It’s very detail & systematic way of approach

It was just an amazing course, learn in detail with clear explanation

Learning Outcomes

Fundamentals of ISO 14971

Major Updates in ISO 14971:2019 & ISO TR 24971

Important Terms for Medical Devices' Risk Management

Lesson Summary

Learn about the clauses and annexes that were changed in the ISO 14971:2019 standard.  Why the standard was revised and how it aligns with other standards. Also there is an overview of changes made in the standard and its technical report, ISO TR 24971, and a collective explanation of the main changes in the standard and its technical report.

The ISO 14971 Standard

The ISO TR 24971 Standard

Process Steps of Risk Management in ISO 14971 & its Impact in Europe

learn the composition of ISO 14971, its standard ISO 14971:2019 and its technical report.  You will also learn the six risk management process steps in ISO 14971:2019, which are of great importance in industrial manufacturing processes. Lastly, the module covers the impact of ISO 14971:2019 in Europe.

ISO 14971:2019 - Risk Management Application on Medical Devices - Course Assessment

Learn the fundamentals of the ISO 14971:2019 standard and its impact on the medical field in this free online course.

ISO 14971:2019 - Risk Management Application on Medical Devices

In this free online ISO certification, you will learn the risk management process in the manufacturing environment of medical devices. You will understand how ISO 14971 can help your organization comply with regulations and learn the new annexes, terms, and clauses in the updated ISO 14971 standard. Learn about ISO TR 24971 and how it helps in implementing ISO 14971. Also, learn about risk management in the standard and its impact across Europe.

This free online interactive ISO training course enables a better understanding of the ISO 14971:2019 standard. It will help you to analyze the impact of ISO 14971:2019 on a medical device manufacturer’s decision-making process and empowers professionals to comprehend how the standard can enhance their medical devices business and associated risk management efforts. While taking this course, it is recommended that you know the basics of the ISO 13485 international standard on medical devices and quality assurance. The knowledge can be validated with Alison’s free online course on ISO 13485, any other formal training course on the standard or if you have experience with it in the medical device industry. This high-quality ISO guide comes with a unique self-paced approach to learning which can be accelerated based on your reading and assimilation appetite and enhances knowledge retention through practical activities.
This course is structured in a way to offer you an in-depth understanding of ISO 14971 and the influence it has on the conceptualization, design, production, and complete life cycle of a medical device. It will also provide you with exactly how ISO 14971:2019 links with the ISO standards 13485:2016, ISO/TR 24971:2020, and MDR 2017/745. In addition to the activities provided in the course, you will receive study reminders and transferable notes to help you learn and comprehend the content and be able to apply it in your daily work. This formal ISO training can be a great addition to your résumé, boost your confidence during job hunting and will enable you to discuss ISO 14971 during your interviews effectively and confidently.
After successful completion of the course which includes an online assessment, professionals can apply and implement risk management activities so that these can be deep-rooted within the processes of an organization. You can retake the online exams as many times as you want, which can keep the content fresh in your mind. This online ISO 14971 course is best for you if you are in a role involved in medical device design, production, and any part of the device life cycle. If you are a quality assurance (QA) professional, working in a Regulatory Affairs role or manufacturing in the medical devices sector, this course will add important technical knowledge to your career. You should enrol in this comprehensive course if you are looking to get a job in any of the above roles in the healthcare sector and want to up-skill yourself in risk management.

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Introduction to Manual Handling

Manual Handling Injuries and Prevention

Manual Handling Risk Assessments

Manual Handling Legislation

The Maximum Weight You Can Lift

Risk At Work

Good Handling Technique

In this module, we will be going through the tips, techniques, and risks associated with transporting material manually. A detailed guide on the risks associated with manual handling and how to prevent injuries shall be provided. The role of legislation and incorporating the proper technique while transporting heavy materials will also be examined.

Fundamentals of Manual Handling - Course assessment

Learn how to manage the risks associated with manual handling and lifting in this free online health and safety course.

Fundamentals of Manual Handling

This health and safety course examines the basic concepts associated with the lifting of heavy objects in the workplace and explains how to make manual handling as safe as possible. Poor lifting techniques lead to many injuries each year so we outline the rules, regulations and techniques that ensure that both employers and employees can safeguard themselves from harm. If your work involves manual handling, enrol now to learn how to manage risk.

Introduction to Security Management

Organisational Security Management

Security Risk Analysis and Risk Reduction

Physical and Information Security Protection

Business Resilience and Crisis Management

Cyber Security and Fraud Prevention

Security Investigations and Threat Awareness

Laws and Regulations

In this module we will learn the basic functions and role of safety management. We will explore the concepts of responsibility, authority, and accountability in safety management. We will then learn about some of the key functions that protect an organization from all types of risks, threats, and fraud.

Course assessment

This free online course teaches how security management works, what functions it has and what risks it poses.

Security Management

This course introduces us to the essential functions and role of safety management. We will examine the organisational structure of safety management and the organisational principles. We will then learn about crucial functions that protect an organisation from all types of risks, threats and fraud. Then, we will explore the importance of physical security and the role of information security protection in organisations.

Introduction to Crisis Management

Preparing for a Crises

Responding to and Recovering From Crises

In this module, you’ll be introduced to the concept of crisis, its various forms, and its impact on organisations. You’ll learn how to identify potential threats, develop contingency plans, and establish response teams. You’ll be guided through the key elements of crisis communication, including strategies for recovery and post-crisis evaluation.

Course Assessment - Introduction to Emergency Crisis Management

Learn how to prepare for emergencies and help communities respond to crises and disasters in this free online course.

Introduction to Emergency Crisis Management

Emergencies caused by various factors can happen unexpectedly. Such disasters disrupt existing systems, making it crucial to be prepared with a thought-out strategy to respond efficiently in crisis situations. This crisis and disaster management course provides such strategies and explains how to handle emergencies. We explore the stages of crisis management and show you how to plan for emergencies and communicate with stakeholders during crises.

Introduction to Food Allergies

Allergen Management in Food Preparation

Communicating Allergen Information

Developing Allergen Management Plans

In this module, you will learn what food allergies and food intolerances are. The lessons discuss how to identify food allergens and prevent cross-contact during food handling and storage. You will understand allergen labelling regulations, how to communicate allergen information, and first aid protocols in the case of allergic emergencies.

Course assessment - Food Allergen Awareness

Learn how to properly label ingredients to prevent allergic reactions in this free online allergen management course.

Food Allergen Awareness

Nearly 10% of the population is allergic to certain ingredients. This means that food manufacturers and services must lower the risk of allergic reactions by providing consumers with clear information and alternatives. This food safety course identifies common food allergens and explains how they affect the body. We go over the regulations governing ingredient labelling and show you how to implement allergen control to protect customers.

History of Food Safety Management Systems

Publication of ISO 22000:2018

Important Definitions in ISO 22000:2018

In this module you will be able to know about the history of Food Safety Management System including the ISO 22000 and the FSSC 22000. This module also covers the details about the publication of ISO 22000:2018 Standard. Explanation and activities on important terminologies and concepts (selected from ISO 22000:2018 standard) are also included in this module.

Leadership Role and Context of Organization

Risk Management and Support Provision

Operations Management

In this module you will learn the expectations of the standard regarding top management to exhibit a leadership role. This module will help you to familiarize yourself about the requirements of the standard to conduct analysis on context of organization and how a food organization can manage it. Also the module covers risk and support management functions. Lastly the module explains the main part of the standard which is on Operations of the Food Safety Management System.

Monitoring, Measurement, Analysis and Evaluation

Internal Audits and Management Reviews

Improvement

This module explains the Check part of the standard which is performance evaluation. This module enlightens performance evaluation at operational level which covers monitoring, measurement, analysis, and evaluation. Also this module describes Performance evaluation at management system level which covers internal Audits and management Reviews. Finally this module incorporates explanation on continual improvement.

ISO 22000:2018 - Elements of Food Safety Management System - End of Course assessment

Learn about how to manage Food Safety Management Systems with this free online ISO 22000:2018 course.

ISO 22000:2018 - Elements of Food Safety Management System (FSMS)

This free online ISO 22000:2018 course will teach you about the Elements of Food Safety Management System (FSMS). FSMS is a collaborative and systematic approach to effectively managing food safety risks. With this course, you will learn how this standard works and the potential benefits it can offer to food organizations. You will also study the requirements of the standard for conducting analysis and how a food organization can manage this.

Introduction to Facilities Management

Duties of a Facility Manager

In this module, you will learn about the various aspects of facilities management and will be apprised of all the necessary information a facilities manager should know to be able to carry out several duties successfully. Upon that, you will also learn about the legal considerations attached to various departments in a facility.

Facility Management - Maintenance and Repairs - Course Assessment

Explore facility management to ensure the efficiency of any organisation with this free online course.

Facility Management - Maintenance and Repairs

In this course, we will introduce you to the basic concepts of facilities management and the various roles of a facilities manager. You will learn about the ins and outs of the numerous duties of this profession like lease purchase, vendor management, health and safety, maintenance and repair. We will show you the importance of having a well-managed workplace and how it can affect employees' productivity and behaviour.

Introduction to Risk Assessment

The Three Processes of Risk Assessment

Identifying the Organizational Hazards

This module presents discussions on important aspects of organizational risk assessment and control in the workplace. Through this module, you will be able to define risk assessment and its importance. Moreover, you will also learn about the reasons for conducting this assessment along with its goals. Lastly, hazard identification is also given.

Risk Assessment & Control - Health & Safety - Course assessment

Learn how to conduct a risk assessment and hazard identification for your organization in this free online course.

Risk Assessment & Control - Health & Safety

This short course is designed to teach its enrollees the importance of conducting a risk assessment as part of organizational health and safety management. It discusses various aspects of risk assessment, such as its essential steps, the reasons for conducting a risk assessment and the goals. The course also contains sufficient learning material on hazard identification and the method of ranking these risks.