The course gives you a very detailed understanding of the standard. Interpreting the literature is simple to understand which makes remembering the content easy. Great course.

This course was every educational, learned a lot from this course, I'll continue reading more about ISO. It's never to late to keep on learning.

Learning Outcomes

Quality Management System of Medical Devices' Suppliers and Manufacturers

ISO 13485:2016 Important Terminologies

Publication of ISO 13485:2016 and Context of Publication

Lesson Summary

This module explains the existing relevant standards and regulation for medical devices' industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.

Quality Management System Requirements

Management Responsibility and Resource Management

Product Realization – Planning to Design and Development

Product Realization – Purchasing and Production

In this module you will learn the operations of the QMS for a medical devices company. It covers top management requirements and offers ideas to manage resource requirements in the organization. It enlightens the concept of medical devices' product realization. It covers all elements of product realization such as quality planning, customer related processes, design and development, purchasing and production etc.

Monitoring and Measurement

Control of Non-Conforming Product

Analysis and Improvement

In this module, Clause - 8 of the ISO 13485:2016 standard is taught. Clause - 8 specifies the general requirements, management of monitoring and measurement issues, nonconforming product management, data analysis etc. Within this clause - 8, Clause - 8.5 is on improvement which paves out ways for the organization to improve its system, products, and processes through the framework of corrective and preventive actions.

ISO 13485:2016 - Quality Management Systems for Medical Devices - Assessment

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

ISO 13485:2016 - Quality Management Systems for Medical Devices

This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!

ISO 13485:2016 is the third edition of ISO 13485 standard, and it is titled "Medical devices -- Quality management systems -- Requirements for regulatory purposes". The updated standard explains the requirements for a quality management system (QMS) where an organization can demonstrate its capability to supply medical devices and associated services so that the organization can fulfill customer and relevant regulatory requirements consistently. ISO 13485:2016 can also be utilized by vendors or external parties that offer services or products, to medical device organizations.
This course begins by covering the context of the publication of this ISO standard, and reviews the various regulations, standards of earlier editions of this publication. Then the course highlights important terminology which are grouped under different titles. The course explains all the requirements of ISO 13485 including specific requirements of quality management system, management responsibilities together with resource management, requirements of product realization such as planning for the QMS, design and development of product, purchasing controls and production management etc. The course also covers the Clause - 8 of ISO 13485 standard as a separate module that explains all about measurement, analysis and improvement.
If you&rsquo;re interested in ISO or regulatory affairs as a future career, or if you&rsquo;re an ISO professional seeking to keep up to date with the latest ISO 13485 standard, then this clear and simple course is for you. Understanding ISO 13485:2016 is of vital importance for all professionals working in the medical device sector. So, start this free online course today and in just 3 hours you&rsquo;ll be up to date with the new changes in this important ISO standard.

After Academia and Finance, Coursera Turns to Amazon for its Next CEO

25% of Coursera Courses Have Peer Reviews: Here Are the Best

Inside the Coursera-Udemy Deal: Three Bids, Two Years and a Rival Suitor

30+ Holiday Discounts & Online Learning Deals

10 Best Organic Chemistry Courses for 2025

Why Duolingo is Worth More Than Coursera and Udemy Combined

EdX’s 2021: Year in Review

Can an AI Teach AI? Learning From an Avatar

262K Courses, 833M Enrollments: Breaking Down Udemy’s Massive Catalog

Duolingo is Shutting Down Its Only Classroom Tool

2U Market Cap Falls Below edX Acquisition Price. Google to Blame?

8 Best Crochet Courses for 2025: Practical, Enriching, Creative

5 Best Free Raspberry Pi Courses for Beginners in 2025

SEO Content Strategy Demystified: Coursera, MasterClass, and edX

900+ Open University Free Certificates

New CEO, New Structure: Greg Hart Reshapes Coursera’s Reporting

Introduction to the Catering Industry

Food safety in the Catering Industry

FATTOM and the 4C’s in Catering

Terms and Definitions

This module introduces the learner to the catering industry, its significance and its different types; along with the importance of food safety to this industry. The key factors and practices that affect the safety of foods prepared and handled during catering are also discussed.

What is HACCP?

HACCP Prerequisite Programs (Part 1)

HACCP Prerequisite Programs (Part 2)

HACCP Prerequisite Programs (Part 3)

HACCP Prerequisite Programs (Part 4)

In this module, you will be introduced to the HACCP food safety system, its history and benefits. Learners will learn about the prerequisite programs that have to be implemented before the application of HACCP such as establishment and facilities requirements, personal hygiene, cleaning , and the control of food preparation operations.

Step 1: Assemble the HACCP Team

Steps 2 & 3: The Product Description and It's intended Use

Steps 4 & 5: The Flow Diagram and On-Site Confirmation

In this module, learners will be introduced to the five preliminary steps that are the foundation of HACCP implementation. Learners will also gain knowledge on how to form the HACCP team, describe products and their intended use, and how to construct a flow diagram and perform an on-site conformation.

The Seven Principles of HACCP (Part 1)

The Seven Principles of HACCP (Part 2)

The Seven Principles of HACCP (Part 3)

This module provides the learner with extensive details about the seven principles of HACCP that have to be applied, along with practical activities on how to implement these principles in the catering industry and how to establish a HACCP worksheet.

HACCP Food Safety System for Restaurants and Other Catering Services - Assessment

In this free online course, learn how to implement the HACCP Food Safety System in your catering establishment.

HACCP Food Safety System for Restaurants and Other Catering Services

This free online course on ‘HACCP Food Safety System for Restaurants and other Catering Services’ will teach you a step-by-step approach to implementing the HACCP system, its preliminary steps and principles in your catering business of any size. You will learn how to establish this system along with its procedures and documents to ensure the safety of food items and dishes being prepared and served in your catering establishment.

Introduction to ISO 45001:2018 OH&SMS

Publication of ISO 45001:2018

Important Terminology in ISO 45001:2018

Learn more about the ISO 45001:2018 OH&SMS standard, its publication, and important terminology used in ISO 45001:2018.

Leadership and Organizational Context

Managing Risk: Opportunities and Support Functions

Operational Controls and Emergency Responses

Learn more about leadership and organizational context related to ISO 45001:2018; how to manage risk, its opportunities and support functions; and effective operational controls and emergency responses.

Monitoring, Measurement and Analysis

Internal Audits and Management Reviews

Continuous Improvement

Learn more about monitoring, measurement and analysis related to ISO 45001:2018;  as well as how to carry out successful internal audits and management reviews; and implement Continuous Improvement.

ISO 45001:2018 Course Assessment

Start this free online course about ISO 45001:2018 - Principles of Occupational Health and Safety Management Systems.

ISO 45001:2018 - Principles of Occupational Health and Safety Management Systems

This free online ISO 45001 course will familiarise you with the Principles of Occupational Health and Safety prescribed by the International Organisation for Standardisation (ISO). New standard ISO 45001 was published in March of 2018, this course will teach you why the ISO has chosen to develop the standard, how the standard works, the potential benefits the standard can deliver to businesses, about the PDCA approach, and more.

History of ISO 9001 Revisions

Process Approach And PDCA Cycle

Context Of Organization And Risk Based Thinking

Reading ISO 9001:2015 is often difficult to understand without having the basic knowledge of concepts discussed in the standard. Some of the basic concepts are Process Approach, PDCA Cycle and Risk based thinking. This module helps you to grasp those concepts which act as a foundation for Quality Management System.

Clauses on Planning of the Quality Management System

Clauses on the Operation of the Quality Management System

Clauses on the Check & Act of the Quality Management System

This module explains the existing auditable clauses of the standard along with all their requirements and guidelines. The clauses are explained in simple terms and with simple meaningful sentences. Auditable clauses are from Clause 4 to Clause 10, and it includes Context of Organization, Leadership, Planning, Support, Operation, Evaluation and Improvement.

Organization Knowledge

Internal Auditing

Management Review

Quality Management System is based on some essential elements. Some of these elements were present in ISO 9001:2008, but ISO 9001:2015 has added one more essential element (management of organizational knowledge), while the other two elements (internal audits and management reviews) are already part of the previous version. However, there are some changes in the latest version to these two elements as well.

ISO 9001:2015 - Quality Management System (QMS) - Course Assessment

In this free online ISO 9001 course learn how ISO 9001:2015 offers a framework for organizations to maintain QMS.

ISO 9001:2015 - Quality Management System (QMS)

This free online Quality Management Systems(QMS) course shows organizations how to maintain QMS according to the ISO 9001 standard. The standard was revised in September 2015 to incorporate some vital changes. This course explains all the clauses and changes to the standard and outlines the basic concepts of the standard to new learners. By taking this course, you will gain expertise, which will make you a valuable asset to companies worldwide.

Introduction to HIPAA

HIPAA Security Rules

Penalties for Non-Compliance

This module on Fundamentals of HIPAA provides comprehensive training on the Health Insurance Portability and Accountability Act of 1996. Participants will learn about HIPAA's Privacy and Security Rules, including key safeguards to protect patient information and ensure compliance. It also offers practical guidance on preventing data breaches.

Fundamentals of HIPAA Law and Its Privacy Rules - Course Assessment

Harness the significance of modern healthcare administrators and privacy officers with this free online course.

Fundamentals of HIPAA Law and Its Privacy Rules

Discover the essentials of HIPAA with our comprehensive free online course. This course will cover the fundamental principles of HIPAA, including patient privacy, security requirements, and compliance strategies, which are perfect for healthcare admins. Gain critical knowledge by enrolling today and empower yourself with the expertise to navigate the complex landscape of HIPAA regulations and ensure the organization adheres to legal standards.

Introduction to International Standards for Auditing

How to Conduct Auditing

Competence and Elements of ISO 9001:2015

In this module, you will be introduced to the roles, required skills and the qualification of the lead auditor with their importance in the different sectors. We cover the challenges and the principles of auditing before delving into managing an audit program and assessing the competence and evaluation of auditors.

ISO 19011 Lead Auditor - Course Assessment

Learn how to set up an effective organisational auditing management system in this free online quality assurance course.

ISO 19011 Lead Auditor

ISO 19011:2018 is an international standard that guides the establishment of auditing management systems for organisations. This course provides an in-depth understanding of the role of a lead auditor and explains how they implement auditing principles to create robust auditing systems. We show you how to manage an audit programme to ensure organisational compliance and boost efficiency by determining the competence and credibility of auditors.

Introduction to OSHA 10 Certificate Program

Workplace Safety and Employee Rights

OSHA Personal Protective Equipment (PPE)

Emergency Action Plan & Electrical Safety

The Fundamentals of the OSHA 10 module summarize OSHA's basic safety regulations, focusing on identifying and preventing workplace hazards. Participants will learn about OSHA's role, key safety standards, and the rights and responsibilities of employers and employees, equipping them to contribute to a safer work environment.

Fundamentals of OSHA 10 Program for Industries - Course Assessment

This free online course teaches you the basics of Workplace Safety and the OSHA for ensuring compliance.

Fundamentals of OSHA 10 Hours Program for Industries

The OSHA 10-Hour Program is a fundamental safety training course designed by the Occupational Safety and Health Administration (OSHA) to promote workplace safety and health. It is intended for entry-level workers in construction, general industry, and maritime sectors. The course covers essential topics such as hazard identification, prevention, and control, focusing on recognizing and mitigating common workplace hazards.

Introduction to Food Safety

The Food Production Chain

What is Meant by GMP - Terms and Definitions

This module will introduce the learner to the meaning and importance of food safety, the food production chain approach, and Good Manufacturing Practices (GMP) as a key prerequisite for the safety of food.

Design Requirements

Facilities and Equipment

Maintenance, Cleaning and Disinfection

In this module, you will learn about the requirements for ensuring the safety of food within a food establishment with respect to location and structure, facilities, equipment and food establishment cleaning and disinfection procedures.

Personal Hygiene

Hand Washing

Training and Competence

In this module, the learner will be introduced to the aspects of health status, personal hygiene and recommended practices in order to prevent food contamination arising from food processing personnel. The importance of personnel training will be also discussed.

Control of Operations

Transportation

Product Information and Consumer Awareness

This module provides the learner with extensive details about food processing operation control and transportation, and their impact on the safety of food. The importance of proper food labeling and consumer awareness is also discussed.

Food Safety: Good Manufacturing Practices (GMP) in the Food Industry - Assessment

In this free online course, learn about the necessary practices to produce hygienic food within your food establishment.

Food Safety: Good Manufacturing Practices (GMP) in the Food Industry

This free online course will teach you about the key food safety requirements and practices to ensure the production of safe food in your establishment, known as GMP or good manufacturing practices. It covers topics ranging from the reception of raw materials to the production of the end product. It also covers establishment design, personal practices, production operations control and conditions, and food product information.