Learning Outcomes

History of ISO 9001 Revisions

Process Approach And PDCA Cycle

Context Of Organization And Risk Based Thinking

Lesson Summary

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.

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 Total Productive Maintenance (TPM)

The Fundamental Concepts of TPM and Benefits

Difference and Similarities between TPM and TQM

This module discusses the fundamental aspects of a TPM program. It empowers learners to introduce TPM within their organizations, summarize the basic seven pillars of TPM program, recognize the founder of TPM, and discusses the fundamental concepts of a TPM along with its objectivity and comparison with Total Quality Management (TQM) program.

Maintenance and Supporting Activities in a TPM Program

The Dynamics of Reliability Centered Maintenance (RCM)

Implementation of TPM Program

This module discusses the maintenance activities in a TPM program. It explains the five different types of maintenance within any organization. It discusses the significance of reliability centered maintenance (RCM) within the TPM scope. It also discusses the seven basic questions for RCM program. It further guides about the implementation process of TPM along-with its significance on product quality.

Total Productive Maintenance (TPM) for Production & Quality Systems - Course Assessment

Learn about the fundamental concepts related to Total Productive Maintenance (TPM) in this free online tpm course.

Total Productive Maintenance (TPM) for Production and Quality Systems

The free online Total Productive Maintenance (TPM) training certification course covers the essential aspects of a TPM program. It includes programs like the seven pillars of TPM, and the benefits and objectives of the TPM program. Start the course and learn about measuring performance in a TPM program, the differences between TPM and TQM programs, and the types of maintenance and reliability centered maintenance.

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

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.

Auditing and ISO 9001 Standard

Managing an  Auditing Program - The PDCA Cycle

Determining the Competence of the Auditor

Information Collection and Processing Procedures

Managing Non-Conformities and Audit Closing

In this module, we will discuss the essential knowledge a person should have to audit an organization according to ISO 9001. Regarding ISO 9001 auditing, this module discusses various aspects, such as categories of audits in ISO 9001, management of an auditing program, conducting an audit review, and information collection, etc.

Effective ISO 9001 Internal Auditing Practices - Course Assessment

Help yourself become a competent professional who can audit organizations against ISO 9001's QMS requirements.

Effective ISO 9001 Internal Auditing Practices

This course describes all the essential aspects of becoming an ISO 9001 internal auditor for QMS. Once you are done with it, you will equip yourself with knowledge of the types of audits in ISO 9001, strategies to manage an audit program, and integration of an ISO 9001 audit program with the PDCA cycle. Moreover, the competence and responsibilities of auditors are also discussed, and primary and minor non-conformities are identified.

Introduction to ISO 19011 and Auditing

Preparations for Auditing

Conducting an Audit

Reading ISO 19011:2011 is often difficult to understand, without having the basic knowledge of auditing as discussed in the standard. This module helps you to grasp these concepts, which act as a foundation for the Auditing Management System. From basic concepts to performance of an audit, this module provides you with a solid understanding.

What to Look For While Auditing

Audit Reporting

Audit Follow-up Activities & Case Studies

An Auditing Management System is based on essential elements, as interpreted from ISO 19011:2011. These elements include details about what to look for during an audit, how to report audit findings and follow-up activities after an audit has been conducted.

ISO Management System Audit Techniques and Best Practices Assessment

Gain a strong understanding of the processes, approaches, and people involved in audit management systems.

ISO Management System Audit Techniques and Best Practices

This free online ISO 19001 - Management System Auditing course teaches you about ISO 9001 audit techniques and best practices. It will give you an overview of evidence and findings, preparation, and pre-audit activities including system standards, protocols, and methodologies. It will also teach you about how information on the audit scope is presented with reference to a physical location, organizational units, and other important factors.

Kaizen Introduction and History

Major Kaizen Concepts

This module explains the existing Kaizen philosophy and concepts among successful business and manufacturing organizations in Japan. It also covers the introductory and historical account of Kaizen. It also incorporates the introduction of Kaizen events, types of Kaizen approaches etc. It also explains the steps for a Kaizen Cycle, which is important for Kaizen culture in organizations.

Major Kaizen Systems

Gemba Kaizen

Kaizen Implementation

This module explains the three important topics related to Kaizen and its implementation. These topics are Kaizen systems, Gemba Kaizen and tools and methodologies for Kaizen implementation. Each topic has sufficient information about itself, for instance, Kaizen Systems talk about TQM, JIT, TPM, Policy Deployment, Suggestion system, Group activity etc. Gemba covers 3Ks, Inverted and normal triangle, direct versus indirect earners etc. The last topic includes 7 steps implementation, PQCDSM etc.

Kaizen Events

The Kaizen Story

International Standards and Monitoring of Kaizen Events

In this module, Kaizen Event, Kaizen Story, and Evaluation are taught. Kaizen Event specifies the management of Kaizen events and important elements related to it, which includes pre-event and post-event issues as well and details about event proceeding. Moreover, Kaizen story narrates methods to select a Kaizen theme, situation analysis on current versus future desired state. Lastly, continual vs. continuous improvement is discussed with the coaching of WITs on Kaizen measurement & monitoring.

Kaizen Approach - Lean Methodology on Continuous Improvement	- Course assessment

Learn how to develop a streamlining Kaizen cultural change in your company with this free online management course.

Kaizen Approach - Lean Methodology for Continuous Improvement

This management course shows you how to use ‘lean’ methods to encourage continuous improvement in your team. More and more organizations are adopting the Japanese Kaizen approach to increase ‘lean’ efficiency and productivity in the workplace. We explain how to change your organization’s work culture through Kaizen principles, action plans and events, thus trimming the fat and streamlining processes to bring the best out in those around you.

Quality Engineers and Supplier Surveys

Conducting Formal Surveys in Supplier's Premises

Supplier Evaluation and Rating

In this module, you will learn to evaluate your role as a quality engineering supplier management. In this regard, you will learn about performing a formal survey at the supplier's premises and performing a thorough evaluation. The module also teaches you about rating your supplier and the contents to be added to your survey report.

Quality Engineer - Supplier Quality Evaluation & Management - Course Assessment

Learn how quality engineers conduct vendor surveys to ensure effective supplier management in this free online course.

Quality Engineer - Supplier Quality Evaluation & Management

This course for quality engineers provides the insights and tools required to perform effective supplier management. We outline the strategies, techniques and best practices used to ensure that materials and components meet quality standards and organizational specifications. We cover each aspect of this job, from supplier evaluation and selection to risk management and performance metrics. Sign up to enhance your quality management skills.

Introduction to Integrated Management System (IMS)

Different Levels of Integration

ISO 9001, ISO 45001 & ISO 14001 High-level Comparison

The high level analysis on Integrated Management System is designed to help learners to understand various IMS concepts, ISO publication on IMS, management system standards, levels of integration, benefits and constraints of correspondence level, generic level and integration level. The module will then discuss three ISO management system standards which are ISO 9001, ISO 45001 and ISO 14001. It presents the correspondence analysis between these standards for integration.

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 will be covered in this module. This module is designed to help you grasp the concepts which act as a foundation for the Quality Management System.

Diploma in ISO Standards - First Assessment

You must score 80% or more to pass this assessment.

History Of Environmental Management Systems (EMS)

Important Terminology

Important Provisions

The fundamentals of environmental management systems include explanation of various EMS terminologies, EMS concepts and the need for revision of ISO 14001. This module also explores the environmental challenges the world is facing, the comparison of earlier standards to ISO 14001:2015 and common steps required to upgrade to the latest standard.

Organizational Objectives

Communications And Documentation

Emergency Planning And Controls

This is main module for learning ISO 14001. This module presents Leadership requirements for an EMS, managing organization's context, support functions required for EMS, EMS scope, EMS risks and opportunities, aspect and impact analysis, internal and external communication for EMS, documentation control requirements, operation planning and change management controls, emergency preparedness and response etc.

Measurement And Evaluation

Conducting EMS Audits and Review

EMS Corrective Measures

Performance evaluation for an EMS includes monitoring, measurement, analysis and evaluation, internal audits and management reviews etc. This module covers all the EMS Performance evaluation endeavors components. It discusses what needs to measured and monitored in an EMS. It also enlightens proactive and reactive measurements, compliance evaluation, environmental incidents, cause analysis for non-conformity, corrective actions and continual improvement.

Diploma in ISO Standards - Second Assessment

Introduction To ISO 45001:2018 OH&SMS

Publication Of ISO 45001:2018

Important Terminology In ISO 45001:2018

The fundamentals of Occupational Health and Safety Management Systems module provides explanation of various OH&SMS terminologies, OH&SMS concepts, the need for bringing up ISO 45001, the workplace health and safety challenges the employees are facing, the comparison with earlier standards to ISO 45001:2018 such as OHSAS 18001. This module also covers common steps required to migrate to the ISO standard and the summary analysis of all auditable clauses of ISO 45001 etc.

Leadership And Organizational Context

Managing Risk: Opportunities And Support Functions

Operational Controls And Emergency Responses

This is main module for learning ISO 45001 standard. This module presents Leadership requirements for an OH&SMS, managing organization's context in perspective of occupational safety, support processes for OH&SMS, OH&SMS scope, OH&SMS risks and opportunities, hazard identification and risk assessment, internal and external communication for OH&SMS, documentation requirements, health and safety operation planning and change management controls, emergency preparedness and response etc.

Monitoring, Measurement And Analysis

Internal Audits And Management Reviews

OH&SMS Continuous Improvement

The module covers all the OH&SMS Performance evaluation endeavors components such as monitoring, measurement, and analysis, internal audits and management reviews etc.  It discusses how incident investigation needs to be carried out in an OH&SMS. It also enlightens incidents analysis approach for OH&SMS, types of incidents, cause analysis for non-conformity, and hierarchy of controls for corrective actions, short-term actions and continual improvement measures.

Diploma in ISO Standards - Third Assessment

You need a score of 80% or more to pass this assessment.

Preparations For ISO Auditing

Conducting an ISO Audit

The module helps learners to understand the introduction of auditing, ISO 19011, terms related to audits, different roles in an audit program, preparation for auditing such as audit plan, check-lists etc., steps to conduct an audit, such as opening meeting, document review, evidence gathering, interviewing and questioning techniques, audit findings, and elements of closing meeting.

What To Look For While ISO Auditing Process

ISO Audit Reporting

ISO Audit Follow-Up Activities

This module help learners to comprehend what elements one needs to look during the audit process as an auditor, how audit reporting is done, and how audit follow-up and closure process is performed. Within these topics, there are discussions related to the auditing of policy documents, planning and objectives, correct non-conformance statement writing, communicating the audit results, style and content of the audit reports etc.

Diploma in ISO Standards - Fourth Assessment

Diploma in ISO Standards - Integrated Management System (IMS) - Course Assessment

Learn about Integrated Management Systems and ISO standards with this free online IMS certification training course.

Diploma in ISO Standards - Integrated Management System (IMS)

This free online IMS training certification course will teach you everything you need about Integrated Management Systems (IMS). You will learn how organizations maintain Integrated Management Systems (IMS) according to the ISO 9001:2015, ISO 45001:2018, and ISO 14001:2015 standards. This course also covers the management system auditing guidelines as per the ISO 19011 standard helpful in looking after the IMS within your organisation.

The Importance of ISO 9001 Updates

Relevant Changes that can be Made in ISO 9001

Navigating Through the Clause-by-Clause Changes in ISO 9001:2026

Regulatory Changes and Change Management in Compliance

Key Topics in Data Governance and Compliance

This module will discuss the revisions and updates on the upcoming version of the ISO 9001 standard. This includes discussions over the necessity of these revisions, changes that should be made in the standard according to the technological advancements, external influences on these updates, and methods of showing compliance to these revisions.

ISO 9001:2026 - Fundamentals of Futuristic Quality Management - Course Assessment

This free online course will discuss the essentials of the upcoming major revision of the ISO 9001 standard.

ISO 9001:2026 - Fundamentals of Futuristic Quality Management

ISO 9001's next update is anticipated in 2026, although the exact date remains unknown. Whatever the outcome, the developers of this course have tried portraying it as a helpful guide for this upcoming revision. Altogether, this course will help students navigate these new changes. It will also guide them in helping organizations become compliant with any revision that happens to other regulations—ensuring seamless adaptation and compliance.

Objective Evidence and Audit Finding Categories

Nonconformance and Severity

Objective Evidence of Conformity

The basis for objective evidence is explained in this module. You will learn what objective evidence is, what audit findings are, what nonconformance is, and how to deal with risks and opportunities.

All About "Shall"

Audit Checklist and Infrastructure

This module introduces you to the term 'shall,' which is frequently used in ISO standards. It will also be compared and contrasted with other terms by the instructor.

Confusing Terms and Quality Objectives

Interested Parties and Competence Records

Risks and Opportunities

This module walks you through some of the unfamiliar terms used in the ISO Standard and helps you better comprehend some of the wordy aspects of the Standard.

Monitoring and Measuring Resources

Control and Writing the Non-conformance

Corrective Actions and Conclusion

This module demonstrates how to use objective evidence to ensure that all ISO requirements are met. You will learn how to put remedial steps into action.

ISO 9001:2015 Non-conformances and Corrective Actions Explained - Course Assessment

Uncover the technicalities of the ISO 9001:2015 standard and how to audit this standard with this free online course.

ISO 9001:2015 Non-conformances and Corrective Actions Explained

Did you know many people typically leave ISO training courses lacking knowledge on what objective evidence to look for when conducting an audit? ISO can be a fairly uninteresting topic which makes it harder for people to grasp. This free online ISO 9001 2015 certification was developed to be more engaging and easier to understand and not only simplifies and clarifies the ISO standard but teaches you how to perform and pass an internal audit.

Defining the Role of Operations Management

Historical Development of Operations Management

Role of Process Management in Operations Management

This module is designed to introduce the learner to the fundamental role of operations management. The module begins by defining the role of operations within an organisation and outlining the key skills and responsibilities of the operations manager. The module then moves onto explain the historical development of operations management and the three major phases of change, namely, craft manufacturing, mass production and the modern period. Lastly, the module also covers process management.

Role of Decision-Making in Operations Management

This module is designed to introduce the learner to the fundamental role of decision-making in operations management. The module will begin by defining the role of decision making in operations management and will then explore the nine types of operations management decisions (i.e. inventory, capacity, quality, scheduling, process,  technology, location, layout and supply chain). The module also covers how to develop the operations strategy using Hayes and Wheelwrights four stage model.

Learn the central principles and practices that drive smart operations management in this free online diploma course.

Diploma in Operations Management (Ops)

This diploma course explains the role of an operations manager and breaks down the key decision-making skills that define the job. We show you how to ensure the smooth running of your business’ operation as you coordinate the daily creation and delivery of goods or services to its customers. We know that ‘professionals talk about logistics’ so sign up for this course to hone your management abilities and take the next step in your career.