Learning Outcomes

Origin and Context of ISO 13485:2016

Key Terms and Concepts in ISO 13485:2016

Application of ISO 13485:2016 in Industry

Lesson Summary

Core Requirements of the QMS

Management Responsibility and Resource Management

Product Realisation – From Planning to Development

Product Realisation – Purchasing and Production

Monitoring and Measurement Activities

Control of Non-Conforming Product

Analysis and System Improvement

ISO 13485:2016 Medical Device Quality Management Systems - Assessment

Explore the principles and implementation of ISO 13485:2016 medical device quality systems with this free online course.

ISO 13485:2016 Medical Device Quality Management Systems

Medical devices play a vital role in delivering safe, effective, and high-quality healthcare, as do the standards that ensure their reliability and performance. This course explores ISO 13485:2016, covering its principles, implementation, and continuous improvement. This course was reviewed and approved by subject matter expert Dr. Anadu Austin, a Medical expert and Consultant. Enrol now to build expertise in medical device quality management.

ISO 13485:2016 is the international standard for medical device quality management systems, providing organisations with a structured approach to ensure product safety, regulatory compliance, and consistent quality. This course introduces learners to the principles, framework, and practical applications of the standard, highlighting its relevance across the medical device lifecycle.This course opens with an exploration of the origins and evolution of ISO 13485:2016, highlighting its relationship with ISO 9001 and the global regulatory factors that shaped its development. You’ll gain insight into key terminology and quality management principles, building a strong foundation for applying the standard across diverse organisational settings.Moving forward, the course delves into the practical operation of a Quality Management System (QMS) — from documentation structures and record control to leadership, resource allocation, and product realisation. Through real-world examples, you’ll learn effective strategies for integrating ISO 13485:2016 requirements into every stage of medical device design, development, procurement, production, and service delivery.This course content was created in partnership with Dr. Anadu Austin, a Medical expert and Consultant. For more information on our subject matter expert, visit https://www.linkedin.com/in/austin-anadu-9a8346244/The authors generated this text in part with GPT-4o, OpenAI’s large-scale language-generation model. Upon generating draft language, the authors and subject matter experts reviewed, edited, and revised the text to ensure it reflected accurate expertise and met high pedagogical standards. Enrol now to develop essential skills, confidently apply ISO 13485:2016 standards, and advance your expertise in medical device quality management.

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Course Overview

Introduction to Bloodborne Pathogens

Protect Yourself from Bloodborne Pathogens

Getting into Contact with Blood

Cleaning Up the Mess

Reporting Exposure to Blood

Next Steps

This module covers the following aspects of Bloodborne Pathogens (BBP): An Introduction to Bloodborne Pathogens, Protecting Yourself from Bloodborne Pathogens, Response to Blood Exposure, Cleaning up the Mess and Reporting Exposure to Blood.

BBP Course assessment

This free online course teaches you how to identify and treat bloodborne pathogens and confers global accreditation.

Bloodborne Pathogens (BBP)

This course on bloodborne pathogens (BBP) trains you to address health concerns by detecting and responding to germs in people’s blood. This training is required annually by the U.S. Occupational and Safety Health Administration (OSHA). We show you how to identify BBPs and respond appropriately, often with a referral. Complete this course and apply for certification to gain international accreditation that signals your ability to work with blood.

Introduction to Sports First Aid

Emergency Response Planning

Drowning, Choking and Bleeding

Common Sports Injuries

In this module, you'll be introduced to sports first aid and the role of a sports first aider in sports emergencies. We'll show you how to deal with casualties while minimising the risk of infection. You'll learn how to treat common and severe sports injuries, including sprains, fractures, head injuries and more.

Course Assessment - Sports First Aid Training

Learn how to provide emergency care to treat various sports injuries in this free online first aid training course.

Sports First Aid Training

Are you passionate about sports and want to ensure the safety of yourself and those around you? This first aid training course provides the skills required to handle any sports-related emergency properly. We show you how to prepare for emergencies and treat common sports injuries, including sprains, fractures, head injuries and more. We go over basic and advanced first aid techniques to help you become a certified sports first aid provider.

Introduction to Infection and Infection Control

Hazard and Risk Assessment

Personal Protective Equipment (PPE)

This module will define infection control and go over what it entails, why it is essential, and how it spreads. You will learn about risk management and risk and hazard assessment. Also, you will discover the different types of personal protective equipment (PPE) and their practical uses.

Training on Infection Prevention and Control Principles - Course Assessment

This free online epidemiology course explains how infection control and prevention curb the spread of disease.

Training on Infection Prevention and Control Principles

This epidemiology course explores the management and prevention of infections. We explain how to direct the implementation of infection prevention and control measures and develop policies that protect public safety. We also emphasise the value of risk assessment and provide risk assessment methods that can be used during emergencies. Sign up to learn about the medical and legal aspects of combating infection in this public health course.

First Aid

Medical Problems

Traumatic Injuries

Environmental Injury and Illnesses

This module will examine the definition of first aid and the components inside the first aid kit. We will define handwashing, the emergency system dispatcher guide and explain when to remove your gloves after administering first aid. We will also explain the causes and symptoms of medical problems and how to give first aid to people suffering from traumatic injuries and environmental injuries.

Adult CPR, AED and Choking

Child CPR, AED and Choking

Infant CPR and Choking

Skills Training Videos

This module will explain what cardiopulmonary resuscitation is comprised of, give a brief outline of when cardiopulmonary resuscitation and automated external defibrillators may be required and explain how to perform them on choking victims. We will analyze the symptoms of choking, how to perform chest compressions, giving breath and how to relieve choking in infants, children and adults.

CPR, AED & First Aid course assessment

This free online certificate course teaches you how to use CPR, AED, and first aid to save lives.

CPR, AED and First Aid

This training course begins with first aid basics, such as how to check responsiveness and recognize common symptoms, before we show you how to treat injuries and cardiac arrest. We explain how to handle choking and how to perform cardiopulmonary resuscitation (CPR) or use an automated external defibrillator (AED). This course offers global accreditation for your new life-saving skills, so sign up to become a qualified safety officer.

Introduction to Medication Management

Medication Safety

Medication Administration Techniques

Documentation and Record-Keeping

In this module, you will delve into the core principles of medication management and its importance. Learn about medication safety, administration techniques, and the significance of documentation through Medication Administration Records (MAR) and Electronic Medication Administration Records (eMAR).

Special Considerations in Medication Management

Medication Calculation and Dosage Adjustments

High-Risk Medications and Administration

In this module, you will focus on the unique needs of specific patient populations and learn the critical skills of medication calculation, and dosage adjustment based on various factors. Gain insights into the administration of high-risk medications, and intricate procedures such as IV push.

Medication Management and Administration - Course Assessment

Learn the best practices for ensuring medication safety through proper medicine management in this free online course.

Medication Management and Administration

This course is designed to empower healthcare professionals with essential knowledge and skills for ensuring proper medication management and administration. From the fundamental principles of proper medication administration to the intricacies of dosage calculations and high-risk medication handling, the course concepts are comprehensive enough to ensure learners are well-equipped to navigate the complex landscape of healthcare and medication.

An Introduction to Safeguarding of Vulnerable Adults

Reporting Your Concern

In this module, you will learn about the basic principles of safeguarding vulnerable adults. We will discuss the different issues safeguarding covers such as human trafficking, domestic violence and abuse, modern slavery and dignity. In addition, you will also study the importance of communication in a care setting and how to raise safeguarding concerns about vulnerable adults with designated safeguarding officers and adult social care.

Safeguarding Vulnerable Adults - Assessment

This free online caregiving course helps you to protect vulnerable adults, at home or as part of your work.

Safeguarding Vulnerable Adults

This free online course on safeguarding vulnerable adults teaches you how to protect people and raise concerns regarding their well-being. We explain the 'Disclosure and Barring Service' checks that prevent harm to British children and certain adults. You'll learn to spot the signs of abuse and neglect while also covering how to appropriately share information with relevant bodies, keeping to the 'seven golden rules' of sharing such information.

Introduction to Infectious Diseases

Infection Prevention and Control Measures

Standard Precautions and Isolation Procedures

Healthcare workers are the first line of defence against infections. In this module, you'll learn about infectious microbes and strategies to disrupt interactions between pathogens and hosts in healthcare settings. We'll teach you various infection prevention and control measures, such as hand hygiene, PPE use, isolation and standard precautions.

Occupational Health and Safety for Infection Control

Antimicrobial Stewardship

Outbreak Management and Response

In this module, you'll learn about the importance of health surveillance for healthcare workers, strategies to prevent healthcare-associated infections (HAIs) and early recognition of an outbreak. We'll introduce you to antibiotic stewardship and its role in addressing antimicrobial resistance and promoting infection prevention.

Infection Control in Health Care - Assessment

Become an indispensable asset in preventing and controlling infections in health care with this free online course.

Infection Control in Health Care

Any infection within a healthcare facility poses significant risks to patients, carers and staff. Being trained in infection control and prevention can help stop disease outbreaks. This course covers infection control, standard precautions for healthcare providers, as well as the role of antibiotic stewardship in combatting antimicrobial resistance. Enrol now and be the infection control champion your facility needs.