Course Name
ISO 13485:2016 Understanding & Internal Audit Training
Course Overview
Welcome to the ISO 13485 Training offered by ARG Academy. In the highly regulated medical device industry, maintaining a robust Medical Device QMS is not just an option. it is a mandatory requirement for market access.
This comprehensive, two-day interactive workshop is specifically designed to help industry professionals recognize, interpret, and apply the critical requirements of the ISO 13485 standard. Whether you are upgrading your current quality systems or preparing for an upcoming certification, this course provides the foundational knowledge and practical auditing skills necessary to ensure total organizational compliance and operational excellence.
Course Objective
By the end of this training session, participants will be able to:
● Explain the purpose and scope, and thoroughly interpret each clause of the ISO 13485:2016 requirements.
● Apply audit principles based on ISO 19011 during the internal auditing process.
● Conduct effective internal audits, which includes mastering practical skills like evidence gathering and staff interviews.
● Identify, classify, and grade audit findings accurately.
● Prepare detailed audit reports and implement corrective and preventive action processes based on the outcomes.
Course Benefits
Participating in this training provides clear advantages for both individuals and their organizations:
● Improves overall management systems and operational performance by utilizing structured audit findings.
● Enhances organizational compliance by effectively implementing correctives based on ISO 13485 and ISO 19011:2018 standards.
● Provides actionable, hands-on experience through interactive sessions, ensuring participants can confidently evaluate and report on quality management systems.
Who Must Attend
While the document does not list specific job titles, based on the curriculum, this ISO 13485 Training course is essential for:
● Professionals tasked with understanding, interpreting, and applying ISO 13485:2016 requirements within their organization.
● Current or prospective Internal Auditors who need to apply ISO 19011:2018 principles, gather evidence, and conduct staff interviews.
● Management and quality assurance personnel responsible for preparing audit reports, classifying findings, and leading Management Review Meetings (MRM).
● Staff involved in developing and implementing corrective and preventive action processes.
Methodology
Our structured ISO 13485 training combines expert instruction with interactive learning to ensure practical understanding and compliance.
● Expert-Led Instruction: Comprehensive overviews of ISO 13485 clauses, Internal Audits, and Management Review Meetings (MRM).
● Visual Learning: Clear presentations, flip charts, and detailed handouts to simplify complex concepts.
● Active Engagement: Focused exercises that highlight the critical importance of ISO 13485 compliance.
● Interactive Practice: Hands-on activities applying ISO 13485 requirements, audit processes, and live Q&A sessions.
● Structured Summaries: A complete course review paired with essential ISO/EN reference guidelines to guarantee knowledge retention.
Course Duration
The training will be conduct for 2 days and it is structured to build your expertise step-by-step:
● Day 1 focuses on a complete review of ISO 13485 Training Course, providing an overview and detailed briefings on each specific clause.
● Day 2 transitions into practical application, covering Internal Audit practices as per ISO 19011:2018 and Management Review Meetings (MRM). Which includes designated time for participant registration, tea breaks, and lunch.
HRD Corp (HRDF) Claimable Training
This is 100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the HRD Corp Claimable Course.
Why Choose ARG Academy?
● No Out-of-Pocket Cash: Fees are deducted directly from your e-TRiS account.
● Certified Trainers: All programs are led by HRD Corp TTT-approved experts.
● Zero Paperwork Hassle: We assist you with the entire grant application process.
● Flexible Programs: Tailored courses in Leadership, Digital Skills, Sales, and Soft Skills.
Secure Your Training Grant Today
Don’t let your training budget go to waste this year while regulatory requirements continue to tighten. Equip your team with the skills they need to ensure total medical device compliance. Slots for this specialized programme fill up fast! Click the Enquiry button below to reserve your seats now.
