ISO 13485:2016 MDQMS Lead Auditor Training Course

Medical Device Quality Management System Lead Auditor Training

ISO 13485:2016 MDQMS Lead Auditor Training Course

SafeQual The Training Company offers ISO 13485:2016 MDQMS Lead Auditor Training for professionals who want to develop practical knowledge and auditing skills for Medical Device Quality Management Systems.

This course helps participants understand ISO 13485:2016 requirements, medical device quality management principles, regulatory expectations, audit planning, evidence collection, audit reporting, and corrective action follow-up. The training is suitable for professionals working in medical device manufacturing, quality assurance, compliance, regulatory affairs, auditing, consultancy, production, and supply chain management

Course Overview

ISO 13485:2016 is an international standard for Quality Management Systems specific to medical devices. It supports organizations in developing consistent processes for medical device quality, regulatory compliance, risk management, documentation, production control, supplier control, monitoring, measurement, and continual improvement.

This training provides participants with the knowledge and practical skills required to plan, conduct, report, and follow up MDQMS audits professionally. Participants will learn how to evaluate a Medical Device Quality Management System against ISO 13485:2016 requirements and support organizations in improving audit readiness and system effectiveness.

Course Objectives

  • Understand ISO 13485:2016 requirements
  • Understand Medical Device Quality Management System principles
  • Understand process-based approach and risk-based thinking
  • Understand documentation and regulatory requirements for medical devices
  • Plan and prepare MDQMS audits
  • Conduct audit interviews and collect objective evidence
  • Identify conformity and nonconformity
  • Write audit findings and audit reports
  • Understand corrective action and audit follow-up process
  • Support organizations in ISO 13485 audit preparation
  • Apply practical auditing skills in medical device industry environments
Duration 5 Days Morning Session or 09 Days Evening Session
Training Mode Online Training
Certificate Course Completion Certificate from SafeQual The Training Company
Availability Registration Open
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  • Medical Device Quality Professionals
  • Quality Assurance and Quality Control Officers
  • Regulatory Affairs Professionals
  • Internal Auditors and Lead Auditors
  • ISO Consultants and Management System Professionals
  • Production and Operations Managers
  • Compliance Officers
  • Supplier Quality Professionals
  • HSE and QHSE Professionals working with medical device organizations
  • Professionals involved in ISO 13485 implementation
  • Individuals planning a career in medical device quality auditing
  • Introduction to ISO 13485:2016
  • Medical Device Quality Management System overview
  • Quality management principles and process approach
  • Context of the organization and regulatory requirements
  • Leadership, planning, and responsibility requirements
  • Risk management approach for medical devices
  • Documented information and record control
  • Resource management and competence requirements
  • Product realization and operational controls
  • Design and development controls overview
  • Audit evidence collection and audit reporting
  • Performance evaluation and internal audit
  • Purchasing and supplier control requirements
  • Production, servicing, and validation of processes
  • Traceability, identification, and preservation requirements
  • Monitoring, measurement, and customer feedback
  • Complaint handling and reporting requirements overview
  • Nonconforming product control and corrective action
  • Internal audit and management review requirements
  • Audit planning and preparation
  • Conducting MDQMS audits
  • Practical exercises and case studies

Registration Open

Start your professional journey in Quality Management System auditing with SafeQual The Training Company.

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Why Choose SafeQual?

  • Registered training institute with a professional learning environment
  • Certified trainers with practical industry knowledge
  • Experienced consultants and advisors for HSE, quality, and management systems
  • Tailored trainings and workshops for individuals and corporate teams
  • Practical course delivery with real workplace examples and case studies
  • Support for HSE documentation, inspections, audits, and system implementation
  • Flexible online training options for individuals and corporate teams
  • Supportive team focused on learner guidance and professional development

Frequently Asked Questions

What is ISO 13485:2016 MDQMS Lead Auditor Training?

ISO 13485:2016 MDQMS Lead Auditor Training is a professional course designed to develop knowledge and skills for auditing Medical Device Quality Management Systems according to ISO 13485 requirements.

Medical device quality professionals, QA/QC officers, regulatory affairs professionals, internal auditors, ISO consultants, supplier quality professionals, production managers, and compliance officers can join this course.

Yes, beginners can join, but basic knowledge of ISO management systems, quality management, and medical device processes is recommended

The course duration is 5 days for morning session. An evening session option is also available for 09 days.

Yes, SafeQual provides this course through online training.

Yes, participants will receive a Course Completion Certificate from SafeQual The Training Company after successful completion.

This should be confirmed before registration. SafeQual should only advertise the course as CQI/IRCA Certified if the course is officially approved by CQI/IRCA or delivered through an approved training partner.

Yes, SafeQual provides customized online training sessions for individuals, companies, and corporate teams according to their requirements.