$300
Course code SM014
ISO 13485:2016 Lead Auditor Course Exemplar Global Certificate
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The ISO 13485 Lead Auditor Course is designed to develop the competence required to plan, lead, and conduct external or internal audits of Medical Devices Quality Management Systems (MDQMS) in accordance with ISO 13485:2016.
This intensive and practical course provides a deep understanding of ISO 13485 requirements, audit principles, and techniques in line with ISO 19011 and ISO/IEC 17021-1.
Participants will gain the expertise to lead audit teams, assess the effectiveness of medical device quality management systems, identify nonconformities, and support regulatory compliance and continual improvement within medical device organizations.
800 + Reviews with 4.9/5 Average Rating
Time commitment
~5 hours / week
Access Duration
6 Months
Mode
Asynchronous
Course access
30 November 2025
Become a Certified Lead Auditor. Audit with Confidence. Lead with Impact.
This comprehensive online certification course empowers you to become a globally recognized ISO 13485:2016 Lead Auditor, equipped with the skills to conduct, manage, and lead audits of Medical Devices Quality Management Systems (MDQMS) in compliance with ISO 13485:2016.
What You'll Gain:
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Lead MDQMS audits with authority – confidently plan, conduct, and report internal and external audits based on ISO 13485:2016.
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Work with Certification Bodies / Independent Consultant – Qualify to perform third-party certification audits or work as a consultant or full-time auditor in the medical devices sector.
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Interpret ISO 13485 requirements and apply them in real-world audit situations within the medical device industry, including regulatory compliance aspects.
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Conduct audit meetings – manage opening and closing meetings with stakeholders and clients effectively.
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Lead audit teams – understand roles, responsibilities, and team dynamics for efficient audit execution.
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Identify and document nonconformities – based on actual standards, best practices, and regulatory requirements.
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Review, write, and improve audit reports – create professional, actionable audit documentation that adds value.
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Learn risk-based thinking, documented information requirements, and practical audit approaches guided by ISO 19011 and ISO/IEC 17021-1.
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Access real-life audit videos and case-based practical sessions tailored to medical device quality management auditing for a hands-on learning experience.
Upon successful completion of session assessments and the final exam, you will receive an Exemplar Global-certified Lead Auditor Certificate, empowering you to:
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Promote yourself as a qualified Lead Auditor in the global medical device quality management job market.
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Add value to your current role or start a career in medical device quality auditing or consulting.
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Become a trusted partner to organizations aiming to achieve and maintain ISO 13485 certification.
Enroll now to take the next step in your professional journey and lead audits that truly make an impact on medical device safety and quality.
Course Objectives – Exemplar Global Certified ISO 13485 Lead Auditor
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Understand the principles and structure of the ISO 13485:2016 Medical Devices Quality Management System (MDQMS), including the Plan-Do-Check-Act (PDCA) cycle.
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Interpret and apply ISO 13485:2016 clauses and sub-clauses, with a deep understanding of the regulatory requirements and the high-level structure.
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Analyze organizational context, including internal and external factors, and the needs and expectations of interested parties in the medical device industry.
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Comprehend the roles of leadership, strategic planning, support processes, operations, and performance evaluation specific to MDQMS.
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Learn how continual improvement is achieved through effective MDQMS implementation and auditing with a focus on patient safety and regulatory compliance.
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Gain hands-on experience in conducting medical device audits, including planning, executing, reporting, and following up on audit results.
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Understand and implement the use of audit checklists, audit interviewing techniques, and proper documentation practices tailored to medical device regulations.
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Learn to conduct effective opening and closing meetings during external audits in the medical device context.
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Master the process of preparing and maintaining internal audit records and documented information as per ISO 13485:2016.
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Understand risk-based thinking, risk assessment, and how to evaluate and address risks within the MDQMS framework to ensure product safety and compliance.
Who can benefit from the course?
ISO 9001 Lead Auditor Certificate can benefit a wide range of individuals and organizations, including:
01
Quality Management Professionals
Enhances their ability to manage, evaluate, and improve medical device quality management systems (MDQMS) within their organization.
03
Quality Control and Assurance Teams
Equips them with tools to effectively audit MDQMS processes, identify nonconformities, and implement corrective actions compliant with regulatory requirements.
05
Consultants
Enables them to offer informed advice and perform internal and third-party audits focused on ISO 13485 compliance.
07
Production and Manufacturing Personnel in Medical Devices
Improves understanding of regulatory and quality requirements, leading to higher product quality and reduced nonconformities.
09
Anyone Involved in ISO 13485 Implementation
02
Medical Device Industry Employees Seeking Career Growth
Provides valuable skills and knowledge, making them more competitive in the medical device sector job market and opening opportunities for advancement.
04
Managers and Supervisors in Medical Device Organizations
Helps in understanding the complexities of MDQMS, leading to better oversight and continuous improvement.
06
Small and Medium Manufacturers of Medical Devices
Assists in implementing and maintaining effective MDQMS systems, improving efficiency, product safety, and customer satisfaction.
08
Regulatory Affairs and Compliance Professionals
Facilitates a better grasp of auditing requirements to support regulatory compliance and certification processes.
Provides skills to conduct internal audits, ensuring the MDQMS is effective, compliant, and continuously improving.
Course Overview
Prerequisites
- Basic understanding of quality management principles and ISO 13485:2016 standards.
- Prior experience in a quality management role is beneficial but not mandatory.
- Familiarity with organizational processes and procedures.
Study Material
- Study material in PDF format to read and download will be provided.
- Refer study material while learning and for future reference, you can save it on your computer.
- The access of study material will be removed after expiry of course access duration.
Exam
Upon completion of the course, participants will be required to pass a comprehensive exam to demonstrate their understanding of the ISO 13485:2016 standards and internal auditing techniques. The exam will consist of multiple-choice questions, case studies, and practical auditing scenarios.
Successful candidates will receive an ISO 13485:2016 Lead Auditor Certificate (Exemplar Global Certified), validating their skills and knowledge in conducting internal audits.
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Testimonial
Rahul Verma
Production Engineer
★★★★★
Submastery is an excellent platform for gaining in-depth knowledge of Quality Management System (QMS) at a very reasonable cost. I have completed several courses through Submastery, but the QMS-focused programs were particularly valuable for my professional growth.
With 8 years of experience in production, the QMS expertise I gained from Submastery helped me secure a new role with an 89% salary increase and a promotion.
The structured and practical Quality Management System training made a significant difference in my career. I highly recommend Submastery to professionals looking to strengthen their QMS skills.
Thank you, Submastery!
Testimonial
Kei Seng Hou
Quality Professional
★★★★★
I have attended many quality courses, but none were as well-structured as SubMastery's Quality Management System (QMS) training. The courses go beyond just issuing certificates— they ensures deep learning through comprehensive modules, including videos, quizzes.
The rigorous approach guarantees that participants truly master QMS principles before advancing to the next level. Thanks to SubMastery, my understanding of QMS has significantly improved, equipping me with practical skills for real-world applications.
Highly recommended for anyone serious about excelling in Quality Management Systems!
Testimonial
V R Ramana
Manufacturing Professional
★★★★★
Highly Recommended! SubMastery has truly transformed my understanding and application of Quality Management Systems. What makes it exceptional is how the courses blend theoretical knowledge with real-world implementation through interactive video lessons, challenging quizzes, and hands-on case studies.
I've gained practical skills that I now use daily to improve processes and compliance in my workplace. The self-paced structure allowed me to balance learning with my professional commitments, while the expert instructors and engaged community provided meaningful support throughout my journey.
For any engineer looking to move beyond basic certificates and develop deep, applicable QMS expertise, SubMastery is the perfect choice. It's not just training – it's career empowerment.
Thank you for elevating my professional impact!
Testimonial
Rommel Francis Decalay
Engineer
★★★★★
My QMS expertise has expanded significantly after completing SubMastery's comprehensive training program. The in-depth curriculum and practical approach have equipped me with both theoretical knowledge and real-world application skills that are highly valued in today's competitive job market.
Now when facing complex quality challenges, I feel confident applying the systematic methodologies and best practices I've mastered.
The training has given me an edge that ensures I'll always be in demand within manufacturing and service industries.
SubMastery hasn't just educated me - they've future-proofed my career. I can now pursue advanced roles with confidence, knowing I have the expertise to excel in any QMS-related position.
This is career security through genuine mastery!
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Investment | Affordable | Free | High cost |
Lifetime Query Support | ✔ | X | X |
Community | ✔ | X | X |
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Certificate | ✔ | X | ✔ |
Editable Formats for actual use | ✔ | X | X |
Training Material | ✔ | X | ✔ |
Course type | Self-paced / Live with accountability | Self-paced | Self-paced/ Live |
Duration | 40 Hours | Confusing | Variable |
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