Course Name
Awareness Training for ISO 13485:2016 Medical Devices – Quality Management System (QMS)
Course Overview
Welcome to the Awareness Training for ISO 13485:2016 Medical Devices – Quality Management System (QMS) offered by ARG Academy. This comprehensive 2-day awareness program is designed to provide participants with a practical understanding of ISO 13485:2016 requirements and the specific intent behind each clause.
The course details how these standard requirements translate into day-to-day controls for medical-device organizations, specifically across design and development, production, and servicing. Throughout the program, there is a strong emphasis on the process approach, risk-based thinking, strict documentation discipline, and alignment with regulatory standards.
Course Objective
By the end of this training, participants will be able to achieve the following learning outcomes:
● Explain the purpose, structure, and key principles of ISO 13485:2016, as well as its direct relationship to regulatory requirements.
● Interpret ISO 13485:2016 clauses 4 through 8 and successfully identify the objective evidence typically expected by auditors.
● Apply the process approach and risk-based thinking to QMS planning, controls, and everyday decision-making.
● Describe core QMS elements, including document control, records control, CAPA (Corrective and Preventive Action), change control, supplier control, and validation.
● Recognize common nonconformities and apply practical compliance tips to prevent them.
● Utilize simple, effective tools such as process mapping, risk logs, traceability matrices, and QMS metrics to strengthen overall implementation.
Course Benefits
Participating in this program offers valuable advantages for both individuals and their organizations:
● Builds a strong foundation of awareness regarding how a medical-device QMS directly supports product safety, product performance, and regulatory compliance.
● Helps organizations proactively avoid common audit findings related to document control, management reviews, training, supplier control, special processes, and CAPA effectiveness.
● Provides hands-on practice through targeted workshops, allowing participants to apply concepts like root cause analysis (5-Why/fishbone) and effectiveness checks directly to real-world scenarios.
● Drives data-driven improvements by helping staff understand how to analyze trends, quality metrics, and make informed decisions.
Who Must Attend
This training is ideal for a broad spectrum of professionals within the medical device industry. The target audience includes:
● Top management.
● QA/RA (Quality Assurance and Regulatory Affairs) professionals.
● Staff involved in production, engineering, purchasing, warehousing, and service provision.
● Internal auditors.
● Personnel in various QMS support functions.
Note: There are no strict prerequisites for this course, though a basic knowledge of your organization’s processes is beneficial.
Methodology
The course is delivered over two days (typically 09:00 – 17:00) using a dynamic and engaging training method. The methodology includes:
● Interactive Lectures & Group Discussions: Facilitating shared learning, including discussing common pain points and examples from actual operations.
● Practical Examples & Case Studies: Analyzing realistic scenarios, such as supplier control failures and common document control nonconformities.
● Hands-On Workshops: Applying learned skills through practical exercises, including a process interaction map workshop, a risk-based thinking mini-case, and a CAPA practical analysis.
● Continuous Assessment: Evaluating participant understanding through quick knowledge checks, group workshop outputs, and an end-of-course quiz featuring a mix of multiple-choice and short-answer questions.
Course Duration
The training is structured as a 2-Day program.
● Typical Hours: Sessions generally run from 09:00 to 17:00 each day.
● Flexibility: Training timings can be adjusted to suit your organization’s specific schedule.
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