Course Name
ISO 13485:2016 Understanding & Internal Audit Training
Course Overview
Welcome to the ISO 13485:2016 Understanding & Internal Audit Training offered by ARG Academy. This comprehensive, two-day workshop is designed to help participants recognize and identify the importance of ISO 13485.
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 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
The training is delivered through a structured lesson plan that combines expert instruction with interactive learning. The course methodology includes:
● Facilitator-Led Instruction: The trainer provides comprehensive briefings and illustrates the overviews of ISO 13485 clauses, Internal Audits, and Management Review Meetings (MRM).
● Visual Aids and Resources: Key concepts are demonstrated using visual tools such as PowerPoint presentations, flip charts, and detailed handouts.
● Active Participant Engagement: Attendees are encouraged to actively participate through ice-breaker exercises, specifically focusing on recognizing and identifying the importance of ISO 13485.
● Interactive Practice: The sessions prompt participants to write down their existing knowledge regarding ISO 13485 requirements and internal audit processes, while also providing opportunities to ask for topic clarifications.
● Structured Summaries: The training concludes by summarizing the entire presentation and distributing relevant international standard reference guidelines (such as ISO/EN) to ensure 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, 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).
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