, training, or leadership positions in medical device quality management
Apply Now For This Course
Fill out the application form below to enroll in ICTQual ISO 13485 Medical Devices Quality Management System Lead Auditor Course. Our team will review your application and contact you shortly with enrollment details.
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