never give up when you are looking for the way forward for you to fulfilled your dream i recommended you to join Alison

This course was very informative and in line with ISO9001:2015 and ISO 17025:2017. I suggest medical and clinical laboratories consider doing it

Learning Outcomes

ISO 15189 and Quality Regulations for Medical Laboratories

Navigating the Changes

Terms and Definitions in ISO 15189

Structural and Governance Requirements

Requirements for Environmental Conditions

Lesson Summary

This module introduces you to ISO 15189, its implications for medical laboratories, and its comparison with its previous version. The module also explains terms and definitions used in the standard along with various critical requirements, such as structural, governance, risk management, resource, and environmental conditions.

ISO 15189 - Requirements for Reagents and Consumables

Laboratory Process Requirements

Examination Process Requirements in ISO 15189

This module explains ISO 15189:2022 requirements regarding reagents and consumables in the laboratory. It also describes the requirements for laboratory information for patients and instructions about sample collection and transport. The module also discusses the examination process requirements and ways to evaluate measurement uncertainty.

Requirements - Post-Examinations and Non-conformities

Management of System Requirements and Record Control

Improvement Requirements and Corrective Actions

In this module, we will explain post-examination and reporting requirements for laboratories of ISO 15189. It also presents requirements for the laboratories to enact a robust management system. Lastly, the requirements regarding improvement and the ways to take corrective actions against nonconformities are also explained in this module.

ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence - Course Assessment

Learn the requirements of ISO 15189 regarding quality regulations of operations of medical laboratories.

ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence

ISO 15189 is an international standard developed by the ISO. It helps medical laboratories to be quality oriented and competent in their operations. The most recent version of this standard was introduced in 2022, and this course explains all its major requirements. By taking this course, you can opt for a career as a quality regulator for medical laboratories. This course can also help you become proficient as a QMS professional.

The concept and practices of quality regulations are extremely crucial for medical laboratories. They must analyze thousands of samples daily, and this mandates integrity, robustness, and impartiality within their quality regulations framework. ISO 15189 is an international standard developed by ISO, and it provides several requirements that medical laboratories can fulfill to enact a foolproof Quality Management System. Exoexcellence Consultants developed this course on Alison that explains the premise and requirements of this standard.
The course is divided into three modules. The first module contains five topics, out of which the initial two explore the fundamental aspects of ISO 15189. These topics will discuss the importance of ISO 15189 for quality regulations in medical laboratories and also navigate the differences between the latest version and the previous versions of the standard. From the third topic onwards, the course explains each clause of ISO 15189.
All the course topics have explained ISO 15189 requirements in easy language and contain vibrant graphics. This said, this course’ certification will equip you with all the necessary information concerning quality regulations in medical laboratories. By taking this course, you can easily establish yourself as a professional who can help medical laboratories become compliant with this standard. Not only that, but you can also upscale your skills as a quality management professional.

Chasing 100M Daily Users, Duolingo Reconsiders Ads, Paying Influencers, and Its Most Expensive Plan

Open edX Conference 2024: Program & Speakers

9 Best Cinema 4D Courses for 2025: Navigating the 3D Universe

Learn Something New: 100 Most Popular Courses For November

6 Best Cyber Threat Intelligence (CTI) Courses in 2025

Four Months After Unveiling Ambitious AI Roadmap, Udemy’s Co-founder CTO is Out

25 Resources to Learn Generative Engine Optimization in 2025

Duolingo Q1 2026: Toward 100M DAUs with Record Engagement and Slower Paid Growth

AI Prompting with Google: From Beginner to Certified

Coursera’s 2025 Strategy: Focusing on Campus, Scaling Back Degrees

FutureLearn’s 2021: Year in Review

9 Best Quilting Courses for 2026: Turn Fabric Scraps Into Heirlooms

White-Labeling in Online Education: Whose Credential Is It Anyway?

[2025] Massive List of Thousands of Free Certificates and Badges

Coursera’s New Deal with Google Could Cost the Company Millions

Harvard CS50 Guide: How to Pick the Right Course (with Free Certificate)

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.

Quality Management System of Medical Devices' Suppliers and Manufacturers

ISO 13485:2016 Important Terminologies

Publication of ISO 13485:2016 and Context of Publication

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!

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.