Auditor/Lead Auditor Training Course to ISO 13485:2016 (QMS-MD)
Five-day instructor-led Auditor/Lead Auditor training for ISO 13485:2016 medical device quality management systems.
Instructor-Led
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Certificate of completion
Expert instructors
Flexible delivery modes
About This Course
This five-day instructor-led Auditor/Lead Auditor training course focuses on ISO 13485:2016, the international standard for quality management systems in the medical device industry. Delivered through classroom workshops, group discussions, practical exercises, and case studies, the course equips participants with the skills to effectively audit medical device QMS.
Designed for quality managers, compliance officers, auditors, and supervisory staff in medical device manufacturing and related sectors, this course provides in-depth knowledge of ISO 13485 requirements and auditing techniques. Participants gain confidence in planning, conducting, reporting, and following up on audits with a specific focus on regulatory compliance and risk management.
Upon completion, delegates will be able to apply auditing principles to assess conformity with ISO 13485:2016, identify nonconformities, and support continual improvement initiatives within medical device quality management systems. The training emphasises real-world scenarios and best practices to prepare professionals for effective internal and external auditing activities.
Designed for quality managers, compliance officers, auditors, and supervisory staff in medical device manufacturing and related sectors, this course provides in-depth knowledge of ISO 13485 requirements and auditing techniques. Participants gain confidence in planning, conducting, reporting, and following up on audits with a specific focus on regulatory compliance and risk management.
Upon completion, delegates will be able to apply auditing principles to assess conformity with ISO 13485:2016, identify nonconformities, and support continual improvement initiatives within medical device quality management systems. The training emphasises real-world scenarios and best practices to prepare professionals for effective internal and external auditing activities.
What You Will Learn
- Identify the key requirements and structure of ISO 13485:2016 for medical device QMS
- Describe the principles and practices of effective auditing in compliance with ISO 13485
- Plan and prepare audit activities including audit scope, objectives, and criteria
- Conduct audit interviews and gather evidence to evaluate conformity and effectiveness
- Analyse audit findings to determine nonconformities and opportunities for improvement
- Report audit results clearly and develop follow-up actions to support continual improvement
Course Outline
1
Introduction to ISO 13485:2016 and Medical Device QMS
2
Auditing Principles and Techniques
3
Audit Planning and Preparation
4
Conducting Audits and Gathering Evidence
5
Reporting Audit Findings and Nonconformities
6
Follow-up Actions and Continual Improvement
7
Lead Auditor Responsibilities and Team Management
8
Practical Audit Exercises and Case Studies
Who Should Attend
- This course is suitable for quality managers, compliance officers, internal and external auditors, regulatory affairs professionals, and supervisory personnel involved in medical device quality management systems and auditing activities.
Prerequisites
There are no formal prerequisites for this course; however, familiarity with medical device industry practices and quality management principles is beneficial.
Frequently Asked Questions
The course is delivered in person through instructor-led classroom sessions and workshops.
The course is delivered in English.
Yes, participants receive a certificate of completion from SMS Training Academy upon successfully completing the course.
There are no formal prerequisites to attend this course.
You can enrol by contacting SMS Training Academy directly through their website or customer service channels.