MMD-101    Understanding the Requirements of ISO 13485:2016 Quality
​                      Management System for Medical Devices

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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ISO 13485:2016 is an internationally recognized standard that sets the requirements for a Quality Management System (QMS) specifically tailored for organizations involved in the design, development, production, installation, and servicing of medical devices. Published by the International Organization for Standardization (ISO), this standard provides a framework for ensuring the safety and effectiveness of medical devices throughout their lifecycle.

ISO 13485:2016 is structured around the Plan-Do-Check-Act (PDCA) cycle, providing a systematic approach to managing processes and improving overall efficiency. The standard consists of several key components, including management responsibility, resource management, product realization, measurement, analysis, and improvement.
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In summary, ISO 13485:2016 is a crucial standard for organizations involved in the medical device industry. Understanding its requirements, implementing effective QMS processes, and integrating risk management practices are essential steps towards achieving and maintaining compliance.

The objective of this training are:

• Gain a detailed understanding of the ISO 13485:2016 standard, its structure, and key requirements.
• Familiarize yourself with the terminology and fundamental concepts of the standard.
• Identify and comprehend the changes introduced in ISO 13485:2016 compared to earlier versions.
• Explore how ISO 13485:2016 can be integrated with other standards, such as ISO 9001, for a comprehensive QMS.
• Learn strategies for adapting ISO 13485:2016 requirements to different stages of the medical device supply chain.
• Understand the significance of supplier quality management in ensuring overall compliance.
• Understand the key principles and objectives of ISO 14971:2019.
• Understand how to identify, evaluate, and mitigate risks associated with medical devices.
• Explore how ISO 14971 integrates with ISO 13485 and other related standards.
• Learn best practices for continuous improvement in risk management processes.

Day 1

• Section 1: Introduction to ISO 13485:2016
• Section 2: Structure and Components of ISO 13485:2016
• Section 3: Key Changes from ISO 13485:2003 to ISO 13485:2016
  
• Section 4: Integrating ISO 13485 with Related Standards
  
• Section 5: Tailor made to the Supply Chain
  
• Section 6: Risk Management in ISO 13485:2016
  

Day 2
Section 1: Introduction to ISO 14971:2019 
Section 2: Understanding the Risk
Section 3: Risk-Based Approach
Section 4: Analyzing and Reporting 
Section 5: Integration of ISO 14971 with ISO 13485
Section 6: Q&A​

This course is designed for individuals in the medical device industry who are involved in the development of a quality management system.

This is a 1 or 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.